Search Results

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
• traumatic arthritis;
• previous tibial condyle or plateau fractures with loss of anatomy or function;
• varus deformities; and
• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

The purpose of this submission is to add a line extension of Size B to the Persona Partial Knee system (PPK). The Persona Partial Knee System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

This FDA 510(k) clearance letter for the Persona Partial Knee is for a medical implant (a knee replacement prosthesis), not an AI/software device. Therefore, the information requested in the prompt, such as "number of experts used to establish ground truth" or "multi reader multi case (MRMC) comparative effectiveness study," is not relevant to this type of device.

The clearance is based on the substantial equivalence principle, meaning the device is shown to be as safe and effective as a previously cleared predicate device. The performance data mentioned in the document refers to non-clinical testing (e.g., mechanical tests, material characterization) to ensure the implant meets established engineering and biocompatibility standards, not an AI algorithm's diagnostic performance.

Here's why the prompt's specific questions cannot be fully answered from this document:

• No AI/Software Component: The Persona Partial Knee is a physical medical device (implant), not a digital health product driven by AI or software.
• Substantial Equivalence: The clearance relies on demonstrating the new "Size B" line extension of the Persona Partial Knee is substantially equivalent to its own previously cleared version (K161592). This typically involves showing that the new size has similar design features, materials, and performance characteristics (e.g., strength, durability, biocompatibility) to the predicate.
• Performance Data Type: The "Performance Data" referenced is non-clinical. For an implant, this would involve mechanical testing (e.g., fatigue testing, wear testing), material characterization, biocompatibility testing, etc., to ensure the device performs as intended and is safe when implanted. It does not involve human readers, expert consensus for ground truth, or analysis of diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria or details about a study evaluating AI performance from this document because it is not an AI/software device.

The document does state in the "Summary of Performance Data" section:
"The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint."

However, it does not detail what those acceptance criteria are or how the performance data was generated beyond stating it was "performance testing." For an implant, these acceptance criteria are typically engineering specifications (e.g., minimum load bearing capacity, maximum wear rate, specific material properties) derived from recognized standards (e.g., ISO, ASTM).

Ask a specific question about this device

MOTO Medial, MOTO Lateral and MOTO Sphere Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The MOTO Partial Knee System Extension is a Medacta partial knee prosthesis portfolio extension including implantable devices, provided individually packed, sterile and single-use. Specifically, the purpose of this submission is to gain the clearance for: MOTO Sphere femoral components, made of Co-Cr-Mo according to ISO 5832-4 and available in 5 sizes with or without TiNbN coating. They are intended to replace the medial or lateral femoral compartment of the natural knee joint and must be implanted in combination with the tibial component of MOTO Medial or MOTO Lateral (K162084, K183029 and K213071); 7mm thick MOTO Medial and MOTO Lateral inserts fixed made of E-cross, available in 8 sizes and intended to be coupled with the subject MOTO Sphere femoral components as well as MOTO Medial or MOTO Lateral tibial components (K162084, K183029 and K213071).

The provided document is a 510(k) Clearance Letter from the FDA for the MOTO Partial Knee System Extension. This document grants clearance for a medical device (knee implant components) and describes its intended use and comparison to predicate devices, but it does not contain the detailed acceptance criteria and study results you are asking for regarding a software or AI-based device.

The prompt specifically asks for details about a study that proves the device meets acceptance criteria, including information on "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)", "ground truth," "training set," etc. These are all concepts related to the validation of Artificial Intelligence (AI) / Machine Learning (ML) enabled software as a medical device (SaMD), often used in diagnostics or image analysis.

The MOTO Partial Knee System Extension is an implantable medical device (hardware). The document explicitly states:

• "No clinical studies were conducted." This is a key indicator that a comparative effectiveness study involving human readers or standalone algorithm performance was not performed or required for this type of device clearance.
• The "Performance Data" section lists "Non-Clinical Studies" focusing on mechanical properties and biocompatibility (e.g., fatigue endurance, contact pressures, wear behavior, pyrogenicity, shelf-life). These are standard tests for orthopedic implants, not AI/ML software.

Therefore, because the provided text is for a hardware implant and not an AI/ML software device, I cannot extract the detailed acceptance criteria and study information related to AI/ML performance from this document.

To answer your request, I would need a 510(k) clearance letter or summary for an AI/ML-enabled medical device.

If you were to provide a document for an AI/ML device, the table and information would be structured as follows (but cannot be populated from the current input):

Acceptance Criteria and Study Proof for an AI/ML Device (Hypothetical, based on expected content)

Since the provided document is for a hardware implant (MOTO Partial Knee System Extension) and not an AI/ML-enabled software device, it does not contain the specific performance evaluation metrics, study designs (e.g., MRMC, standalone), or ground truth establishment methods typically associated with AI/ML device validation.

If this were an AI/ML device, the information requested would be typically found in a "Performance Data" or "Clinical Performance" section of the 510(k) Summary, detailing studies conducted to demonstrate the algorithm's accuracy, sensitivity, specificity, or impact on human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)

Ask a specific question about this device

The iBalance UKA System is indicated for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:

• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or fracture;
• Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.

The iBalance BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.

These components are single use only and are intended for implantation with bone cement.

The Arthrex iBalance Partial Knee System encompass the following FDA cleared devices:

• Arthrex iBalance UKA System
• Arthrex iBalance PFJ System
• Arthrex iBalance BiCompartmental Arthroplasty System

These systems are comprised of femoral, tibia and patellar components for use in knee prosthesis.

The provided FDA 510(k) clearance letter for the Arthrex iBalance Partial Knee System does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

This document is a clearance letter for a physical medical device (a knee replacement system), not an AI-powered diagnostic or treatment algorithm. The "performance data" mentioned refers to non-clinical and in-vivo electromagnetic simulation related to the device's "MR Conditional" status, which is about its safety in an MRI environment, not its diagnostic or therapeutic accuracy as an AI would have.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, expert consensus, MRMC studies, etc.) from this document because it is not relevant to an AI/algorithm-based device study.

To provide the information you're looking for, I would need a 510(k) clearance letter or a clinical study report specifically detailing the performance evaluation of an AI/algorithm-based medical device.

Ask a specific question about this device

The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

• · Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis.
• · Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty.
• · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The ACHIEVE™ PARTIAL KNEE SYSTEM is a knee joint femorotibial (unicompartmental) prosthesis that is intended for cementless or cemented fixation.
The implant system consists of individually packaged implants: a metal tibial tray (titanium alloy), a polyethylene tibial insert, and a metal femoral component (titanium alloy or cobalt-chromium). All tibial inserts are composed of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE).

This document does not contain information about the acceptance criteria and study detailed in the request. The document is a 510(k) premarket notification for a medical device (ACHIEVE™ Partial Knee System) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, ground truth, or MRMC studies, as these aspects are typically associated with clinical trials or performance studies involving AI/software devices.

The document describes engineering tests and analyses performed on the physical components of the knee system. For instance:

• Range of Motion (RoM) Evaluation: Acceptance criteria met per ASTM F2083.
• Femoral Fatigue Testing: Acceptance criteria met per modified ASTM F3210 (10 Mc).
• Tibial Tray Fatigue Testing: Acceptance criteria met per modified ASTM F3140 (10 Mc).
• Component Interlock Strength Testing: Acceptance criteria met for static AP and ML shear testing and static tensile pull-off testing.
• Wear Resistance Evaluation: Wear rate does not represent a new worst-case compared to the predicate device per ISO 14243-3.
• Biocompatibility Assessments: Devices found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Meets recommendations of Class II Special Controls Guidance Document per ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, and ASTM F1854.
• Shelf-Life Evaluation: Five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 found per ISO 11137-1 and ISO 11137-2.

However, these are all engineering benchmarks for the physical orthopedic implant, not performance metrics for a diagnostic AI/software device.

Ask a specific question about this device

The ACTIFY™ Unicondylar Knee System is indicated for unicompartmental knee replacement due to the following conditions:

1. Moderately disabling joint disease of the knee resulting from painful osteo- and/or post-traumatic arthritis, or avascular necrosis.
2. Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
3. Alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
4. Previous tibial condyle or plateau fractures with loss of anatomy or function.
5. Varus or valgus deformities.
   These devices are indicated for cemented use only.

The ACTIFY™ Unicondylar Knee System implants consist of femoral and tibial implants that are used as part of a unicompartmental knee system for partial knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. ACTIFY Unicondylar femoral implants are manufactured from cobalt chrome alloy, tibial inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) with and without Vitamin E, and tibia trays are manufactured from titanium alloy.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (ACTIFY™ Unicondylar Knee System) and does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.

The document discusses:

• The FDA's decision of substantial equivalence to predicate devices.
• The indications for use of the device.
• The materials and components of the device.
• A list of performance tests conducted (fatigue, wear, interlocking strength, etc.) according to various ASTM and ISO standards.
• A general statement that "Performance data demonstrate substantial equivalence to the predicate devices."

It does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any clinical or large-scale performance study.
3. Information on experts, adjudication methods, or ground truth for a test set.
4. Details on MRMC studies or AI assistance.
5. Information about standalone algorithm performance.
6. Sample sizes or ground truth establishment for a training set.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

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 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, rheumatic 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 Augment components are intended for cemented or cementless use.

Triathlon Pro Posterior Stabilized Femoral Components 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. Additional Indications for Posterior Stabilized (PS) 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.
  The Triathlon® Pro PS Femoral Components are intended for cemented use only.

Triathlon Tritanium Tibial Baseplate Indications for Use:
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 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 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.

Triathlon Low Profile Tibial Tray Indications for Use:
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.

Triathlon Metal Backed Patella Indications for Use:

• · Noninflammatory degenerative joint disease including osteoarthritis 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.

Triathlon Partial Knee System Indications for Use:
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.

Avon Patello-femoral Joint Prosthesis Indications for Use:
The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity, or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

Restoris Multi-Compartmental Knee System Indications for Use:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis 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.

All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.
An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.

This document is a 510(k) premarket notification for knee arthroplasty devices, specifically for the Triathlon Knee System and related components. It is important to note that this document does NOT describe a study evaluating the performance of a device driven by an AI algorithm or software.

Instead, this submission is for physical medical devices (knee implants) and their associated labeling. The core purpose of this 510(k) submission is to modify the MR conditional information in the instructions for use for these existing, previously cleared devices due to updated FDA guidance on MR safety testing. The document explicitly states:

• "There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified." (Page 16)
• "There have been no changes requiring 510(k) clearance to the technological characteristics of the Stryker Knee systems as a result of the revision to the labeling." (Page 19)
• "Clinical testing was not required as a basis for substantial equivalence." (Page 20)

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven device's performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies) cannot be extracted from this document, as it pertains to entirely different types of evaluation (mechanical performance, biocompatibility, and in this specific case, MR safety of physical implants, not AI algorithm performance).

To explicitly answer your questions based on the provided document, even if they don't fully apply to the nature of this submission:

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

   • Acceptance Criteria (Implicit for this submission): The new MR safety testing results must demonstrate that the device is safe for use in an MR environment under the updated parameters to justify the labeling changes, and that the device remains substantially equivalent to its predicates.
   • Reported Device Performance: The document states: "New testing was performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone, following the FDA guidance document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021." (Page 19). While the specific quantitative results of this testing are not provided in this summary document, the FDA's clearance (the letter at the beginning) implies the acceptance criteria for MR safety were met.

2. Sample sized used for the test set and the data provenance:

   • This document describes non-clinical (laboratory) testing for MR safety. It does not involve "test sets" in the sense of patient data for AI evaluation. The "sample size" would refer to the number of physical implants tested for MR compatibility. This specific number is not provided in the summary.
   • Data Provenance: N/A for clinical data; the testing was performed per FDA guidance, implying controlled laboratory conditions.

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

   • N/A. This is not a study requiring expert readers or ground truth establishment in the context of AI performance. The "ground truth" for MR safety is established by quantitative measurements in a laboratory setting based on physics principles and regulatory standards.

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

   • N/A. Not a clinical study requiring human 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:

   • No. This document does not pertain to AI or human reader performance.

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

   • No. This document does not describe an algorithm.

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

   • N/A for artificial intelligence context. The ground truth for this submission relates to physical properties and safety in an MR environment, established through standardized physical testing and engineering measurements.

8. The sample size for the training set:

   • N/A. There is no training set mentioned or implied for an AI algorithm in this submission.

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

   • N/A. There is no training set mentioned or implied.

In summary, this 510(k) notification is for knee replacement components and deals with updating their MR conditional labeling based on physical testing, not with the performance evaluation of an AI-powered device.

Ask a specific question about this device

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

· Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; and · Partial revisions to replace the tibial insert of the previously implanted JOURNEY II UK knee in the femoral and tibial components are well-fixed.

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

The JOURNEY II Unicompartmental Knee System includes femoral components, tibial inserts that restore either compartment of the knee (K190085, K230653). JOURNEY II UK provides joint replacement on a single condylar compartment, meaning that only one condyle will be replaced instead of the entire femoral component replaces the damaged condylar component of the femur. The tibial baseplate replaced the damaged part of the tibial insert is the articulating surface which allows the knee to bend and flex smoothly and is placed above the tibial baseplate.

The Smith & Nephew JOURNEY II Unicompartmental Knee System consists of OXINUM femoral components, titanium tibial baseplates, and cross-linked polyethylene (XLPE) tibial inserts.

The provided text is a 510(k) summary for the JOURNEY II Unicompartmental Knee System. It focuses on labeling updates and explicitly states that there are no changes to the design features, materials, or manufacturing methods of the device.

Therefore, the document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria for performance in the typical sense of a new or significantly modified medical device that would require such studies. It explicitly states:

"Therefore, since there are no changes to the design features, materials, or manufacturing methods of the subject I I Unicompartmental Knee System devices, no performance testing (bench, animal, clinical) was required." and "Not Applicable." and "No modifications are being introduced to the subject devices as a result of this filing."

Hence, I cannot provide the requested information from this document. The submission is a request for clearance for labeling updates only, not for a new or modified device requiring new performance studies.

Ask a specific question about this device

The OvertureTi Knee Resurfacing System"is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.

The OvertureTi Knee Resurfacing System™ is comprised of femoral implants, and a set of ancillary instruments. The femoral implants are titanium and feature a spherical polished articulating surface with a titanium nitride (TiN) coating. The tibial implants are comprised of a titanium tibial tray with an integrated ultra-high molecular weight polyethylene (UHMWPE) tibial insert. The UHMVPE has Vitamin-E infused (0.1% by weight). The femoral implants and tibial trays utilize cemented pegs and porous titanium bone-contacting surfaces to allow for fixation. The femoral implant articulates against the tibial insert in a non-constrained manner.

The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. Femoral implants are offered in oblong and round configurations. The oblong femoral implants are offered in lengths ranging 25-40mm and diameters ranging 17.5-27.5mm, and the round femoral implants are offered in diameters ranging 17.5-27.5mm. The tibial implants are offered in diameters ranging 17.5-22.5mm. The implants are provided gamma sterilized and individually packaged.

The provided text is a 510(k) Premarket Notification from the FDA for the "OvertureTi Knee Resurfacing System™." This document is a regulatory approval letter and does not contain information about a study proving the device meets acceptance criteria related to AI/ML or diagnostic performance. Instead, it focuses on the device's substantial equivalence to a predicate device for its intended use as a knee resurfacing system.

Therefore, I cannot extract the requested information about acceptance criteria for device performance in the context of an AI/ML study, nor details about sample sizes, expert involvement, or MRMC studies, as these elements are not present in this type of submission.

The "Testing" section mentions:

• "Vitamin-E UHMWPE Rationale"
• "Characterization of Vit-E UHMWPE"
• "Vitamin-E Tibial Alignment Feature Test Report"

These are related to material characterization and mechanical/design features of the implant, not to diagnostic or AI/ML performance. The conclusion states that "rationales and testing... indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." This refers to the mechanical and biological safety of the implant itself, not its diagnostic accuracy or AI assistance.

Ask a specific question about this device

The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:

• Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
• Correction of varus, valgus, or posttraumatic deformity. .
• As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
• Revision procedures where other treatments or devices have failed. ●
  This device is intended for cemented use only.

KMTI's TRIBRID® Unicompartmental Knee System is a partial knee replacement prostheses intended for application with bone cement. Partial knee replacement components include femoral and tibial components. Femoral baseplates are CoCrMo Alloy while the Tibial implants are Ti6Al4V Alloy. The Tibial bearing inserts are made from Ultra-High Molecular Weight Polyethylene (UHMWPE) variations. Components are available in a variety of designs and size ranges intended for both primary and revision applications.

This document is a 510(k) summary for the Kyocera TRIBRID® Unicompartmental Knee System, a medical device. It focuses on mechanical, non-clinical performance data rather than AI/software performance. Therefore, many of the requested criteria related to AI device performance are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical performance is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. The document does not provide specific quantitative pass/fail values as acceptance criteria; rather, it lists the types of tests performed and concludes that the results support substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (based on the provided document)

Since the document describes a mechanical device and its non-clinical performance testing rather than an AI/software device, many of the typical questions for AI acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance) are not applicable.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in this summary. Mechanical tests typically use a small number of samples (e.g., 3-6 or more, depending on the standard) to demonstrate compliance with a standard or to compare to predicate devices.
   • Data Provenance: Not applicable. This is in vitro mechanical testing, not human data.

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

   • Not applicable. Ground truth for mechanical testing is established by engineering specifications, material properties, and industry standards (e.g., ASTM, ISO), not by expert consensus on clinical data.

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

   • Not applicable. This is for mechanical testing, not interpretation of clinical imagery or data by experts. Test results are typically compared directly to standard requirements or predicate device performance.

4. 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-powered diagnostic or assistive tool.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • Mechanical Testing Standards: The "ground truth" for this type of device is compliance with industrial standards (e.g., ASTM, ISO) for mechanical properties, durability, and wear, and demonstrating substantial equivalence to predicate devices that have established safety and effectiveness through their historical use.

7. The sample size for the training set:

   • Not applicable. This is non-clinical mechanical testing, not a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this is mechanical engineering testing.

Ask a specific question about this device

Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:

• unicondylar knee replacement (UKR)
• . total knee arthroplasty (TKA)

The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.

The provided text is a 510(k) summary for the CORIOGRAPH Knee Pre-Op Plan. It discusses the device's substantial equivalence to a predicate device and details non-clinical testing. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving those criteria are met.

Here's a breakdown of what can be answered and what information is missing:

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

The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness."

This is a general statement of compliance, not a detailed table of specific acceptance criteria (e.g., accuracy metrics, specific tolerances) and their corresponding reported performance values. Therefore, a table cannot be fully constructed.

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

This information is not provided in the text. The document refers to "verification and validation testing" and "summative usability testing" but does not specify the sample size for these tests or the origin/nature of the data used.

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 information is not provided in the text. The document mentions "participating surgeons" in the usability testing, but their number or specific qualifications (beyond being surgeons) are not detailed. It does not mention experts establishing ground truth for a test set in the context of performance metrics.

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

This information is not provided in the text.

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

The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a "Knee Pre-Op Plan" which suggests it aids in surgical planning, not necessarily in interpretation tasks typically associated with MRMC studies with human readers.

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

The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System." This implies standalone testing of the software's output, as well as its interaction as an input to another system. However, specific metrics of "algorithm-only" performance are not provided.

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

This information is not explicitly provided in the text. Given the device provides "pre-operative planning for surgical procedures based on patient imaging," the ground truth for evaluating its accuracy would likely be related to the accuracy of anatomical landmark identification, implant positioning, or surgical outcomes, but this is not specified.

8. The sample size for the training set

This information is not provided in the text. The document discusses "software applications" and "planning tools and processes" but does not detail any machine learning models or training sets.

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

This information is not provided in the text, as no training set details are given.

Ask a specific question about this device