(71 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 Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. 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 Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices 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 handpieces.
The provided text describes a 510(k) submission for the PEAK Surgery System, an electrosurgical device. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria in a quantitative manner as typically expected for imaging or AI-driven diagnostics.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is similar enough in intended use, technological characteristics, and performance to devices already approved for marketing.
Here’s a breakdown of what can be extracted or inferred based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device's intended use is substantially equivalent to predicate devices. | The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive, ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures. This is presented as substantially equivalent to predicate devices. |
| Technological Characteristics Equivalence: Device's technological characteristics are substantially equivalent to predicate devices. | The PEAK Surgery System functions as an electrosurgical instrument using RF energy for cutting and coagulation, similar to predicate devices. Microcontroller-based generator, single-use sterile handpieces with insulated blade electrode, rotating bendable shaft, handle controls, and cable. |
| Safety and Effectiveness: Demonstrate the device is safe and effective when used as intended, comparable to predicate devices. | "Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." |
| Sterility: Devices provided sterile (where applicable). | The PEAK PlasmaBlade Tissue Dissection Devices are provided sterile and are not intended for reuse or resterilization. |
Missing specific quantifiable acceptance criteria. For example, there are no reported thresholds for cutting efficiency, coagulation depth, tissue damage profiles, or specific electrical parameters and their tolerance levels that typically would be defined as acceptance criteria in a detailed engineering or performance report. The provided text only states that tests "met design specifications," without detailing those specifications.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Preclinical laboratory and performance tests," but does not provide details on the number of tests conducted, the type of samples (e.g., in vitro tissue, animal models), or the quantity of each.
- Data Provenance: Not explicitly stated. The tests are described as "Preclinical laboratory and performance tests," implying they were conducted in a lab setting, likely by the manufacturer, PEAK Surgical, Inc. Country of origin for data is not specified, but the company is based in Palo Alto, CA, USA. The study design is not specified as retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
Given that this is a 510(k) for an electrosurgical device (not AI, imaging, or diagnostics), the concept of "ground truth" established by human experts in the context of diagnostic accuracy is not directly applicable. The "ground truth" for electrosurgical devices typically relates to objective physical or physiological measurements (e.g., tissue temperature, cut depth, coagulation size, impedance readings) rather than expert interpretation of images or clinical outcomes in the same way.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable/not mentioned. This concept is usually relevant for studies involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: Not done, or at least not reported in this summary. MRMC studies are typically for evaluating diagnostic imaging devices or AI algorithms where human readers interpret cases. This device is a surgical tool.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic or interpretative device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a physical electrosurgical tool, not an algorithm. Its performance is inherent in its physical operation, not a separate algorithmic component.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated in the context of diagnostic accuracy. For this type of device, ground truth would likely refer to:
- Engineering Specifications: Device output parameters (e.g., power, voltage, current) meeting pre-defined ranges.
- Biophysical Effects: Objective measurements of tissue effects (e.g., measured cut depth, coagulation zone, thermal spread, histological analysis) demonstrating performance within acceptable limits or comparable to predicate devices.
- Functional Performance: Successful operation of mechanical and electrical components (e.g., blade articulation, control responsiveness).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a conventional electrosurgical device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary: The provided 510(k) summary for the PEAK Surgery System states that "Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications" and that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." However, it does not provide the specific details regarding the acceptance criteria, the scope of the tests, the sample sizes, or the qualitative/quantitative results of these tests, which are typically contained in more in-depth sections of a 510(k) submission not included here. This summary focuses on establishing substantial equivalence based on overall performance and functional similarity to already marketed devices rather than detailed performance metrics against explicit acceptance criteria.
§ 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.