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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):

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The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include:

1. Post-traumatic arthritis;
2. Degenerative arthritis; and
3. Failed osteotomies and unicompartmental replacement.
   These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

The Smith & Nephew, Inc. Journey Select Knee System is composed of existing unicompartmental femoral components, patellofemoral implant components, and unicompartmental tibial components previously cleared by FDA. These components may be used in various combinations to create a bicompartmental knee replacement prosthesis and allow the physician to choose the most appropriate option to treat the patient.

This document is a 510(k) premarket notification for the "Smith & Nephew, Inc. JOURNEY Select Knee System." It is a submission for a medical device that aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria and proving performance through a study in the same way one would for a novel device with a new intended use.

Here's an analysis based on the provided text, addressing your questions to the best of my ability given the nature of a 510(k) summary:

The core of this document is a claim of "Substantial Equivalence," not a study proving the device meets specific performance acceptance criteria via a clinical trial or algorithm performance study. The device is a combination of existing components already cleared by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and the results of a performance study proving adherence to them are not explicitly detailed in the provided text in the manner you might expect for a novel device. Instead, the "performance" is demonstrated through substantial equivalence to predicate devices and mechanical testing.

Regarding Questions 2-7, 8, 9, these types of studies and details are generally not part of a 510(k) submission for substantial equivalence based on mechanical testing and existing components.

• No clinical study to establish these points was conducted for this 510(k) submission. The entire premise of a 510(k) is to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate).

Specifically:

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 this type of 510(k) submission, as it relies on mechanical testing of components and equivalence to existing devices, not a clinical "test set" of patient data.

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. Ground truth as typically defined for diagnostic or prognostic devices (e.g., expert interpretation of images) is not relevant here. The ground truth for this device's safety and effectiveness is established by the prior FDA clearances of its individual components and the predicate devices.

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

• Not applicable. No clinical test set with adjudicated outcomes or diagnoses was described.

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 knee prosthesis system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a knee prosthesis system, not an algorithm.

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

• The "ground truth" in the context of this 510(k) is effectively the prior FDA clearance and established safety/effectiveness profiles of the individual components and the predicate devices. Mechanical testing also serves as an engineering "ground truth" for the device's physical capabilities.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this 510(k) for a knee prosthesis system.

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

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a new combination of existing, cleared components for a knee prosthesis system. The "proof" it meets acceptance criteria (primarily safety and effectiveness) is primarily through demonstrating substantial equivalence to predicate devices that are already legally marketed and through mechanical testing showing the integrated system can withstand expected in-vivo loads. It does not involve a clinical efficacy study with patient data, expert ground truth, or AI performance metrics as would be seen for a diagnostic or prognostic device or a novel therapeutic with new mechanism of action.

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