FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 810nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 1060nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign vascular lesions.

ENEKA SELECTIF System with 810 - 1060mm Laser applicator is intended for:

-Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).

Device Description

The ENEKA SELECTIF is a non-invasive diode laser system used for hair removal, prevention and treatment of Pseudofolliculitis barbae and treatment of vascular and pigmented lesions.

The system operates at different wavelengths (755, 810 and 1060 nm) separately plus a blended handpiece combining three wavelengths (810, 940 and 1060 nm).

The ENEKA SELECTIF is a diode laser device with 7 handpieces (spot sizes 10x9mm, 20x9mm and 30x12mm) and it allows two modes of treatment, DHR and FDHR. Both of them can be applied with every handpiece. Mode DHR allows the configuration of pulse width, frequency and fluency and mode FDHR allows the configuration of frequency and fluency.

AI/ML Overview

The provided FDA 510(k) summary for the ENEKA SELECTIF device does not contain specific acceptance criteria, reported device performance (in terms of clinical metrics like efficacy percentages for hair reduction or lesion treatment), or detailed information about a study that proves the device meets such criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate and reference devices (Primelase Excellence and ENEKA PRO). This means that the device is considered safe and effective because it is sufficiently similar in technological characteristics and intended use to devices already on the market.

However, I can extract the information related to the device's characteristics and the types of testing performed to support its safety and performance based on the provided document.

Here's an attempt to structure the answer based on your request, highlighting what is available and what is not:

Acceptance Criteria and Device Performance Study (as inferred from the 510(k) submission)

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the 510(k) summary does not present a table of specific quantitative acceptance criteria (e.g., "X% hair reduction") or corresponding numerical device performance data from a clinical study. The assessment is based on demonstrating substantial equivalence to pre-existing cleared devices and compliance with recognized standards.

However, the "Performance Testing" section states that: "Verification and validation activities were successfully completed and establish that the ENEKA SELECTIF performs as intended." This implies that the device met its design specifications and functional requirements as confirmed by the listed engineering and safety tests.

Summary of Device Performance (from "Performance Testing" and "Conclusion" sections):

Intended Performance: Performs as intended for dermatologic and general surgical procedures, specifically for hair removal (permanent reduction in hair regrowth), treatment/prevention of Pseudofolliculitis barbae (PFB), use on all skin types (Fitzpatrick I-VI), and treatment of benign pigmented/vascular lesions.
Output Power: Verified at each power level with all handpieces.
Safety & Essential Performance: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22.
Biocompatibility: Patient-contacting materials are identical to the previously cleared Eneka Pro, implying acceptable biological safety.
Software: Verification and validation testing conducted in accordance with FDA guidance.
Contact Detection System: Includes a contact detection system for increased safety, designed to avoid firing the laser when no contact with skin is established.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable (N/A) for clinical data. The submission states "Clinical Evidence - N/A. No clinical studies were conducted as part of this submission."
Data Provenance: N/A for clinical data. The technical and safety testing data would be from laboratory and engineering tests, likely conducted at the manufacturer's facilities (TermoSalud, Gijón, Spain) or by certified testing bodies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A for clinical data. Since no clinical studies were conducted, there was no "ground truth" derived from expert consensus on patient outcomes for this submission. The ground truth for technical performance and safety would be established through compliance with recognized standards and internal engineering specifications, validated by internal technical experts and external testing laboratories.

4. Adjudication Method for the Test Set

N/A for clinical data. No clinical adjudication method was used given the absence of clinical trials.

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

N/A. This device is a laser system, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant to its performance assessment as described in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device does not have an "algorithm only" component in the sense of AI or image analysis. Its performance is the direct output of the laser system itself.

7. The Type of Ground Truth Used

For technical performance and safety: The "ground truth" is established by compliance with international and national standards (e.g., IEC 60601 series, ISO 10993-1) for medical electrical equipment, laser safety, electromagnetic compatibility, and biological compatibility. This is demonstrated through testing that verifies the device meets the requirements of these standards.
For demonstrating substantial equivalence: The "ground truth" for the device's therapeutic efficacy (hair removal, PFB, lesion treatment) is based on the established safety and effectiveness of the legally marketed predicate devices (Primelase Excellence and Eneka Pro) which have similar technological characteristics and indications for use.

8. The Sample Size for the Training Set

N/A. This type of device does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

N/A. As above, no training set in the context of machine learning is applicable.

In summary: The FDA 510(k) for ENEKA SELECTIF demonstrates substantial equivalence through extensive technical characteristic comparison with predicate devices and by ensuring compliance with established safety and performance standards. It explicitly states that "No clinical studies were conducted as part of this submission." Therefore, quantitative clinical acceptance criteria, clinical performance data, expert ground truth establishment for clinical cases, and MRMC/AI-related studies are not present in this document.

Summary

Regulation Number and Section

§ 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.