(231 days)
LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
Here's a breakdown of the acceptance criteria and study information for the LightStim for Acne Mini device, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria for the LightStim for Acne Mini are primarily based on demonstrating substantial equivalence to existing predicate devices. This means the device needs to show similar performance characteristics, indications for use, and safety attributes as the predicates. The document doesn't explicitly state quantitative performance targets for effectiveness (e.g., "reduce acne by X%"), but rather focuses on aligning with the established parameters of comparable devices already on the market.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (based on predicate devices) | Reported LightStim for Acne Mini Performance |
|---|---|---|
| Intended Use | Mild to moderate acne. (Matches all predicates: Tanda Skincare, Quasar Blue Light Therapy System, Silk'n Blue) | Mild to moderate acne. (Stated in the Indications for Use / Intended Use section and the comparison table. This is a direct match, indicating criterion met.) |
| Indications for Use | Treatment of mild to moderate acne. (Explicit from predicates) | Treatment of mild to moderate acne. (Explicit in the Indications for Use / Intended Use section and comparison table. This is a direct match, indicating criterion met.) |
| Target Population | Women and men with mild to moderate acne. (Matches all predicates) | Women and men with mild to moderate acne. (Stated in the comparison table. This is a direct match, indicating criterion met.) |
| Output in mW | 50mW/cm² (Matches all predicates) | 50mW/cm². (Stated in the comparison table. This is a direct match, indicating criterion met.) |
| Treatment Time | 3 to 4 minutes per area (Matches Quasar and Silk'n Blue predicates, Tanda is 3 minutes twice daily) | 3 to 4 minutes per area. (Stated in the comparison table and Device Description. This aligns with two of the three predicates, with Tanda being slightly different but within a similar range for single treatment duration. This is considered met for substantial equivalence.) |
| Treatment Area (cm²) | In line with similar hand-held devices (Predicates range from 7 to 27 cm²) | 15.5 cm². (Stated in the comparison table. This falls within the range of the predicate devices. This is considered met for substantial equivalence.) |
| Wavelengths (nm) | 415 nm (Matches all predicates) | 415 nm. (Stated in the comparison table and Device Description. This is a direct match, indicating criterion met.) |
| Where Used | Home use (Matches all predicates) | Home. (Stated in the comparison table. This is a direct match, indicating criterion met.) |
| Design | Hand-held device (Matches all predicates) | Hand-held device. (Stated in the comparison table. This is a direct match, indicating criterion met.) |
| Materials | Rigid ABS or similar (Predicates use Rigid ABS or Stainless Steel) | Rigid ABS. (Stated in the comparison table. This matches two of the three predicate devices, indicating criterion met.) |
| Electromagnetic Compatibility | IEC 60601-1-2 compliant (Matches all predicates) | IEC 60601-1-2. (Stated in the comparison table. This is a direct match, indicating criterion met.) |
| Basic Safety and Essential Performance | IEC 60601-1 compliant (Matches all predicates) | IEC 60601-1. (Stated in the comparison table. This is a direct match, indicating criterion met.) |
| Radiation Safety | Addressed by recognized standards (Predicates "Unknown," but the subject device identifies its standard, suggesting adherence to modern safety practices) | IEC 62471/IEC 62471-2. (Stated in the comparison table. While predicates are "Unknown," the subject device explicitly states compliance with a relevant standard, suggesting it meets safety expectations in this regard, and likely exceeds the "unknown" status of predicates by providing a specific standard.) This is considered met for substantial equivalence. |
| Usability/User Comprehension | Users adequately decide whether to use the device and comprehend risks, warnings, cautions, precautions, and proper use. | "results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehended risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual." (Stated in the Performance Data section. This directly confirms meeting the criterion for usability.) |
Study Details for LightStim for Acne Mini:
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 40 participants.
- Data Provenance: The document does not explicitly state the country of origin. It appears to be a prospective study, as participants used the device and their comprehension and decision-making were evaluated as part of the study.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The study described is a usability study, not a clinical efficacy study requiring expert assessment of medical outcomes. Therefore, there is no mention of experts establishing a "ground truth" for acne severity or improvement. The "ground truth" for this study was user comprehension and appropriate device selection, which was assessed through observation and potentially questionnaires.
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Adjudication Method for the Test Set:
- Not applicable. The study was a usability study focused on user comprehension, not on medical diagnoses or outcomes requiring adjudication by multiple experts.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study focuses on usability and safety, not on comparing diagnostic accuracy or clinical effectiveness with or without AI assistance. The device is not an AI-powered diagnostic tool.
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Standalone Performance Study:
- Yes, a standalone usability study was conducted. The described "Performance Data" section details a study where 40 participants used the device and were assessed on their "adequacy" in deciding to use the device and their "comprehension" of the instruction manual. This evaluates the device's human-interaction performance without comparison to other devices in terms of usability effectiveness.
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Type of Ground Truth Used:
- For the usability study, the "ground truth" was user comprehension and appropriate decision-making regarding device use, as evaluated through the study protocol. This is observational/feedback-based, not medical pathology or outcomes data.
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Sample Size for the Training Set:
- Not applicable. This device is a light therapy device, not an algorithm or AI model that requires a training set.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
§ 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.