(135 days)
The SHASER HRS2 Hair Removal System is an over-the-counter device intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and12 months after the completion of a treatment regimen.
The SHASER HRS2 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 permanent hair reduction as defined below using Intense Pulsed Light (IPL) technology.
The SHASER HRS2 Hair Removal System consists of a powered base unit and a tethered hand piece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light carring a cloth, and user's manual.
Here's a breakdown of the acceptance criteria and the study details for the SHASER HRS2 Hair Removal System, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Definition of Permanent Hair Reduction) | Reported Device Performance (Average Hair Reduction) |
|---|---|
| Long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | At 3 months: 37% average hair reduction |
| At 6 months: 48% average hair reduction | |
| At 12 months: 66% average hair reduction |
Note: The acceptance criteria itself is qualitative ("long-term stable reduction"). The clinical trial aims to demonstrate that the device achieves this by reporting quantitative hair reduction percentages at specified time points.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number, but the study was conducted on "a population of approximately 50% female and 50% male subjects from diverse demographic sub-groups." The specific number of subjects is not provided, but it implies a cohort designed to represent a diverse user base.
- Data Provenance: The document does not specify the country of origin of the data. It indicates a "clinical trial was conducted," suggesting prospective data collection.
3. 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 given document. The summary focuses on hair count measurements without detailing expert involvement in establishing ground truth for the hair counts.
4. Adjudication Method for the Test Set
This information is not provided in the given document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study typically involves comparing human readers' performance with and without AI assistance, which is not applicable to this hair removal device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the SHASER HRS2 Hair Removal System. This device is a physical, light-based hair removal system, not an algorithm or AI system that would have a standalone performance measured independently of a human user. The "performance" here refers to the physical outcome of hair reduction on human subjects.
7. The type of ground truth used
The ground truth used was hair counts. These were "taken before treatment and 3, 6, and 12 months following the final treatment." This is a direct, objective measurement for assessing hair reduction.
8. The sample size for the training set
This information is not applicable as this device is a physical light-based hair removal system, not an AI/ML algorithm that would undergo training on a dataset.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.