(77 days)
The Intended Use for Ellipse I²PL is:
Ellipse IPPL is intended for use in dermatology:
- Hair removal (permanent hair reduction). .
- Treatment of benign pigmented lesions (including, but not limited to solar . lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne. .
The Indications for Use for Ellipse I-PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | |||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| Hair Removal | |||||||
| HR Applicator | |||||||
| HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal | |||||||
| HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions | |||||||
| and Benign Vascular Lesions | Pigmentation / Vessel Size | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Telangiectasias | Vessel size (Thin, medium, thick) | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Port Wine Stains | Color (Red, blue) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Individual Pigmented Lesions | Pigment Color | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Inflammatory Acne | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ | |
| Key: ✓ Allowed; ⊖ Not Allowed |
Ellipse I2PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains and inflammatory acne in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 400 nm - 950 nm.
The provided text describes a 510(k) summary for the Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL system. This document is a premarket notification for a medical device trying to demonstrate substantial equivalence to previously cleared devices, rather than a study designed to prove acceptance criteria through clinical trial data. Therefore, many of the requested elements about acceptance criteria and study design are not applicable or explicitly stated as would be found in a clinical study report.
The primary "acceptance criteria" in a 510(k) submission is demonstrating substantial equivalence to a predicate device. The "study" proving this is essentially the comparison provided by the manufacturer.
Here's an analysis based on the information provided:
Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary focused on substantial equivalence, there are no explicit quantitative "acceptance criteria" presented in the sense of performance thresholds (e.g., "device must achieve X accuracy"). Instead, the "acceptance criterion" is the demonstration of substantial equivalence to predicate devices, which implies similar safety and effectiveness for the stated Indications for Use. The "reported device performance" is implicitly that it performs as safely and effectively as the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Determination) | Reported Device Performance |
|---|---|
| Intended Use: Functionally identical to predicate devices. | Met: Ellipse I2PL (B02) is stated to have identical modules, applications, and intended uses to Ellipse IPL (A01), and identical and substantially equivalent technology, modules, applications, and intended uses to Ellipse Flex PPT. |
| Technological Characteristics: Similar to predicate devices, with no new issues of safety or effectiveness raised by differences. | Met: Comparison matrix shows similar technology (IPL/broad spectrum), energy output, pulse duration, applicator spot size, charge time, and cooling method. Differences in energy spectrum (400-950nm for B02/Flex PPT vs. 555-950nm for A01) are noted but deemed not to raise new safety/effectiveness issues. |
| Safety and Effectiveness: No significant differences in overall performance characteristics compared to predicate devices that would raise new questions of safety or effectiveness. | Met: Danish Dermatologic Development A/S (DDD) concludes that no significant differences exist and the added applications do not raise new issues of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document is a 510(k) summary for substantial equivalence, not a clinical study report. It does not contain data from an external test set with a defined sample size for performance evaluation.
- Data Provenance: Not applicable. The "data" here refers to the specifications and intended uses of the device and its predicates, as presented by the manufacturer, rather than clinical data from a patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No external test set requiring expert-established ground truth is mentioned in this submission. The "ground truth" for demonstrating substantial equivalence rests on comparing the device's technical specifications and intended uses against already cleared predicate devices.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no test set requiring ground truth adjudication. The FDA's review process for 510(k) submissions involves regulatory experts evaluating the manufacturer's claims and comparison data.
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 device is an Intense Pulsed Light (IPL) system, not an AI diagnostic or assistance device. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (IPL system), not a standalone algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a 510(k) clearance based on substantial equivalence, the "ground truth" is established by the previously cleared predicate devices and their established safety and effectiveness profiles. The manufacturer's submission effectively argues that the new device's characteristics align sufficiently with these predicates such that it poses no new questions of safety or effectiveness. There is no specific "expert consensus, pathology, or outcomes data" presented as ground truth for this specific device's performance beyond what was established for its predicates.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This device does not involve machine learning or an algorithm that requires a training set with established ground truth.
§ 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.