(263 days)
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."
| Metric / Characteristic | Acceptance Criteria (Predicate Device K172729) | Reported Device Performance (Proposed Polypectomy Snare) |
|---|---|---|
| Principles of Operation | Snare delivers monopolar electrical current to cut and cauterize tissue. | Same, plus cold indication (mechanical cutting) and removal of specified Hemoclip. Bench tests conducted to demonstrate substantial equivalence for these additions. |
| Snare Open Width | 10mm, 15mm, 25mm, 32mm | 10mm, 15mm, 25mm, 32mm |
| Electrode Shape | Oval, hexagon, polygon, round, duck bill | Oval, shield, diamond, hexagon, polygon, round, crescent |
| Loop Length | 28mm, 32mm, 50mm, 63mm | 16mm, 22mm, 30mm, 31mm, 45mm, 50mm, 52mm, 60mm |
| Loop Area | 225mm², 330mm², 850mm², 1335mm² | 130mm², 135mm², 140mm², 210mm², 245mm², 250mm², 400mm², 650mm², 790mm², 830mm², 1050mm², 1250mm² |
| Usability Performance | 7 specific tests (Durability of mechanical resection; Extension and retraction of snare loop; Rotation degree of snare loop; Tilting length; Change of loop width; Durability of snare loop wire-Pull force of keeping required width; Durability of snare loop wire-Service life of snare loop). | 9 specific tests (includes all 7 from predicate, plus Disassembly performance; Mechanical cutting force). All test results show the proposed device is as safe and effective as the predicate. |
| Electrical Safety | Meets requirements of IEC 60601-1:2005+A1:2012, IEC 60601-2-2:2009, and IEC 60601-2-18. | Meets requirements of IEC 60601-1:2005+A1:2012, IEC 60601-2-2:2017, and IEC 60601-2-18. |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 |
| Sterility | Complies with ISO 11135 | Complies with ISO 11135 |
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.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).