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510(k) Data Aggregation
(231 days)
The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis.
The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Sunny device is a high frequency electrosurgical unit that conveys current to the human body through non-invasive electrodes. The device includes three different high frequencies: 6.78MHz (RF), 1MHz (RF), and 2 MHz (RF). It is composed of the main body, Sunny handpiece, Pulsar handpiece, treatment tips, neutral electrode pad, refrigerant gas, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.
Based on the provided text, the device in question is an electrosurgical unit (Sunny™) and not an AI-powered diagnostic device. Therefore, a significant portion of the requested information, such as multi-reader multi-case (MRMC) comparative effectiveness studies, ground truth establishment by experts, and sample sizes for training/test sets related to AI model validation, are not applicable.
The acceptance criteria and study that proves the device meets them are focused on hardware performance, safety, and substantial equivalence to a predicate device.
Here's an organized description of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Sunny™ (Electrosurgical Cutting and Coagulation Device and Accessories)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit/Explicit from Text) | Reported Device Performance/Testing Result |
|---|---|
| Device Performance (Sunny RF Handpiece - 6.78MHz) | |
| Effectiveness for electrocoagulation and hemostasis (based on thermal effect) | Histopathology testing conducted to demonstrate the thermal effect of the device, showing it functions comparatively to the predicate (Thermage CPT) despite differences in max power and electrode size. |
| Energy Output Range (25 to 135 Joules) | Achieved. "Similar" to predicate's 20 to 137 Joules, with the small differences not impacting safety or effectiveness. |
| Device Performance (Pulsar Handpiece - 1MHz and 2MHz RF) | |
| Ability to provide topical heating for temporary relief of pain, muscle spasms, and increase in local circulation (based on temperature maintenance) | A temperature maintenance test was performed and confirmed that the device can maintain skin temperature of 40°C-45°C for 10 minutes on three different anatomical sites. The performance goal for the reference device (Nuera Tight RF) was 40-42°C +/- 2°C for 15 minutes, showing the Sunny device meets similar therapeutic temperature ranges, albeit for a slightly shorter duration. |
| Energy Output levels for 1MHz and 2MHz | 10 levels, specifically: Level 1 (1MHz: 15.2W, 2MHz: 7.6W), Level 10 (1MHz: 40.5W, 2MHz: 20.2W). |
| Power Density (60 J/cm² for Pulsar) | "Similar" to predicate's 45.6 J/cm². |
| Safety & Compliance | |
| Electrical Safety | Compliance with IEC 60601-1:2005 + A2:2020. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 + A1:2020 and IEC TR 60601-4-2 Edition 1.0 2016-05. |
| High-Frequency Surgical Equipment Specific Requirements | Compliance with IEC 60601-2-2:2017 + A1:2023. |
| Software Life Cycle Processes | Compliance with IEC 62304:2006+A1:2015. Software verification and validation testing conducted per FDA guidance. |
| Risk Management | Compliance with EN ISO 14971:2019. |
| Biocompatibility | Materials contacting intact patient skin (<24 hours) determined to be biocompatible through testing. Compliance with ISO 10993-1:2018. |
| Accuracy of RF energy | Bench testing performed to verify accuracy. |
| Predicate Equivalence (Sunny RF Handpiece) | Demonstrated equivalence to Thermage CPT in general design, frequency (6.78 MHz), and intended use for electrocoagulation and hemostasis, supported by thermal testing. |
| Predicate Equivalence (Pulsar Handpiece) | Demonstrated equivalence in intended use, mechanism of action, and general design to the predicate device, supported by tissue temperature maintenance testing despite differences in output power and frequency. Also heavily references Nuera Tight RF (K210867) as a reference device sharing frequencies and specific indications. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for bench tests (RF accuracy, temperature maintenance, histopathology). For biological evaluation (biocompatibility), it typically involves testing material samples, not patient data in the context of device performance.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. The testing appears to be primarily bench testing and materials testing, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the provided document describes a hardware medical device (electrosurgical unit) and not an AI/software diagnostic tool. The "ground truth" for this device's performance is established through physical measurements, electrical output verification, thermal effect demonstration, and adherence to international safety and performance standards. Histopathology for thermal effect assessment would involve trained pathologists, but the number and qualifications are not specified nor is it a "ground truth" in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of discrepancies in human expert labels for AI ground truth, which is not relevant here. The testing methods described are standard engineering and safety compliance tests.
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
- Not applicable. The device is an energy-based surgical tool, not an AI diagnostic aid. No MRMC study involving human readers assisting with AI was performed or is relevant to its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This pertains to AI algorithm performance. The device performs its intended function autonomously based on user input (setting power, mode), and its performance is evaluated by its physical effects (e.g., thermal effect, temperature maintenance), not as an algorithm generating diagnostic outputs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is established primarily by:
- Bench Testing Measurements: Direct measurement of electrical parameters (power, frequency, energy output).
- Histopathology: Microscopic examination of tissue after device application to demonstrate thermal effects (for electrocoagulation/hemostasis). This is a form of pathology.
- Temperature Measurement: Direct measurement of skin temperature during operation to confirm therapeutic heating.
- Compliance with Standards: Meeting the requirements and specifications outlined in various IEC and ISO standards (e.g., 60601-1 for basic safety, 14971 for risk management, 10993-1 for biocompatibility).
8. The sample size for the training set
- Not applicable. The device is a hardware product, not a machine learning model. There is no "training set" in the context of AI. Design and development follow engineering principles, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable. Refer to point 8.
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