(78 days)
The Gyrus ACMI® HALO PKS Cutting Forceps is indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).
The Gyrus ACMI®HALO PKS Cutting Forceps is a bipolar electrosurgical device that may be utilized in minimally invasive surgery for general endoscopic use to grasp, coagulate, transect, dissect and retract tissue. The Gyrus ACMI® HALO PKS Cutting Forceps is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Gyrus General Surgery Generator (G400).
The Gyrus ACMI®HALO PKS Cutting Forceps is a modification of the Gyrus Bipolar Cutting Forceps and includes hand switching capabilities and a redesigned handle based on human factors considerations. The device handle has been ergonomically redesigned with additional areas of soft polymer around the device where the user contacts it. Thumb tabs for advancing the blade that were present on the predicate have been replaced with a pistol like trigger for user comfort. The ratchet mechanism blade activation has been redesigned and the latch mechanism has been moved to a place that allows single hand use. The HALO Cutting Forceps includes new features including hand activation, and a mode switch (Select Button) on the handpiece that allows the user to select either of up to two devices attached to the G400 generator at any one time. Selection of either device is indicated by the illumination of a green LED on top of the handpiece showing that the device has been selected. The jaws are identical as those found on the predicate Gyrus Bipolar Cutting Forceps except that they are sclectively rotatable via a rotation wheel on the device which allows for rotation of the jaws about the device shaft.
The provided 510(k) summary for the Gyrus ACMI® HALO PKS Cutting Forceps does not contain information about specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the requested data points (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details). The document primarily states that performance testing was conducted to establish substantial equivalence to a predicate device.
Here's an analysis of what can be extracted and a clear indication of what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility requirements | Complies with ISO 10993-1. |
| Sterility Assurance Level (SAL) | SAL of $10^{-6}$ and complies with ISO 11135-1. |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1. |
| Electrical Safety (IEC 60601-2-2) | Complies with IEC 60601-2-2. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2. |
| Functional Performance (non-clinical bench and preclinical testing) | Device performance is substantially equivalent to the predicate, and modifications raise no new issues of safety and effectiveness. |
| Intended Use | Same as predicate; electrosurgical coagulation, mechanical cutting, grasping of tissue during laparoscopic and open general surgical procedures when used with G400 generator. |
| Operating Principle | Same as predicate. |
| Radiofrequency Generator | Same as predicate (G400). |
| Patient Contacting Materials | Similar to predicate. |
| Packaging and Sterilization Processes | Same as predicate. |
| Distal End Design | Not changed from predicate. |
| Jaws | Identical to predicate (with added rotation). |
| Hand Activation (new feature) | Functionally successful (implied by substantial equivalence). |
| Mode Switch (new feature) | Functionally successful (implied by substantial equivalence). |
| Rotation of Jaws (new feature) | Functionally successful (implied by substantial equivalence). |
| User Comfort (redesigned handle) | Achieved (implied by human factors consideration and design change). |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Performance testing was utilized to establish the performance characteristics... and preclinical testing" but no specific numbers are given for the test set size for any of the performance tests.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective, as the testing appears to be primarily bench and preclinical in nature rather than human clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable / Not Provided. The testing described is primarily engineering and performance verification (biocompatibility, sterility, electrical safety, functional bench testing). There's no indication of a "ground truth" requiring expert consensus in the context of diagnostic or interpretive tasks.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. As there's no mention of a ground truth established by experts or human interpretation, adjudication methods are not relevant to the described tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with or without AI assistance was evaluated. The device is a surgical instrument, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. The device is a surgical instrument with electrosurgical capabilities, not an algorithm, so a standalone algorithm performance study is not relevant here. The "algorithm" here would be the physical function of the device, which was tested through bench and preclinical studies.
7. Type of Ground Truth Used
- For biocompatibility: Compliance with ISO 10993-1 standards and internal testing results.
- For sterility: Compliance with ISO 11135-1 standards and internal testing results demonstrating SAL of $10^{-6}$.
- For electrical safety/EMC: Compliance with IEC 60601 series standards and internal testing results.
- For functional performance (cutting, coagulation, grasping, rotation, etc.): Comparison against the established performance of the predicate device and internal design specifications, likely using standardized test methods for electrosurgical devices (e.g., tissue impedance, cutting force, coagulation efficacy in ex-vivo or in-vivo models). The "ground truth" would be the expected functional outcome based on the predicate and design requirements.
8. Sample Size for the Training Set
- Not Applicable / Not Provided. The device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The development of the device would involve engineering design and iterative testing, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As there is no training set, this question is not relevant.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.