(90 days)
The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair of the face and the body in skin types I to IV through selective targeting of melanin in the hair follicle. The L600® is intended to effect permanent hair reduction.
According to the Food and Drug Administration, permanent hair reduction is defined as a long term and stable reduction in number of hair follicle re-growing after a treatment regime. The number of hair re-growing must be stable over time greater than the duration of a complete growth cycle of hair follicles according to body location.
The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair.
Here's an analysis of the provided text regarding the A&M Technology L600® Photoepilation System's acceptance criteria and studies, based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the L600® Photoepilation System. Instead, it relies on a determination of "substantial equivalence" to predicate devices. The performance data presented is a general statement about safety and efficacy without quantifiable metrics.
| Acceptance Criteria (Not explicitly stated in K030480) | Reported Device Performance (from K030480) |
|---|---|
| Implicit Criteria for Substantial Equivalence: | The clinical data demonstrated that the device can be used effectively and safely by a trained skin professional. |
| - Demonstrate safety equivalent to predicate devices | (Implicitly met by the safety findings of the clinical data) |
| - Demonstrate efficacy (permanent hair reduction) equivalent to predicate devices | (Implicitly met by the efficacy findings of the clinical data) |
Definition of Permanent Hair Reduction (from K030480): A long-term and stable reduction in the number of hair follicles re-growing after a treatment regime. The number of hair re-growing must be stable over time, greater than the duration of a complete growth cycle of hair follicles according to body location.
Regarding the Absence of Detailed Criteria:
It's important to note that 510(k) submissions often focus on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new, specific performance criteria. The FDA's letter confirms that they reviewed the submission and found the device substantially equivalent for the stated indications. This implies that the provided clinical data, even if not numerically detailed in this summary, was deemed sufficient to support this claim in comparison to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for any clinical test set. It mentions "clinical data" in a general sense.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth for a test set or their specific qualifications. It only generally states that the device is to be used by a "trained skin professional."
4. Adjudication Method
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. There is no mention of human readers, AI assistance, or an effect size for improvement.
6. Standalone (Algorithm Only) Performance Study
This device, the L600® Photoepilation System, is a physical medical device (an intense pulsed light system), not an AI algorithm. Therefore, the concept of a "standalone (algorithm only) performance study" is not applicable to this product.
7. Type of Ground Truth Used
The document does not explicitly define the type of ground truth used for evaluating "permanent hair reduction" in its clinical data. Given the nature of hair removal, it would typically involve:
- Clinical observation and measurement: Direct counting of hair follicles in treated areas, potentially using standardized photography or dermatoscopic examination to assess hair density and regrowth over time.
- Patient self-assessment/satisfaction: Though less objective, this can be part of clinical evaluation.
8. Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning algorithms. Since the L600® is a physical device, there is no training set in the context of an algorithm. If "training set" refers to the subjects involved in establishing the clinical efficacy for the device itself, this information is not provided in the summary.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" for an algorithm is not applicable. For the clinical evaluation of the device, the establishment of "ground truth" (i.e., confirmation of permanent hair reduction) would likely follow standard dermatological assessment methods, as mentioned in point 7, but this is not detailed in the provided summary.
§ 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.