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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:

1. 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.
2. 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.
3. 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.
4. 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).
5. 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.
6. Standalone (algorithm only) performance: The performance of the AI algorithm independently, without human intervention.
7. 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.
8. Sample size for the training set: The number of cases used to train the AI model.
9. 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.

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The Endoscopic Clip Appliers with clip magazine are intended for use in endoscopic surgery for ligating, marking vessels and tubular structures wherever a ligating clip is used/indicated.

Aesculap's Endoscopic Clip Appliers consists of two types of clip appliers (multifire (manual) or pneumatic (used CO2 cartridge). The clip appliers are reusable instruments that have either a 5 or 10 mm diameter and range in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The new clip magazine cartridge hold 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.

The provided text does not contain detailed information regarding specific acceptance criteria, a formal study proving device performance against such criteria, or data related to AI/algorithm performance. The document is a 510(k) summary for an Endoscopic Clip Applier line extension, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." Therefore, there is no table of acceptance criteria or reported device performance against such criteria in the provided text. The submission relies on demonstrating substantial equivalence based on similar technological characteristics and materials to a predicate device (Aesculap Endoscopic Clip Appliers, K962493).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document does not describe a performance study with a test set. The substantial equivalence argument is based on design and material similarities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No test set was described to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No test set was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document does not describe a comparative effectiveness study involving human readers or AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence of a physical device.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical medical instrument, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

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The devices presented in this submission are intended for use in endoscopic surgery for ligating and marking vessels and tubular structures.

Aesculap's Endoscopic Clip Appliers (PL506R, PL508R) are reusable stainless steel instruments 10mm in diameter and ranging in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The clip magazine cartridge holds 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.

Like Aesculap's Modular Endoscopic Instruments, these clip appliers can be disassembled for cleaning, disinfection and sterilization. The handle can be removed, allowing the shaft of the instrument to be disassembled into three separate pieces.

The provided text describes a 510(k) summary for Aesculap Endoscopic Clip Appliers. This document is for a medical device (surgical instrument) and does not contain information about an AI/ML algorithm or a study involving acceptance criteria and device performance in the context of diagnostic or prognostic AI.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices, discussing device description, intended use, and manufacturing standards (ISO, German Din Standards), which are typical for traditional medical devices rather than AI-powered systems.

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