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

Polypectomy Snare described in this submission is a sterile, single use devices compatible with the working channel of endoscope. The device is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. The device can remove the specified released Hemoclip. EO sterilization and use for single use only.

The provided text describes a 510(k) summary for the Polypectomy Snare, which is submitted to demonstrate substantial equivalence to a predicate device. This document does not detail acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of the new Polypectomy Snare to an existing one based on technical characteristics, performance data (bench tests), and compliance with medical device standards.

However, I can extract information related to the device attributes and how its performance was evaluated against a predicate device, which can be adapted to the structure of your request if we interpret "acceptance criteria" as meeting or being equivalent to the predicate device's performance, and "study" as the bench testing conducted.

Based on the provided text, here's an attempt to answer your questions by interpreting "acceptance criteria" as the performance of the predicate device and "study" as the bench testing performed for substantial equivalence:

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

Since this is a substantial equivalence submission for a traditional medical device (Polypectomy Snare, not an AI/ML device), the "acceptance criteria" are implied by the performance of the predicate device (K172729) and compliance with relevant standards. The "reported device performance" refers to the results of bench tests conducted on the proposed Polypectomy Snare to demonstrate it is "as safe and effective as our predicate device."

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 refers to "bench tests" and "non-clinical performance tests."

• Sample Size: Not specified in the provided text for any of the individual bench tests. The text mentions "All the test results show that the proposed device is as safe and effective as our predicate device," implying sufficient testing was done, but specific sample numbers are absent.
• Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd., which is based in Hangzhou, Zhejiang, China. The data is prospective, generated specifically for this submission.

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 is not applicable as the submission is for a physical medical device (Polypectomy Snare) and relies on performance bench tests against engineering specifications and predicate device performance, not expert-labeled ground truth like in AI/ML studies.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation of results where adjudication would be necessary. The evaluation is based on objective measurements from bench testing.

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 is not an AI/ML device, and no MRMC comparative effectiveness study was performed. The device is a surgical instrument.

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

This question is not applicable to the Polypectomy Snare, as it is a physical medical instrument requiring human operation, not a standalone algorithm.

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

The "ground truth" for demonstrating substantial equivalence for this device is based on:

• Engineering Specifications: Meeting design specifications for various physical and functional parameters (e.g., snare open width, loop length, usability performance tests like durability, extension/retraction, cutting force).
• Compliance with Standards: Meeting recognized international standards for medical devices (IEC 60601 for electrical safety, ISO 10993 for biocompatibility, ISO 11135 for sterility).
• Predicate Device Performance: Demonstrating performance "as safe and effective as" the legally marketed predicate device (K172729) through comparative bench testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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Polypectomy Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

The polypectomy snare consists of handle, sheath, flexible wire and electrode that is used to remove polys utilizing monopolar RF energy under endoscopic visualization. The rotary snares' cable and polypectomy can be rotated using the rotation actuator on the handle. Polypectomy snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance. The electrode of polypectomy snare has five shapes to be used in clinical practice: Oval, Polygon, Duck Bill, Hexagonal and Round, and the electrode can extend, retract from the snare's flexible outer sheath.

The provided document is a 510(k) summary for a medical device called "Polypectomy Snare." This type of document is a premarket notification to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

The information requested pertains to the acceptance criteria and study for an AI/ML powered medical device. Based on the content of this document, the device in question is a Polypectomy Snare, which is a physical medical device and NOT an AI/ML powered device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are specific to the evaluation of AI/ML software.

The document primarily focuses on:

• Biocompatibility Testing: Evaluating the device's interaction with biological systems using ISO standards.
• Performance Testing (Bench Tests): Assessing physical attributes like appearance, size, material, usability, and electric properties.
• Substantial Equivalence: Comparing the proposed device to a predicate device (Captivator II, Single-Use Polypectomy Snares, K133987) to show it meets the same safety and effectiveness standards.

There is no mention of an algorithm, AI, machine learning, or software performance in the document. The statement "No Clinical Study is included in this submission" further reinforces that this submission does not involve clinical performance data that would be relevant to an AI/ML device.

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The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, and pedunculated polyps within the GI tract.

The proposed device Polypectomy Snare is a sterile, single-use endoscopic device, intended to be used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.

The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop. The proposed device has eighteen (18) specifications; the main differences of these specifications are dimension and if the loop can be rotatable with the rotation of the handle.

The document describes the Micro-Tech (Nanjing) Co., Ltd. Polypectomy Snare, which is equivalent to the GIP/MEDI-GLOBE POLYPECTOMY SNARES cleared under K943935.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but includes a "Comparison of Technology Characteristics" table for substantial equivalence. The "Acceptance Criteria" here are inferred to be "Similar" or "Same" to the predicate device's performance characteristics.

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

The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

It does not provide specific sample sizes for the "test set" for each non-clinical test. The data provenance is primarily from non-clinical testing conducted by Micro-Tech (Nanjing) Co., Ltd. in China. The study is retrospective in the sense that it relies on established standards and comparative data with a predicate device.

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

Not applicable. The ground truth for this device's performance is established through adherence to recognized international and national standards for medical devices and electrosurgical equipment (e.g., ASTM, IEC, ANSI/AAMI, ISO, USP). There is no mention of human experts establishing a ground truth for a test set in the traditional sense of a clinical study.

4. Adjudication method for the test set:

Not applicable. As this is a non-clinical study based on engineering compliance and comparison to a predicate, there is no mention of an adjudication method involving experts. The compliance is against predetermined standards.

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 a non-clinical evaluation of a medical device (polypectomy snare), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI was conducted.

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

Not applicable. This device is a surgical instrument and does not involve an algorithm. The performance is the device's physical and electrical characteristics.

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

The "ground truth" for the non-clinical tests is based on established industry standards and regulatory requirements (e.g., ASTM, IEC, ISO, AAMI, USP) for seal integrity, biocompatibility, electrical safety, sterilization, and material properties. The comparative analysis against the predicate device also serves as a benchmark for equivalence.

8. The sample size for the training set:

Not applicable. This is a non-clinical evaluation of a medical device, not a machine learning model. Therefore, there is no training set in the context of AI.

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

Not applicable, as there is no training set mentioned in the document.

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