(31 days)
The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
The LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier is a sterile, single patient use, disposable surgical instrument designed to provide a means of ligation through an appropriately sized trocar. The instrument configuration consists of a pistol grip hadle, an actuation trigger, a rotation knob, a shaft having an outer diameter of 5.5mm and a length of 33cm. At the distal end of the shaft is a set of jaws for forming ligating cligs. The device contains 15 clips.
The provided text describes a 510(k) premarket notification for the LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier. The submission asserts substantial equivalence to a predicate device based on similar intended use and operation.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | "All testing results demonstrated satisfactory performance." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be bench testing. The country of origin and whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Number of Experts: Not applicable, as ground truth typically refers to clinical data or expert review for diagnostic devices. This device is a surgical instrument.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This is a surgical instrument, not a diagnostic device requiring adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices to assess human reader performance with and without AI assistance. This device is a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Study: Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable in the traditional sense for diagnostic AI. For a surgical instrument, "ground truth" would relate to its mechanical function and safety. The text states "Bench testing was performed to ensure that the device performs as intended," implying functional and performance tests.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a surgical instrument, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
Summary of the Study:
The document states: "Bench testing was performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance." This indicates that the study was limited to bench testing, which assessed the device's mechanical and functional performance, likely against internal specifications or engineering requirements. The specific acceptance criteria and detailed results of this bench testing are not provided in the summary. The basis for clearance is substantial equivalence to an existing predicate device, implying that its performance is considered acceptable if it performs comparably to the predicate for its intended use.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.