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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.

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.

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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 or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.

The provided text describes a 510(k) submission for Hem-o-lok® Ligating Clips, asserting substantial equivalence to predicate devices rather than presenting novel performance criteria that would necessitate a new clinical study with specific acceptance criteria, human experts, and ground truth establishment methods for device performance beyond basic safety and mechanical integrity.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document explicitly states: "The proposed Hem-o-lok® Ligating Clips have the same technology and functional characteristics as the predicate systems." and "A comparison of the technological characteristics of the proposed Hem-o-lok® Ligating Clips and the predicates has been performed. The results of this comparison demonstrate that the Hem-o-lok® Ligating Clips are equivalent to the marketed predicate devices."

   Therefore, the primary acceptance criterion for this 510(k) submission is Substantial Equivalence to the predicate devices (K062914 and K030311). The "reported device performance" is that it is equivalent in technological and functional characteristics to these cleared predicates.

   Acceptance Criterion	Reported Device Performance
   Substantial Equivalence to Predicate Devices (K062914 & K030311) in technology and functional characteristics	Demonstrated equivalence to predicate devices. Modifications (MR Safe claims, cleaning/sterilization instructions, three-clip configuration, packaging changes) do not introduce new safety/effectiveness issues.
   Compliance with ISO 10993-1	All patient contacting materials are in compliance.
   Compliance with ISO 11607-1:2006	Testing conducted to support changes to packaging materials.
   Validation of Cleaning and Sterilization Processes	Performed for reusable clip appliers and removers.

2. Sample size used for the test set and the data provenance:

   The submission focuses on non-clinical performance testing for packaging and cleaning/sterilization validation. There is no mention of a "test set" in the context of clinical performance or diagnostic accuracy that would involve patient data. The provenance of any materials testing or validation data is not specified (e.g., country of origin, retrospective/prospective), as it's typically laboratory-based engineering and materials testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable. This 510(k) is about demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics, not a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   Not applicable, as there is no "test set" in the context of a clinical performance study with human readers or image analysis.

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:

   Not applicable. This is not an AI/CAD device. It is a ligating clip.

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 (expert consensus, pathology, outcomes data, etc.):

   Not applicable for clinical performance. For the non-clinical tests mentioned:

   • Packaging: Adherence to ISO 11607-1:2006 standards.
   • Cleaning/Sterilization: Successful validation against pre-defined microbiological and cleanliness acceptance criteria as per recognized standards (not explicitly named beyond "validation").
   • Biocompatibility: Compliance with ISO 10993-1.

8. The sample size for the training set:

   Not applicable. The device is a ligating clip, not a machine learning model.

9. How the ground truth for the training set was established:

   Not applicable.

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