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The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw 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 colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and so forth.

The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.

The proposed LigaSure™ XP Maryland Jaw Sealer/Divider is a sterile, single-use bipolar vessel sealer. It is labeled as prescription use only. The device connects to the Valleylab™ FT10 Electrosurgical Platform generator for tissue ligation. Energy is applied to tissue interposed between the nano-coated Maryland-style jaws creating a ligation. The jaws contain an independent cutting blade for division of tissue. A distinctive characteristic is the new continuous rotation capability of the jaws and shaft. The shaft is a common 5 mm diameter available in three lengths (23 cm, 37 cm, 44 cm) for various general surgical procedures in both open and minimally invasive (laparoscopic) approaches. The instrument body is a pistol grip design which can be used by right or left-handed users to access the controls. The new device is offered with two handle body designs, One-Step Sealing (LXMJ23S, LXMJ37S, LXMJ44S) or Latching Handle (LXMJ23L, LXMJ37L, LXMJ44).

The provided text does not contain information about the acceptance criteria and study proving a digital health device's performance. Instead, it describes a substantial equivalence determination for a surgical instrument, the LigaSure™ XP Maryland Jaw Sealer/Divider.

Therefore, many of the requested categories in your prompt, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set," are not applicable to this medical device submission, which focuses on hardware and electrosurgical performance rather than an AI-powered diagnostic or assistive tool.

However, I can extract the relevant performance testing and acceptance criteria information that is present in the document for the LigaSure™ XP Maryland Jaw Sealer/Divider.

Here's the information structured to the best of my ability given the provided document:

Acceptance Criteria and Study for LigaSure™ XP Maryland Jaw Sealer/Divider

This submission details the substantial equivalence of an electrosurgical cutting and coagulation device, the LigaSure™ XP Maryland Jaw Sealer/Divider. The performance testing described focuses on various engineering, biological, and functional aspects of the surgical instrument, not on the performance of a digital health or AI device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set (e.g., number of vessels, lymphatic segments, or animals).

• Provenance: The tests described (bench, animal) are laboratory-based performance studies, likely conducted by the manufacturer Covidien, llc. The document does not mention data provenance in terms of country of origin or whether human data was retrospective or prospective, as clinical trials for efficacy/safety in humans were not the primary evaluation method shown (literature review was used for clinical support).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this device's performance would be objective measurements in engineering, biological models, and animal studies (e.g., burst pressure, hemostasis, thermal spread), not expert consensus on interpretations.

4. Adjudication method for the test set
This is not applicable and not provided. Performance outcomes are likely based on direct measurement against predefined physical/biological thresholds.

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
This is not applicable. This device is a surgical instrument, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's performance is based on:

• Engineering standards (e.g., ISO, ASTM, IEC for sterilization, packaging, electrical safety).
• Biocompatibility standards (ISO 10993-1).
• Predefined physical and biological thresholds/measurements from ex vivo (vessel/lymphatic sealing/burst) and in vivo (hemostasis, thermal spread) studies.
• "Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use." This implies that existing clinical evidence for similar devices and principles contributes to the overall justification, but no new clinical study data from the sponsor is explicitly referenced.

8. The sample size for the training set
This is not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established
This is not applicable.

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