(271 days)
The LiNA Loop is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectorny. It is used with standard electrosurgical generators.
The LiNA Loop is a 5 mm laparoscopic instrument. It is available with two different loop dimensions; 160mm x 80mm and 200mm x 100mm. The outer 15mm on each side of the loop are not insulated i.e. the monopolar cutting area length is totally 30mm. The device is sterile for single use and is compatible with all standard electrosurgical generators that have a monopolar outlet.
The provided document is a 510(k) premarket notification for a medical device called the "LiNA Loop." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.
Therefore, the document explicitly states: "No clinical tests have been performed." This means there is no study described that proves the device meets acceptance criteria in the way a clinical trial would for novel, high-risk devices or software. The acceptance criteria and "device performance" in this context refer to the electrical and safety testing conducted to show the device functions as intended and is safe under those specific conditions, without involving human patients.
Here's a breakdown based on the provided information, addressing your points where applicable but also highlighting what is not available due to the nature of this submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Deemed safe under tested conditions |
- Explanation: The document states "Test data include electrical testing which deems the LiNA Loop to be safe under those conditions." This indicates that the device's electrical properties met the predefined safety standards or criteria for electrosurgical devices. Specific numerical acceptance criteria (e.g., maximum leakage current, impedance ranges) and corresponding measured values are not detailed in this summary, but would have been part of the full submission.
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 Test Set: Not applicable in a clinical sense, as no clinical tests were performed. For the electrical testing, the "sample size" would refer to the number of devices tested. This information is not provided in the summary.
- Data Provenance: Not applicable for clinical data. For the electrical testing, the data would have originated from LiNA Medical ApS (Denmark) as part of their internal validation process. The testing would be prospective in the sense that the new device was manufactured and then tested according to a plan.
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. Since no clinical tests were performed, there was no "ground truth" establishment by medical experts in the context of diagnostic or interventional performance on patients. The "ground truth" for the electrical safety testing would be the established engineering and safety standards for electrosurgical devices, evaluated by qualified engineers/technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies when there's a need to resolve discrepancies in expert opinions, especially for subjective assessments. This was not a clinical study.
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 a medical device (monopolar electrosurgical loop), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Electrical Safety Standards/Specifications. The "ground truth" for the non-clinical testing was compliance with established electrical safety standards and the device's own design specifications for safe operation.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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).