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The ORTHO® ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.

The ORTHO® ALL-FLEX® Diaphragm (arcing spring), is a molded, buff-colored, shallow silicone rubber cup with a flexible rubber covered spring rim. The ORTHO® ALL-FLEX® Diaphragm vaginal diaphragm contains a distortion-free, dual spring-within-a-spring that provides unique arcing action no matter where the rim is compressed. It is appropriate for use not only where ordinary diaphragms are indicated, but also in patients with mild cystocele, rectocele or retroversion.

The provided text is a 510(k) summary for the ORTHO® ALL-FLEX® Diaphragm. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this type of document, as they are not the primary focus of a 510(k) for a diaphragm. A 510(k) of this nature typically relies on comparisons of technological characteristics to existing legally marketed devices.

However, I can provide what information is available and indicate where the requested information is not present or not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or reported device performance in terms of contraceptive efficacy rates (e.g., Pearl Index) as would be demonstrated in a clinical trial. Instead, it demonstrates substantial equivalence by comparing technological characteristics and intended use.

The "acceptance criteria" here are implicitly meeting the functional and safety characteristics of the predicate devices.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of performance evaluation (e.g., a clinical trial with a specific number of subjects). The evaluation is based on a comparison of the device's technical specifications and intended use against legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. As no clinical "test set" with ground truth determination is described, this information is not applicable. The substantial equivalence determination is made by the FDA based on the provided technical information and comparison to predicates, not by experts establishing clinical ground truth for a test set.

4. Adjudication method for the test set

N/A. No clinical "test set" or adjudication process described.

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

N/A. This device is a physical medical device (diaphragm) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

N/A. This is a physical non-AI device.

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

N/A. For a 510(k) of this nature, the "ground truth" for substantial equivalence is based on established technical standards and the performance of legally marketed predicate devices. Clinical outcomes data or expert consensus for the new device's performance is not part of this 510(k) summary, as it's not a new technology requiring such a demonstration for initial market clearance under the substantial equivalence pathway.

8. The sample size for the training set

N/A. This is a physical non-AI device; therefore, there is no "training set" in the context of machine learning.

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

N/A. No training set is applicable.

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