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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

The Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove product line is a two piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. The system is composed of one type of femoral and two types of patellae. The system can be used with any commercially available Biomet® Tibial Tray, Vanguard™ CR, CR-L, or AS bearing, or augment.

The femoral component is cruciate retaining (CR) in both left and right configurations. The femoral implants are available in both Interlok® and porous finish. The sizes of femoral implants range from: 55 - 80mm.

Two different all-polyethylene patellae designs will function with the new femoral components a round, modified dome and a medially offset patella. Both designs have 3-pegs, concentric grooves, and cement pockets for cement fixation.

The provided document is a 510(k) summary for the Biomet Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove knee replacement system. It details the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data.

Here's why and what information is missing:

• Non-Clinical Testing: The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This generally refers to bench testing (e.g., mechanical strength, wear resistance) rather than clinical performance measured against acceptance criteria. The specific acceptance criteria for these non-clinical tests and the detailed results are not provided in this summary.
• Clinical Testing: Crucially, the document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." This means no human studies were conducted or provided to the FDA to demonstrate the device's clinical performance.

Therefore, I cannot provide the requested table or detailed information on studies that prove the device meets acceptance criteria because such information is not present in the provided text.

Based on the available text, here's what can be inferred or stated about the lack of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document mentions non-clinical testing for "functional within its intended use," but no specific performance metrics or acceptance criteria are detailed.
2. Sample Size used for the test set and the data provenance: This information is not provided as no clinical test set was used for substantial equivalence. For non-clinical tests, details of the sample size are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as no clinical test set was used.
4. Adjudication method for the test set: This information is not applicable as no clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. The document states "Clinical Testing: None provided as a basis for substantial equivalence."
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 medical implant (knee prosthesis), not an algorithm or AI.
7. The type of ground truth used: This information is not applicable as no clinical studies are mentioned. For non-clinical (bench) testing, "ground truth" would typically refer to engineering standards or material properties, but these details are not provided.
8. The sample size for the training set: This information is not applicable as no clinical studies or AI/algorithm development (which would require a training set) are described.
9. How the ground truth for the training set was established: This information is not applicable for the same reasons as above.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices primarily through technological characteristics (material, design, sizing, indications) and non-clinical bench testing. It explicitly states that no clinical testing was provided as a basis for this equivalence.

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