(98 days)
The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
The FMwand Handpiece SE is a sterile, single-patient use, soft tissue cutting and coagulation device intended to be used with the FMwand Generator and FMwand Power Module (both previously cleared in 510(k) #K130606) and also with an effective user-supplied smoke evacuation system.
Here's a breakdown of the acceptance criteria and study information for the FMwand Handpiece SE, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for performance; instead, it establishes substantial equivalence to predicate devices primarily through design and functional similarity, coupled with bench testing to confirm the added smoke evacuation feature. The performance is reported implicitly by comparing its features and functions to the predicate devices and confirming the smoke evacuation functionality.
| Performance Feature / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Smoke Evacuation Effectiveness | Shown through bench testing. |
| Cutting and Coagulation of Soft Tissue | Performed using ferromagnetic induction heating, similar to K130606 predicate. |
| Biocompatibility | Complies with ISO 10993-1 and 510(k) Memorandum G95-1 (materials chosen based on common use or results of accredited testing). |
| Electrical Safety | Complies with IEC 60601-1 and IEC 60601-2-2. |
| Sterility | Provided to user in a sterile state (Ethylene Oxide - SAL 10-6). |
| Single-use | Designed for single-patient use. |
| Compatibility with Generator | Compatible with FMwand Generator (K130606). |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical or performance data. The primary performance assertion for the new feature (smoke evacuation) was demonstrated through bench testing. Therefore:
- Sample Size for Test Set: Not applicable/not specified in terms of clinical or "case" samples. Performance was demonstrated via bench testing.
- Data Provenance: Bench testing data. The document does not provide details on country of origin or if it was retrospective/prospective, as it's laboratory-based testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. Given that the primary performance evaluation for the new feature was bench testing for smoke evacuation effectiveness, the concept of "ground truth established by experts" as seen in clinical studies (e.g., for diagnostic AI) does not directly apply in the same way. The efficacy would be measured against objective physical criteria during bench testing.
4. Adjudication Method for the Test Set
This information is not provided nor is it applicable, as the evaluation type was bench testing for smoke evacuation, not a reader-based clinical study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not reported or performed. The device is an electrosurgical handpiece, and its improvements are mechanical/functional (integrated smoke evacuation), not related to AI-assisted interpretation or diagnostic accuracy in human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in the sense of bench testing. The document states that "The ability of the FMwand Handpiece SE to effectively remove smoke from the surgical site was shown through bench testing." This constitutes a standalone (algorithm-only if thinking broadly about the device's function) evaluation of the new smoke evacuation feature, without human intervention in the smoke removal process itself (beyond activating the device). The device's electrosurgical cutting and coagulation function is also evaluated intrinsically.
7. The Type of Ground Truth Used
For the new smoke evacuation feature, the ground truth was based on objective measurements during bench testing to demonstrate the effectiveness of smoke removal. For the core electrosurgical functions (cutting and coagulation), the ground truth is established by the device's design and mechanism (ferromagnetic induction heating) being substantially equivalent to the cleared predicate device (K130606), which itself would have demonstrated its intended functionality during its own clearance process.
8. The Sample Size for the Training Set
This information is not applicable as the device is a medical instrument and not an AI/ML algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.