(47 days)
The Bovie J-Plasma Precise Flex Handpiece is used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.
The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.
The Bovie J-Plasma Precise Flex handpiece, is an electrosurgical accessory that is connected to a Bovie Ultimate Electrosurgical Generator and used to deliver helium gas plasma (J-Plasma) and standard electrosurgical monopolar coagulation during surgical procedures. The accessory has a flexible shaft that can be advanced through a cannula during minimally invasive surgical procedures. The handpiece is activated by the generator footswitch.
The primary difference between the Bovie J-Plasma Precise Flex handpiece and currently available Bovie J-Plasma handpieces is that the Bovie J-Plasma Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps, or grasping instruments during minimally invasive surgical procedures.
The Bovie J-Plasma Precise Flex handpiece uses the same basic technology and delivers the same J-Plasma helium plasma energy as currently available J-Plasma handpieces (K151325, K152570, K170188) and are compatible only with Bovie Ultimate electrosurgical generators.
The provided text describes the Bovie J-Plasma Precise Flex Handpiece, an electrosurgical accessory. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document provides a table of tests performed but does not explicitly state specific acceptance criteria in measurable terms. It describes the objective of each test and the protocols used, but not the pass/fail thresholds.
| Test | Objective | Reported Performance (from summary description) |
|---|---|---|
| Electrical Verification | Verify the electrical functionality and safety of the handpiece | Meets objective by complying with IEC Electrical Safety Standards |
| Bench Equivalency | Measure effect of generator settings on the plasma stream, plasma stream characterization | Demonstrated equivalent tissue effect as the predicate device J-Plasma handpiece |
| Mechanical Performance | Verify the mechanical functionality of the handpiece | Demonstrated ability of the J-Plasma Precise Flex device to be grasped and maneuvered |
| Electromagnetic Compatibility | EMC testing for emissions and immunity | Implied compliance, as no issues are reported and it's a standard regulatory test for electrosurgical devices |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily bench and electrical verification, which typically do not involve human patient data.
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. The tests described (electrical, bench, mechanical, EMC) are primarily engineering and technical verifications, not typically requiring expert interpretation of clinical data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the tests (bench, electrical, mechanical), an adjudication method like 2+1 or 3+1, which is common in clinical imaging studies for ground truth establishment, would not be applicable.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study is typically associated with AI-powered diagnostic devices, not electrosurgical handpieces. The device described is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is an electrosurgical handpiece, not an AI algorithm. It's a hand-held tool used by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench equivalency testing, the "ground truth" for tissue effect was established by comparison to the predicate J-Plasma handpiece. This would likely involve observable and measurable tissue effects (e.g., coagulation depth, cutting efficiency) under controlled bench conditions. For electrical, mechanical, and EMC tests, the ground truth is simply meeting predefined engineering specifications and regulatory standards.
8. The sample size for the training set
This information is not provided. The device is not an AI/ML product, so the concept of a "training set" in the context of machine learning does not apply.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML product.
In summary, the provided document is a 510(k) summary for an electrosurgical handpiece, focusing on substantial equivalence. It outlines technical performance tests but lacks the detailed clinical study data, acceptance criteria, ground truth establishment methods, and sample sizes that would be found in a clinical trial report or for AI/ML device submissions.
§ 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.