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The ShortShot Saeed Hemorrhoidal MultiBand Ligator with TriView Anoscope is used to ligate internal hemorrhoids facilitated by an anoscope, for use in adult patients only.

The ShortShot Saeed Hemorrhoidal Multi-Band Ligator consists of a polycarbonate barrel attached to the tip of a polycarbonate handle. The barrel is preloaded with four (4) latex rubber ligation bands, and a trigger cord is utilized for deployment of the bands. The TriView Anoscope consists of transparent polystyrene Anoscope and Obturator. The TriView Anoscope enables the physician to dilate the anal canal, to complete a visual examination of the anal-rectal anatomy, and isolate the internal hemorrhoids for ligation using the ShortShot Saeed Hemorrhoidal Multi-Band Ligator.

The provided 510(k) summary for the "ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope" does not contain information about explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device, rather than providing independent performance metrics against predefined acceptance criteria.

Therefore, many of the requested fields cannot be filled as the information is not present in the document.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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 / Not provided. The summary makes no mention of a specific test set or clinical study with a defined sample size for the new device's performance. The "performance data" mentioned refers to the comparison with predicate devices, not a new study.

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 / Not provided. No test set or ground truth establishment by experts is described for this submission.

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

• Not applicable / Not provided. No test set or adjudication process is 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:

• No. This device is a mechanical ligator and anoscope, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its type.

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

• No. This device is a mechanical medical instrument, not an algorithm.

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

• Not applicable / Not provided. As no new performance study is described, there's no ground truth established for the new device. The device's "effectiveness" is inferred by its substantial equivalence to already cleared devices.

8. The sample size for the training set:

• Not applicable / Not provided. This is not a machine learning or AI device, so there is no concept of a "training set."

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

• Not applicable / Not provided. See above.

Summary of the Study (or lack thereof):

The submission for the "ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope" relies on a substantial equivalence comparison to two predicate devices:

• Ligator component: Deemed "identical" to the currently marketed predicate device (Wilson-Cook Multiple Band Ligator, K020526).
• Anoscope component: Deemed "substantially equivalent" to the currently marketed predicate device (O'Regan Disposable Anoscope, K020702).

The "study" in this context is the comparison of the proposed device's characteristics (Intended Use, Indications for Use, performance characteristics, and sterility) against those of the predicate devices. The document states that based on this comparison, the manufacturer believes the proposed device is substantially equivalent. This type of submission generally does not require new clinical performance data if substantial equivalence can be demonstrated through design, materials, and intended use comparison.

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