Search Results
Found 1 results
510(k) Data Aggregation
(100 days)
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document. Typically, for a device like this, acceptance criteria would include metrics related to:Tissue Transection Time: Speed of cutting various tissue types.Coagulation Effectiveness: Ability to achieve hemostasis.Thermal Spread: Lateral thermal damage to adjacent tissues.Burst Pressure: Sealing strength for vessels.Mechanical Durability: Device lifetime, tip integrity.Electrical Safety: Compliance with standards. | The document broadly 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." It also notes that results "did not raise any new issues of safety or efficacy." No specific performance metrics or values are provided. |
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
Page 1 of 1