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The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of noninflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.

The Pegged Acetabular Component is a full hemispherical metallic shell. The shell has three superiorly places peas or spikes to provide initial fixation and rotational control. The outer surface of the shell is porous coated. The device is to be used in conjunction with Biomet's Ringloc Acetabular Liners. The device may be used in coniunction with any commercially available femoral component.

The provided text is a "Summary of Safety and Effectiveness" for a medical device (Biomet Pegged Acetabular Component) submitted to the FDA in 1997. This document, characteristic of a 510(k) submission, aims to demonstrate substantial equivalence to existing predicate devices, not novel performance or effectiveness studies in the way you might find for a new drug or diagnostic AI.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI-related metrics cannot be found or inferred from this document. This type of submission predates the widespread use of AI in medical devices and focuses on benchmarking against existing, legally marketed devices.

Specifically:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics and acceptance criteria in the manner you've outlined. It focuses on device description, intended use, and potential risks.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI-driven device performance study. This is a traditional medical device (implant).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not a concept relevant to this document.
4. Adjudication method: Not applicable.
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 pre-dates AI medical devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
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.
9. How the ground truth for the training set was established: Not applicable.

The "Summary of Safety and Effectiveness" for the Biomet Pegged Acetabular Component only states that the device is "substantially equivalent to almost all acetabular devices on the market in overall design and intended function" and lists predicate devices. It does not contain any performance studies, clinical trials, or AI-related data that would address your questions.

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