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The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy.

The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. The Dispos-A-Scope has 11cm speculum length enabling visualization of the ano-rectal canal. The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument. The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic. The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage. The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology. The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures. The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation.

This submission for the Dispos-A-Scope does not contain information about a study proving the device meets specific acceptance criteria in the manner typically associated with AI-driven medical devices or complex diagnostic tools.

Instead, the provided text is a 510(k) summary for a disposable anoscope, which is a physical medical device. The "acceptance criteria" discussed are primarily related to general device characteristics, material safety, and functionality, rather than quantitative performance metrics from a clinical study. The "study" mentioned is the USP Class VI testing for the resin, which is a biocompatibility standard, not a performance study in the traditional sense of comparing a device's diagnostic output against a ground truth.

Therefore, many of the requested categories for a study (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to the evaluation of algorithms or diagnostic efficacy, which is outside the scope of this particular device's submission.

Here's an attempt to address the request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to USP Class VI testing for the resin material. This is a standard battery of biocompatibility tests conducted on materials to demonstrate their safety for medical device use.

• Sample Size for Test Set: Not specified in this document. USP Class VI testing involves standardized tests on biological systems, often using a certain number of animal subjects (e.g., mice, rabbits) or cell cultures per test, depending on the specific battery of tests performed (e.g., systemic toxicity, intracutaneous reactivity, implantation). The document only states that the resin "has passed" this testing.
• Data Provenance: Not specified, but generally, such testing would be conducted in a laboratory setting, typically in the country of manufacture or a certified testing facility. It is a prospective test specifically for the material in question.

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

Not applicable. USP Class VI testing involves standardized biological response evaluations, not expert clinical interpretation of results. The "ground truth" is defined by the passing criteria of the USP (United States Pharmacopeia) standards.

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

Not applicable for USP Class VI testing. The results are typically quantitative measurements and observations against predefined criteria, not subjective interpretations requiring adjudication.

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 is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the material safety aspect, the "ground truth" is defined by the passing criteria outlined in the USP Class VI standard for biocompatibility and toxicity. For the functional aspects (e.g., ergonomic handle, operative port), the implicit ground truth is that the device possesses these features as designed and these features contribute to the device's intended use and substantial equivalence to predicate devices. There is no external "ground truth" in the sense of pathology or outcome data generated by this device's use that is presented here.

8. The sample size for the training set

Not applicable. The specific device described is a physical anoscope, not an AI model requiring a training set.

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

Not applicable. There is no AI model or training set discussed in this document.

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