(184 days)
The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.
The Autosuture™ ENDO CLIP™ III 5mm Clip Applier contains 18 titanium clips. The applier is designed for introduction and use through an appropriately sized Trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
The provided text describes a 510(k) summary for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. However, it does not contain the specific details required to answer all aspects of your request, particularly regarding acceptance criteria, device performance, sample sizes, and expert qualifications for ground truth establishment in a study context. This document focuses on demonstrating substantial equivalence to a predicate device for an updated indication.
Here's the information that can be extracted and a note on what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "In-vitro and in-vivo animal tests were performed to support the inclusion of 'manipulation of tissue and the dissection of blood vessels and other tubular structures' to the general indications for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier."
Without access to the full test reports, specific acceptance criteria and detailed performance metrics are not provided in this summary. The summary only indicates that tests were performed to support the new indication.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in-vitro and in-vivo animal tests."
- Sample Size: Not specified for either in-vitro or in-vivo tests.
- Data Provenance: "in-vivo animal tests" imply animal data. The country of origin is not specified, but the submission is from the United States Surgical, a division of Tyco Healthcare Group LP in Norwalk, CT, USA. The study type (retrospective or prospective) is not explicitly stated, but typically these types of tests for 510(k) submissions would be prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a surgical clip applier, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would. The performance is assessed through mechanical and biological (animal) testing.
4. Adjudication Method
Not applicable for a device performance study of this nature. Adjudication is typically used for expert consensus in diagnostic ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI image analysis or diagnostic tools involving human readers. This document describes a physical medical device (clip applier) and its performance in a surgical context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the in-vivo animal tests, the "ground truth" would be the observed biological outcomes in the animals related to the new indications (e.g., successful occlusion of blood vessels, lack of adverse events related to tissue manipulation/dissection). For in-vitro tests, the ground truth would be established by direct measurement of device characteristics (e.g., clip closing force, material integrity).
8. The Sample Size for the Training Set
Not applicable. This involves performance testing of a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
§ 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.