(72 days)
Weck Auto Endo10 Hem-o-lok L automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok L non-absorbable polymer ligating clips. These appliers are designed for use with 10/11 mm cannulas.
Hem-o-lok ligating clips are intended for use involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the vessel or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
The Weck® Auto Endo10® Automatic Endoscopic Clip Applier is an automatic, endoscopic applier that is pre-loaded with twelve (12) Hem-o-lok large, nonabsorbable polymer ligating clips. The applier is an ethylene oxide (EO) 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 Endo10 Automatic Endoscopic Applier employs a pistol 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 10/11mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
The provided text describes the 510(k) summary for the Weck Auto Endo10 Automatic Endoscopic Clip Applier, a medical device for ligating vessels or tissue structures. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Weck Auto Endo5 Automatic Endoscopic 35cm Applier, K152081) and lists the non-clinical performance tests conducted. These tests confirm the device's physical properties, biocompatibility, sterilization, and packaging integrity, but not its clinical performance or accuracy in a diagnostic or interventional context that would typically involve specific acceptance criteria and detailed performance metrics.
Therefore, I cannot provide the requested information. The document is about a device (clip applier) which is an instrument, not an AI/ML-driven diagnostic or therapeutic device that requires detailed performance metrics like sensitivity, specificity, or reader studies.
If this were an AI/ML device, the following information would typically be present and is what the original request asks for:
- Table of acceptance criteria and reported device performance: This would list metrics like sensitivity, specificity, accuracy, F1-score, AUC, etc., along with the target values (acceptance criteria) and the actual performance achieved by the device.
- Sample size used for the test set and data provenance: Details on how many cases were in the test set, their origin (e.g., specific hospitals, countries), and whether the data was collected retrospectively or prospectively.
- Number of experts and their qualifications for ground truth: How many clinical experts (e.g., radiologists, pathologists) independently reviewed the test cases to establish the ground truth, and their experience level.
- Adjudication method for the test set: How disagreements among experts were resolved to determine the final ground truth (e.g., 2+1 means two experts agree, or a third adjudicator decides).
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If conducted, the effect size indicating the improvement in human reader performance (e.g., sensitivity, specificity, reading time) when assisted by the AI compared to reading without AI. This is a common requirement for AI in diagnostics.
- Standalone (algorithm only) performance: The performance of the AI algorithm independently, without human intervention.
- Type of ground truth used: Whether the ground truth was based on expert consensus, pathology reports (considered a gold standard), clinical outcomes data, or other methods.
- Sample size for the training set: The number of cases used to train the AI model.
- How ground truth for the training set was established: The process by which the training data was labeled or annotated.
None of this information is available in the provided text because the device is a surgical instrument (clip applier), not an AI/ML diagnostic or prognostic tool.
§ 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.