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Ellipse I2PL+ and Ellipse MultiFlex+ systems are intended to be used in dermatology, as tabled below:

• 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).

• Treatment of Telangiectasias (530-750nm or 555-950nm).

• Treatment of Port Wine Stains (530-750nm or 555-950nm).

• Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffüse Redness) (530-750nm or 555-950nm).

• Treatment of Rosacea (530-750nm or 555-950nm).

• Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm).

• Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).

• Treatment of Inflammatory Acne vulgaris (530-750mm).

Using Nd: YAG laser. (1064nm) (Ellipse MultiFlex+ system, only):

• Treatment of Leg vessels (0.1 -3.0mm diameter).

• Treatment of Benign Vascular Lesions.

• Treatment of Venous Lakes.

• Treatment of Port Wine Stains.

• 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.

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.

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Ellipse MultiFlex is intended for use in dermatology.

Ellipse MultiFlex used with IPL applicators (9APP7133, 7116, 7114, 7134, 7212, 7377, 7213):

• 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.

Ellipse MultiFlex used with Nd: YAG applicator (9APP7472):

• Treatment of leg vessels (0.1 3.0 mm diameter).

Ellipse Multiflex is an 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 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.

IPL Applicators/hand-pieces are connected to the system 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 under Intended Use.

The provided text is a 510(k) summary for the Ellipse MultiFlex device and does not contain detailed information about specific acceptance criteria, study methodologies, or performance results in the way typically expected for a clinical study proving device effectiveness. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards.

Therefore, many of the requested sections cannot be fully answered from the text. Here's what can be extracted and what is not available:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table comparing criteria to reported performance for the Ellipse MultiFlex with Nd:YAG handpiece as a new submission.

Instead, it relies on demonstrating substantial equivalence to predicate devices for its intended uses. The "Performance Standards" section lists compliance with various regulatory and international standards, which implicitly serve as acceptance criteria for safety and general performance, but not for specific clinical efficacy metrics.

Table of Acceptance Criteria and Reported Device Performance (as inferred or not stated):

Study Information

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting novel clinical study data for new claims.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified. The submission primarily refers to substantial equivalence to predicate devices, implying that their previously established performance supports the new device's claims. There is no mention of a new clinical test set for the Nd:YAG handpiece.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as no specific new clinical trial data is presented for the Nd:YAG handpiece in this summary. The ground truth for the predicate devices' performance would have been established previously, but details are not provided here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No new test set is described.

4. 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 a laser/IPL system for dermatological treatment, not an AI-assisted diagnostic device that uses human readers.

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

   • Not applicable. This is a medical device for direct patient treatment, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the Nd:YAG handpiece, the "Intended Use" states "Treatment of leg vessels (0.1 - 3.0 mm diameter)". The implicit ground truth for efficacy would be successful treatment and reduction/elimination of these vessels, as demonstrated by the predicate devices. However, no specific ground truth methodology for this submission is detailed.

7. The sample size for the training set:

   • Not applicable. The document does not describe a machine learning model or a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set is described.

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