(65 days)
The Weck Auto Endo5® Hem-o-lok® ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok® ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
Hem-o-lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok® medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49cm long with a working length of 35cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
This document describes the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), a device intended for delivering Hem-o-lok ML non-absorbable polymer ligating clips during laparoscopic procedures. The provided information is from an FDA 510(k) summary (K230480) and does not contain details about a study evaluating AI performance. Therefore, I cannot address aspects related to AI/human reader studies, ground truth establishment, or specific acceptance criteria for an AI device.
However, I can extract information related to the performance data and acceptance criteria for the medical device itself, as described in the 510(k) summary.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria and corresponding performance metrics in a quantitative format as might be seen for an AI device. Instead, it states that:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Performance after sterilization, environmental conditioning, and simulated distribution | Non-clinical performance testing was conducted following these conditions. The purpose was to "support device modifications and ensure the device performed equivalently to the predicate." (Implies successful performance upholding equivalence). |
| Usability and design validation in a simulated use environment | "Usability and design validation... was conducted to document that the user was able to operate the system as intended, and the product conformed to user needs." (Implies successful demonstration of intended operation and user satisfaction). |
| Substantial Equivalence to Predicate | The conclusion states: "Based upon the performance and comparative test results, the proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K152081." (Implies all necessary performance aspects were met to establish substantial equivalence). The modifications "do not introduce any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of clinical data for human or AI performance. The performance testing mentioned ("Non-clinical performance testing") likely refers to mechanical, functional, and usability evaluations of the device itself. No explicit sample sizes for these tests are provided, nor is the provenance of any data specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes a medical device, not an AI system that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a study involving expert adjudication for a test set.
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
This information is not applicable. The document describes a medical device (surgical clip applier), not an AI system, and therefore no MRMC study or AI assistance evaluation was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI performance evaluation is not relevant here. The device's performance is assessed against engineering specifications, functional requirements, and equivalence to a predicate device. This would involve objective measurements, material analysis, mechanical testing, and usability assessments, rather than an expert-determined "ground truth."
8. The sample size for the training set
This information is not applicable as the device is not an AI system.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI system.
§ 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.