(30 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, nonabsorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant 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 49.37cm long with a working length of 35.2cm. 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.
Here's an analysis of the provided text regarding the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier, specifically addressing the requested information about acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided document is a 510(k) summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria in the same way one might for an AI/ML algorithm. Therefore, many of the requested points, especially those related to AI/ML study design (sample size for test/training sets, expert ground truth, MRMC studies, standalone performance), are not directly applicable or present in this context. The answers below will reflect the information that is available.
Acceptance Criteria and Device Performance Study
The Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier is a ligation clip applier, a mechanical surgical device, not an AI/ML diagnostic system. Therefore, the "acceptance criteria" and "device performance" are typically related to its mechanical function, safety, and effectiveness in performing its intended task, usually compared against a similar legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device and document, explicit, quantitatively defined acceptance criteria (e.g., "sensitivity > X%, specificity > Y%") are not presented in a traditional table format. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device and successful performance in non-clinical and usability testing.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The device should perform its intended function similarly to the predicate. | "The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier has the same technology and functional characteristics as the predicate device." "The results of this comparison demonstrate that the Auto Endo5 5mm Automatic Endoscopic 35cm Applier is equivalent to the marketed predicate device." "The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K142777." |
| Safety and Effectiveness (Post-Modification): Modifications should not introduce new safety or effectiveness issues. | "The modifications made to the Auto Endo5 5mm Automatic Endoscopic 35cm Applier do not introduce any new issues of safety and effectiveness." (This is a conclusion reached based on the non-clinical performance testing and usability study). |
| Mechanical Integrity/Performance (after sterilization, conditioning, distribution): The device should maintain its intended function and integrity under various conditions. | "Non-clinical performance testing has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support a change to the device's working length and ratcheting mechanism." (No specific quantitative results are presented in this summary, but the conclusion is that it was successful in demonstrating equivalence and safety.) |
| Usability/User Needs: The device should be operable by the user as intended and meet user needs. | "Usability and design validation of the Auto Endo5 5mm Automatic Endoscopic 35cm Applier in a porcine model was conducted to document that the clip applier performed to its intended use in vivo, the user was able to operate the system as intended, and the product conformed to user needs." (Again, no quantitative metrics are given in this summary, but the study conclusion supports satisfactory performance against this criterion.) |
| Biocompatibility: Patient-contacting materials must be safe. | "All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1." (This is a compliance statement, not a performance metric from a study, but an underlying safety requirement.) |
| MR Safety: (Relevant for the associated clips, reaffirmed). | "Hem-o-lok Ligating Clips are 'MR Safe' and pose no known hazards in MR environments. This claim was cleared under K133202, December 30, 2013." (This is a historical clearance, not directly tested in this submission's study, but relevant for the overall product system.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the summary for the non-clinical and usability testing. These studies typically use a pre-determined number of devices or animal models to generate sufficient data for statistical confidence or to demonstrate functionality.
- Data Provenance: The usability and design validation study was conducted "in a porcine model." This indicates prospective animal model data. The non-clinical performance testing would have been conducted in a laboratory setting. There is no mention of human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device and study. The "ground truth" for a mechanical device like a clip applier is its physical function (e.g., does it successfully deploy a clip? does the clip close correctly? does it damage tissue unnecessarily?). The "experts" in this context would be the engineers performing the tests and potentially the surgeons/physicians conducting the usability study, but they are evaluating mechanical performance against design specifications and intended use, not establishing a "ground truth" in the diagnostic sense. The summary refers to the device being used "by a surgeon or physician's assistant."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in diagnostic studies to resolve disagreements among multiple expert readers in establishing ground truth for images or clinical cases. This is not relevant for a mechanical device undergoing performance and usability testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are specific to diagnostic performance, often for AI/ML systems or new imaging modalities, where multiple human readers assess multiple cases. This is not relevant for a surgical clip applier.
6. If a Standalone Study Was Done
Yes, in a sense. The non-clinical performance testing and usability/design validation in a porcine model were "standalone" in that they evaluated the device itself (with its associated clips) in a controlled environment or animal model to confirm its function and safety. This is not "standalone algorithm performance" as you'd ask for an AI/ML product, but standalone device performance.
7. The Type of Ground Truth Used
For the usability/design validation study in the porcine model, the "ground truth" was the successful and intended application of the Hem-o-lok clips by the applier in vivo, confirming that "the clip applier performed to its intended use in vivo, the user was able to operate the system as intended, and the product conformed to user needs." For non-clinical testing, it would be adherence to engineering specifications and performance criteria. This is based on observational performance and functional assessment rather than, for example, pathology reports or long-term outcomes data, which are typically used for diagnostic or treatment efficacy studies.
8. The Sample Size for the Training Set
Not applicable. The device is a mechanical surgical tool, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.