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Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
  · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.

The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.

This is a medical device submission for the Insignia Hip Stem, which is a physical implant, not a software device or AI algorithm. Therefore, the questions regarding acceptance criteria and studies related to AI or algorithm performance are not applicable to the provided text.

The document discusses the mechanical and material performance of the hip stem rather than the diagnostic or predictive performance of an AI system. No information about AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI devices is present in the provided text.

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1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.

The EXETER 2.5mm Intramedullary Bone Plug is intended to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

The subject devices, EXETER Centralizer and EXETER 2.5mm Intramedullary Plug, are a modified version of the predicate EXETER Centralizer and EXETER 2.5mm Intramedullary Plug. The subject devices are identical to the predicate devices in design and geometry. The subject centralizers and plugs will be manufactured from Acrylic Resin Colacry1® TS2270, an alternate PMMA material.

The labeling for the modified devices is being updated to add MR Conditional labeling. This labeling was previously cleared in K171768.

The provided text describes a 510(k) premarket notification for two devices: the EXETER Centralizer and the EXETER 2.5mm Intramedullary Plug. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific clinical acceptance criteria through a study with experts and ground truth.

Therefore, the input text does not contain the information requested in points 1-9 of your prompt regarding acceptance criteria, study design, expert involvement, or ground truth establishment in a diagnostic or clinical performance study. The 510(k) summary explicitly states: "Clinical testing was not required as a basis for substantial equivalence."

Instead, the submission relies on:

• Comparison to predicate devices: The subject devices are stated to be identical to predicate devices in intended use, indications, design, and operational principles.
• Material change: The primary difference is a change in the PMMA material used for manufacturing.
• Non-clinical testing: This testing was performed to evaluate the new material and device mechanics, not to establish clinical performance in a human study.

The non-clinical testing performed includes:

• Biological Evaluation per ISO 10993-1: 2018
• IM Plug Off-Axis Impaction testing
• Centralizer Insertion (fracture) testing
• Centralizer retention (pull-out) testing
• Centralizer wing flexibility testing
• Material Characterization (Tensile Modulus, Ultimate Tensile Strength, Elongation at Break, Flexural Modulus, Flexural Strength, Izod Impact Strength)
• MRI Analysis

Since no clinical study with human data, expert evaluation, or ground truth establishment was conducted for this 510(k) submission, I cannot provide the requested information for points 1-9.

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Indications for Use:

General Total Knee Arthroplasty (TKR) Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Post-traumatic loss of knee joint configuration and function.
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• · Revision of previous unsuccessful knee replacement or other procedure.
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.

The Triathlon® Total Knee System beaded with Per-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

· Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

· Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

Additional Indications for Cone Augments:

• Severe degeneration or trauma requiring extensive resection and replacement
• · Femoral and Tibial bone voids
• · Metaphyseal reconstruction

The Triathlon TS Cone Augments are intended for cemented or cementless use.

The additional components being added to the Triathlon Total Knee System are:

• Size 0 Cruciate Retaining Femoral Component (cemented use) .
• o Size 0 Primary Cemented Tibial Baseplate
• Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
• Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
• New PS Femoral Component with modified intercondylar PS box (cemented use) ●
• o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO

Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. It is not a clinical study report that would typically include detailed acceptance criteria and performance data for an AI/ML device.

Therefore, the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, especially for an AI-based medical device. The document concerns modifications to an existing total knee system (implants), not an AI/ML device.

The questions you've asked are highly relevant for the regulatory approval of AI/ML medical devices. If this document were for an AI/ML device, here's how I would break down why the requested information is missing:

Reasoning for Missing Information (Applicable if this were an AI/ML device submission):

The provided text is a 510(k) summary for a "Triathlon Total Knee System - Additional Components." This is a premarket notification for an orthopedic implant (knee replacement components), not an AI/ML (Artificial Intelligence/Machine Learning) device.

The questions posed are specifically for describing the regulatory submission and study design for an AI/ML medical device, which often requires:

• Demonstrating performance metrics (e.g., sensitivity, specificity, AUC) against established acceptance criteria.
• Detailing the ground truth establishment process (expert consensus, pathology, etc.).
• Describing the size and provenance of training and test datasets.
• Explaining human-in-the-loop studies (multi-reader multi-case studies).

Since the device under review is a physical medical implant (knee components), these types of studies and acceptance criteria are not applicable. The sponsor instead provides:

• Engineering analyses and finite element analyses: To document range of motion.
• Non-clinical testing: Fatigue testing, static shear testing, contact area/stress analysis, range of constraint, sterilization validation, and MR Conditional status.
• Bacterial endotoxin testing.

The document explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." This further confirms that the type of performance evaluation relevant to AI/ML devices was not conducted or required for this orthopedic implant.

In summary, none of the requested information regarding acceptance criteria, study design for AI/ML device performance, sample sizes for training/test sets, ground truth establishment, or human expert involvement is present in this 510(k) summary because it pertains to a mechanical orthopedic implant, not an AI/ML software device.

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The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The Exeter® V40TM Femoral Stem Hip System is indicated for:

· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• · rheumatoid arthritis:
• · correction of functional deformity;

· revision procedures where other treatments or devices have failed; and,

· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemented total and hemi-hip arthroplasty. The femoral stems have a tapered distal portion with a V40™ neck taper. The stems are available in various offsets and body sizer. The Exeter Hip System continues to be manufactured from the same materials, the same design and the same manufacturing process as the previously cleared Exeter® V40™ femoral stems.

The provided text describes a submission for a medical device called the "Exeter® V40™ Femoral Stem Hip System" to the FDA, seeking a determination of substantial equivalence (510(k)). However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers.

The document focuses on demonstrating substantial equivalence to predicate devices primarily through:

• Intended Use and Indications: Stating that the new device has similar intended uses and indications as the predicate devices.
• Technological Characteristics: Asserting that the materials, design, and operational principles are similar or identical to predicate devices.
• Non-Clinical Testing: Listing various laboratory tests performed, such as Range of Motion Analysis, Femoral Stem Neck and Body Fatigue (according to ISO standards), Bacterial Endotoxin Testing, and Magnetic Resonance Imaging Analysis. These tests are performed to show adherence to established engineering and safety standards, and material properties, rather than diagnostic or clinical performance metrics.
• Clinical Testing: Explicitly stating that "Clinical testing was not required as a basis for substantial equivalence."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the subject of this 510(k) submission.

The document's purpose is to show that a new version or extension of an existing hip implant system is substantially equivalent to previously cleared devices, meaning it doesn't raise new questions of safety or effectiveness. It does not describe a study to measure the performance of a diagnostic or therapeutic device against specific clinical or computational acceptance criteria.

If you have a different document that details such a study, I would be happy to analyze it.

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General Total Knee Arthroplasty (TKR) Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Post-traumatic loss of knee joint configuration and function.
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• · Revision of previous unsuccessful knee replacement or other procedure.
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

• · Severe instability of the knee secondary to compromised collateral ligament integrity or function.
  Indications for Bone Augments:

• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

• · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
  Additional Indications for Cone Augments:

• · Severe degeneration or trauma requiring extensive resection and replacement

• · Femoral and Tibial bone voids

• Metaphyseal reconstruction

The Triathlon TS Cone Augments are intended for cemented or cementless use.

The subject Triathlon Intermediate Tibial Inserts will be available in the following configurations:

• Cruciate Retaining (CR) intermediate thicknesses of inserts (10mm, 12m, 14mm) will . be added to the previously cleared size range of 9mm, 13mm, 16mm and 19mm
• Cruciate Substituting (CS) intermediate thicknesses of inserts (10mm, 12mm and ● 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm
• Posterior Stabilizing (PS) intermediate thicknesses of inserts (10mm. 12mm and . 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm

The design of these inserts are identical to the predicate devices in terms of condylar geometry. post dimensions (in PS design) and locking wire feature. The inserts will be available in X3 ETO, and N2Vac styles.

Additionally. MR Conditional labeling is being added for the subject intermediate thickness inserts as well as those X3 ETO tibial inserts and patellar components previously cleared in premarket notification K172634.

This document is a 510(k) premarket notification from the FDA for the Triathlon Total Knee System. It is a regulatory approval and not a detailed study report with acceptance criteria and performance metrics typically seen in AI/ML device submissions. Therefore, many of the requested fields cannot be filled.

However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as a form of acceptance criteria and evidence of performance for this type of medical device.

Acceptance Criteria and Study for Triathlon Total Knee System (K173849)

This submission is for a Traditional 510(k) for an orthopedic implant (knee replacement system), not an AI/ML diagnostic device. As such, the concept of "acceptance criteria" and "device performance" relies on demonstrating substantial equivalence to already legally marketed devices through material characterization, mechanical testing, and biocompatibility, rather than evaluating diagnostic accuracy or clinical outcomes as would be done for AI/ML.

The "study" here refers to the non-clinical testing conducted to support the substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally compliance with recognized standards and demonstration that new designs do not create a "new worst case" compared to predicate devices. "Reported device performance" is the manufacturer's conclusion that these criteria are met.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified in terms of traditional patient data sample size. The "test set" here refers to physical components and materials subjected to laboratory testing. The document states that the design of the new inserts was analyzed to determine if they created a "new worst case" for material thickness, contact area/stress, moments, and forces. The implication is that specific samples of the new intermediate thicknesses (10mm, 12mm, 14mm) were subjected to various mechanical and material tests, or that the previous test results from predicate devices were deemed representative for these new configurations. The exact number of physical samples tested is not disclosed in this summary.
• Data Provenance: Not applicable in the context of human data. The data provenance is from laboratory testing of medical device components and materials. It is neither retrospective nor prospective in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context is established through recognized engineering standards, physical measurements, and material science principles, not expert medical opinion on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to human-read data (e.g., radiologists reviewing images), not to laboratory testing of physical implants.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a knee implant, not an AI/ML diagnostic device with human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a knee implant, not an algorithm.

7. The Type of Ground Truth Used

• For Material and Mechanical Testing: The "ground truth" used is defined by internationally recognized standards (ASTM, ISO), FDA guidance, and established engineering principles for material properties, mechanical strength, wear, biocompatibility, and sterilization.
• For MR-Conditional Labeling: The ground truth is defined by ASTM standards for measuring magnetic displacement, torque, image artifact, and RF-induced heating.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device approval for an orthopedic implant. The design and manufacturing process are subject to quality systems, but there isn't a machine learning training phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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General Total Knee Arthroplasty (TKR) Indications:

• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative . joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
• Post-traumatic loss of knee joint configuration and function.
• . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure. ●
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

• . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.
• Severe anteroposterior instability of the knee joint. ●

Additional Indications for Total Stabilizer (TS) Components:

• Severe instability of the knee secondary to compromised collateral ligament integrity or ● function.
  Indications for Bone Augments:
• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, . accompanied by bone loss.

Additional Indications for Cone Augments:

• Severe degeneration or trauma requiring extensive resection and replacement .
• Femoral and Tibial bone voids ●
• Metaphyseal reconstruction o

The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Indications for Use for the Triathlon Tritanium Tibial Baseplate are:
General Total Knee Arthroplasty (TKR) Indications:

• . Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis
• Post-traumatic loss of knee joint configuration and function ●
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be ● returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:

• Ligamentous instability requiring implant bearing surface geometries with increased o constraint
• . Absent or non-functioning posterior cruciate ligament
• Severe anteroposterior instability of the knee joint .

The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

Indications for Use for the Triathlon Low Profile Tibial Tray are:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:

Indications for Use:

• · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• · Post-traumatic loss of knee joint configuration and function.
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Indications for Use for the Triathlon Metal Backed Patella are:

• . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;
• Rheumatoid arthritis; .
• Correction of functional deformity; ●
• Revision procedures where other treatments or devices have failed; ●
• Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, ● dysfunction or prior patellectomy; and,
• Irreparable fracture of the knee. .

These products are intended to achieve fixation without the use of bone cement.

Indications for Use for the Triathlon PKR System are:

• . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
• . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis ●
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as ● indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Indications for Use for the Restoris MCK System:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIQ, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis, or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

The specific knee replacement configurations include:

• Medial unicondylar ●
• Lateral unicondylar
• Patellofemoral ●
• Medial bi-compartmental (medial unicondylar and patellofemoral)

Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

The devices covered by this submission include femoral components, tibial baseplates, tibial inserts, all-polyethylene tibial components, patellar components, metal backed patellar components, tibial and femoral augments, stems, stem extenders and offset adaptors used in total knee arthroplasty procedures, as well as femoral components, tibial inserts, tibial baseplates, patellofemoral components and patellar components used in partial knee replacements. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Triathlon/Restoris Knee system components are manufactured from the following materials Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.

The purpose of this submission is to modify the labeling of the Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK System to add MR Conditional labeling. Additionally, a revision to the contraindications for the Triathlon PKR System is being made.

This document describes the premarket notification (510(k)) for the Stryker Orthopaedics Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK System. The submission primarily focuses on modifying the labeling to add MR Conditional labeling and revising contraindications for the Triathlon PKR System. Therefore, the "device" in question is the existing knee replacement systems with updated MRI compatibility information.

As such, the provided text DOES NOT describe a study that proves a device meets acceptance criteria related to its functional performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance for an AI/CAD device). Instead, it details the non-clinical testing performed to establish the MR compatibility of the knee systems.

Given this, I will tailor the answer to reflect the information available regarding the MR compatibility studies, rather than a clinical performance study often associated with AI/CAD devices.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the standards and guidance used for MR compatibility testing. The reported performance is that the devices passed these tests and are therefore deemed "MR Conditional" under specific parameters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not specify the sample size in terms of the number of devices tested for MR compatibility. Typically, for such non-clinical bench testing, a representative sample of device types and sizes would be tested according to the standards. The data provenance is "non-clinical laboratory testing." This is implicitly a prospective study conducted in a controlled lab setting, not involving human or animal data, and thus no country of origin for patients or retrospective/prospective human data is applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the type of testing performed. For MR compatibility, the "ground truth" is established by the physical measurements taken according to standardized test methods (e.g., measuring temperature rise, displacement, torque, or evaluating artifact characteristics against defined limits). This does not involve human expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to the type of testing performed. Adjudication methods are typically used when human interpretation of data (e.g., radiologist reads) is required to establish ground truth or evaluate performance, for example in clinical trials of AI algorithms. For MR compatibility testing, the results are objectively measured per established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed or described. This type of study is relevant for AI/CAD devices where human reader performance is a key metric. This submission is for knee implants and their MR compatibility, not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical knee implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for MR compatibility testing is based on:

• Physical measurements: Quantifiable measurements of magnetic force, torque, temperature rise, and the extent of image artifacts, as defined by the respective ASTM standards.
• Standardized protocols: Adherence to established test methods that determine safety in the MR environment.

This is a form of objective, physical measurement ground truth, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable. The device is a physical product (knee implant) and there is no mention of an AI/machine learning component that would require a training set.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set mentioned for this product.

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In general, these devices are intended for use in primary or revision hip arthroplasty. Specific indications appear below:

Trident PSL Shell, Trident Tritanium Shell, Trident Hemispherical Shell

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The Trident shells are intended for cementless fixation within the prepared acetabulum.

Tritanium Acetabular Shell System

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The Tritanium Acetabular Shell System is intended for cementless use only.

Accolade II Femoral Stem, Secur-Fit Advanced Femoral Stem, Anato Femoral Stem
The indications for use for total hip arthroplasty with stems include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  Accolade II, Secur-Fit Advanced and Anato Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

Exeter® V40TM Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Hip System is intended for use in total hip replacement. It is intended for cemented use only.

The Exeter® Hip is indicated for:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis:
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Restoration Anatomic Shell
Indications for Use

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners

• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks

When used with Constrained Liner:

• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
  The Restoration® Anatomic Shell is indicated for cementless use only.

Omnifit HFX Femoral Stems
Indications:
For use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.
• Femoral neck fractures.

For use as a Total Hip Replacement:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.

Omnifit EON Cemented Femoral Stems
Indications
For use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Secur-Fit Max and Secur-Fit Max Plus Hip Stems
Secur-Fit Max and Secur-Fit Max Plus Hip stems are single use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.

Indications for use as a Total Hip Replacement include:

• noninflammatory degenerative joint disease. including osteoarthritis and avascular necrosis:
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade C Femoral Stems
The Accolade C Femoral Stems are single-use devices intended for cemented fixation.

Indications for use as a Total Hip Replacement include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade HFx Femoral Stems

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis:
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' trunnion.

Indications:

• Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
• Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Revision procedures where other treatments or devices have failed.

Restoration Acetabular Wedge Augments
The indications for use of the Restoration Acetabular Wedge Augments:

General Indications for Total Hip Replacement Components:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications Specific to the Acetabular Wedges:

• As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.
  Acetabular Augments are intended for cementless use only to the bone interface, and are affixed to the mating cup using bone cement

Trident AD Acetabular shells
The Trident AD Acetabular shells are single use devices. The shell is intended for cemented or cementless fixation within the prepared acetabulum. The Trident AD Acetabular Component System is compatible with any appropriately selected Howmedica Osteonics hip stem/femoral head combination.

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Trident T Acetabular shells
The Trident Acetabular shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.

General Indications for Total Hip Replacement Components:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Restoration ADM System, Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert
The indications for use of the total hip arthroplasty prostheses include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis:
• Correction of functional deformity; .
• Revision procedures where other treatments or devices have failed;
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks.

These devices are intended for cementless use only

Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the acetabular cup. The Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.

Indications

• In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.
  Trident X3, Trident Crossfire, Trident X2Vac and Trident X3/Crossfire Elevated Rim Acetabular Liners
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated bv deficiencies of the acetabulum.

Trident® Constrained Acetabular Insert
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

BIOLOX Delta Ceramic Heads (C-Taper, Universal Taper, V40 to Universal Taper Adapter Sleeve, and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty

V40 BIOLOX Delta Ceramic Heads
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions. .
• Aseptic necrosis of the femoral head.
• Osteo-. rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other considerations:

• Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty

Alumina C-Taper Ceramic Heads
For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
• Revision of previous cup arthroplasty or other procedures
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty .

Alumina V40 Ceramic Heads

• Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
• Rheumatoid arthritis
• Correction of functional deformity
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by the deficiencies of the acetabulum;
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques;
• Revision procedures where other treatments or devices have failed.

C-Taper CoCr Femoral Heads (LFIT and non-LFIT)
For use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions 1.
• 2. Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement 3. or distortion.

Other Considerations:

• 1. Pathological conditions or age considerations which indicate a more conservative approach to the acetabulum and the avoidance of the use of bone cement in the acetabulum.
• 2. Salvage of failed total hip arthroplasty.

Indications for use as part of a Total Hip Replacement include:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 1. arthritis, post-traumatic arthritis or late stage avascular necrosis.
• 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
• 3. Clinical management situations where arthrodesis or alternate reconstructive techniques are less likely to achieve satisfactory results.
     V40 CoCr Femoral Heads (LFIT and non-LFIT)
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis
• Correction of functional deformity
• Revision procedures where other treatments or devices have failed
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Unitrax Endoprosthesis, Unitrax V40 Adapter Sleeve, Unitrax C-Taper Adapter Sleeve

• The Howmedica Osteonics Unitrax Endoprosthesis, and the Unitrax V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and non-unions. The Unitrax C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or non-unions, aseptic necrosis of the femoral head/neck and osteo- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis.
  Universal Distal Spacer
  Howmedica Osteonics Corp.'s accessory products for cemented arthroplasty are optional devices intended to assist in the preparation, implantation and/or positioning of a femoral implant intended for cemented application.

Indications
For cement spacers, mid-shaft restrictors and Cement Plugs:

• In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
  Torx Screws, GAP Plate Screws and Osteolock Bone Screws
• Howmedica Osteonics Torx Cancellous Bone Screws are intended for supplemental fixation of associated Howmedica Osteonics cementless Acetabular Shells or Howmedica Osteonics Tibial Tray components.
• Howmedica Osteonics Osteolock Bone Screws are intended for supplemental fixation of associated cementless Trident Tritanium Multihole Acetabular shells, Restoration Acetabular Augments, and Restoration Anatomic Shell.
• Howmedica Osteonics Restoration GAP Plate Screws are intended only for fixation of the dome and iliac plates of the associated Howmedica Osteonics Restoration GAP Acetabular Shells, Trident Tritanium Hemispherical Multihole Acetabular Shells, Restoration Acetabular Augments and Restoration Anatomic Shell.

V40 to C-Taper Adapter Sleeve For Use as a Total Hip Replacement

• Painful disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
• Revision of previous cup arthroplasty or other procedures.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

All of the subject devices have been found substantially equivalent in previous premarket indications. The purpose of this submission is to modify the labeling to add MR compatibility to the labeling for the devices indicated above, and to remove a contraindication for selected devices. There have been no changes made to the devices requiring 510(k) clearance - only the labeling is being modified.

The provided text is a 510(k) Summary for a labeling update of Stryker Orthopaedics Total Hip Systems, not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a labeling update to include MR compatibility and remove a contraindication. It mentions non-clinical testing for MR compatibility but does not provide specific acceptance criteria or performance numbers in the requested format.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Study Supporting Device Performance

Not directly available. This document is a 510(k) summary for a labeling update, not an original submission demonstrating device performance against specific clinical or non-clinical acceptance criteria with quantitative results. It describes non-clinical testing performed to update MR compatibility labeling, but it does not present acceptance criteria in a table format with corresponding device performance metrics.

What is present regarding testing:
Non-clinical laboratory testing was performed to characterize the MR compatibility of the devices. The tests were conducted according to specific ASTM standards:

• ASTM F2052-06 and ASTM F2052-14 for Magnetically Induced Displacement Force.
• ASTM F2213-06 (Reapproved 2011) for Magnetically Induced Torque.
• ASTM F2119-07 (Reapproved 2013) for Image Artifact.
• ASTM F2182-11a for Heating by RF Fields.

The document states that the labeling was modified to include the MR conditional symbol and provide parameters for safe scanning, and for certain devices, a contraindication was removed. This implies that the devices met the requirements of these ASTM standards for MR compatibility, allowing for the labeling update. However, no specific numerical "acceptance criteria" or "reported device performance" are provided in a table.

Detailed Breakdown of Requested Information:

1. A table of acceptance criteria and the reported device performance

   • Not available in this document. The document describes the type of non-clinical tests performed (e.g., Magnetically Induced Displacement Force per ASTM F2052-06) for MR compatibility, but it does not provide a table with specific numerical acceptance criteria (e.g., "Displacement less than X") and the corresponding measured performance (e.g., "Measured displacement Y"). It only states that the labeling was updated to reflect MR compatibility based on these tests.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not available. The document mentions non-clinical laboratory testing but does not specify sample sizes for these tests (e.g., how many hip components were tested for MR compatibility). It is a regulatory submission, not a research paper detailing experimental methodology. Data provenance for non-clinical lab tests is not typically documented in this way in a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not available. The testing described is non-clinical "MR compatibility" testing performed in a laboratory setting, not clinical evaluation requiring expert interpretation or ground truth establishment in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not available. As the testing is non-clinical (laboratory-based MR compatibility), there is no adjudication process involving human interpretation of results in the way it would be for a clinical diagnostic study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This submission is for a labeling update for existing orthopedic implants and does not involve AI or any diagnostic imaging interpretation requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This submission is for a labeling update for existing orthopedic implants and does not involve an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable / Not available. For the non-clinical MR compatibility testing, the "ground truth" would be the physical properties and responses of the hip system components under MR conditions, as measured by the ASTM standards, not a clinical "ground truth" like pathology or expert consensus. These are engineering measurements.

8. The sample size for the training set

   • Not applicable. This submission relates to physical orthopedic implants and MR compatibility testing, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. This submission relates to physical orthopedic implants and MR compatibility testing, not a machine learning algorithm that requires a training set.

In summary, the provided document is a regulatory submission focusing on demonstrating substantial equivalence for a labeling change for established orthopedic implants, particularly concerning MR compatibility. It outlines the types of non-clinical tests performed but does not present a detailed study report with specific acceptance criteria, performance metrics, or clinical study details as requested.

Ask a specific question about this device

· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Dislocation risks

When used with Constrained Liner:
· The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.

The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the Restoration Anatomic Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.

This document is a 510(k) premarket notification for a medical device and therefore describes a device that is substantially equivalent to a predicate device. Information regarding acceptance criteria and detailed study results as requested in the prompt are generally not included in 510(k) summaries to the same extent as they would be for a PMA application or a clinical trial publication.

Based on the provided text, the device is the Restoration Anatomic Shell, which is a hip joint prosthesis component. The submission is for adding compatibility with Trident Polyethylene Liners and clarifying indications for use.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds or performance targets for a device that uses AI/algorithm. Instead, it refers to non-clinical testing performed to establish substantial equivalence to predicate devices. This type of regulatory submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The non-clinical tests performed are:

Important Note: This document does not describe the acceptance criteria or performance of an AI/algorithm-based device. It pertains to a physical medical device (a hip prosthesis component).

Regarding AI/Algorithm-specific questions (which are not applicable to this document):

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device, not an AI algorithm.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

• Study Type: Non-clinical laboratory testing.
• Clinical Testing: The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.
• Basis for Equivalence: The submission claims substantial equivalence to predicate devices (Restoration Anatomic Shell K142462 and Trident Porous Titanium Acetabular Shell K010170) in terms of intended use, indications, design, materials, performance characteristics, and operational principles.
• Device Description: The device is a sterile, single-use, cementless acetabular shell made from Ti-6Al-4V ELI alloy with a porous CP-Ti coating. Its design features and screw hole locations are identical to its primary predicate. The submission focuses on adding compatibility with different liners.

Ask a specific question about this device

The Stryker Orthopaedic Acetabular Shells for use with the Total Hip Instruments are intended for use in total hip arthroplasty and are intended for either primary or revision total hip arthroplasty. The Stryker Orthopaedic Hip Implant Stems for use with the Total Hip Instruments are intended for use in total or hemi-arthroplasty of the hip and are intended for either primary or revision procedures. The Direct Superior Approach does not change the intended use of the subject devices.

Indications for Use (Trident PSL Shell, Tritanium Shell, Trident Hemispherical Shells):

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The Trident shells are intended for cementless fixation within the prepared acetabulum.

Indications for Use (Tritanium Acetabular Shell System):

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The Tritanium Acetabular Shell System is intended for cementless use only.

Indications for Use (Accolade II Femoral Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Accolade II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Secur-Fit Advanced Hip Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Anato Hip Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Anato Hip Stem with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  The Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

The devices covered by this submission include Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments. The Instruments consist of Retractors, Cup Impactors, U-Joint Bolt Driver, Alignment Guide, Angled Reamer Handle, Instrument Trays and a Case. All instruments are hand-held surgical instruments used during orthopaedic surgery and are nonsterile, reusable devices. All Class II devices in this submission have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The acetabular shells and femoral stems are manufactured from the following materials: titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium plasma spray, commercially pure titanium and PureFix® hydroxylapatite (HA).

This document is a 510(k) premarket notification from Stryker Orthopaedics to the FDA for their Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach.

It is important to note that this submission is for a labeling modification to introduce a new surgical approach (Direct Superior Approach) for existing devices, not for a new device requiring extensive performance studies. Therefore, the details requested for acceptance criteria and studies proving device performance (like sample sizes, expert qualifications, etc., which are typically associated with evaluating a new device's diagnostic or predictive performance) are largely not applicable in the context of this specific regulatory submission.

Here's an attempt to address your request based on the provided document, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report on device performance based on a study, because the submission is for a labeling modification of already cleared and marketed devices. The core of the submission is to demonstrate that the new surgical approach (Direct Superior Approach) does not fundamentally change the intended use, safety, or effectiveness of the previously cleared devices.

Instead of performance metrics, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the new labeling (for the Direct Superior Approach) does not raise new questions of safety or effectiveness and that the devices, when used with this new approach, are as safe and effective as existing legally marketed predicate devices.

The "performance" in this context is the general safety and efficacy of the existing devices, which was established in their original 510(k) clearances.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No specific test set to evaluate device performance for a new device was used. The submission focuses on the surgical approach for existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment for a diagnostic or predictive device was involved. The safety and effectiveness of the devices themselves were established in prior 510(k)s.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring ground truth adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/diagnostic device submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/diagnostic device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the sense of a new performance evaluation for a new device. The "ground truth" for this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable. No new device or algorithm requiring a training set was involved.

9. How the ground truth for the training set was established

Not applicable. No new device or algorithm requiring a training set was involved.

Summary of the Study (as per the document):

The document explicitly states:

• Non-Clinical Testing: "Performance testing was not required in support of this submission because this submission covers a labeling modification to introduce an additional surgical protocol, Direct Superior Approach."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."

Conclusion of the Study:

The "study" in this case is the review of the modified labeling and comparison to predicate devices, rather than experimental testing of the device itself.

The conclusion is that the Stryker Orthopaedics Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach are substantially equivalent to the predicate devices identified in the premarket notification. This substantial equivalence is based on:

• The intended use and indications for the implants with the Direct Superior Approach being identical to those of the cleared predicate devices.
• The materials, design features, and functionality for the components being substantially equivalent to previously cleared predicate devices.
• The fundamental scientific technology of the modified device (i.e., the surgical instruments for the new approach) not having changed relative to the predicate devices.
• The material and design of the Total Hip Surgery Instruments for use with the Direct Superior approach being identical to those of the predicate devices cleared for use with other approaches (Posterolateral Approach and Direct Anterior Approach), and their operational principles being similar.

In essence, the "study" for this submission was a comparative analysis of design, materials, intended use, indications for use, and operational principles between the proposed devices (with the new approach) and their already cleared predicates, confirming that no new safety or effectiveness concerns were raised by adding the Direct Superior Approach to the labeling.

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The Triathlon® Tritanium® Cone Augment is intended for use in primary or revision total knee arthroplasty where there is a femoral and/or tibial metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration. The Triathlon Cone Augment is intended to be affixed to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, with or without bone cement.

The Triathlon® Tritanium® Cone Augment is an extension of the Triathlon® Total Knee System product line intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is compatible for use with other Triathlon® Total Knee System components. The Tritanium® Cone Augment is composed of commercially pure titanium (raw material per ASTM F1580, processed material per ASTM F67).

The subject device is designed to be used with the Triathlon® TS femoral components and Triathlon® Universal baseplates and is compatible with other Triathlon® Total Knee System components. The cones are intended to be cemented to the respective Triathlon femoral and/or tibial component, and are intended for fixation within the proximal tibia or distal femur with or without bone cement. Tritanium Femoral and Tibial Cones are intended to be used where there is a femoral and/or tibial metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration.

There are three designs of Triathlon Tritanium Cone Augments:

• Femoral Cone Augments
• Symmetric Tibial Cone Augments
• Asymmetric Tibial Cone Augments

The provided FDA 510(k) summary for the Triathlon® Tritanium® Cone Augments indicates that no clinical studies were performed or required to establish substantial equivalence. Instead, the determination was based on non-clinical (laboratory) testing, a comparison of technological characteristics, intended use, and materials to predicate devices.

Therefore, the requested information regarding acceptance criteria, device performance from a clinical study, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be provided from this document as no such clinical studies were conducted or reported.

However, I can extract the non-clinical acceptance criteria and the reported performance from the laboratory testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The following information cannot be provided from this document as no clinical studies were performed:

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The non-clinical tests involved various laboratory setups and simulated environments, often comparing against predicate devices or regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set: Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a physical implant and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device is a physical implant and not an algorithm.
7. The type of ground truth used: Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" was established by engineering standards, material specifications (e.g., ASTM F67, ASTM F1800), and compliance with FDA guidance documents.
8. The sample size for the training set: Not applicable, as no machine learning algorithm was involved, hence no training set.
9. How the ground truth for the training set was established: Not applicable, as no machine learning algorithm was involved.

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