(164 days)
The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The Poly Rejuv is a portable device that has a detachable treatment head, containing a total of 1,820 red LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment head) for the device. 12 pairs of protective eyewear are included with the device. The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use. The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.
The Poly Rejuv device (Model 633) is intended for dermatological use to treat periorbital wrinkles by emitting red region energy. The clearance is based on substantial equivalence to predicate devices, supported by non-clinical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the Poly Rejuv Model 633 does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., specific percentage reduction in wrinkles, or a statistical significance level for improvement). Instead, substantial equivalence is established through comparison of technological characteristics with a predicate device and extensive non-clinical (bench) testing. The "acceptance criteria" can be inferred as demonstrating that the device is as safe and effective as legally marketed predicate devices, with no new issues regarding safety and effectiveness.
The table below summarizes the key comparative characteristics presented in the 510(k) summary that serve as the basis for demonstrating this "acceptance."
| Characteristic | Acceptance Criteria (based on predicate/reference devices) | Reported Poly Rejuv Model 633 Performance |
|---|---|---|
| Indications for Use | Treatment of periorbital wrinkles | Treatment of periorbital wrinkles |
| Wavelengths | 630 +/- 3nm (Predicate) | 633nm |
| Total Power Density (Red) | 80 mW/cm² (Predicate K162098) / 65 mW/cm² (Reference K150098) | 60 mW/cm² |
| Treatment Regimen | 2 treatments per week for 6 weeks | 2 treatments per week for 6 weeks |
| Treatment Time (per Tx) | 3 minutes per target area (Predicate) / 3 minutes (Reference) | 4 minutes |
| Standard Dose per treatment (Red) | 14.4 J/cm² (Predicate) | 14.4 J/cm² |
| Modes of Operation | ON/OFF | ON/OFF |
| Electrical Safety | Conformance to IEC60601-1 | Conforms to IEC60601-1 |
| EMC | Conformance to IEC 60601-1-2:2014 | Conforms to IEC 60601-1-2:2014 |
| Lamp Safety | Conformance to IEC 62471 | Conforms to IEC 62471 |
| Device Specific Safety | Conformance to IEC 60601-2-57:2011 | Conforms to IEC 60601-2-57:2011 |
| Usability | Conformance to IEC 62366-1 and IEC 60601-1-6 | Conforms to IEC 62366-1 and IEC 60601-1-6 |
| Software Validation | In accordance with FDA guidance | Software tested and validated |
| Performance Testing | Bench tests for Power Density, Timer, Functions, Use Life, Storage | Bench tests conducted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not describe a clinical study or a test set of data (e.g., patient data). The clearance is based on non-clinical (bench) testing and comparison of technical specifications to predicate devices. Therefore, there is no mention of sample size for a test set or data provenance from a human study.
The testing conducted was primarily hardware-related (electrical safety, EMC, lamp safety, device-specific safety, usability, and bench testing for power density, timer, functions, use life, and storage conditions) and software validation. These tests are conducted on the device itself, not on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set or ground truth by medical experts was described for this 510(k) submission. The evaluation was based on engineering and performance standards conformance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was 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
Not applicable. This device is an LED therapy system for wrinkle reduction, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (LED therapy system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical ground truth from human studies was used for this 510(k) submission. The "ground truth" for the non-clinical testing was based on established engineering and safety standards (e.g., IEC standards) and the specified performance characteristics of the device and its predicates.
8. The sample size for the training set
Not applicable. As no artificial intelligence (AI) or machine learning (ML) algorithm is mentioned in the submission, there is no "training set" in that context. The device's software was subjected to validation testing, but this is distinct from training an AI model.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm was described.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.