(38 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The implication is that performance should be equivalent to the predicate device. | "Bench testing was performed to demonstrate that the devices perform as intended." (No specific results or metrics are given.) |
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.
N/A