(150 days)
The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
The PEAK Surgery System consists of the PULSAR II Generator, PEAK PlasmaBlade Tissue Dissection Devices and an optional wireless footswitch. The PULSAR II Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar RF energy for cutting and coagulation during surgery. The PULSAR II Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices which are single use, sterile handpieces for monopolar energy delivery. The PlasmaBlade Tissue Dissection Devices consist of an insulated blade electrode, rotating 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 handpieces.
The provided text describes a 510(k) submission for the PEAK Surgery System, specifically the PULSAR II Generator, which is a modification of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, not on meeting specific performance acceptance criteria through a clinical study with a defined dataset.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not provide specific acceptance criteria (e.g., a certain sensitivity, specificity, accuracy, or performance metric) for the device. Instead, it states that "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications." It then concludes that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." This is a regulatory statement of equivalence, not a report of specific performance against predefined acceptance criteria from a study.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This was not a study evaluating performance against a test set with human data. The "tests" mentioned were likely engineering and functional performance tests for the device's hardware, circuitry, and output energy, comparing them to the predicate device. The context implies these were laboratory tests rather than tests on a dataset of clinical cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
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
No. This device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's performance was evaluated independently. However, this was not an "algorithm only" evaluation as understood in AI/software. Rather, it refers to the engineering and functional performance of the electrosurgical unit. The "Laboratory and performance tests" assessed the device itself (PULSAR II Generator and PlasmaBlade Tissue Dissection Devices) to ensure it functioned as intended and met design specifications, and that its output energy and delivery system were similar to the predicate.
7. The Type of Ground Truth Used
Not applicable in the context of clinical ground truth (e.g., pathology, outcomes data, expert consensus). For electrosurgical devices, "ground truth" would typically refer to established engineering specifications, safety standards, and performance benchmarks for electrosurgical energy output, tissue cutting, and coagulation characteristics. The "performance data" likely referred to measurements and observations against these engineering standards.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware electrosurgical unit, not a machine learning model. There is no concept of a "training set" for such a device in the context of this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.