(72 days)
755mm:
Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I-VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Temporary increase of clear nail in patients with onychomycosis ( e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Alexandrite Nd:YAG laser Models CPMT CANLASE , CPMT TORLASE contain two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat.
The provided document is a 510(k) premarket notification for a medical laser device, specifically the Alexandrite and Nd:YAG Laser models CANLASE and TORLASE. The FDA's letter states that the device is substantially equivalent to a legally marketed predicate device (GentleMax Pro Plus, K201111). The document primarily focuses on demonstrating this substantial equivalence through comparison of technological characteristics and performance data related to safety standards.
Regarding the specific requests for acceptance criteria and study details, it's important to note an inherent limitation of this type of regulatory document:
- This is a 510(k) summary, not a clinical study report. A 510(k) demonstrates substantial equivalence to a predicate device, often relying on existing knowledge of the predicate device's safety and effectiveness, and non-clinical performance testing of the new device. It generally does not include detailed clinical trials with specific acceptance criteria for efficacy in the way a PMA (Premarket Approval) submission would.
- The "performance data" section primarily addresses safety standards. The performance data explicitly mentioned are for biocompatibility, electrical safety, and electromagnetic compatibility (EMC), not clinical effectiveness for the stated indications.
Therefore, many of the requested details about acceptance criteria for clinical performance, sample sizes for test/training sets, expert involvement, and ground truth are not present in this document or are not applicable in the context of a 510(k) for this type of device.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison of technological characteristics and states that the device complies with certain safety standards. It does not list specific clinical acceptance criteria for efficacy (e.g., a specific percentage of hair reduction) for the subject device or its reported performance against such criteria. Instead, it relies on the substantial equivalence of its indications for use and technological characteristics to a predicate device already on the market.
| Feature / Standard | Acceptance Criteria (from predicate or general standards) | Subject Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 for "Surface - intact skin" | Met all evaluation acceptance criteria (Cytotoxicity, Irritation, Sensitization) |
| Electrical Safety | IEC 60601-1, IEC 60601-2-22 | Complies with these standards |
| Laser Safety | IEC 60825-1 | Complies with this standard |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies with this standard |
| Product Code | GEX (matches predicate) | GEX |
| Regulation Number | 21 CFR 878.4810 (matches predicate) | 21 CFR 878.4810 |
| Regulatory Class | Class II (matches predicate) | Class II |
| Laser Type | Alexandrite and Nd:YAG laser (matches predicate) | Alexandrite and Nd:YAG laser |
| Laser Classification | Class IV (matches predicate) | Class IV |
| Wavelength | 755 & 1064 nm (matches predicate) | 755 & 1064 nm |
| Spot Size | 1.5-26 mm range (matches predicate) | 1.5–26 mm range |
| Frequency | 1-10 Hz (predicate) | 0.5-10Hz |
| Maximum Energy (J) | Predicate: 68 J ALEX; 90 J Nd:YAG | Subject: 60 J ALEX (optional 70 J); 110 J Nd:YAG |
| Accuracy of Output | ± 20% (matches predicate) | ± 20% |
| Pulse Duration | 0.25-100 ms (matches predicate) | 0.25-100 ms |
| System Cooling | Ambient Air (matches predicate) | Ambient Air |
Note on Efficacy Acceptance Criteria: The document does not state explicit quantitative clinical acceptance criteria (e.g., "70% hair reduction in 3 months") or report the device's performance against such criteria. The "indications for use" themselves serve as the qualitative efficacy claims, which are deemed substantially equivalent to the predicate device. For hair reduction, the definitions are provided (e.g., "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."). However, no specific clinical study data is presented to quantify this for the subject device.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable for a clinical test set from this document. The "performance data" section refers to non-clinical (biocompatibility, electrical safety, EMC) testing, not clinical studies on human subjects.
- Data provenance: For the non-clinical tests, the data would originate from the manufacturer's testing facilities (Canadian Pioneer Medical Technology Corporation). No country of origin for clinical data is specified as no clinical data is presented.
- Retrospective or prospective: Not applicable as no clinical study data is presented.
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 data requiring ground truth establishment by experts is presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical study data requiring adjudication is presented.
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 a laser device, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable as no clinical study data requiring ground truth is presented. For the non-clinical tests, the "ground truth" is compliance with established international safety standards (e.g., IEC, ISO).
8. The sample size for the training set:
- Not applicable as no algorithm or training set for clinical performance is mentioned.
9. How the ground truth for the training set was established:
- Not applicable as no algorithm or training set is mentioned.
In summary: This 510(k) notification demonstrates substantial equivalence primarily through comparing the technical specifications and intended uses of the new device to a predicate device, and by showing compliance with relevant safety and performance standards through non-clinical testing. It does not contain the detailed clinical efficacy study data with specific acceptance criteria, expert involvement, or ground truth that would be found in a PMA submission or a full clinical trial report.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance data (biocompatibility, electrical safety, EMC) that demonstrates the device meets the specified safety and performance standards, and comparison of its technological characteristics and indications for use to a legally marketed predicate device to establish substantial equivalence.
§ 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.