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The LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm bipolar/monopolar electrosurgical instrument intended for use in minimally invasive surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7mm in diameter. The monopolar L-Hook can be used to dissect through tissue planes and to create enterotomies or gastrotomies.

It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to gastric bypass, hysterectomy, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, oophorectomy, etc.

The LigaSure System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm sterile, single-use, hand-held bipolar electrosureical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during general procedures (as indicated) and monopolar capabilities to electrically dissect through tissue planes and to create openings in bowel (enterotomies) and stomach (gastrotomies). Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The new device will be provided EO sterilized with a 5mm diameter shaft, in shaft lengths of 37 cm and 44 cm with a fine curved jaw featuring an extendable and retractable monopolar L-Hook. The proposed devices do not contain software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LigaSure™ Ret retractable L-Hook Laparoscopic Sealer Divider:

The document provided is a 510(k) Summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria against a defined performance target. Therefore, the information provided does not directly outline "acceptance criteria" in the way one might see for a novel device with specific performance metrics to meet. Instead, the study aims to show that the new device performs similarly to the predicate devices.

However, based on the performance data presented, we can infer the intent of the testing and the outcomes that demonstrate substantial equivalence.

Here's an attempt to structure the information based on the requested categories, keeping in mind the nature of a 510(k) submission:

Acceptance Criteria and Study for LigaSure™ Retractable L-Hook Laparoscopic Sealer Divider

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" are not stated. The studies aim to demonstrate performance that is "similar" to or "as expected" and "conforms to requirements defined in related design inputs and subsequent product specifications," thereby supporting substantial equivalence to the predicate devices.

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

• Sample Size for Test Set: Specific numerical sample sizes for each test are not provided in this summary. The studies are described as "ex-vivo" and "in-vivo acute" using "porcine models" for many performance tests. A "Chronic Hemostasis Porcine study" was also conducted.
• Data Provenance: The animal studies (porcine models) indicate the data is from pre-clinical studies. The country of origin for the animal studies is not specified in this document. Given Covidien (now Medtronic) is a US-based company with a facility in Boulder, Colorado, it is plausible the pre-clinical studies were conducted in the US or a region with similar regulatory and ethical standards. All studies mentioned appear to be prospective as they are specifically conducted to evaluate the new device.

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

This type of study does not typically involve "experts" in the sense of clinical reviewers establishing ground truth for a test set. Instead:

• For Biocompatibility, Electrical Safety, EMC, Mechanical/Functional Testing: Compliance is assessed against established international standards (e.g., ISO 10993-1, IEC 60601 series) by qualified testing personnel and laboratories.
• For Animal Studies (e.g., renal burst pressure, lymphatic sealing, hemostasis, thermal spread, enterotomy, chronic hemostasis): The "ground truth" or evaluative metrics are physiological measurements (e.g., burst pressure, thermal spread measurements, successful hemostasis, proper enterotomy formation) as assessed by trained researchers, veterinarians, and possibly pathologists involved in the pre-clinical studies. The exact number of individuals or their specific qualifications (e.g., DVM, Ph.D. in physiology, toxicologist) are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations, often in clinical imaging or diagnostic studies. This document describes pre-clinical engineering and animal studies with objective or semi-objective measurements. Therefore, an "adjudication method" in that sense is not applicable or described for this type of testing. The results would be based on direct measurements and observations during the experiments, recorded and analyzed by the research team.

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

No, an MRMC comparative effectiveness study was not conducted. This is a pre-clinical submission for substantial equivalence based on engineering, bench, and animal testing. There is no human reader component in the studies described.

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

This device is an electrosurgical instrument, not an AI algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable. The device inherently requires a human operator to function. The "standalone" performance here refers to the device's functional performance in isolation from a clinical human context, which is what the bench and animal tests aim to assess (e.g., the device's ability to seal a vessel, its thermal spread, its electrical safety).

7. Type of Ground Truth Used

• Bench Testing (Biocompatibility, Electrical Safety, EMC, Mechanical/Functional): Ground truth is established by referencing international standards, internal design specifications, and objective measurement validation.
• Animal Studies (Ex-vivo Renal Burst Pressure, Ex-Vivo / Lymphatic, In-Vivo Acute, Ex-vivo Monopolar Thermal Effect, In-Vivo Acute Enterotomy, Chronic Animal Study): Ground truth is based on physiological measurements and observations from the animal models, such as burst pressure readings, histological evaluation of thermal spread, visual confirmation of hemostasis, successful tissue dissection/formation, and pathological examination (if conducted for chronic studies).

8. Sample Size for the Training Set

This document describes pre-clinical testing for a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The design and development of the device might involve internal testing iterations, but a formal "training set" as understood in AI/ML is not part of this type of submission.

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

As there is no "training set" mentioned or applicable in the context of this device and submission, this question is not applicable.

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