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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.

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