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The EndoWrist Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The EndoWrist Vessel Sealer Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer Extend device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

The provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of AI/ML performance. The document is a 510(k) summary for the "Intuitive Surgical EndoWrist Vessel Sealer Extend," a surgical instrument, and primarily discusses its substantial equivalence to a predicate device, its intended use, and various types of performance testing (bench testing, animal/cadaver studies, and a chronic animal study).

Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria, AI/ML performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment.

The document focuses on the safety and effectiveness of a physical surgical instrument, not on software performance or diagnostic/prognostic capabilities involving AI.

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The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The 8 mm Harmonic ACE Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with a compatible da Vinci Surgical System and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with a compatible da Vinci Surgical System are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

The EndoWrist Vessel Sealer is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

The da Vinci 8 mm Harmonic ACE Curved Shears is a single-use, sterile instrument used to deliver ultrasonic energy to enable transection and coagulation of tissue. The movement and function of the da Vinci 8 mm Harmonic ACE Curved Shears are controlled by the surgeon from the Surgeon Console of a compatible da Vinci Surgical System. This instrument consists of a housing, instrument shaft, and instrument jaws comprised of a clamp arm and blade.

The da Vinci Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy using the compatible da Vinci Surgical System.

This document is a 510(k) premarket notification from the FDA, classifying the submitted devices as substantially equivalent to previously marketed devices. The purpose of this submission is to change the Indications for Use for three devices: the EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, and da Vinci Single-Site Instruments and Accessories. The document explicitly states that design verification and validation testing were not required as design inputs were not changed.

Therefore, there is no information about specific acceptance criteria, device performance, or a study that proves the device meets acceptance criteria presented in this document. The submission is focused on modifying the labeling regarding compatible systems.

Consequently, I cannot provide the requested information from the given text as it does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study or related effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document essentially states that the devices are identical to their predicate devices and the changes are only to the wording of the Indications for Use regarding compatibility with different da Vinci Surgical System models.

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The EndoWrist® Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation procedures, and should not be used for these procedures.

The EndoWrist Vessel Sealer is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to the da Vinci Model 154000 Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the da Vinci Model IS4000 Surgical System foot pedals.

A slider on the housing allows the user to manually open and close the instrument jaws for intraoperative cleaning and grip release. A lock button on the housing allows the user to hold the jaws open for intraoperative cleaning. Two release buttons on the housing allow removal of the Vessel Sealer from the sterile adapter on the da Vinci Model IS4000 System instrument arm.

The ERBE VIO dV generator provides the high frequency (radio frequency) electrical current for tissue sealing.

This document describes the EndoWrist® Vessel Sealer, a surgical instrument intended for grasping, bipolar coagulation, and mechanical transection of vessels up to 7mm in diameter and tissue bundles. The device is for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator.

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly define specific numerical acceptance criteria. Instead, it states that performance was evaluated against "design output meets the design input requirements" and demonstrated "substantial equivalence" to the predicate device, the EndoWrist® One Vessel Sealer.

However, based on the descriptions of the tests, we can infer some performance aspects that were evaluated:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Testing: No specific sample size is given for architectural, functional, or reliability testing. Burst pressure testing also lacks a specified sample size.
• Animal and Cadaver Testing:
  • Clinical validation (porcine model): No specific sample size (number of animals) is stated.
  • In-vivo tissue bundle testing (living animal model - porcine): No specific sample size (number of animals or tissue bundles) is stated.
• Human Factors Evaluation:
  • Summative usability validation study: Sixteen (16) teams of users (Surgeons and Operating Room (OR) staff).
• Data Provenance: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the US or in a manner compliant with US regulatory guidelines. The studies appear to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Bench Testing: The ground truth for bench tests (e.g., physical dimensions, range of motion, electrical properties) is typically established by engineering specifications and objective measurements, not by experts in the same way clinical ground truth is established.
• Animal and Cadaver Testing: For clinical validation and in-vivo tissue bundle testing, the "ground truth" would be the observed acute effects (e.g., successful sealing, transection, tissue effect) as assessed by the researchers and potentially veterinary surgeons involved in the studies. The text mentions "clinical validation to confirm the device meets the user needs and intended use," implying expert assessment of clinical outcomes, but specific numbers or qualifications of these experts are not provided.
• Human Factors Evaluation: The evaluators/observers in the usability study would assess the user performance against predefined tasks and safety criteria. The participants themselves (16 teams of Surgeons and OR staff) represent the "experts" whose interaction with the device is being evaluated, rather than establishing a ground truth for a diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in any of the testing types. It suggests that performance was observed and evaluated by the study teams.

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 comparative effectiveness study was not done. This device is a surgical instrument (vessel sealer), not a diagnostic or AI-assisted interpretation device, so this type of study is not applicable. The human factors study focused on user interaction and usability of the instrument itself, not on improving human "reading" or diagnostic accuracy.

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

No, a standalone algorithm performance study was not done. The device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Bench Testing: Engineering specifications, objective physical and electrical measurements, and mechanical performance standards.
• Animal and Cadaver Testing: Direct observation of surgical outcomes (e.g., successful sealing, lack of burst, effective transection), tissue effects (likely assessed visually and potentially histopathologically, though not explicitly stated), and clinical performance in simulated procedures. This is a form of direct observation/outcomes data in a preclinical model.
• Human Factors Evaluation: Observational data of user performance on critical tasks, error rates, and subjective feedback regarding ease of use, all assessed against predefined usability and safety criteria.

8. The sample size for the training set

This is not applicable as the device is a mechanical surgical instrument, not an AI or machine learning algorithm requiring a training set.

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

Not applicable (see point 8).

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