(245 days)
The DEKA Motus AX laser system is indicated for:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
The provided document is a 510(k) summary for the DEKA Motus AX medical laser system. The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.
Based on the content of this document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or reduction percentages common in clinical trials for new medical treatments and AI/ML devices). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and ensuring safety and regulatory compliance.
The "device performance" reported is primarily in terms of technical specifications compared to the predicate device and conformance to electrical/safety standards.
| Feature / Criterion Type | DEKA Motus AX Performance (New Device) | Predicate Device (DEKA Synchro Repla: Y) | Acceptance (Implied) |
|---|---|---|---|
| Laser Type | Alexandrite | Alexandrite | Equivalent |
| Wavelength | 755 nm | 755 nm | Equivalent |
| Max Fluence | Range from 600 J/cm² (2.5mm hp) to 8 J/cm² (Moveõ hp) | Range from 600 J/cm² (2.5mm hp) to 14 J/cm² (24mm hp) | Comparable range, some differences in specific handpieces and max fluence for largest spot sizes, but considered substantially equivalent for indications. |
| Spot Sizes | 2.5 to 20mm | 2.5 to 24mm | Comparable (small difference in largest spot size) |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms | Equivalent |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz | Equivalent |
| Skin Cooling System | Yes, integrated in Moveo handpiece, external optional for others | Yes, optional, integrated by Smartcooler handpiece or external | Similar functionality/availability |
| Indications for Use | Temporary hair reduction; Stable long-term or permanent hair reduction (6, 9, 12 months on all skin types incl. tanned); Treatment of benign pigmented lesions; Treatment of wrinkles; Photocoagulation of benign dermatological vascular lesions. | Identical to DEKA Motus AX (stated in text) | Equivalent |
| Compliance to Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1 | (Implied predicate also complies or was tested for relevant standards) | Met for DEKA Motus AX |
| Ex-vivo Performance | Produces comparable thermal energy distribution and adversely affected tissue region as predicate. | (N/A - used as comparison for new device) | Met for DEKA Motus AX |
| Biocompatibility | Performed on Moveo handpiece tip. | (N/A - specific to new device component) | Met for DEKA Motus AX |
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 explicitly states "Clinical Performance Data: None". This means there was no clinical test set (i.e., human subject data) used to demonstrate performance against specific clinical acceptance criteria in the context of an effectiveness study.
The non-clinical performance data included "ex-vivo performance data on three different tissue types". This refers to laboratory testing, not human patient data. The provenance of this ex-vivo data is not specified (e.g., country of origin). It would be considered prospective for the device under review, as these tests were conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical performance data was presented, there was no test set requiring multi-expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used for performance evaluation that would require adjudication.
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 comparative effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo non-clinical performance data, the "ground truth" would be the measured thermal energy distribution and adversely affected tissue regions, as assessed by the scientific methods used in the laboratory setting. There is no mention of expert consensus, pathology, or outcomes data as ground truth for clinical performance, as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This is a hardware device (laser system), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.