(52 days)
The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned 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. There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration.
The provided text is a 510(k) summary for a Dermatological Diode Laser System for hair removal and permanent hair reduction. This type of device falls under the "Laser surgical instrument for use in general and plastic surgery and in dermatology" regulation.
Critically, this document describes a traditional 510(k) submission, not a study performing a clinical evaluation of an AI/ML powered device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of specifications.
Therefore, many of the requested items related to "AI/ML device performance" (e.g., sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance) are not applicable to this document as it does not describe an AI/ML powered medical device.
Here's a breakdown of the requested information based on the provided document, highlighting what is and isn't applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device (K180353) and reference device (K142845), and compliance with various international standards. The "reported device performance" in this context refers to the device's technical specifications and the successful completion of non-clinical tests proving compliance with safety and performance standards.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance / Evaluation |
|---|---|---|
| Primary Indication for Use | 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. | Met by Substantial Equivalence: The Indications for Use statement is "Same" as the predicate and reference devices, indicating that the device serves the same purpose. The efficacy for "permanent hair reduction" is not demonstrated via a new clinical study in this submission, but rather through equivalence to legally marketed devices cleared for this indication. |
| Technical Specifications (for Substantial Equivalence) | Laser Type: Diode Laser | |
| Laser Classification: Class IV | ||
| Laser Wavelength: Approx. 808 nm | ||
| Spot Size: Comparable to predicate/reference, with acceptable differences | ||
| Fluence: Within range of predicate/reference, with acceptable differences | ||
| Frequency: Within range of predicate, with acceptable differences | ||
| Pulse Duration: Comparable to predicate, with acceptable differences | ||
| Power Supply: Consistent with predicate/reference | ||
| Dimension/Weight: Acceptable differences that do not impact safety/effectiveness | Met: |
- Laser Type: Diode Laser (Same)
- Laser Classification: Class IV (Same)
- Laser Wavelength: 808 nm (Same as predicate, similar to reference 810 nm)
- Spot Size: CM01D: 10x30 mm; CM02D: 9x12 mm. Noted as "Analysis" – accepted because it only affects area of treatment, not therapeutic effect.
- Fluence: CM01D: 5-100 J/cm2; CM02D: 3-30 J/cm2. Noted as "Analysis 2" – accepted as "very slight" difference and within range of predicate/reference, and safety confirmed by standard compliance.
- Frequency: CM01D: 1-10 Hz; CM02D: 1-3 Hz. Noted as "Analysis 5" – accepted as within predicate range and safety confirmed by standard compliance.
- Pulse Duration: CM01D: 15-400 ms; CM02D: 35-400 ms. Noted as "Similar" to predicate's 10-400 ms.
- Power Supply: AC 110V/60Hz (Same as predicate, similar to reference).
- Dimension/Weight: Noted as "Analysis 3/4" – accepted as mechanical performance is covered by IEC 60601-1 compliance. |
| Safety Standards Compliance | Electrical Safety, EMC, Laser Safety, Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Met via Non-Clinical Testing: - Electrical Safety: Complies with ES60601-1:2005+A1:2012, IEC 60601-2-22:2007 + A1:2012.
- EMC: Complies with IEC 60601-1-2:2014.
- Laser Safety: Complies with IEC 60825-1:2014, IEC 60601-2-22.
- Biocompatibility: Complies with ISO 10993-5:2009 (Cytotoxicity - "No Cytotoxicity"), ISO 10993-10:2002/Amd. 1: 2006 (Irritation - "No evidence of irritation"; Sensitization - "No evidence of sensitization"). Patient contact materials (Tip of Handle, Device Housing) verified by testing per ISO 10993-1. |
| Software Validation | Software verification and validation activities were carried out. The product software is safe and effective. | Met: "Verification and validation activities include the verification and validation of product function, product performance and product interface. All verification and validation activities can meet the specified requirements, and the product software is safe and effective." (According to "guidance for the content of premarket submissions for software contained in medical devices"). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission relies on substantial equivalence through non-clinical testing (safety standards, performance specifications) and does not include a clinical study with a "test set" of patient data for evaluating device performance in the way an AI/ML device would.
- The document explicitly states: "No clinical study is included in this submission."
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. As there is no clinical "test set" and no AI/ML component, there's no need for experts to establish ground truth in this context. The "ground truth" for this submission are the established safety and performance standards and the specifications of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating the safety and effectiveness of this device in the context of a 510(k) submission are:
- Established regulatory standards and consensus standards (e.g., IEC 60601 series, ISO 10993 series) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility.
- The performance and safety profile of the legally marketed predicate device (K180353) and reference device (K142845), against which the new device demonstrated substantial equivalence in its indications for use and technical specifications.
8. The sample size for the training set
- Not Applicable. There is no AI/ML component requiring a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.