(85 days)
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:
Single-Wavelength Handpiece
810nm wavelength
The 810nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes)
Trio-Wavelength Handpiece
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).
Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. There is plenty of melanin in hair follicles and hair shafts. Melanin scatters among hair bulbs and shaft structures (like medullary substance, cortex, and cuticula pili). The laser wavelengths that ST-803 Diode Laser System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths.
The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.
This is a premarket notification (510(k)) for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. Therefore, the information provided does not typically include clinical study data in the same way an approval for a novel device would. The "performance data" section focuses on non-clinical testing.
Here's the breakdown based on the provided document:
There is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the document focuses on establishing substantial equivalence for a Class II medical device based on non-clinical performance data and comparison to a predicate device.
The document details the device's technical specifications and compares them to a predicate device, along with outlining various non-clinical tests (electrical safety, EMC, software verification, sterilization, biocompatibility, and bench testing) to demonstrate its safety and performance.
Here's what can be extracted:
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No specific acceptance criteria related to a performance study (e.g., accuracy metrics for an AI device) are mentioned. The “acceptance criteria” for a 510(k) submission primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through engineering testing and substantial equivalence arguments rather than a direct clinical performance study with acceptance criteria.
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No study proving the device meets acceptance criteria in the sense of a clinical performance trial is described. The "performance data" section (Section VII) details non-clinical tests.
However, I can extract the information relevant to a 510(k) submission, even if it doesn't directly map to the clinical performance study questions:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a laser device, "acceptance criteria" and "reported device performance" are primarily focused on safety, electrical characteristics, software functionality, and biocompatibility, rather than clinical efficacy metrics typically seen in AI/diagnostic device performance studies. The comparison tables are generally for technical characteristics against the predicate.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (as per non-clinical testing) |
|---|---|
| Electrical safety | Complies with IEC 60601-1: 2005+A1:2012 |
| Electromagnetic compatibility (EMC) | Complies with IEC 60601-1-2:2020 |
| Laser product safety | Complies with IEC 60825-1:2014 |
| Laser equipment basic safety/performance | Complies with IEC 60601-2-22:2019 |
| Software functionality | Software verification and validation testing conducted; deemed "moderate" level of concern. |
| Sterilization | Not provided sterile, cleaned with ethanol. Reusable, no restricted shelf-life. |
| Biocompatibility | Meets ISO 10993-1 requirements (Cytotoxicity, Sensitization, Irritation tests passed). |
| Energy Output Parameters | Bench testing validated energy output parameters similar to predicate device. |
2. Sample size used for the test set and the data provenance:
- No clinical test set is described. The tests are non-clinical (laboratory/bench testing).
- For Biocompatibility:
- Cytotoxicity: L-929 cell cultures were used (cell lines, not human or animal subjects in the clinical sense).
- Skin Sensitization: Guinea Pigs were used.
- Skin Irritation: Rabbits were used.
- Data Provenance: The tests are conducted internally or by a contracted lab and reported by Smedtrum Medical Technology Co., Ltd. (Taiwan).
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 information is for clinical performance studies, which were not described. The non-clinical tests rely on established scientific methods and laboratory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This applies to clinical performance studies, particularly for diagnostic devices where subjective interpretation might require adjudication.
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 system for hair reduction, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. For non-clinical tests, "ground truth" is defined by adherence to international standards and validated laboratory methodologies. For example, in biocompatibility, the ground truth for "no cytotoxicity" is a certain cell viability percentage.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a hardware medical device.
§ 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.