Search Results

The da Vinci 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 da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece. .

The Intuitive Surgical Harmonic™ Curved Shears Instrument 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 da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

The Intuitive Surgical Harmonic ACE™ Curved Shears is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical System. The distal end is the Disposable Harmonic ACE™ Insert, which consists of a shaft and grip assembly. The instrument housing and the disposable insert are assembled together, attached to the da Vinci Surgical System and connected to Ethicon's Endo-Surgery Generator using the Hand Piece. When the Harmonic ACE™ Curved Shears is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in 2 configurations: one for the da Vinci (IS1200) and one for the da Vinci S/Si (IS2000/ IS3000) Surgical Systems, respectively. The same disposable insert is used with all configurations of the instrument.

The Intuitive Surgical Harmonic™ Curved Shears Instrument is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical Systems. The distal end is the Disposable Harmonic™ Curved Shears Insert, which consists of a shaft and grip assembly. The instrument housing and the disposable insert are assembled together, attached to the da Vinci Surgical Systems and connected to Ethicon's Endo-Surgery Generator using the Hand Piece. When the Harmonic ACE™ Curved Shears is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in 2 configurations: one for the da Vinci (IS1200) and one for the da Vinci S/Si (IS2000/ IS3000) Surgical Systems, respectively. The same disposable insert is used with all configurations of the instrument.

The provided text is a 510(k) summary for a medical device modification, specifically for the da Vinci Harmonic ACE™ Curved Shears and Intuitive Surgical Harmonic™ Curved Shears Instrument. It explicitly states that "Performance testing was not required for this labeling change." The submission is based on the substantial equivalence to predicate devices, noting that the subject devices are "identical in technological characteristics as compared to the predicate device."

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not applicable to this specific submission.

Here's a breakdown of the information that can be extracted or deduced from the provided text, and where the information is explicitly stated as not applicable or not provided:

Acceptance Criteria and Device Performance

Explanation: The documentation explicitly states, "Performance testing was not required for this labeling change." The basis for clearance is solely on substantial equivalence to predicate devices, meaning the modified device shares the same technological characteristics and intended use as devices already on the market. There are no acceptance criteria defined or met through new performance studies in this submission because no new performance studies were conducted.

Study Details

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

   • Sample Size: Not applicable. No performance test set used.
   • Data Provenance: Not applicable. No performance data generated or used from any country or retrospectively/prospectively.

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

   • Not applicable. No ground truth establishment was required as no new performance data was generated or analyzed.

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

   • Not applicable. No adjudication method was used as no test set was analyzed.

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:

   • Not applicable. This device is a surgical instrument (curved shears) used within a robotic surgical system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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

   • Not applicable. This device is a physical surgical instrument, not an algorithm.

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

   • Not applicable. No ground truth was established or used for performance testing.

7. The sample size for the training set:

   • Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm. Therefore, no training set was used.

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

   • Not applicable. As no training set was used, no ground truth needed to be established.

Summary Statement from the Document:

The critical statement that governs all these answers is found under "Performance Data" in the submission: "Performance testing was not required for this labeling change." The basis for clearance is the substantial equivalence to predicate devices based on identical technological characteristics and indications for use.

Ask a specific question about this device