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The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• · inflammatory degenerative joint disease including rheumatoid arthritis;
• · correction of functional deformity:
• · revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.

The Responsive Orthopedics Total Knee Arthroplasty System is a total knee system for the restoration of alignment, stability and range of motion, and alleviation of pain, by replacing the articulating surfaces of the knee joint. The system includes femoral, tibial and patellar components available in cruciate retaining, ultra-conforming cruciate sacrificing, medial-pivot cruciate sacrificing and posterior stabilizing versions.

This document is a 510(k) summary for the Responsive Orthopedics Total Knee Arthroplasty System. It serves as a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already legally marketed. As such, it focuses on demonstrating equivalence rather than proving novel efficacy or meeting specific acceptance criteria based on clinical outcomes.

Therefore, many of the requested items related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) are not applicable to this type of device submission. This device is a prosthetic implant, and its performance is evaluated through bench testing to ensure mechanical properties and safety are comparable to existing, legally marketed devices.

Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing the closest relevant points:

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

This document does not present "acceptance criteria" or "reported device performance" in the typical sense of a diagnostic or AI device's clinical efficacy. Instead, it relies on demonstrating substantial equivalence to predicate devices through various bench tests that ensure the mechanical integrity and safety of the knee implant. The "acceptance criteria" here are implicitly the standards set by the predicate devices and the relevant ASTM standards for mechanical performance. The "reported device performance" is that it passed these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: This is not applicable in the context of clinical testing for diagnostic performance. For the bench tests, the "sample size" would refer to the number of physical device components tested, but this specific number is not provided in the summary.
• Data provenance: Not applicable to this type of bench testing. The testing is performed on physical prototypes of the device.

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

Not applicable. Ground truth as established by experts (e.g., radiologists) is for diagnostic devices where human interpretation is involved. This device is a mechanical implant subjected to engineering tests.

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

Not applicable. Adjudication methods are relevant for clinical studies, particularly for diagnostic accuracy, which is not the focus of this submission.

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 is not an AI/diagnostic device.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this device's performance is compliance with established engineering and material standards (e.g., ASTM F1800, F648, F1223, F2083, F1814) and demonstrating mechanical properties comparable to the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve a machine learning "training set".

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