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The Acculoc Total Knee System is indicated in knee arthroplasty for relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.

The Acculoc Tibial tray is a component of "Acculoc Total Knee System" cleared under K170753 which consist of Femoral component, Tibial tray, Tibial Insert, Patella components and Instrumentation- Acculoc Total Knee Instrumentation System for use with the implants components. The current premarket notification is related to the addition of the Acculoc Tibial tray manufactured from CoCrMo alloy (Cobalt-chromium-molybdenum alloy), this is same size and same design with the predicate device tibial tray (K170753) and only the material is different. The Tibial tray AP and ML size ranges are exact same as the predicate device Tibial tray (K170753).

The provided text is a 510(k) premarket notification for a medical device called the "Acculoc Total Knee System." It specifically focuses on an update to this system, adding a new material (CoCrMo alloy) for the Tibial tray component.

This document does not contain information about acceptance criteria for device performance in the context of an AI/ML algorithm or a clinical study proving its performance against such criteria. Instead, it details:

• Device Name: Acculoc Total Knee System
• Regulatory Information: Product code, regulatory class, regulation number.
• Intended Use/Indications for Use: What the device is designed to do and for whom.
• Predicate Devices: Previously cleared devices that the current one is being compared against for substantial equivalence.
• Device Description: Information about the components and materials.
• Performance Testing: Refers to mechanical and pyrogenicity testing of the physical implant components against relevant ASTM/ISO standards, not clinical performance or performance of a diagnostic algorithm. This is typical for orthopedic implants to demonstrate safety and durability.

Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance because the provided text does not describe such a study or requirements. The "performance testing" mentioned is for the physical knee implant itself, not an AI or diagnostic device.

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The Acculoc Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.

The Acculoc Total Knee System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a Patellofemorotibia, polymer.metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.

This document describes the Acculoc Total Knee System, a medical device for knee arthroplasty. The information provided is primarily focused on its 510(k) submission for substantial equivalence to other legally marketed devices. Therefore, the details regarding specific acceptance criteria, performance studies with reported metrics, and related methodology are presented in a manner typical for such submissions, which may not align directly with the detailed breakdown requested for AI/algorithm-based devices.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance values like a typical AI/algorithm efficacy study would. Instead, it states that the device was tested for various performance aspects and performs as well, or better than, predicate devices. The acceptance is based on demonstrating substantial equivalence to these predicates.

2. Sample size used for the test set and the data provenance

The document describes performance testing of mechanical properties of the device components (fatigue, strength, etc.) rather than clinical data or a "test set" in the context of an AI/algorithm. Therefore, concepts like patient sample size or data provenance (country, retrospective/prospective) are not applicable to the reported testing. These tests typically involve a defined number of physical samples of the device components undergoing simulated wear and stress conditions in a lab. The specific number of samples for each test is not provided in this summary.

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

This question is not applicable. The "ground truth" for mechanical performance tests of a knee implant is established by engineering specifications, material science standards (e.g., ASTM F75, F136, F648), and comparison to predicate devices, not by expert human interpretation of data like in image analysis.

4. Adjudication method for the test set

This question is not applicable, as there is no "test set" in the sense of clinical data requiring expert adjudication. The assessment is based on physical testing against engineering standards and comparison with predicate devices.

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 question is not applicable. The Acculoc Total Knee System is a physical medical implant (prosthesis), not an AI algorithm or a diagnostic tool that involves "human readers" or AI assistance.

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

This question is not applicable as the device is a physical medical implant.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering standards and material specifications (e.g., ASTM F75 for CoCrMo Alloy, ASTM F136 for Ti-6Al-4V ELI, ASTM F648 for UHMWPE), and comparative performance metrics against legally marketed predicate devices under simulated physiological conditions.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reason as above.

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