(166 days)
The SHASER IPL Hair Removal System is an over the counter device intended for removal of unwanted hair.
The SHASER IPL Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The SHASER IPL Hair Removal System consists of a powered base unit and a tethered handpiece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light cartridges, cleaning cloth, and user's manual.
Here's an analysis of the provided text regarding the Shaser IPL Hair Removal System's acceptance criteria and study details:
Acceptance Criteria and Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Hair reduction at 3 months post-final treatment | Average reduction of 37% |
| Hair reduction at 6 months post-final treatment | Average reduction of 48% |
| Safety and effectiveness for over-the-counter use | Demonstrated through clinical trial |
| Compliance with 21CFR § 1040.10 & 1040.11 (Performance Standards) | Device complies with these standards |
Study Details
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Sample size used for the test set and data provenance:
- Sample Size: 111 test sites from an unspecified number of subjects (approximately 50% female and 50% male). The exact number of individual subjects is not explicitly stated, but it implies more than one since "approximately 50% female and 50% male subjects" is mentioned.
- Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies a prospective design. Diverse demographical sub-groups were included.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This information is not provided in the document. The method for assessing hair count reduction (ground truth) is stated as "Hair counts were taken before treatment and 3 and 6 months following the final treatment," but it does not specify who performed these counts or their qualifications.
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Adjudication method for the test set:
- This information is not provided in the document.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial to demonstrate the device's standalone effectiveness, not a comparison involving human readers with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the described clinical trial evaluated the standalone performance of the Shaser IPL Hair Removal System. There is no mention of an algorithm or AI assistance; it's a device performance study.
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The type of ground truth used:
- The ground truth was based on measured hair counts ("Hair counts were taken before treatment and 3 and 6 months following the final treatment"). This is objective, quantitative data.
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The sample size for the training set:
- This device is an IPL hair removal system, not an AI or algorithm-based device that would typically have a "training set" in the machine learning sense. Therefore, this information is not applicable/provided. The clinical trial is the performance validation of the physical device.
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How the ground truth for the training set was established:
- As in point 7, this question is not applicable as there is no mention of a training set for an AI model.
§ 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.