(191 days)
Ellipse I2PL+ and Ellipse MultiFlex+ systems are intended to be used in dermatology, as tabled below:
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Permanent hair reduction (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) (overall 600-950nm).
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Treatment of Telangiectasias (530-750nm or 555-950nm).
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Treatment of Port Wine Stains (530-750nm or 555-950nm).
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Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffüse Redness) (530-750nm or 555-950nm).
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Treatment of Rosacea (530-750nm or 555-950nm).
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Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm).
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Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
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Treatment of Inflammatory Acne vulgaris (530-750mm).
Using Nd: YAG laser. (1064nm) (Ellipse MultiFlex+ system, only):
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Treatment of Leg vessels (0.1 -3.0mm diameter).
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Treatment of Benign Vascular Lesions.
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Treatment of Venous Lakes.
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Treatment of Port Wine Stains.
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Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Ellipse PPL+ and Ellipse Multiflex+ are identical Intense Pulsed Light (IPL) systems used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, are spots, diffuse redness, and for the treatment of telangiectasias, port wine stains, rosacea, poikiloderma of civatte and inflammatory acne in the area of dermatology.
The systems consist of a console containing power unit and control electronics with control and display panel including software.
IPL Applicators/hand-pieces are connected to the systems in order to generate light energy for treatment in the waveband 400 nm - 950 nm.
Additionally a Nd: YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex+ for treatment of vascular lesions as stated below under Intended Use/Indications for Use.
The document does not provide details of a study that proves the device meets specific acceptance criteria in the format typically used for medical device performance evaluation. This document is a 510(k) summary for the Ellipse I2PL+ and Ellipse MultiFlex+ systems, primarily focused on establishing substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria.
However, based on the provided text, we can glean some information about performance standards applied to the device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance standards that the device complies with, which can be seen as "acceptance criteria" in a regulatory compliance sense, although it doesn't present a table with specific numerical performance metrics and their corresponding acceptance thresholds.
| Acceptance Criteria (Compliance Standard) | Reported Device Performance (Compliance Statement) |
|---|---|
| US FDA 21 CFR 1040.10 and 1040.11 (for class IV Laser Products) | Complies |
| IEC 60601-1 3rd edition | Complies |
| UL 60601-1 | Complies |
| CSA C22.2 No. 601.1 | Complies |
| IEC 60601-2-57 | Complies |
| IEC 60825-1 | Complies |
| IEC 60601-2-22 | Complies |
| IEC 60601-1-2 | Complies |
| European Medical Device Directive 93/42/EEC (Annex II) | Complies |
| US FDA 21CFR Part 820 (Quality System Regulation) | Complies (Manufactured under ISO13485 QMS certified by Presafe/DGM and QMI, and also complies with US FDA 21CFR Part 820) |
2. Sample size used for the test set and the data provenance:
The document does not mention any specific sample sizes for a clinical test set or details about data provenance (e.g., country of origin, retrospective/prospective). The performance evaluation appears to be based on compliance with harmonized standards and comparison to predicate devices, rather than a clinical study with a dedicated test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The regulatory submission emphasizes substantial equivalence and compliance with technical standards, not detailed clinical trial results involving ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This type of study is not mentioned. The device described is an Intense Pulsed Light (IPL) and Laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a therapeutic energy-based system, not an algorithm. Its "standalone" performance would relate to its physical and energetic output specifications, which are presumably covered by the referenced compliance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly defined in the context of clinical performance data. The "ground truth" implicitly refers to the device's ability to consistently meet the technical specifications and safety requirements outlined in the cited standards. For the "Indications for Use" (e.g., permanent hair reduction, treatment of telangiectasias), the effectiveness would be determined by clinical outcomes, but no specific outcome data or how it was established is provided in this summary. The definition of "Permanent hair reduction" does indicate measurement at "6, 9, and 12 months after the completion of a treatment regime," implying clinical follow-up for that specific indication, but details of such a study are absent.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.