Search Results

Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak. And/or
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.

The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).

This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.

The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.

Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:

Acceptance Criteria and Device Performance for a Mechanical Implant:

For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.

No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.

Table of Non-Clinical Tests (Analogous to Performance Metrics):

Ask a specific question about this device

The MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

• · 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 the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):

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

The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. This submission is to add a cruciate retaining (CR) device type to the system, including the CR femoral component and corresponding CR Tibial inserts. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.

The MOBIO Total Knee System includes left and right femoral components for the Cruciate Retaining (CR) system. These components are manufactured from cast cobalt chrome conforming to ASTM F75. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Fixed femoral pegs on the femoral components provide additional medio-lateral fixation.

The CR Tibial Inserts are offered in a total of 50 sizes, size A/1-4 through HJ/7-10, with 10 thicknesses ranging from 9 to 25mm (total thickness with Tibial Baseplate is 9 to 25mm). The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

All system components are supplied sterile and are single use devices.

The provided text is a 510(k) premarket notification for the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria or reporting on the performance of an AI/ML powered medical device.

Therefore, the information required to answer your questions about acceptance criteria for an AI/ML device and its study is not present in the provided text. The document describes a traditional medical device (knee replacement system) and addresses its physical properties, materials, manufacturing, and intended use, comparing them to existing devices.

The "Performance Data" section in the document refers to non-clinical studies for the physical knee replacement components (e.g., locking mechanism strength, contact stress, range of motion, material characterization, biocompatibility, shelf life, bacterial endotoxin testing). These are for the mechanical device itself, not for an AI/ML algorithm's performance.

To answer your request, I would need a document detailing the performance evaluation of an AI/ML medical device, which would typically involve clinical validation studies, metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.

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), theumatoid 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

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

The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, the document is a 510(k) premarket notification for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, which are orthopedic implants (knee joint replacement components).

The document details the substantial equivalence of this device to previously cleared predicate devices based on material, design, intended use, and non-clinical performance testing. It explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."

Therefore, I cannot provide the requested information, including:

1. Table of acceptance criteria and reported device performance: This document does not specify performance metrics or acceptance criteria for an AI/ML driven device.
2. Sample size, data provenance: Not applicable as no clinical study for an AI/ML device is discussed.
3. Number of experts, qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study, effect size: Not applicable.
6. Standalone performance: Not applicable.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth for training set: Not applicable.

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 stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Tibial Baseplate and Tritaium® Metal-Backed Patella components are indicated for both uncemented and cemented use.

The Triathion® 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.

The Triathlon® Tritanium® Metal-Backed Patella is an extension of the Triathlon® Total Knee System product line for use in primary and revision Total Knee Arthroplasty. It is a sterile, single-use, non-modular metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in symmetric and asymmetric designs that are available in multiple sizes. The metalbacking features a porous-coated posterior surface and three porous-coated pegs to provide cemented or cementless fixation to bone.

This document, a 510(k) Summary for the Triathlon® Tritanium® Metal-Backed Patella, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of a device meeting specific acceptance criteria through performance data. Therefore, many of the requested elements for describing an acceptance criteria study are not present in this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria with corresponding device performance metrics in the typical sense of a clinical or analytical performance study. Instead, it lists non-clinical laboratory tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context is the successful completion of these tests, implying that the new device performs comparably to the predicates.

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

• Sample Size: Not explicitly stated for each test. For non-clinical laboratory testing, the sample size typically refers to the number of test articles (patellar components) subjected to each specific test. This tends to be much smaller than clinical study sample sizes and is dependent on the specific ASTM standard or internal protocol used.
• Data Provenance: The tests are non-clinical laboratory tests, likely conducted by the manufacturer (Stryker Orthopaedics) or a contract laboratory. The "country of origin of the data" would typically be the location of the testing facility, which is not specified but presumed to be a regulated environment. The data is retrospective in the sense that these are engineering and material characterization tests performed on manufactured devices.

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

This information is not applicable as this submission is for a medical device and relies on engineering and material testing standards (ASTM) to demonstrate substantial equivalence, not on expert ground truth for an AI or diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. The "test set" here refers to physical components undergoing laboratory testing, not, for example, medical images requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic or AI-assisted devices to assess human reader performance. This submission is for a physical orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which this orthopedic implant is not.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established engineering and material specifications, as well as the performance characteristics of the predicate devices. The new device is tested against these benchmarks (often defined by ASTM standards) to show that its properties are within acceptable ranges and comparable to the predicates.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an orthopedic implant submission based on substantial equivalence through non-clinical testing. This term is relevant for machine learning algorithms.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device

The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The ShapeMatch Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the ShapeMatch Cutting Guides are:

General Total Knee Arthroplasty (TKR) Indications:

• 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.
• Failed reconstruction procedures which did not involve the implantation of hardware on . the condylar surfaces

Additional Indications for Posterior Stabilized (PS):

• 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 ShapeMatch Cutting Guides are intended for single use only.

The ShapeMatch Cutting Guides are single-use, disposable, cutting guides designed and manufactured from patient imaging data (MRI/CT). The cutting guides are used to aid the surgeon intra-operatively in making the initial distal femoral and the initial proximal tibial bone cuts during a total knee arthroplasty surgery. The cutting guides also establish the references for component orientations. The cutting guides are manufactured from polyoxymethylene per ASTM F1855.

The ShapeMatch Cutting Guides are intended for use with the Triathlon® Knee System (Cruciate Retaining (CR), Posterior Stabilized (PS) and Condylar Stabilizing (CS)) determined substantially equivalent via the following 510(k)s K031729, K040267, K042993, K051146, K051380, K053514, K062037, K061251, K063423, and K072575.

The accessory Triathlon® Extra-medullary (EM) Universal Goniometer is available for the surgeon to use intra-operatively to check the position of the femoral and tibial components. The goniometer mates with the saw slots on both the femoral and tibial guides for use in referencing the cuts with anatomic landmarks prior to resection of the bone. The accessory Triathlon® EM Universal Goniometer is made from Stainless Steel per ASTM A564.

The provided 510(k) summary for the ShapeMatch® Cutting Guides ([K122053](https://510k.innolitics.com/search/K122053)) does not include information about specific acceptance criteria or a clinical study designed to prove the device meets such criteria.

Instead, it relies on non-clinical testing and substantiates equivalence to a predicate device. Here's a breakdown based on the categories requested:

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

• Acceptance Criteria: Not explicitly stated in terms of measurable performance thresholds.
• Reported Device Performance: The document states "Detailed software verification and validation were performed per FDA Guidance, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." This indicates that the software aspects of the device (likely related to generating the custom guides from imaging data) were tested for correctness and functionality, but specific performance metrics (e.g., accuracy of cuts, fit of components) are not quantified in this summary.

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 for clinical efficacy. The document explicitly states "Clinical Testing: Not Applicable to validate changes." The software verification and validation would have involved various test cases, but details on sample size or data provenance for those tests are not provided.

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 for clinical efficacy. Since clinical testing was deemed "not applicable," there's no mention of experts establishing a ground truth for a clinical test set.

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

• Not applicable for clinical efficacy. No information on adjudication methods for a clinical test set.

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 device is a cutting guide, not an AI-assisted diagnostic tool for "human readers." No MRMC study was conducted or referenced.

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

• The device's function is to generate physical cutting guides from imaging data. The "algorithm" here would be the software that processes the MRI/CT data and designs the guide. The "Detailed software verification and validation" would assess the standalone performance of this software in accurately translating image data into guide designs. However, no specific metrics or studies demonstrating this standalone performance (e.g., how precisely the software determines bone geometry or cut planes compared to a 'gold standard') are provided in this summary.

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

• For the "software verification and validation," the ground truth would likely be established through engineering specifications, validated anatomical models, or potentially comparisons to manual measurements/designs. Specific details are not provided.

8. The sample size for the training set:

• This information is not provided, as the summary focuses on software verification and validation rather than a deep learning machine learning model that would require a distinct training set. The device appears to be based on algorithmic design from patient imaging.

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

• Not applicable as no specific training set for a machine learning model is described. The ground truth for the software development (if one considers the development data as a "training set" in a broader sense) would be based on established anatomical knowledge, engineering principles, and potentially measurements from cadaveric or synthetic models.

In summary: The 510(k) for the ShapeMatch® Cutting Guides relies on non-clinical software verification and validation for regulatory submission, asserting substantial equivalence to a predicate device. It explicitly states that clinical testing was "Not Applicable to validate changes." Therefore, many of the requested details regarding clinical study design, acceptance criteria, and ground truth establishment for clinical performance are not present in this document.

Ask a specific question about this device

The Stryker® Patient Specific Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

The Stryker Patient Specific Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the Stryker Patient Specific Cutting Guides are:

General Total Knee Arthroplasty (TKR) Indications:

• 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.
• Failed reconstruction procedures which did not involve the implantation of hardware on the condylar surfaces

Additional Indications for Posterior Stabilized (PS):

• 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 Stryker Patient Specific Cutting Guides are intended for single use only.

The Stryker® Patient Specific Cutting Guides are single-use, disposable, cutting guides designed and manufactured from patient imaging data (MRI/CT). The cutting guides are used to aid the surgeon intra-operatively in making the initial distal femoral and the initial proximal tibial bone cuts during a total knee arthroplasty surgery. The cutting guides also establish the references for component orientations. The cutting guides are manufactured from polyoxymethylene per ASTM F1855.

The Stryker Patient Specific Cutting Guides are intended for use with the Triathlon® Knee System (Cruciate Retaining (CR), Posterior Stabilized (PS) and Condylar Stabilizing (CS)) determined substantially equivalent via the following 510(k)s K031729, K040267, K042993, K051146, K051380, K053514, K062037, K061251, K063423, and K072575.

The accessory Triathlon® Extra-medullary (EM) Universal Goniometer is available for the surgeon to use intra-operatively to check the position of the femoral and tibial components. The goniometer mates with the saw slots on both the femoral and tibial guides for use in referencing the cuts with anatomic landmarks prior to resection of the bone. The accessory Triathlon® EM Universal Goniometer is made from Stainless Steel per ASTM A564.

Here's a breakdown of the acceptance criteria and the study information for the Stryker Patient Specific Cutting Guides, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria. Instead, the non-clinical testing aimed to demonstrate comparable accuracy to conventional jig-based instrumentation, and the clinical testing aimed to show a strong co-relationship between MRI and long-standing radiograph measurements.

2. Sample Size and Data Provenance

• Non-Clinical (Cadaveric Assessment):

  • Sample Size (Test Set): Not explicitly stated, described as "a cadaveric model."
  • Data Provenance: Cadaveric data; implicitly from a controlled laboratory setting (likely within the US, but not specified). It is a prospective study as it involved active experimentation.

• Clinical Research Study:

  • Sample Size (Test Set): Not explicitly stated.
  • Data Provenance: Not specified (e.g., country of origin). Described as a "clinical research study," implying prospective data collection on human subjects.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the non-clinical or clinical studies.

4. Adjudication Method for the Test Set

The document does not provide any information regarding an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is reported that details the effect size of human readers improving with AI vs. without AI assistance. The non-clinical study compared the device's accuracy to conventional jig-based instrumentation, which is a different type of comparison.

6. Standalone Performance Study

The studies conducted describe the performance of the "Stryker Patient Specific Cutting Guides" which are patient-specific surgical instruments generated from patient imaging data (MRI/CT). The studies assess the accuracy of these guides and the MRI protocol used to generate the data for the guides. This can be considered a standalone performance assessment of the device's ability to facilitate accurate cuts and the accuracy of the imaging protocol that informs the device. However, it's not "algorithm-only" in the sense of a diagnostic AI, as the device itself is a physical cutting guide. The software component mentioned (detailed software verification and validation) relates to the generation of these guides.

7. Type of Ground Truth Used

• Non-Clinical (Cadaveric Assessment): The ground truth was based on the "pre-operative plan" for bone cuts, which would have been established by a surgeon or planning software. The success was measured by comparing the actual cuts made using the guides to this plan.
• Clinical Research Study: The ground truth for knee alignment was established by "long standing radiograph images," which are a standard clinical method for assessing mechanical alignment.

8. Sample Size for the Training Set

The document makes no mention of a training set sample size. The device is generated from individual patient MRI/CT data, so it's a patient-specific design rather than an AI model trained on a large dataset in the conventional sense. The "software verification and validation" would be a separate process from a training set for a machine learning model.

9. How Ground Truth for Training Set was Established

As no training set is described for an AI model, there is no information on how its ground truth would have been established. The core of the device relies on patient-specific imaging data translated into a physical guide, not on a machine learning model trained on a general dataset.

Ask a specific question about this device

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Indications For Use:

• Painful, disabling joint disease of the knee resulting from: noninflammatory . 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

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).

The provided document is a 510(k) Summary for a medical device called the Triathlon® CS (Condylar Stabilizing) Lipped Insert. This document is related to a knee implant component, not an AI/ML-driven diagnostic or prognostic device. Therefore, much of the information requested in your prompt regarding AI/ML study design (such as sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable.

The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a knee implant component), the "acceptance criteria" are demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and operational principles, rather than performance metrics typically seen in AI/ML studies (like sensitivity, specificity, or AUC). The reported "performance" relates to its physical characteristics and how they compare to established implants.

2. Sample Size for Test Set and Data Provenance

Not applicable for this type of submission. This is a medical device (implant) and its equivalence isn't typically demonstrated through a "test set" of patient data in the way an AI/ML algorithm would be. The "test" for this device involves engineering analysis, material testing, and potentially bench testing, not clinical data sets for performance evaluation against a ground truth.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no "ground truth" establishment in the context of clinical images or data for this engineering-focused substantial equivalence. The "experts" involved would be engineers, materials scientists, and regulatory specialists evaluating the design and testing of the implant.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device that assists human readers.

6. Standalone Performance Study

While the device undergoes extensive standalone engineering and material testing (e.g., fatigue testing, wear testing, range of motion, contact stress analysis), these are not presented as "standalone performance" in the context of an algorithm's output. The summary explicitly states: "Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market." This indicates engineering performance testing was conducted, but specific details or test results are not provided in this regulatory summary.

7. Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety of the predicate devices and fundamental engineering and biomechanical principles for knee implants. Compliance with these established standards and the demonstrated equivalence to existing safe and effective devices serve as the basis for regulatory acceptance.

8. Sample Size for the Training Set

Not applicable.

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

Not applicable.

Summary Conclusion for this Specific Device:

This 510(k) summary demonstrates the substantial equivalence of the Triathlon® CS (Condylar Stabilizing) Lipped Insert to predicate devices, thereby establishing its safety and effectiveness without needing extensive new clinical trials or AI-specific performance metrics. The "study" here refers to the comparative analysis of its design, materials, and biomechanical properties against legally marketed knee implant components, conforming to engineering standards and principles rather than statistical performance on patient data.

Ask a specific question about this device

The intended use of the size one Triathlon™ Cruciate Retaining Tibial Insert is the same as that of the predicate device described in premarket notification K040267 – it is intended for use with Triathlon™ Cruciate Retaining femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The cruciate retaining design is intended to accommodate the posterior cruciate ligament if it is present.

Indications:

• · Painful, disabling joint disease of the knee resulting from: nonimflammatory 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.

This premarket notification describes a smaller size of Triathlon™ Cruciate Retaining Tibial Insert. This smaller size insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ CR Femoral component in primary or revision total knee arthroplasty. This size I tibial insert has smaller anterior-posterior and medio-lateral dimensions than the size 2 predicate.

This document is a Special 510(k) Premarket Notification for a new size of a previously cleared device. It primarily focuses on demonstrating substantial equivalence to the predicate device and does not contain information about acceptance criteria, efficacy studies, or performance benchmarks as would be found in a clinical trial report.

Therefore, the requested information cannot be extracted from the provided text. The document is a regulatory submission for a Class II medical device, which often relies on demonstrating equivalence rather than comprehensive clinical performance studies to the extent that a new drug or high-risk device might.

Specifically, the document does NOT contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm performance study.
• Type of ground truth used for performance evaluation.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document states: "This premarket notification describes a smaller size of Triathlon™ Cruciate Retaining Tibial Insert. This smaller size insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ CR Femoral component in primary or revision total knee arthroplasty." It then lists the intended use, which is identical to the predicate device. This confirms that the submission is for a minor modification (new size) to an existing, cleared device, and thus leverages the predicate's established safety and effectiveness. Studies demonstrating performance against acceptance criteria are typically not required for such modifications; rather, the focus is on showing that the new size does not introduce new safety or efficacy concerns compared to the predicate.

Ask a specific question about this device