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The EndoWrist® One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D 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 One 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 EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are actuated by the daVinci Si Surgical System foot pedals. The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.

Here's an analysis based on the provided 510(k) summary:

This 510(k) summary for the Intuitive Surgical EndoWrist® One Vessel Sealer is for clearance of a device that is stated to be identical in technological characteristics to a previously cleared predicate device (K110639). It also states that the proposed indications for use are a subset of another predicate device (K071728). In such cases, extensive new performance data may not be required beyond demonstrating equivalence and that the design outputs meet the design input requirements.

Therefore, the information regarding in-depth clinical studies, ground truth establishment, expert consensus, and sample sizes for AI/algorithm performance is not present in this 510(k) summary, as it is not a submission for an AI/ML powered device. Instead, the focus is on a traditional surgical instrument.

Acceptance Criteria and Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific reported device performance metrics in the way one would for an AI/ML algorithm. Instead, it relies on demonstrating substantial equivalence to predicate devices.

The "acceptance criteria" can be inferred as the demonstration that the new device's design outputs meet its design input requirements and that its performance is equivalent to the predicate devices, not raising new questions of safety or effectiveness.

Study Details (Based on available information)

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

   • The document mentions "Design validation and animal testing." It does not specify the sample size for this testing or the provenance of the data in terms of country of origin or whether it was retrospective or prospective. Animal testing is typically prospective.

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

   • Not applicable/Not provided. The "ground truth" for a traditional surgical instrument would relate to its physical performance (e.g., ability to seal vessels, cut tissue, withstand stress), which is typically evaluated by engineers and veterinarians/surgeons in animal studies, not by expert interpretation of images or other data for establishing a medical diagnosis "ground truth."

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation, not for evaluating the mechanical and electrosurgical performance of an instrument in design validation or animal testing.

4. 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. This is not an AI-powered device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or reported.

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

   • No. This is not an AI-powered device.

6. The type of ground truth used:

   • For this type of device, the "ground truth" would be established through a combination of engineering specifications, empirical measurements (e.g., burst pressure of sealed vessels, tissue cutting efficacy), and observations in animal models regarding the device's ability to perform its intended functions without adverse events. It would not be expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/ML device that requires a "training set."

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

   • Not applicable/Not provided. This is not an AI/ML device.

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The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One 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 EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are operated by the da Vinci Si Surgical System foot pedals.

The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.

The provided text is a 510(k) summary for the Intuitive Surgical EndoWrist One Vessel Sealer, which describes the device and its intended use, and states that performance tests (bench and animal lab tests) were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not provide specific acceptance criteria, reported device performance metrics, detailed study designs, sample sizes, information on ground truth establishment, or any comparative effectiveness study results. Therefore, I cannot complete most of the requested table and answer many of the subsequent questions based solely on the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance

Explanation: The document states "Performance tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or effectiveness as compared to the predicate devices." However, it does not specify what those "design input requirements" or "acceptance criteria" were, nor does it provide quantitative performance data (e.g., vessel sealing strength, time to seal, burst pressure, etc.).

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

• Sample Size for Test Set: Not provided. The document mentions "bench and animal lab tests" but does not specify the number of samples, animals, or tests conducted.
• Data Provenance: Not provided.

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)

• Not applicable/Not provided. The tests mentioned are "bench and animal lab tests," which typically involve direct measurement of physical or physiological parameters, rather than expert interpretation for ground truth.

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

• Not applicable/Not provided. As mentioned above, the tests are primarily objective measurements.

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. The device is a surgical instrument (vessel sealer), not an AI-driven diagnostic or interpretative tool that would involve human readers. The study performed was to demonstrate substantial equivalence of a physical medical device.

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

• Yes, in a sense, a standalone performance assessment was done for the device itself. The "bench and animal lab tests" evaluate the intrinsic performance of the vessel sealer in sealing and transecting vessels, independent of human variability in technique, though human operators would be performing the procedures. This isn't an "algorithm only" test as it's a physical device.

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

• For "bench tests," the ground truth would typically be established by validated measurement techniques and scientific standards (e.g., burst pressure measurements, tensile strength, seal integrity).
• For "animal lab tests," the ground truth would likely involve direct observation, physiological measurements (e.g., blood pressure, hemorrhage), and potentially histological examination of sealed vessels. The document doesn't specify which particular metrics were used.

8. The sample size for the training set

• Not applicable. This device is a mechanical/electrosurgical instrument, not an AI/machine learning system that requires a "training set."

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

• Not applicable. This device does not use a "training set."

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through "bench and animal lab tests" for a medical device. It does not provide the detailed scientific study design, specific performance metrics, or information relevant to AI-based diagnostic tools.

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