(49 days)
Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.
Sutter Swyng® non-stick bipolar forceps, single-use are electrosurgical instruments. The bipolar forceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.
The provided text describes a 510(k) submission for the Sutter Swyng® non-stick bipolar forceps, single-use. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against pre-defined acceptance criteria for a new AI/software device.
Therefore, many of the requested categories related to AI/software performance (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.
However, I can extract the acceptance criteria and performance data relevant to this medical device's physical and functional properties, as described in the "Non-Clinical Performance Data" section.
Here's the information based on the provided text:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Category) | Reported Device Performance (Conclusion) |
|---|---|
| Electromagnetic Compatibility and Electrical Safety Testing | Pass (Compliance to IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2 shown) |
| Mechanical Strength and Functionality Performance Testing | Pass (Design specifications met) |
| Thermal Effects on Tissue | Pass (Equivalent coagulation performance to predicate device shown through visual comparison and digital morphometric measurement using histology) |
| Sterilization | Pass (Sterility Assurance Level (SAL) 10^-6 achieved in accordance with ISO 11137 via validated gamma irradiation cycle) |
| Shelf Life Testing | Pass (Functional and maintain sterility for up to 3 years in accordance with ISO 11607-1) |
| Biocompatibility Testing | Pass (Compliance to ISO 10993-1) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size:
- For "Thermal effects on tissue," tests were performed in triplicate for three different types of tissue.
- For other tests (Electromagnetic Compatibility, Electrical Safety, Mechanical Strength, Functionality, Sterilization, Shelf Life, Biocompatibility), specific numerical sample sizes are not explicitly stated in the provided text. The text refers to "performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance."
- Data Provenance: The studies were internal to Sutter Medizintechnik GmbH (Germany). The type of study (retrospective or prospective) for the bench tests is not specified, but given their nature, they would be considered controlled laboratory experiments.
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. This submission pertains to physical medical devices and their functional and safety characteristics, not AI/software performance requiring expert ground truth for classification or diagnosis. "Thermal effects on tissue" involved "visual comparison as well as digital morphometric measurement using histology," implying expert evaluation, but the number and qualifications are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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/software device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For "Thermal effects on tissue," the ground truth involved histology for digital morphometric measurement and visual comparison against the predicate device.
- For other tests, the "ground truth" refers to compliance with established international standards (IEC, ISO) and internal design specifications for safety and performance.
8. The sample size for the training set:
- Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/software device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.