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The Sapimed Self Ligh®t Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit varying clinical needs. Illumination is provided by either coldlight source GLF 100 or pen-light. The anoscopes are provided in the following configurations: Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination. Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either coldlight source GLF 100 or pen-light. Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc. Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument. ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide

The provided text is a 510(k) summary for the Sapimed Self Light Disposable Anoscope. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results typical of clinical efficacy or analytical validation studies for novel devices.

Therefore, many of the requested elements for a performance study (like sample size, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The assessment of this device is based on its similarity to previously cleared devices.

Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, explicit "acceptance criteria" for a performance study in the sense of accuracy, sensitivity, specificity, etc., are not defined because it's a substantially equivalent submission for a physical instrument, not a diagnostic or AI-driven device. The "performance" assessment is based on demonstrating similar fundamental characteristics, intended use, and safety/efficacy to predicate devices.

Regarding the Absence of Performance Study Details:

The provided document is a 510(k) summary for a medical device (anoscope), which is a physical instrument. It is not an AI/ML-driven diagnostic or imaging device. Therefore, a "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, accuracy, or reader studies, is generally not required or presented for this type of submission.

The "acceptance criteria" here relate to demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and physical properties (like material, sterility, shelf life) to legally marketed predicate devices. The "study" that proves this is primarily the comparison to predicates, biocompatibility testing, and shelf-life testing, as mentioned.

Let's address the specific numbered points based on the nature of this submission:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This submission does not involve a "test set" or clinical performance data in the typical sense for a diagnostic device. The evaluation is based on engineering principles (material properties, design), biocompatibility testing results (which would involve samples of the device material), and accelerated aging studies (which use samples of the final product). The provenance of data for these engineering tests is generally from the manufacturer's testing facilities (SAPIMED S.P.A., Alessandria, ITALY).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. No "ground truth" establishment by medical experts for a test set is part of this type of device submission. The safety and effectiveness are established through comparison to predicates and standard engineering/biocompatibility testing managed by qualified laboratory personnel.

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

• Not Applicable. No "test set" and thus no adjudication method for expert review of cases.

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 device is a manual, physical instrument, not an AI-driven system. Therefore, no MRMC study was conducted or is relevant.

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

• Not Applicable. This is not an algorithm-only device.

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

• Not Applicable. The "ground truth" for the characteristics assessed (e.g., biocompatibility) would be defined by the results of the ISO 10993 tests themselves against established acceptable limits for those tests. For shelf-life, the ground truth is the physical and material integrity of the device over time demonstrated by accelerated aging.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. No training set.

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