(260 days)
The Poly Clear combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
The Poly Clear is a portable device that has three separate detachable treatment heads, each containing a total of 1,820 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 heads) for the device. 6 pairs of protective eyewear are included with the device.
The provided text is a 510(k) summary for the Poly Clear device, which is a light therapy device for treating mild to moderate acne vulgaris. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.
Crucially, the document explicitly states that "no clinical studies required" (page 6). This means there are no acceptance criteria related to a clinical study demonstrating the device's efficacy in treating acne vulgaris, nor is there a study detailing device performance against such criteria.
The acceptance criteria provided in the document and the associated "study" (non-clinical testing) are focused on safety and technological equivalence.
Here's an analysis based on the information provided, highlighting the absence of clinical performance data:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria for clinical performance (e.g., reduction in acne lesions) because it states no clinical studies were required. The "performance" discussed is primarily non-clinical.
| Acceptance Criteria (Based on Non-Clinical Testing) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Electrical Safety: Conformance to IEC60601-1 | Tested and conforms to IEC60601-1. |
| EMC (Electromagnetic Compatibility): Conformance to IEC 60601-1-2:2014 | Tested and conforms to IEC 60601-1-2:2014. |
| Lamp Safety (Photobiological Safety): Conformance to IEC 62471 First Edition 2006-07 | Tested and conforms to IEC 62471 First Edition 2006-07. |
| Device Specific Safety (Non-Laser Light Source): Conformance to IEC 60601-2-57:2011 | Tested and conforms to IEC 60601-2-57:2011. |
| Software Validation: Validated in accordance with FDA guidance for software in medical devices. | Software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." |
| Performance Bench Tests: Spectral Transmittance of Eyewear, Power density, Timer and Functions Test, Electrical Safety Test, Use Life Test, and Storage Condition Test meet specifications. | The device has been tested to ensure it meets specifications for Spectral Transmittance of Eyewear, Power density, Timer and Functions Test, Electrical Safety Test, Use Life Test, and Storage Condition Test. (Specific results not detailed, but implied successful conformance). |
| Usability/Label Comprehension: Training is effective; intended users understand labeling and can apply information for primary operating functions. | Usability/Label Comprehension study results showed that training was effective and intended users were able to understand the labeling and apply this information to device use for the primary operating functions of the device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For safety and bench testing: The document does not specify sample sizes (e.g., number of devices tested). These are typically laboratory tests on a representative number of units. The provenance is internal testing performed by the sponsor or contracted labs.
- For usability testing: The document mentions "intended users" were involved in the Usability/Label Comprehension study, but does not state the sample size, country of origin, or whether it was prospective or retrospective. It's almost certainly prospective as it's a study conducted for this submission.
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. For non-clinical (engineering/safety) testing, "ground truth" is established by adherence to recognized international standards and specifications, rather than expert human assessment of medical images or conditions. For usability, the "ground truth" is the ability of intended users to successfully operate the device and understand instructions, as observed during the usability study, not by experts establishing clinical truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpreting diagnostic results or assessing patient outcomes, particularly when there is subjectivity. The provided non-clinical testing does not involve such methodologies.
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 Poly Clear device is a light therapy device, not an AI-powered diagnostic or assistive tool. No MRMC studies were conducted, as the device does not involve "human readers" or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Poly Clear is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by:
- International Consensus Standards: For electrical, EMC, and lamp safety, the ground truth is compliance with the specified IEC standards.
- Device Specifications: For performance bench tests (e.g., power density, timer), the ground truth is meeting the manufacturer's defined specifications.
- Observational Data/User Feedback: For usability testing, the ground truth is the successful demonstration of understanding and operation by the intended users during the study.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
In summary: The 510(k) submission for the Poly Clear device relies on demonstrating substantial equivalence through non-clinical testing (safety and performance bench tests) and comparative analysis of technological characteristics with predicate devices. No clinical studies were required, and therefore, no clinical performance acceptance criteria or corresponding clinical efficacy data are present in this document.
§ 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.