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• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid l. arthritis, traumatic arthritis where one or more compartments are involved;
• correction of varus, valgus or posttraumatic deformity; 2.
• correction of revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
  Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated amiliation only cemented and uncemented blological fixation upprication.
  and all polyethylene patellar components are indicated for cemented application only.

The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the Device Description. "The Valleula "The knee joint. They offer increased anterior and posterior replacement on the articular portions of they are to be used with the Vanguard™ CR femoral stablization and the with grouter sagtas components cleared in K915132, both of which were Components citation in 10259 10 the title the new learners and withing any Biomet commercially available patella button.

This document is a 510(k) summary for the Biomet Vanguard™ Anterior Stabilized Tibial Bearings. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

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

Based on the provided document, there are no explicit acceptance criteria or reported device performance metrics in the format of a table related to clinical outcomes. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting clinical trial results against specific performance criteria.

The document states:

• "Risk analysis has demonstrated equivalence between the modified and predicate devices."
• "No clinical testing was necessary to support the claim of substantial equivalence."

This indicates that the equivalence was demonstrated through non-clinical testing and risk analysis, not through performance metrics against pre-defined clinical acceptance criteria.

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

The document explicitly states: "No clinical testing was necessary to support the claim of substantial equivalence."

Therefore, there was no clinical test set, no sample size, and no data provenance from human subjects or patient data. The evaluation was based on non-clinical testing and comparison to predicate devices.

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)

Since "No clinical testing was necessary," there was no clinical test set requiring ground truth established by experts.

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

Since "No clinical testing was necessary," there was no clinical test set and thus no adjudication method for establishing ground truth from clinical data.

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

The document is for a knee prosthesis, not an AI or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

This is a physical medical device (knee prosthesis), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For a physical device like a knee prosthesis, ground truth in design and engineering typically refers to established biomechanical principles, material science properties, and comparison to existing, cleared devices. The document mentions "Risk analysis has demonstrated equivalence between the modified and predicate devices" and that the device "have the same intended use, are made of the same materials and have the same or similar design and sizing as the predicate bearings." This suggests the ground truth was based on:

• Engineering and design specifications: Conforming to established design principles for knee prostheses.
• Material properties: Verifying that the materials meet established standards and are equivalent to those used in predicate devices.
• Biomechanical testing: Although not detailed, "non-clinical testing" would typically include mechanical and fatigue testing to ensure the device performs as expected under simulated physiological conditions. This implicitly relies on an 'engineered' ground truth derived from industry standards and previous device performance.
• Predicate device characteristics: The fundamental premise of a 510(k) is demonstrating substantial equivalence to a device already on the market, meaning the predicate device's safety and effectiveness implicitly serve as a form of "ground truth" for comparison.

8. The sample size for the training set

This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning. The design and manufacturing of the device would follow established engineering and quality control processes.

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

As there is no training set for an AI/ML model, this question is not applicable. The design and validation of the device rely on engineering principles, material science, and comparison to predicate devices, not on data-driven "ground truth" for a training set in the AI sense.

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