(217 days)
The apollo"M is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
The apollo™ system delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The system consists of:
- Main Unit (includes the Controller)
- Control Panel (User Interface)
- RF Generator
- Three Treatment Applicators
- Foot Switch
- Patient-Controlled Manual Switch
The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with low pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.
The RF power module provides RF energy to the selected applicator at a frequency of 1 MHz and a maximum output RMS power of 50 watts for applicators No. 1 and 2 and a maximum RMS power of 15 watts for applicator No. 3.
The Pollogen apollo™ system is a non-invasive device intended for dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific, quantifiable acceptance criteria for clinical performance (e.g., a specific percentage reduction in wrinkles, or a minimum success rate). Instead, it relies on the established safety and efficacy of similar radiofrequency technologies.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Implicit: Compliance with relevant electrical safety and electromagnetic compatibility standards and general safety of similar devices. | Complies with European Medical Directive 93/42/EEC and standards: EN 60601-1, IEC 60601-1-2, ANSI AAMI 60601-2-2. Safety of 1 MHz, up to 50W RF devices is "well established in scientific research and clinical studies" with multiple similar systems showing safety in dermatologic therapy and FDA clearance for wrinkles/rhytides. |
| Efficacy | Implicit: Effectiveness in non-invasive treatment of mild to moderate facial wrinkles and rhytides, consistent with similar, previously cleared RF devices. | Efficacy of 1 MHz, up to 50W RF devices is "well established in scientific research and clinical studies" with multiple similar systems cleared by FDA for therapy of wrinkles and rhytides. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study was conducted for the apollo™ device for its 510(k) submission. Therefore, there is no sample size for a test set and no data provenance (country of origin, retrospective/prospective). The submission relies on existing literature and regulatory clearances of predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific clinical study was performed for the apollo™ device to establish new clinical performance data, there were no experts specifically engaged to establish ground truth for a new test set in this submission. The ground truth essentially relies on the body of evidence from prior research and regulatory clearances of similar devices, implicitly reviewed by regulatory bodies (like the FDA) and the broader scientific community.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated clinical study with a test set was conducted for this 510(k) submission.
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. This device is an energy-based cosmetic/medical treatment device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device for treatment, not an algorithm.
7. The Type of Ground Truth Used
The ground truth relies on expert consensus based on previously published scientific research and clinical studies of similar radiofrequency devices. The document explicitly states: "The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1 MHz and power of up to 50 W is well established in scientific research and clinical studies. Multiple studies with similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides."
8. The Sample Size for the Training Set
Not applicable. As no new clinical study was conducted for this device, and it's not an AI/machine learning device requiring a "training set" in the computational sense, there is no training set sample size mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used. The submission relies on existing, established scientific and clinical evidence documented in the broader literature, which served as the "ground truth" for the predicate devices and the general understanding of RF technology's effects.
§ 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.