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510(k) Data Aggregation
(308 days)
The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 diode laser for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is described in the table below:
The provided text describes a 510(k) premarket notification for a "Diode Laser for Hair Removal" (K131838) and references a predicate device (K112031). However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any details related to AI performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence to the predicate device based on technical specifications and intended use. The table provided in the input is a comparison of the Honkon device's technical specifications to those of the predicate device (Alma Lasers 810nm Diode Laser System with HR Mode).
Therefore, I cannot fulfill the request for information on acceptance criteria, a proving study, sample sizes, expert details, or ground truth, as none of this information is present in the provided text.
Here's an output reflecting what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, it compares the technical specifications and intended use of the proposed device to a predicate device to establish substantial equivalence. The "performance" is implied by meeting similar specifications.
| Parameter | Predicate Device (K112031) Alma Lasers | Proposed Device (K131838) Honkon Diode Laser |
|---|---|---|
| Intended Use | Hair removal, permanent hair reduction (Fitzpatrick skin types I-VI), including tanned skin. | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. |
| Wavelength (nm) | 810 nm | 808 nm |
| Output power (W) | 30 W | 30 W |
| Fluence (Energy Density) | <120 J/cm² | <120 J/cm² |
| Pulse Duration | 5-200 ms | 5-300 ms |
| Frequency | Up to 10 Hz | 1-10 Hz |
| Spot Size | 12 cm² | 12 mm² |
| Material | Sapphire | Sapphire |
| Cooling | Contact cooling | Contact cooling |
| Anatomical Sites | Axilla, Facial, Neck | Axilla, Facial, Neck |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-1-2 | Comply with IEC 60601-1 and IEC 60601-1-2 |
| Radiation Safety | Comply with IEC 60601-2-22, IEC 60825-1 and 21 CFR 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS | Comply with IEC 60601-2-22, IEC 60825-1 and 21 CFR 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is based on a technical comparison to a predicate device, not on clinical trial data with test sets.
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)
This information is not provided in the document. There is no mention of expert involvement in establishing a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. There is no test set or adjudication process 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
This information is not provided in the document. The device is a diode laser for hair removal, not an AI-assisted diagnostic tool, and therefore MRMC studies with human readers are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical laser system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No specific ground truth establishment method is described for performance evaluation. The substantial equivalence is based on technical specifications and intended use alignment with the predicate device. The intended use for "permanent hair reduction" is defined as a "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," which implies an outcomes-based ground truth for clinical efficacy, but the document does not present any study data to demonstrate this for the proposed device.
8. The sample size for the training set
This information is not provided in the document. The device is not an AI algorithm with a training set.
9. How the ground truth for the training set was established
This information is not provided in the document. Not applicable as there is no training set mentioned for an AI device.
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