(250 days)
The SAPPHIRE is an over -the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.
The Sapphire device is an over-the-counter, battery powered, hand-held device that emits light energy in the blue spectrum for the treatment of mild to moderate inflammatory acne by emitting 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diode [LEDs] energy source. The Sapphire device operates by a cordless system drawing upon its rechargeable Li-Ion batteries to deliver the treatment. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. There are no user settings or adjustments required. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
The provided text describes the Sapphire device, an over-the-counter hand-held, battery-operated light therapy device that uses LEDs emitting 415nm (Blue Light) for treating mild to moderate inflammatory acne. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against acceptance criteria in a clinical study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific quantitative acceptance criteria or a direct comparison of the Sapphire device's performance against such criteria in a clinical efficacy study. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended use. The "performance" described is in terms of safety and technical conformance.
| Feature/Standard | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Treatment of mild to moderate inflammatory acne | Same as predicate |
| Output (Energy Level) | 50 mW/cm² | 50 mW/cm² |
| Wavelength | 415 nm +/- specified range (e.g., 6nm or 15nm) | 415 nm +/- 5nm |
| Total Energy Delivered per Treatment | 9-12 J/cm² | 12 J/cm² |
| Treatment Time | 3-4 minutes per area, or 4 minutes per area twice per week for 4 weeks | 4 minutes per area, twice per week for 4 weeks (total of 8 treatments) |
| Handheld | Yes | Yes |
| Location for Use | Over-the-Counter (OTC) | OTC |
| Modes | On/Off | On/Off |
| Electrical Safety (IEC60601-1) | Conformance to standard | Conforms |
| EMC (IEC 60601-1-2) | Conformance to standard | Conforms |
| Battery Safety (IEC 62133) | Conformance to standard | Conforms |
| Home Healthcare Environment (IEC 60601-1-11) | Conformance to standard | Conforms |
| Photobiological Safety (IEC 62471) | Conformance to standard | Conforms |
| Biocompatibility (ISO 10993-1, -5, -10) | Conformance to standards | Conforms |
| Software Validation | Conformance to FDA guidance | Software was tested and validated |
| Usability/Label Comprehension | High percentage of participants able to comprehend labeling and use device successfully | 96% comprehended labeling, 96% used device successfully |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Usability/Label Comprehension Study: 35 participants.
- Data Provenance: The document does not specify the country of origin for the usability study. It is implied to be a prospective study as participants "were able to comprehend" and "were able to use," suggesting active participation during the study.
- For Efficacy: The document does not report a clinical efficacy study for the Sapphire device; instead, it relies on substantial equivalence to predicate devices. Therefore, there is no sample size for an efficacy test set.
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)
This information is not applicable as no clinical efficacy study with a ground truth established by experts is reported for the Sapphire device. The "test set" mentioned applies to the usability/label comprehension study, which doesn't involve medical experts establishing a "ground truth" in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical efficacy study requiring adjudication of findings is reported. The usability study would likely involve direct observation or survey responses, not an adjudication process.
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
This information is not applicable. The Sapphire device is a light therapy device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Sapphire device is a physical light therapy device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for a clinical efficacy study, as such a study is not reported. For the usability study, the "ground truth" would be the observed ability of participants to understand the labeling and operate the device successfully.
8. The sample size for the training set
This information is not applicable as no clinical efficacy study requiring a training set for an algorithm is reported for the Sapphire device.
9. How the ground truth for the training set was established
This information is not applicable as no clinical efficacy study requiring a training set is reported.
§ 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.