Search Results

The Intuitive Surgical da Vinci Harmonic ACE™ Device 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 (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).

The Intuitive Surgical Harmonic ACE™ Device 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 a disposable insert which consists of a shaft and grip assembly. The instrument housing and disposable insert are assembled together, attached to the da Vinci Surgical System and connected to Ethicon's Endo-Surgery Generator 300 (Model GEN04) using the Hand Piece (Model HP054). When the Harmonic ACE™ Device is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in two configurations: one for use with the da Vinci (IS1200); and the other for the da Vinci Surgical (122000/123000) Systems, respectively. The same disposable insert is used with all configurations of the instrument.

The provided text describes a 510(k) premarket notification for the Intuitive Surgical da Vinci Harmonic ACE™ Device. It states that "Performance tests (bench and animal lab tests) were conducted to demonstrate that the device is substantially equivalent to the predicate devices and that the design output meets the design input requirements."

However, this document does not provide specific acceptance criteria or detailed results of these performance tests. It states that the results "did not raise any new issues of safety or efficacy as compared to Intuitive Surgical's currently cleared Harmonic™ Curved Shears (K042855)," implying comparison to the predicate device's performance, but without detailing what those performance metrics or criteria were.

Therefore, many of the requested details cannot be extracted from this particular regulatory summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified. The document mentions "bench and animal lab tests" but does not give sample sizes for either.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. Animal lab tests would be prospective in nature, but no further details are given.

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

• This information is not provided in the document. For a surgical device, "ground truth" might involve assessments by veterinary surgeons (for animal studies) or engineers/pathologists, but no details are given.

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

• This information is not provided in the document.

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

• Not applicable. This device is a surgical instrument (Harmonic ACE™ Device) and not an AI/imaging diagnostic device that would involve human "readers" or AI assistance in interpretation. The studies performed were performance tests (bench and animal lab tests) for device function.

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

• Not applicable. This device is a surgical instrument and does not involve an algorithm working in "standalone" mode in the context of interpretation. Its performance is inherent to its mechanical and energy delivery capabilities.

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

• The document does not explicitly state the "type of ground truth." For bench tests, it would likely involve objective measurements against engineering specifications (e.g., thermal cameras for thermal spread, load cells for cutting force, pressure sensors for burst pressure). For animal tests, it might involve histological examination (pathology) of tissue effects or direct observation of surgical outcomes. However, this is inferred, not stated.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that would require a "training set" in the traditional sense. The device's design is based on engineering principles and preclinical testing, not on learning from a dataset.

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

• Not applicable. As there is no "training set" for an AI algorithm, this question is not relevant to the described device.

Ask a specific question about this device

The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.

The Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.

The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control are a sterile, single patient use instrument consisting of a grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The grip housing has an integrated audible/tactile mechanism for indicating full trigger closure. The instruments have a rotating shaft with a curved blade and clamp arm and is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instruments are available in 14 cm (scissor handle only), 23 cm and 36 cm lengths with a shaft diameter of 5.5 mm and a 15 mm active bladc length.

The provided text outlines the 510(k) premarket notification for the "Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control" and "Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control" devices.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Bench testing was performed to demonstrate that the devices perform as intended." However, it does not explicitly list specific acceptance criteria in terms of quantitative or qualitative thresholds. It also does not provide detailed reported device performance metrics from these bench tests. The FDA's substantial equivalence determination implies that the device met the necessary performance expectations compared to its predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document states "Bench testing was performed." It does not specify the sample size used for these tests. The country of origin and whether the data was retrospective or prospective are not mentioned.

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

The provided text does not mention the use of experts to establish ground truth for the bench testing. The testing appears to be objective performance testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

Since experts are not mentioned in relation to ground truth, an adjudication method is not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or described in the provided text. The device is a surgical instrument, not an interpretive diagnostic tool that typically involves human readers.

6. Standalone Performance (Algorithm Only Without Human-in-The-Loop Performance)

This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI. The concept of "standalone performance" in this context would refer to the instrument's functional effectiveness without human manipulation, which is inherent in surgical tools (i.e., it doesn't "perform" on its own). The bench testing would assess its functional capabilities.

7. Type of Ground Truth Used

Based on the description of "bench testing" for a surgical instrument, the ground truth would likely be objective physical measurements and observations related to the device's functional characteristics (e.g., cutting efficacy, coagulation properties, thermal spread, mechanical integrity, etc.) as defined by engineering specifications and predicate device performance. No specific type of ground truth is explicitly stated.

8. Sample Size for the Training Set

This question is not applicable as the device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable as the device is a physical surgical instrument, not an AI/ML algorithm.

Ask a specific question about this device