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Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

The provided document is a 510(k) summary for a medical device called "Multi-Band Ligator." It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices.

Here's an analysis of the acceptance criteria and the study information as requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format for each test. Instead, it describes the purpose or goal of each test and then generally states that the device "meets the related requirements" or "complied with the Indication for Use."

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

The document does not specify the sample sizes used for any of the bench tests (e.g., how many units were tested for appearance, functional performance, chemical properties, etc.).

The data provenance is from China, as the submitter, Beijing ZKSK Technology Co., Ltd., is located in Beijing, China, and the designated submission correspondent is in Shanghai, China. The testing described is prospective in nature, as it involves testing new units of the device against predefined requirements.

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)

This section is not applicable as the document describes bench testing for a mechanical device, not an AI/imaging device where expert ground truth establishment for a test set would be relevant. The "ground truth" for these tests comes from engineering specifications and industry standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not the type of testing described here. The testing involves objective measurements and compliance with engineering specifications.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical multi-band ligator and not an AI-assisted diagnostic tool or an imaging device involving human readers.

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

No, a standalone (algorithm-only) performance study was not done. This is a mechanical medical device, not an algorithm or software.

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

The "ground truth" for the bench tests described is based on:

• Engineering specifications and design requirements: For functional and mechanical performance, appearance, and physical properties.
• International standards: Such as ASTM F 1980-16 for shelf life and ISO 10993 for biocompatibility.
• Company's technical requirements: For specific mechanical properties of the loop.

8. The sample size for the training set

This is not applicable. The document describes a medical device, not an AI/machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this device.

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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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Used to endoscopically ligate esophageal varices at or above the gastroesophagea1 junction or to ligate internal hemorrhoids.

The Wilson-Cook 10 Shot Multi-Band Ligator consists of a friction fit adapter for attachment to the distal tip of an endoscope, a barrel preloaded with ten (10) ligation bands, a trigger cord and handle for band deployment, an irrigation adapter and a loading catheter. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

This submission focuses on establishing substantial equivalence to a predicate device rather than meeting specific performance acceptance criteria through a dedicated study. Therefore, many of the requested elements (like sample size for test/training sets, expert qualifications, and MRMC studies) are not applicable or explicitly stated in this type of submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not specify numerical "acceptance criteria" in the traditional sense (e.g., a specific percentage success rate, accuracy, etc.) nor does it report specific quantitative device performance against such criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing design, materials, and intended use, and by confirming adequate functional testing.

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

• Sample Size: Not specified. The submission refers to "functional testing" but does not provide details on the number of tests performed or the sample size of devices used in this testing.
• Data Provenance: Not specified. The context suggests internal testing by the manufacturer (Wilson-Cook Medical Inc.) to demonstrate comparability with their own predicate device. It is a retrospective comparison to the results of the predicate device.

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

• Not Applicable. This type of premarket notification for substantial equivalence does not typically involve external experts establishing ground truth for a test set in the way an AI/diagnostic device study would. The assessment is primarily based on engineering and materials comparison, and functional testing to confirm the device operates as intended and is comparable to the predicate.

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

• Not Applicable. There is no indication of a test set requiring adjudication in this submission.

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. An MRMC study was not conducted as this is a medical device for therapeutic intervention (ligation), not a diagnostic or AI-powered device involving "human readers" or "AI assistance."

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

• No. This is not an AI algorithm; it's a mechanical/manual device. Therefore, standalone algorithm performance is not applicable.

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

• Functional Comparability to Predicate Device: The "ground truth" or basis for acceptance is primarily the established safety and effectiveness of the existing predicate device. The new device's functional performance, materials, and intended use are compared to this known predicate. Biocompatibility relies on "history of use in other similar medical devices" and "applicable biocompatibility test results" (which are not detailed here).

8. The sample size for the training set

• Not Applicable. This is not an AI device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to this submission.

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