(205 days)
The LiNA Gold Loop HC is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectomy. It is used with standard electrosurgical generators.
The LiNA Gold Loop HC is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; EL-160-H (160mm x 80mm), EL-200-H (200mm x 100mm) and EL-240-H (240mm x 120mm), with an uninsulated cutting area of 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a monopolar outlet.
The provided document is a 510(k) premarket notification for a medical device (LiNA Gold Loop HC). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data for the modified device itself. Therefore, a significant portion of the requested information (points 1-9) about a device performance study is not available in the provided text.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The document states that "Testing shows that the modified device complies with the same testing requirements as the predicate device" and "The LiNA Gold Loop HC passed all the testing in accordance with national and international standards." However, it does not list specific quantitative acceptance criteria or the reported device performance values against those criteria. The focus is on compliance with standards rather than presenting a performance study with detailed metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided: The document does not mention sample sizes for any specific performance tests. It also does not specify the origin or nature (retrospective/prospective) of any data beyond stating that testing was performed.
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 clinical study involving expert ground truth establishment is described for the modified device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical study or expert review adjudication is mentioned.
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 device is a surgical instrument (electrosurgical loop), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical surgical instrument. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: As no clinical study or expert review for performance was detailed, there's no mention of ground truth types. The document refers to compliance with standards (e.g., ISO10993-1:2009 for biocompatibility, IEC60601-1:2006 for electrical safety, ISO11135-1:2007 for sterilization). The "ground truth" for these would be the specific pass/fail criteria defined within those standards.
8. The sample size for the training set
- Not Applicable: This is not an AI/Machine Learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not applicable.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).