(28 days)
The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
The Pixel8-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel. The RF Energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The Pixel8-RF System creates heat within the target tissue using micro-needles inserted from the tip.
This FDA 510(k) summary for the PiXel8-RF System does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for AI/ML device studies. This document is a premarket notification for a medical device that uses radiofrequency energy for dermatological and general surgical electrocoagulation and hemostasis. It is not an AI/ML device.
Here's why your request cannot be fully answered with the provided document:
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Nature of the Device: The PiXel8-RF System is an electrosurgical device, not an AI/ML diagnostic or predictive system. Therefore, the concepts of sensitivity, specificity, AUC, human reader improvement with AI, standalone performance, training/test sets, or ground truth established by expert consensus are not applicable in this context.
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Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves performance testing to ensure safety and effectiveness are comparable, not necessarily a clinical study demonstrating superior performance or meeting specific diagnostic performance metrics characteristic of AI/ML.
However, I can extract the relevant "performance data" and "conclusion" provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion for a 510(k) is demonstrating that the device is as safe and effective as its predicate device. This means its performance characteristics should be comparable, and it should not raise new questions of safety or effectiveness. Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity) for the device's function are not typically presented in this summary format for non-AI devices. Instead, compliance with recognized safety and performance standards, and comparable functional output, are key.
- Reported Device Performance:
| Performance Metric/Study Type | Reported Outcome |
|---|---|
| IEC 60601-1 | Performed for General Requirements for basic safety and essential performance. |
| IEC 60601-1-2 | Performed for General Requirements for basic safety and essential performance: electromagnetic compatibility. |
| IEC 60601-2-2 | Performed for particular requirements for the basic safety and essential performance of high-frequency surgical equipment. |
| In-Vivo Testing | Conducted on 3 types of tissue (Liver, Kidney, and Muscle). Results showed measurable thermal damage and no instances of unexpected injury. |
| Clinical Study | No clinical study was conducted to support this 510(k) submission (as substantial equivalence was demonstrated through other means like technical comparison and bench/in-vivo testing). |
| Technical Comparison (with K180654) | System Type: BiPolar RF (Same) |
| Output Energy Type: High Frequency (Same) | |
| Max Power: 25 W @ 500 ohm (Same) | |
| Total RF Treatment Level: Up to 20 (Same) | |
| RF Duration: 50 ms – 950ms (Same) | |
| Tips: MicroNeedle Electrodes (25, 49, 64 pins for subject vs. 25, 64 pins for predicate - difference noted but deemed not to raise new safety/effectiveness questions) | |
| Frequency: 4 MHz (Subject) vs. 2 MHz (Predicate) - difference noted but deemed not to raise new safety/effectiveness questions. |
Regarding the other aspects of your request, which are pertinent to AI/ML studies, the document provides no relevant information:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" for this device would be the tissues used in the in-vivo study (3 types: Liver, Kidney, Muscle). The geographical origin of these tissues or animals is not specified, nor is the setting (retrospective/prospective, as it's an animal study).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the in-vivo study was based on direct pathological analysis of tissue, not expert consensus on images. The qualifications of the pathologists are not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for AI/ML image interpretation, not device performance testing.
- 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: Not applicable. This is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the in-vivo testing, the ground truth was pathology (analysis of thermal damage).
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
Conclusion stated in the document:
"The difference in the frequency does not raise new or different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as its predicate device for the intended use. Therefore, the PiXel8-RF system is substantially equivalent to its predicate 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.