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510(k) Data Aggregation
(131 days)
The Diode Laser Therapy Systems are 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 Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
Note: This document is a 510(k) summary for a medical device (Diode Laser Therapy Systems, Model SDL-B) and focuses on establishing substantial equivalence to a predicate device, not necessarily on demonstrating clinical efficacy through a traditional comparative effectiveness study with pre-defined acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to meeting regulatory standards and demonstrating equivalence in function and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard Met | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | To be substantially equivalent to the predicate device for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), with a definition of permanent hair reduction as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. | The proposed device, Diode Laser Therapy Systems, has the same intended use as the predicate device (Emvera Diolux, K123257). Both are intended for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), with the same definition for permanent hair reduction. |
| Technological Equivalence | Demonstrate similar technological characteristics or that differences do not raise new questions of safety or effectiveness. | Wavelength: Same (808 nm) Fluence (Energy Density): Same (<120 J/cm²) Frequency: Same (1Hz-10Hz) Material: Same (Sapphire) Cooling: Same (Water cooling) Output Power: Proposed device (500W) is less than predicate (600W). Regarded as acceptable. Pulse Duration: Proposed device (5ms-400ms) has a smaller maximum pulse duration than predicate (5ms-625ms). Regarded as acceptable. Spot Size: Proposed device (12mm x 10mm) is smaller than predicate (12mm x 12mm). Regarded as acceptable. Anatomical Sites: Proposed device covers fewer anatomical sites (Axilla, Face, bikini, Upper limb and lower limb) than predicate (Axilla, Face, bikini, Upper limb and lower limb, brow, upper lip, neck, chest, back). Regarded as acceptable. |
| Biocompatibility | Compliance with ISO 10993-1. | Testing included Cytotoxicity, Sensitization, and Irritation for the laser output window. The evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Results are assumed to be compliant as the device was cleared. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60825-1, and IEC 60601-1-2. | The system complies with IEC 60601-1 (safety), IEC 60825-1 (laser safety), and IEC 60601-1-2 (EMC). |
| Software Verification & Validation | Compliance with FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software V&V testing was conducted, and documentation was provided. The software was deemed a "moderate" level of concern. Results are assumed to be compliant as the device was cleared. |
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 does not report any clinical test set or data provenance for human subjects. The performance data presented are primarily non-clinical: biocompatibility testing, electrical safety and EMC testing, and software verification and validation. The claim of substantial equivalence is largely based on the device's technical specifications being similar to or safer than the predicate device.
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 applicable as no clinical test set with human subject data requiring expert ground truth establishment is described in this 510(k) summary. The "ground truth" for this submission revolves around meeting engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set requiring 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
An MRMC comparative effectiveness study was not done. This 510(k) is for a laser therapy system (hardware device), not an AI/software as a medical device (SaMD) that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not done. This device is a physical laser system for direct patient treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to established regulatory and engineering standards:
- Biocompatibility: Adherence to ISO 10993-1 standards (e.g., negative results for cytotoxicity, sensitization, irritation).
- Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60825-1, and IEC 60601-1-2 standards.
- Software V&V: Adherence to FDA guidance for software in medical devices.
- Substantial Equivalence: Comparison of technical specifications and intended use against a legally marketed predicate device.
8. The sample size for the training set
This information is not applicable as this submission does not describe an AI model with a training set. The "training" for this device would refer to its engineering design and validation against specified requirements.
9. How the ground truth for the training set was established
This information is not applicable as this submission does not describe an AI model with a training set. The "ground truth" for the device's development was established through engineering specifications, regulatory standards, and performance evaluation against those standards.
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