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total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect.

The Richards Total/Partial Prosthesis and the predicate devices both have trimmable shafts made of Plasti-Pore and heads that may be tilted for proper angulation against the tympanic membrane. The Richards Total/Partial Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes a medical device (Richards Total/Partial Prosthesis) and establishes its substantial equivalence to a predicate device. It does not contain any performance metrics or acceptance criteria as would be found in a study for an AI/software device. It's a 510(k) notification for a physical medical device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable to the provided document. The 510(k) notice is for a physical device and doesn't involve a "test set" in the context of AI or software performance evaluation. The device type means there is no data provenance in this case.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided document. Ground truth for a test set is relevant to AI/software performance, not a physical prosthesis.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document.

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

This information is not applicable to the provided document. An MRMC study is for evaluating AI-assisted workflows in diagnostics, which is not relevant to a physical prosthesis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable to the provided document. "Standalone performance" in this context refers to AI algorithm performance, which is not relevant to a physical prosthesis.

7. The Type of Ground Truth Used

This information is not applicable to the provided document.

8. The Sample Size for the Training Set

This information is not applicable to the provided document. "Training set" is relevant to machine learning, not a physical medical device submission like this one.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable to the provided document.

Summary of Document Relevance:

The provided document is a 510(k) premarket notification for a physical medical device, the "Richards Total/Partial Prosthesis." This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device. It highlights the device's materials, indications for use, and design similarities.

The questions you've asked (about acceptance criteria, test sets, experts, MRMC studies, standalone performance, training sets, and ground truth) are highly relevant to the evaluation of AI/software medical devices. They are not applicable to this particular hardware device submission from 1996. The document's purpose is to show that the new device is as safe and effective as existing ones, primarily through material composition and function, rather than through performance metrics derived from a study involving data and algorithms.

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