(46 days)
The Spirit Hair Removal laser Family intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy.
The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin.
The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm² for the 918 model and 4.5 to 10J/cm² for the 916 model) is preset.
For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair.
The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.
The provided text is a 510(k) premarket notification for the "Spirit Hair Removal Laser Family" (K153718). It focuses on demonstrating substantial equivalence to a predicate device (Soprano XL K112031) rather than presenting a study to prove a device meets specific acceptance criteria based on its own clinical performance for effectiveness.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted directly from this document. The document primarily describes the justification for substantial equivalence through comparison with a previously cleared device and adherence to safety standards.
Here's a breakdown of the information that can be extracted, and where requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for clinical performance that the device itself must meet (e.g., a specific percentage of hair reduction to be considered effective). Instead, it establishes substantial equivalence by comparing its technological characteristics and intended use to a predicate device.
The tables provided compare features of the Spirit Hair Removal Laser Family to the predicate device, demonstrating they are technologically similar and perform comparably, which serves as the basis for substantial equivalence rather than fulfilling novel performance criteria.
| Subject | Spirit Hair Removal Laser Family (916 Data) | Spirit Hair Removal Laser Family (918 Data) | Predicate Device (Soprano XL-SHR mode) | Predicate Device (Soprano XL-LHR mode) |
|---|---|---|---|---|
| Intended Use | Hair removal, permanent hair reduction | Hair removal, permanent hair reduction | Hair removal, permanent hair reduction | Hair removal, permanent hair reduction |
| Severity and stage of the clinical condition | For all hair densities | For all hair densities | For all hair densities | For all hair densities |
| Site of application | Hairy Skin | Hairy Skin | Hairy Skin | Hairy Skin |
| Patient population | Fitzpatrick I-VI | Fitzpatrick I-VI | Fitzpatrick I-VI | Fitzpatrick I-VI |
| Energy intensity | 4.5-10 J/cm² | 6-90 J/cm² | 5-10 J/cm² | 1-120 J/cm² |
| Spectrum | 810nm | 810nm | 810nm | 810nm |
| Pulse train duration | 11-38ms | Up to 310ms | Up to 20ms | Up to 200ms |
| Pulse repetition rate | ≤10Hz | ≤10Hz | ≤10Hz | ≤3Hz |
| Treatment area size | 12*16mm | 12*16mm | 10*12mm | 10*12mm |
| Conditions of use | Used on Healthy skin | Used on Healthy skin | Used on Healthy skin | Used on Healthy skin |
| Biocompatibility of materials | Complies (ISO10993) | Complies (ISO10993) | Complies | Complies |
| Safety and Performance (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2) | Complies | Complies | (Implied by prior clearance K112031) | (Implied by prior clearance K112031) |
The acceptance criterion for this submission is "substantial equivalence" to the predicate device. The performance shown is that the Spirit Hair Removal Laser Family's characteristics and safety comply with relevant standards and are comparable to those of the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Bench and clinical data demonstrate that the Spirit Hair Removal laser Family meet the required specifications." However, no sample size or specific details about a clinical test set are provided. The focus is on demonstrating equivalence through technical specifications and safety standards, rather than direct new clinical efficacy data for this specific device. The clinical data referred to might be from the predicate device or a general understanding, but details are absent for the Spirit Hair Removal Laser Family.
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)
Not applicable. This document does not describe a study involving expert assessment to establish a "ground truth" for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No such study involving adjudication is described.
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
Not applicable. This device is a laser for hair removal, not an AI-assisted diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an algorithm's performance, which is not relevant for a physical laser device. The "performance" of the laser is its ability to meet documented technical specs and operate safely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no specific clinical efficacy study is detailed for this device where a ground truth would be established. The document relies on the "ground truth" that the predicate device is safe and effective for its indicated use, and the new device is substantially equivalent. The definition of "Permanent reduction in hair regrowth" as "the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime" could be considered an "outcomes data" ground truth for hair removal efficacy generally, but it's not a parameter measured in a new clinical study for this submission.
8. The sample size for the training set
Not applicable. This device is a physical laser system, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical laser system, not an algorithm that requires a training set.
§ 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.