(78 days)
The Bovie J-Plasma Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
The Bovie J-Plasma Handpiece is compatible only with Bovie J-Plasma generators.
The Bovie J-Plasma Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue.
The Bovie J-Plasma Handpiece is available with a retractable cutting blade tip for excising tissue or a needle tip. Both tip configurations serve as electrodes to generate helium plasma. The device is available in 15cm, 33cm, and 45cm lengths. The device can be used in laparascopic or open surgical procedures.
The provided text describes a 510(k) summary for the Bovie J-Plasma Handpiece (K151325). The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and detailed device performance metrics in a table format.
Therefore, much of the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not explicitly available in the provided document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists various performance tests and implies their successful completion to demonstrate equivalence.
| Test Title | Objective | Results/Performance (Implied) |
|---|---|---|
| Mechanical Verification and Functionality | Verify the mechanical functionality of the handpiece. | Met performance requirements. (Implied by conclusion of SE) |
| Electrical Verification | Verify the electrical functionality and safety of the handpiece. | Met performance requirements. (Implied by conclusion of SE) |
| Plasma Characteristics | Measure effect of generator settings on the plasma stream, plasma stream characterization. | Met performance requirements. (Implied by conclusion of SE) |
| Performance Evaluation | Confirm device performance on various tissue types. | Met performance requirements. (Implied by conclusion of SE) |
| Usability Evaluation | Verify and validate the usability of the J-Plasma Pistol Grip Handpiece as it relates to safety. | Met performance requirements. (Implied by conclusion of SE) |
| Shipping Study | Verify the device meets requirements after shipping and handling. | Met performance requirements. (Implied by conclusion of SE) |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document mentions "Performance testing" but does not detail the sample sizes for any of the tests. Data provenance (country of origin, retrospective/prospective) is also not stated.
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 are primarily bench tests and engineering assessments, not clinical or diagnostic studies that would typically involve expert ground truth.
4. Adjudication method for the test set:
This information is not provided in the document. As there is no mention of expert ground truth, an adjudication method is not applicable in this context.
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:
This information is not provided in the document. The device in question is an electrosurgical handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. The device is a surgical instrument and does not involve an algorithm for standalone performance evaluation in the context of AI.
7. The type of ground truth used:
For the listed performance tests (mechanical, electrical, plasma characteristics, performance evaluation, usability, shipping), the "ground truth" would likely be based on engineering specifications, industry standards (e.g., IEC standards listed), and predefined functional requirements. For "Performance Evaluation on various tissue types," the ground truth would be the observed effect of the device (cutting, coagulation, ablation) on those tissues, assessed against desired outcomes or predicate device performance. However, the specific methodology for establishing this ground truth (e.g., histological analysis, expert observation) is not detailed.
8. The sample size for the training set:
This information is not provided in the document. The document describes a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not provided in the document. Not applicable as this is not an AI model.
Summary of what is available:
The document primarily serves as a 510(k) summary for a medical device and describes various performance tests (bench tests) conducted to ensure the device meets requirements and is substantially equivalent to a predicate. It does not provide detailed results or specific acceptance criteria in a quantitative, tabular format beyond the general statement that the device "meets performance requirements." The "study" here refers to the collection of these performance tests. There is no mention of clinical studies, human readers, AI, or large datasets for algorithm training or testing.
§ 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.