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The family of THD disposable Anoscope, Proctoscope and Rectoscope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The family of THD Disposable Anoscope, Proctoscope and Rectoscope are designed for the examination and treatment of the anal (anoscope) and recturn (proctoscope and rectoscope) examination. The devices consist of transparent plastic anoscope. proctoscope or rectoscope for diagnostic or therapeutic use. The family of THD disposable Anoscopes, Proctoscopes and Rectoscope is made by 2 categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscope and Surgical Proctoscopes. The family of THD disposable Anoscopes, Proctoscopes and Rectoscope consist of the evolution of the family of THD disposable Anoscope and proctoscope previously cleared (K080132). As in the previous submission, this family is provided with two accessories for illumination the "Shining Light" and the "pen light".

Here's a breakdown of the acceptance criteria and study information for the THD Disposable Anoscope, Proctoscope, and Rectoscope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes a medical device modification and subsequent 510(k) submission, not a clinical study involving a "test set" of patient data. The "test performed" refers to design verification and validation activities. Therefore, information on sample size for a patient test set or data provenance (country of origin, retrospective/prospective) is not applicable in this context. The tests relate to the physical device itself.

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

Similar to point 2, this is not applicable. Ground truth, in the context of expert consensus, typically refers to diagnostic accuracy studies or evaluations of imaging. For a physical medical device like an anoscope, proctoscope, or rectoscope, "ground truth" is established by engineering and biocompatibility standards, not expert consensus on patient data.

4. Adjudication method for the test set:

Not applicable. There was no "test set" in the sense of patient data requiring adjudication.

5. If a multi-reader multicase (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 document describes a traditional medical device (an anoscope/proctoscope/rectoscope), not an AI-powered diagnostic tool or a device that impacts human reader performance.

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

Not applicable. This device is a physical instrument for examination, not an algorithm.

7. The type of ground truth used:

For this type of device modification, the "ground truth" for the tests performed can be characterized as:

• Engineering and Design Specifications/Standards: For "Dimensions of the proctoscope" and "Design verification," the ground truth would be precise engineering specifications for the device's physical attributes, ensuring it meets functional and safety requirements.
• Regulatory Standards (Biocompatibility): For "Materials of the tip of new size devices" and "Biocompatibility," the ground truth is established by recognized medical device material standards (e.g., ISO 10993 series) that define "Medical Grade material" suitable for contact with human tissue.
• Regulatory Standards (Sterilization): For "Sterilization of the rectoscopes" and "Sterilization Validation," the ground truth is defined by validated sterilization cycles and regulatory standards (e.g., ISO 11135, ISO 11137) that ensure the device is sterile when provided for use.

8. The sample size for the training set:

Not applicable. This document describes physical device modifications and their associated validation, not an AI model or machine learning algorithm that requires a "training set."

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

Not applicable. As mentioned above, there is no "training set" in this context.

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