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The Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.

The Polypectomy Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a threering handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.

The document provides a 510(k) summary for the "Rotatable Snares, Non-Rotatable Snares" device (Polypectomy Snare). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent clinical performance studies. Therefore, much of the requested information regarding AI device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies is not applicable to this submission type and the provided documentation.

However, the document does contain information about performance testing to ensure the device meets specified criteria.

Here's a summary of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." A summary of the tests performed is provided, implying that the device successfully met the acceptance criteria for these tests. The specific quantitative acceptance criteria for each test are not detailed in this summary document, but the device is reported to have met them.

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

• Sample Size: The document does not specify the sample sizes used for each of the in-vitro performance tests. It only states that "all components, subassemblies, and/or full devices" underwent testing.
• Data Provenance: The tests are in-vitro, meaning they were performed in a lab setting. The country of origin of the data is not explicitly stated for each test, but the manufacturer is based in Hangzhou, Zhejiang, China. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

• This information is not applicable. The performance testing described is in-vitro engineering and biocompatibility testing, not clinical studies requiring expert ground truth for diagnostic or prognostic purposes.

4. Adjudication method for the test set

• This information is not applicable. The tests performed are objective measurements against predefined specifications, not subjective assessments requiring adjudication.

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

• This information is not applicable. The device is an endoscopic accessory (polypectomy snare), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This information is not applicable. The device is a physical medical instrument, not an algorithm, and therefore there is no standalone algorithm performance to evaluate.

7. The type of ground truth used

• The "ground truth" for the performance tests outlined (e.g., working length, tensile strength, electrical resistance, biocompatibility, sterilization residuals) is defined by established engineering specifications, international standards (ISO, ASTM, AAMI/ANSI), and regulatory guidance, rather than expert consensus, pathology, or outcomes data. For example, ISO 11135 defines acceptable EO residual levels.

8. The sample size for the training set

• This information is not applicable. The device is a physical medical instrument, not an AI model, and therefore there is no training set.

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

• This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

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The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.

The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.

This document is a 510(k) premarket notification for a medical device called "Rotatable Snares" from Boston Scientific Corporation. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness via clinical studies with acceptance criteria in the same way one would for a novel device or a PMA.

Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test sets (in the context of clinical data), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not typically found or required in a 510(k) submission for a device like this, especially when the changes are related to ergonomic improvements and not a fundamental change in the intended use or technology.

However, I can extract the information provided regarding performance data from the document:

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

The document states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." It then lists the tests performed. While specific numerical acceptance criteria and reported values are not provided in the summary, the conclusion is that the device met all specifications.

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

This document describes in-vitro testing, not clinical studies with patients. Therefore, the concept of sample size for a "test set" in the context of clinical data, country of origin, or retrospective/prospective data is not applicable here. The testing was performed on components, subassemblies, and/or full devices in a laboratory setting.

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. The tests performed are engineering/performance specification tests (e.g., electrical safety, tensile strength), not diagnostic or interpretative tasks requiring expert consensus.

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

Not applicable. The tests are objective measurements against predefined 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

Not applicable. This is for an endoscopic snare, not an imaging or AI-assisted diagnostic device.

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

Not applicable. This is for an endoscopic snare, not an algorithm.

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

For the in-vitro testing, the "ground truth" would be the defined engineering specifications or performance standards for each test category (e.g., a specific tensile strength value, acceptable electrical resistance range, proper actuation of the snare).

8. The sample size for the training set

Not applicable. This document refers to in-vitro testing for an existing device with an ergonomic modification, not a machine learning model requiring a training set.

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

Not applicable. As above, this is not a machine learning context.

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