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510(k) Data Aggregation
(75 days)
ELLIPSE FLEX PPT, MODEL 9ESF7255
Ellipse Flex PPT 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 Flex PPT 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 | Vessel size/Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| 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 |
Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse for trounnell of 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.
paint moduling bothware. waveband 400 nm - 950 nm.
The provided text describes the regulatory submission for the Ellipse Flex PPT dermatologic IPL system and asserts its substantial equivalence to predicate devices. However, it does not contain information about formal acceptance criteria, specific device performance against those criteria, or details of a study that proves the device meets such criteria (e.g., sample size, expert qualifications, ground truth, MRMC study, standalone performance, training set details).
Instead, the document focuses on:
- Identifying the device and its manufacturer.
- Describing its intended use and indications.
- Comparing its technical specifications and intended use to three predicate devices (Ellipse I²PL, StarLuxTM Pulsed Light System, and Lumenis Family of IPL).
- Concluding that the Ellipse Flex PPT is "substantially equivalent" to these predicate devices for the specified modules, applications, and intended uses.
The concept of "substantial equivalence" in a 510(k) submission means that the new device is as safe and effective as a legally marketed predicate device. This is often demonstrated through a comparison of technological characteristics, indications for use, and a declaration that it does not raise new questions of safety or effectiveness. The document itself is the submission detailing this comparison, rather than a report of a specific study proving acceptance criteria for the new device.
Therefore, most of the requested information cannot be extracted directly from this document as it pertains to a formal performance study against explicit acceptance criteria, which is not detailed here.
However, based on the provided text, here's what can be stated about the device and its comparison to predicates:
1. A table of acceptance criteria and the reported device performance
The document does not list specific numerical "acceptance criteria" for performance (e.g., a minimum efficacy rate or a maximum side effect rate) nor does it provide detailed "reported device performance" against such metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended uses.
| Acceptance Criterion (Implicitly based on Predicate Equivalence) | Reported Device Performance (as presented for comparison) |
|---|---|
| Intended Use: Hair removal, treatment of benign pigmented/vascular lesions, treatment of inflammatory acne. (Matches predicate devices' scope where relevant). | Ellipse Flex PPT's Intended Use: Hair removal; Treatment of benign pigmented and vascular lesions; Treatment of inflammatory acne. (Stated as matching or being a subset of predicate uses). |
| Energy Spectrum: Comparable to predicate devices. | Ellipse Flex PPT: 400-950 nm (Compared to 555-950 nm for Ellipse I²PL, 400-1200 nm for StarLuxTM, 515-1200 nm for Lumenis). |
| Energy Output/Setting: Comparable to predicate devices. | Ellipse Flex PPT: 0-26 J/cm² (Identical to Ellipse I²PL, within range of StarLuxTM (Max 50 J/cm²), and Lumenis (10-60 J/cm²)). |
| Pulse Duration: Comparable to predicate devices. | Ellipse Flex PPT: 1.5-100 ms (Compared to 5-55 ms for Ellipse I²PL, 1-500 ms for StarLuxTM, 3-100 ms for Lumenis). |
| Applicator/Hand-piece Spot Size: Comparable to predicate devices. | Ellipse Flex PPT: 10 x 48 mm (Identical to Ellipse I²PL, within range of StarLuxTM (16x46mm, 12x28mm, 10x15mm), and Lumenis (9x9mm, 8x15mm, 15x35mm)). |
| Cooling Method: Similar to predicate devices to manage thermal effects. | Ellipse Flex PPT: Cooling handpiece by circulating water (Identical to Ellipse I²PL, comparable to contact cooling/integrated cooling in other predicates). |
| Safety and Effectiveness: Should not raise new issues of safety and effectiveness compared to predicate devices. | Conclusion: "The Ellipse Flex PPT system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices." |
2. Sample size used for the test set and the data provenance
Not applicable. This document does not describe a performance study with a test set that would have a sample size or data provenance details. The comparison is based on technical specifications and intended uses of the device and its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe a performance study requiring expert ground truth establishment for a test set.
4. Adjudication method for the test set
Not applicable. This document does not describe a performance study requiring 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 device is an Intense Pulsed Light (IPL) system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study related to "human readers improving with AI assistance" is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical IPL device, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document does not describe a performance study that would establish ground truth for a diagnostic or treatment outcome using such methods. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearance, to which the new device is compared.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning device or algorithm that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning device.
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