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The IS4000 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 the IS4000 (da Vinci Xi) Surgical Systems and a compatible Ethicon Endo - Surgery Generator and Hand Piece.

The IS4000 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 IS4000 8 mm Harmonic ACE Curved Shears are controlled by the surgeon from the Surgeon Console of the da Vinci Xi Surgical System (model IS4000). The instrument is compatible with the Ethicon Hand Piece (model HP054) and Ethicon Endo-Surgery Generator (model G11).

The provided text describes the IS4000 8mm Harmonic ACE™ Curved Shears, a surgical instrument intended for soft tissue incisions. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive clinical trials. Therefore, the information typically requested for AI/algorithm-based devices (such as sample sizes for test sets, expert qualifications for ground truth, MRMC studies, standalone performance, and training set details) is largely absent as it is not relevant to this type of device submission.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance tests and their results. The "acceptance criteria" are implied by the "Results" column, which consistently states "All final tests PASSED," indicating the device met its pre-defined requirements. Specific numerical acceptance criteria are not detailed in this summary.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Design Verification: "Sample sizes up to six units were used."
• Reliability (Life Test): "A sample size of six was used."
• Animal Testing: The document states "simulated clinical models (animal)" were used, but the specific sample size for animal testing is not explicitly mentioned beyond the general statement for "Design Validation."
• Data Provenance: The tests are internal performance tests conducted by Intuitive Surgical, Inc. They are not clinical studies in a traditional sense with country of origin data.

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

This information is not applicable or provided. The tests described are engineering performance tests (dimensional, mechanical, electrical, reliability cycling) and animal model evaluations, not diagnostic or AI-based analyses requiring expert consensus for ground truth. User needs and intended use in animal testing would be evaluated by relevant veterinary or surgical professionals involved in the study, but their specific number or qualifications are not stated.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or cases to establish ground truth in diagnostic studies. The tests here relied on pre-defined test procedures and objective pass/fail criteria, indicating a direct measurement/observation approach rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device in question is a surgical instrument, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a surgical instrument controlled by a surgeon (human-in-the-loop with the da Vinci Xi Surgical System). There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used:

The "ground truth" for the various tests are:

• Design Verification: Engineering specifications, dimensional tolerances, mechanical performance requirements, electrical safety standards, functional requirements.
• Reliability (Life): Expected lifespan characteristics, satisfactory visual inspection, functional integrity after simulated use.
• Animal Testing: "User needs and intended use as documented in the Product Requirements document." This implies the "ground truth" is adherence to predefined functional and performance characteristics in a physiological environment, confirmed by observations during animal surgery.

8. The Sample Size for the Training Set:

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

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

Not applicable, as there is no training set for this type of device.

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