(266 days)
The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.
The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpiece.
The provided text describes a 510(k) submission for the PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Device. It states that preclinical laboratory and performance tests were conducted to ensure the device met design specifications and functioned as intended. However, the document does not provide explicit acceptance criteria or a detailed study report with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) or their corresponding values.
Instead, it relies on a statement of "substantial equivalence" to predicate devices. This means the device's safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device (predicate device) that has already been cleared by the FDA.
Therefore, many of the requested details cannot be extracted directly from this document. Below is a summary of what can be inferred or explicitly stated, with clear indications where information is missing.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functioned as intended (cutting and coagulation of soft tissue). | "Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications." The device is intended for "cutting and coagulation of soft tissue during surgical procedures." |
| Met design specifications. | "Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications." |
| Substantial equivalence to predicate devices (safety and effectiveness). | "Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." The FDA concurred with this assessment, stating, "We have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence was established by evaluating "the indications for use, materials incorporated, product specification and energy requirements of those systems." Actual quantitative performance metrics for comparison are not provided in this summary. |
Additional Information
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Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Preclinical laboratory and performance tests."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This type of test typically refers to a clinical study with expert interpretation of results, which is not detailed here. The tests mentioned are "preclinical laboratory and performance tests," which are likely engineering or bench tests rather than clinical studies requiring expert ground truth for interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies involving multiple expert readers, which is not described.
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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:
- No. This document describes an electrosurgical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Preclinical laboratory and performance tests" would assess the standalone performance of the device against its design specifications. However, the exact methodology and metrics are not provided. The assessment is focused on the device's physical and electrical function rather than an algorithm's performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "preclinical laboratory and performance tests" of an electrosurgical device, ground truth would likely refer to objective measurements against established engineering standards, material specifications, and functional requirements (e.g., power output, temperature, tissue cutting/coagulation characteristics observed in lab settings). It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.
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The sample size for the training set:
- Not applicable/Not specified. This involves an electrosurgical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable/Not specified, as this device does not involve a machine learning training set.
§ 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.