(54 days)
The Bovie J-Plasma Precise 360 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 Precise 360 Handpiece is compatible only with Bovie J-Plasma generators.
The Bovie J-Plasma Precise 360 Handpiece is a sterile, single-use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating and ablating of soft tissue.
The Bovie J-Plasma Precise 360 Handpiece is available with a retractable needle tip, or with a retractable cutting blade tip for excising tissue. Both tip configurations serve as electrodes to generate helium plasma. A 30 degree angled shaft tip provides improved visibility during use, and a rotating knob is used to orient the angled shaft tip to the optimal position. The device is available with 33cm and 45cm shaft lengths. The device can be used in laparoscopic procedures using a standard 5mm trocar.
The provided text describes performance testing for the Bovie J-Plasma Precise 360 Handpiece. Based on the information given, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each test with specific numerical targets. Instead, it lists objectives for performance tests, implying that meeting these objectives constitutes acceptance. The reported device performance is described as the device fulfilling these objectives, as evidenced by the corresponding test reports.
| Test | Objective (Implied Acceptance Criteria) | Reported Device Performance (as per document) |
|---|---|---|
| Mechanical Verification & Functionality | Verify the mechanical functionality of the device. | Met (Reports VR-1318, VR-1324) |
| Electrical Verification | Verify the electrical functionality and safety of the device. | Met (Report VR-1318) |
| Plasma Characteristics | Measure effect of generator settings on the plasma stream, plasma stream characterization. | Met (Report VR-1324) |
| Performance Evaluation | Confirm device performance on various tissue types. | Met (Report VR-1324) |
| Usability Evaluation | To verify and validate the usability of the J-Plasma Precise 360 as it relates to safety. | Met (Report VP-1387) |
| Shipping Study | Verify the device meets requirements after shipping and handling. | Met (Report VP-1384) |
| Evaluation of Rotation Effects | Evaluation of Shaft Rotation Effects on Plasma stream for Bovie J-Plasma Precise 360 Handpieces. | Met (Report VR-1383) |
| Biocompatibility Testing | Verify material safety. | Met (Report VR-1335) |
| Shelf Life Testing | Confirm product and package performance at labeled shelf life. | Met (Report VP-1326) |
Additionally, the device was designed in accordance with several international standards (IEC-60601-1, IEC 60601-1-2, IEC-60601-2-2, ANSI/AAMI/ISO 10993-1, ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 10993-7), implying that compliance with these standards (including their safety and performance requirements) served as acceptance criteria.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test set (e.g., number of devices tested, number of tissue samples, number of users for usability). It also does not mention the provenance of the data (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench and laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth, as the testing described appears to be primarily technical and engineering-focused rather than involving clinical judgment for ground truth.
4. Adjudication method for the test set
The document does not specify any adjudication method. This is consistent with the type of technical performance and safety testing described, which typically relies on objective measurements and established protocols rather than expert adjudication.
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
The document does not describe an MRMC comparative effectiveness study, nor does it mention any AI assistance. The device is an electrosurgical handpiece, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a medical instrument (electrosurgical handpiece) that requires human operation. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this device.
7. The type of ground truth used
The ground truth for the performance tests was established through objective measurements and adherence to engineering and safety standards. For example:
- Mechanical and Electrical Verification: Ground truth would be the device meeting specified mechanical tolerances, electrical safety parameters, and functional requirements.
- Plasma Characteristics: Ground truth would involve quantitative measurements of plasma stream properties under various generator settings.
- Performance Evaluation (on tissue): Ground truth would relate to the observed effects on tissue (cutting, coagulation, ablation depth, etc.) as per predefined expectations for safety and efficacy.
- Usability Evaluation: Ground truth would be based on user feedback and demonstrated safe and effective operation by representative users.
- Biocompatibility: Ground truth from standard tests to ensure material safety.
- Shelf Life: Ground truth from measurements demonstrating maintained performance and integrity over time.
8. The sample size for the training set
The document does not mention a training set. This is because the Bovie J-Plasma Precise 360 Handpiece is a physical medical device (electrosurgical instrument) and not an algorithm or AI system that requires a training set.
9. How the ground truth for the training set was established
Since there is no training set mentioned or implied for this physical device, this question is not applicable.
§ 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.