(158 days)
The Dermatological diode laser system is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined 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.
The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via s laser handpiece. The emission laser is activated by a foot-switch.
The laser light targets on melanin and treat selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells.
The four models of different products produced by our company are consistent in Wavelength , Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency and so on. It's just that the shell is slightly different.
The provided text is a 510(k) summary for a Dermatological diode laser system. It describes the device's substantial equivalence to a predicate device based on non-clinical testing and comparison of technical specifications. However, the document explicitly states "No clinical study is included in this submission" (page 6), meaning there is no data to describe acceptance criteria or a study that proves the device meets those criteria from a clinical performance perspective.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria related to clinical performance.
- Reported device performance related to clinical outcomes.
- Sample size for the test set or data provenance for clinical studies.
- Number of experts used to establish ground truth or their qualifications for a clinical test set.
- Adjudication method for a clinical test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used for clinical studies.
- Sample size for a clinical training set.
- How ground truth for a clinical training set was established.
The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technical characteristics to relevant standards.
However, I can provide information regarding the non-clinical tests and their "acceptance criteria" as implied by compliance with standards:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1, IEC 60601-2-22 | Complies with IEC 60601-1, IEC 60601-2-22 |
| EMC (Electromagnetic Compatibility): Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Laser Safety: Compliance with IEC 60601-2-22, IEC 60825-1 | Complies with IEC 60601-2-22, IEC 60825-1 |
| Biocompatibility - Cytotoxicity: No cytotoxicity | No Cytotoxicity |
| Biocompatibility - Sensitization: No evidence of sensitization | No evidence of sensitization |
| Biocompatibility - Irritation: No evidence of irritation | No evidence of irritation |
| Performance - Spot Size Accuracy | Performance Testing for Spot Size Accuracy passed (details not provided) |
| Performance - Energy Output Accuracy | Performance Testing for Energy Output Accuracy passed (details not provided) |
| Software Validation & Verification | Software Validation & Verification Test passed (details not provided) |
2. Sample size used for the test set and the data provenance: Not applicable for a clinical study as none was performed. For non-clinical tests, the sample sizes are typically determined by the specific test methods outlined in the standards (e.g., number of units tested for electrical safety, materials for biocompatibility). The document does not specify these sample sizes. Data provenance is internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was performed. Ground truth for non-clinical tests is based on objective measurements and established standards.
4. Adjudication method for the test set: Not applicable, as no clinical study was performed.
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, as no clinical study was performed and this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no clinical study was performed and this is not an AI device.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" is adherence to the specifications and performance requirements outlined in the referenced international standards (e.g., AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10).
8. The sample size for the training set: Not applicable, as no clinical study was performed and this is not an AI device requiring a training set in that context.
9. How the ground truth for the training set was established: Not applicable.
§ 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.