(281 days)
Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.
The Strialite is an over the counter (OTC) device utilizing a combination of light emitting diode (LED) lights and a heating element as a phototherapy/thermal treatment for the end users' stretch marks (striae). It is a hand-held, compact, lightweight device, designed to specifically treat and reduce the visible appearance of an individual's red stretch marks. A stretch mark is a defect in the skin caused by damaged collagen that occurs from rapid skin stretching, that may have a red appearance. The red LED light and heat work together to stimulate the skin at the cellular level to produce and repair collagen. As the damaged collagen tissue is gradually replaced, over time the appearance of the stretch mark is reduced. Typical areas for treatment are the abdomen, breasts, back, hips, and thighs. The recommended treatment schedule is two (2) 20-minute sessions a week for at least four (4) weeks. Strialite is intended for home use by adults under the age of 50 years.
The Strialite device consists of a housing enclosure with an ergonomic handle, electronic circuit boards, treatment plate with a specific array of LED lights, thermal heating elements that generate temperature up to 105 degree F (40 degree C), touch control power button (On/Off), and a power cord. The flat LED panel, consisting of thirty-five (35) visible red LEDs in the 633 nm (±5nm) spectrum, is located on the base of the device, and directly contacts the area of skin to be treated. The device is provided non-sterile and reusable.
Here's a breakdown of the acceptance criteria and study information for the Strialite device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Clinical Study) |
|---|---|
| Improvement in severity of redness of stretch marks (at least 2 grades on a 1-10 scale), self-assessed by subjects. | 16 out of 30 subjects (53.3%) reported at least 2-grade improvement. |
| Improvement in severity of redness of stretch marks (blinded photographic assessment). | 18 out of 30 subjects (60%) demonstrated improvement. |
| No adverse effects observed or reported. | No adverse effects were observed or reported during the study. |
| Ability of subjects to read and comprehend Instructions for Use and Quick Start Guide. | 39 out of 40 subjects (97.5%) were able to read and comprehend the information. |
| Ability of subjects to correctly demonstrate critical steps in device use. | 38 out of 40 subjects (95.0%) were able to correctly demonstrate the six critical steps. |
| Correct self-selection for device use based on carton labeling. | All responders (41 subjects) correctly determined the device use; all but one correctly self-selected. |
Note: The document explicitly states "Strialite passed all testing stated in Table 5B below as shown by the acceptable results obtained," but Table 5B outlines non-clinical performance data (e.g., design verification, electrical safety, EMC, photobiological safety). The acceptance criteria for the clinical performance data are inferred from the outcomes presented in Section 10 ("Clinical Performance Data").
2. Sample Sizes Used for the Test Set and Data Provenance
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Clinical Study Test Set:
- Sample Size: 33 subjects initially enrolled, with 30 completing the full series of 8 treatments.
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions are typically conducted in the US or in countries with equivalent regulatory standards. The document doesn't specify if it was retrospective or prospective, but clinical trials for regulatory submission are generally prospective.
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Usability Study Test Set:
- Sample Size: 40 subjects.
- Data Provenance: Not explicitly stated, but likely prospective.
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Self-Selection Study Test Set:
- Sample Size: 41 subjects.
- Data Provenance: Not explicitly stated, but likely prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Clinical Study: "blinded photographic assessment was performed." The number and qualifications of the individuals performing this blinded assessment are not specified in the provided text.
- Usability Study: "observed and recorded by the trained interviewer." The number and qualifications of the trained interviewers are not specified.
- Self-Selection Study: "When interviewed, all responders correctly determined..." The number and qualifications of the interviewers are not specified.
4. Adjudication Method for the Test Set
- Clinical Study (blinded photographic assessment): The adjudication method is not specified. It only states "blinded photographic assessment was performed," not how discrepancies (if any) among assessors were resolved.
- Other studies: Not applicable as ground truth was derived from direct observation or participant responses, not expert consensus on ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC comparative effectiveness study was done. The clinical study assessed the effect of the Strialite device on its own, without comparing human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone clinical study was done. The Strialite device is an over-the-counter device intended for direct user application. The clinical study directly assessed the device's performance based on subject self-assessment and blinded photographic assessment of the effects of the device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Clinical Study:
- Subjective Ground Truth: Subject self-assessment of "improvement of the severity of the redness of their stretch marks of at least 2 grades when graded on a scale of 1 to 10." This is a subjective outcome report from the users.
- Objective/Expert-Assessed Ground Truth: "blinded photographic assessment." While the experts are not explicitly defined, this implies an objective evaluation by trained individuals based on photographic evidence. This is a form of expert assessment of visual outcomes.
- Usability Study: Ground truth was established by direct observation of subjects' actions (demonstrating correct simulated use) and their responses to survey questions (comprehension of instructions).
- Self-Selection Study: Ground truth was established by subjects' responses to interview questions regarding their understanding of the device's indications for use.
8. The Sample Size for the Training Set
- The document describes a clinical study to assess the device's effect and usability studies for its OTC claim. It does not mention any training set as this device is a physical light therapy device, not an AI/software algorithm that requires a training dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no mention of a training set for an AI/software algorithm.
§ 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.