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The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc.

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

The Covidien™ LigaSure™ 5 mm Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744) is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The outer diameter of the instrument shaft is 5 mm with a working length of 23 cm, 37 cm, or 44 cm.

The provided text describes the regulatory clearance for reprocessed LigaSure Maryland Jaw Sealer/Divider devices and includes information about the performance testing conducted. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, particularly for AI/machine learning devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent for many of your points:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including: burst pressure, maximum jaw temperature, device functionality, device reliability, and generator compatibility." It also states, "The results of the evaluations demonstrate that the Reprocessed LigaSure Maryland Jaw Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter."

However, specific numerical acceptance criteria (e.g., "burst pressure must be greater than X mmHg") and concrete performance data (e.g., "average burst pressure was Y mmHg") are not provided in the text.

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

• Sample size for test set: Not specified. The text only mentions "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
• Data provenance: "Preclinical laboratory evaluations in an animal model" implies animal data. It is a prospective study design for these evaluations. The "bench and laboratory testing" would be laboratory-based data, also prospective. The country of origin is not specified.

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

• Not applicable / Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic image analysis). For a surgical device, ground truth would be based on objective physical measurements and biological outcomes in animal models, not expert consensus on interpretations.

4. Adjudication method for the test set:

• Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert opinions, which is not relevant to the type of testing described for this surgical device.

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:

• No. An MRMC study is not mentioned because this device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This device is a manual surgical instrument, not an algorithm. Its performance inherently involves a human operator.

7. The type of ground truth used:

• For the "preclinical laboratory evaluations in an animal model," the ground truth was based on:
  • Direct observation of hemostasis: "ability to achieve hemostasis of vessels."
  • Measurements of thermal spread: "evaluate thermal spread."
  • Effectiveness of cutting and coagulation: "effectively cut and coagulated vessels."
• For the "bench and laboratory testing," the ground truth would be established through:
  • Physical measurements: burst pressure, maximum jaw temperature.
  • Functional tests: verifying device functionality, reliability, and generator compatibility against engineering specifications.

8. The sample size for the training set:

• Not applicable / Not specified. This device is not an AI/machine learning algorithm that requires a training set in that conventional sense. The "training" for a reprocessed device involves validating the reprocessing methods, which is a different type of validation.

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

• Not applicable / Not specified. (See point 8 above). For the reprocessing validation, the "ground truth" would be the successful demonstration that the reprocessed devices meet the original device's specifications and are safe for use, established through validation protocols for cleaning, sterilization, and functional testing.

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