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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):

Since this is for a mechanical knee implant system (not an AI/software device), most of the requested points related to AI are not applicable. Here's a breakdown based on the provided document:

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

   • As shown above, the acceptance criteria are implicitly defined by the successful completion of the listed non-clinical tests and analyses. The performance is "Met performance standards" or "Acceptable," as detailed in the Notes column. The document doesn't provide specific numerical results of these tests (e.g., how many cycles endured, specific force resistance values) but states they were performed to determine substantial equivalence.

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

   • This concept (test set, data provenance) is typically for AI/software. For mechanical device testing, the "sample size" refers to the number of physical units tested according to each standard. These details are generally found in the full test reports, which are not part of the public 510(k) summary. The "data provenance" would refer to the lab where tests were conducted (e.g., an accredited testing lab).
   • Not explicitly stated in the 510(k) summary.

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

   • This is an AI/software concept. For mechanical device testing, "ground truth" is defined by established engineering and medical device standards (e.g., ASTM, ISO guidelines) and the physical properties and performance characteristics of the materials and design. Expert engineers and quality assurance specialists verify the test results against these standards.
   • Not applicable for a mechanical device.

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

   • This is an AI/software concept for resolving discordant expert opinions. For mechanical testing, test results are typically objective and quantitative, allowing for direct comparison against predefined acceptance criteria from standards.
   • Not applicable for a mechanical device.

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:

   • This is an AI/software concept measuring clinical impact with human-AI interaction. For this mechanical device, the comparison is to legally marketed predicate devices through substantial equivalence, primarily based on design, materials, and non-clinical performance, rather than an MRMC study.
   • No MRMC study was done, as it's not applicable to a mechanical implant.

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

   • This refers to AI performance. For a mechanical device, its "standalone" performance is assessed through the non-clinical benchtop tests listed.
   • The non-clinical tests listed in the summary represent the "standalone" performance assessment of the device.

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

   • For a mechanical implant, "ground truth" for performance is established by engineering principles, material science, and performance standards (e.g., ASTM, ISO). For biocompatibility, the ground truth is established per ISO 10993-1. For MRI safety, it's established by ASTM standards.
   • Ground truth established by relevant engineering and medical device standards.

8. The sample size for the training set:

   • This refers to AI algorithm development. For a mechanical device, there isn't a "training set" in this sense. The training for the design of the device comes from established engineering principles, prior device designs, and material science research.
   • Not applicable for a mechanical device.

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

   • Again, this is an AI concept.
   • Not applicable for a mechanical device.

In conclusion, the Triathlon® Hinge Knee System is a physical implant, and its clearance is based on demonstrating substantial equivalence to existing legally marketed devices through a series of rigorous non-clinical (benchtop) tests and engineering analyses that confirm its material properties, mechanical performance, biocompatibility, and safety (e.g., MRI compatibility, sterility). Clinical testing was explicitly stated as not required for this 510(k) submission, a common occurrence for devices demonstrating substantial equivalence through non-clinical data.

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The MAKO Surgical Corp. Patellofemoral Knee Implant System II is intended to be used in cemented patello-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, 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.

This device consists of a CoCrMo patellofemoral component and an ultra-high molecular weight polyethylene patella components are intended for cemented, one-time use only. The anterior surface of the patellofemoral component is polished and features a trochlear groove. The posterior surface of the patellofemoral and patella component employ features such as cement pockets and pegs for enhanced stability of the prosthesis when cemented onto the femur and patella, respectively.

The provided text describes the MAKO Surgical Corp. Patellofemoral Knee Implant System II and its regulatory clearance, but it does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or comparative effectiveness studies).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you requested, as this information is not present in the provided document.

This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed clinical study results or performance metrics against specific acceptance criteria for a new AI/software-based medical device.

Ask a specific question about this device