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The Apollo™ Revision/Constrained Knee System is intended use in the following diagnostic indications:

• Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
• Correctable valgus-varus deformity and moderate flexion contracture.
• Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
• Revision of previously failed knee arthroplasty.

The Apollo Revision/Constrained Knee System is intended only for use with bone cement in the United States. Uncemented use of the Apollo Revision/Constrained Knee System is considered to be investigational in the United States.

The Apollo™ Revision/Constrained Knee System is a non-porous total knee replacement intended for primary and revision knee surgeries. The components are intended for resurfacing of the knee joint where the posterior cruciate ligament is absent, deficient, or has been removed at the time of surgery. The system is a semiconstrained design and both medial and lateral collateral ligaments must be intact.

The Apollo Revision/Constrained Knee femoral component is manufactured from cobalt chromium/molybdenum alloy (CoCr) with seperate left and right components. Femoral spacers manufactured from Ti-6Al-4V are also available for use with the Apollo Revision/Constrained Knee femoral component.

The Apollo Revision/Constrained Knee tibial components include a baseplate, spacers, and polyethylene insert. The tibial components are also symmetrical in design, eliminating the need for left/right orientations. The tibial baseplate and tibial spacers is manufactured from Ti-6A1-4V. The tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPe). A Ti-6Al-4V pin passing vertically from the constrained condylar (high medial/lateral constraint) eminence of the tibial insert to the tibial baseplate provides additional stability.

The Apollo Revision/Constrained Knee System is to be used with the Apollo all poly patellar components.

The Natural-Knee II Revision Stems may be used with either the Apollo Revision/Constrained Knee System femoral or tibial components.

This device is intended for use with the following previously cleared devices:

• Apollo All-Poly Elliptical Patella
• Apollo PS All-Poly Tibia
• Apollo Posterior Stabilized (PS) Tibial Insert and Apollo Tibial Baseplate
• Apollo All-Poly Single-Lug Patella
• Natural-Knee II Revision Femoral Stems

The Apollo Revision/Constrained Knee Tibial Baseplate may also be used with the Apollo Congruent Tibial Insert. The Apollo Congruent Tibial Insert is not compatible with the Apollo Revision/Constrained Knee Femoral Component.

This document is a 510(k) Summary of Safety and Effectiveness for the Apollo™ Revision/Constrained Knee System. It details product information, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

The 510(k) submission process for medical devices typically focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study in the way a clinical trial for a drug or an AI-powered diagnostic might.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or provide performance metrics for the Apollo™ Revision/Constrained Knee System. The 510(k) submission relies on demonstrating equivalence to predicate devices, which implies that its performance is expected to be similar and safe for its intended use, rather than meeting specific numerical performance targets laid out in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, study, or data provenance is mentioned in this summary.
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, as there is no test set or ground truth mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set mentioned.
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, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a knee prosthesis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This device is a knee prosthesis, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Product Description: Detailing the materials, components, and design of the knee system.
• Intended Use/Indications: Specifying the patient conditions for which the device is intended.
• Substantial Equivalence: Listing predicate devices (Apollo PS Knee System, Kinemax Plus Superstabilizer, PFC TC3) to which the Apollo™ Revision/Constrained Knee System is considered substantially equivalent. This is the core of the 510(k) approval process and implicitly means that the new device is as safe and effective as the predicate devices.
• Limitations/Conditions of Use: The FDA's letter imposes specific limitations, such as the minimum thickness of the tibial insert (8.00 mm polyethylene under the condyles) and the requirement for cemented use only. These are regulatory conditions, not performance acceptance criteria from a study.

To find information on acceptance criteria and performance studies for a medical device like this, one would typically need to look for:

• Design control documentation: Where the manufacturer would define specifications, test methods, and acceptance criteria.
• Verification and Validation (V&V) reports: Summarizing tests performed to ensure the device meets its design specifications and user needs.
• Clinical trial reports (if applicable): Though for a 510(k) device, extensive clinical trials might not be required if substantial equivalence can be demonstrated through other means (e.g., bench testing, material characterization, comparison to predicate device performance history).

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