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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).

Device Description

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.

AI/ML Overview

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.

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