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The EES Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Ethicon Endo Surgery® Slotted Anoscope consists of a transparent plastic disposable anoscope in sterile condition. The Slotted Anoscope comprises a cylindrical body, with a closed end conical-shaped distal tip and a longitudinal open channel that accommodates a removable slide. The removable slide comprises a longitudinal open channel of 11mm in width. The body of the Slotted Anoscope has an outer diameter (OD) of 34mm. The Slotted Anoscope is a single patient use device.

The transparent characteristics of the material used in the Slotted Anoscope allows for visualization of the tissue in contact with the device in the anal canal. The opening in the removable slide provides access to tissue in the canal. The removal of the slide provides a wider margin of access to the targeted area.

The provided 510(k) summary for the Ethicon Endo-Surgery® Slotted Anoscope (K093896) indicates that it is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (such as sample size for test set, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable in this context.

The device is a simple, transparent plastic anoscope with a removable slide for physician use to examine the anal sphincter and anus. Its clearance is based on substantial equivalence to a predicate device (Sapimed Self Light Disposable Anoscope, model A.4083, K070913).

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on substantiating that the new device has "the same technological characteristics" as the predicate, with only "minor difference" in the width of the open channel. The acceptance criteria are implicitly that these minor differences do not affect safety or performance.

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

Not applicable for this type of medical device clearance. The evaluation was based on bench testing and preclinical laboratory evaluations, not a clinical study with a human test set.

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

Not applicable. No ground truth in the sense of expert consensus on clinical data was established for a test set.

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

Not applicable.

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. The device is not an AI/ML algorithm.

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

Not applicable.

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

For this device, the "ground truth" equivalent would be engineering specifications and functional performance metrics confirmed through bench testing and preclinical laboratory evaluations to ensure the device performs as intended and is substantially equivalent to the predicate. This is based on physical and functional characteristics, not clinical outcomes data or expert interpretation of images.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm, and thus no training set was used.

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

Not applicable.

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