(31 days)
The DEKA AGAIN PRO family is a medical laser family intended for:
Alexandrite laser (755nm):
- 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) included tanned skin.
- Treatment of benign pigmented lesions.
- Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064nm):
- Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin.
- Photocoaqulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
- Coagulation and hemostasis od soft tissue.
- Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
- Pigmented lesions to reduce 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.
The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser.
The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wider range of interchangeable, quick release laser handpieces with electronic spot recognition.
The modifications to the device consist in a restyling of the device (new chassis, cover plastic, dimensions, weight and GUI, removal of Pulsed Light FT handpiece) and in modification to spot size ranges (new spot size available).
The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.
The provided text describes the 510(k) summary for the DEKA AGAIN PRO family device. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEKA SYNCHRO REPLA:Y family of Laser system, K150516) rather than detailing specific clinical performance studies with acceptance criteria for an AI/ML-driven device's diagnostic performance.
The document states:
- The DEKA AGAIN PRO family is a medical laser system.
- The modifications to the device are primarily cosmetic (new chassis, cover plastic, dimensions, weight, GUI, removal of a handpiece) and a slight modification to spot size ranges.
- The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.
- The manufacturer is asserting the new device is substantially equivalent to the predicate.
Therefore, the information you're asking for regarding acceptance criteria and performance studies typical for an AI/ML diagnostic device (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) is not present in this 510(k) summary. This document is for a physical medical device (laser) and its review focuses on showing that the changes made to a previously cleared device do not introduce new questions of safety or effectiveness, often through engineering, electrical safety, and software validation testing, rather than new clinical outcome studies.
Based on the provided text, I cannot answer the questions directly as they pertain to the clinical performance evaluation of an AI/ML diagnostic device.
However, I can extract the information that is present regarding testing and conclusions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic performance or reported performance metrics (like sensitivity, specificity, AUC) because it is a laser device, not an AI/ML diagnostic software. The "performance data" section focuses on regulatory compliance:
| Test/Category | Reported Performance |
|---|---|
| Electrical safety and electromagnetic compatibility (EMC) | Conducted according to the following standards: |
- AAMI/ANSI ES60601-1: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2: Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral standard: Electromagnetic Disturbances – Requirements and tests.
- IEC 60601-2-22: Medical Electrical Equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- IEC 60825-1: Safety of laser products – Part 1: Equipment classification and requirements.
(The document implies these tests were passed, as the device received clearance.) |
| Software Validation and Verification Testing | Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions".
(The document implies these tests were passed, as the device received clearance.) |
| Clinical Performance | Not applicable/Not performed. The device is cleared based on substantial equivalence to a predicate laser device with unchanged intended use despite minor design modifications. The submission claims general improvements since predicate clearance but does not present new clinical data beyond the predicate's established performance based on its original clearance. |
Regarding the specific questions for an AI/ML diagnostic device:
- Sample sizes used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is described.
- 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. No ground truth establishment for AI/ML performance is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for AI/ML performance is described.
- 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 assistance device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for AI/ML performance is described.
- The sample size for the training set: Not applicable. This is not an AI/ML diagnostic device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML diagnostic device.
In summary, the provided document is a 510(k) summary for a laser surgical instrument (DEKA AGAIN PRO family) demonstrating substantial equivalence to a predicate device, not an AI/ML diagnostic software. Therefore, the detailed performance study information typically required for AI/ML devices is not found here.
§ 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.