Search Results

Ellipse Nordlys system is intended to be used in dermatology, as tabled below:

• Permanent Hair Reduction (defined as teh 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)(overall 600 - 950 nm).
• Treatment of Telangiectasias (530-750 nm or 555-950 nm)
• Treatment of Port Wine Stains (530-750 nm or 555-950 nm)
• Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness) (530-750 nm or 555-950 nm)
• Treatment of Rosacea (530-750 nm or 555-950 nm)
• Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm)
• Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris)(400-720 nm)
• Treatment of Inflammatory Acne Vulgaris (530-750 nm)

Ellipse Nordlys + Nd: YAG Laser (1064 nm):
*Treatment of Leg Vessels (0.1-3.0 mm diameter).

• Treatment of Benign Vascular Lesions.

• • Treatment of Venous Lakes.

• Treatment of Port Wine Stains.
• Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
• Treatment of benign cutaneous lesions, such as warts.
  Podiatry (ablation, vaporization, incision, and coagulation of soft tissue), including:

• Matrixectomy
• Periungal and subungal warts
• Plantar warts.

Ellipse Nordlys + Frax 1550 Laser, (1550 nm)

• The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Nordlys + Frax 1940 Laser (1940 nm):

• The Frax 1940 nm Laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

Ellipse Ydun system is intended to be used in dermatology, as tabled below:
Ellipse Ydun + Frax 1550, (1550 nm):
*The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Ydun + Frax 1940, (1940 nm)
*The Frax 1940 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures

The Frax 1940 applicator is used with the Ellipse Nordlys (K150907 and K161162) and Ellipse Ydun (K180406). The Nordlys and Y dun systems consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1940 applicator connects to the system and have built in Laser diodes emitting 1940 nm light in a fractionated pattern. The mode of action is delivering a series of light pulses in a row of up to 10 mm as the applicator is moved across the skin. This leaves a pattern of micro dots (Micro Thermal Zone) of irradiated skin, typically in the order of 100 MTZ/cm2. Due to the area of the damaged skin in each MTZ, a certain percentage of the covered skin is affected, and this is referred to as the Coverage (percentage) of the treatment. The control of pulses as the applicator is moved is by a magnetic motion sensor embedded in the roller that also acts as skin distance controlling device. The motion detection and the control of the laser diodes is done in a micro controller embedded in the handpiece. The materials used are the same as the predicate device Frax 1550 (aluminum and ABS), and the applicator is intended to be in contact with the patient for 15-30 minutes. The system is intended to be used in healthcare facilities and hospital environments.

The provided text is a 510(k) premarket notification for the Ellipse Frax 1940 laser system. It seeks to demonstrate substantial equivalence to a predicate device, the Fraxel Dual 1550/1927 Laser System (K130193). The document focuses on showing that the new device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" in a quantitative table format with specific thresholds for performance metrics. Instead, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device in terms of technological characteristics, performance, and intended use/indications for use.

The reported device performance is primarily focused on safety and histological outcomes, which are compared to expected outcomes for similar devices.

• Reported Performance: Theoretical analysis showed negligible difference in chromophore absorption at the two wavelengths, supported by a statement from a Professor of Dermatology. |
  | Technological Equivalence (Beam Diameter) | - Beam Diameter: Comparison based on measurements for Frax 1940 and labeling for Fraxel 1927.
• Reported Performance: Frax 1940 has a smaller beam diameter than the predicate device. Beams are comparable. |
  | Technological Equivalence (Energy Release & Coverage) | - Energy Levels and Coverage: Comparisons to predicate. |
  | | - Reported Performance: Energy levels and Coverage are equivalent for the two devices. |
  | Clinical Safety/Healing Process | - Tissue Damage and Healing: Evaluate adverse events, healing time, and skin reaction. |
  | | - Reported Performance: Complete healing with no significant adverse events.
• Healing complete after 7 days for 5 mJ exposure and 34 days for 20 mJ.
• Good tolerance to applicator angulation.
• Immediate effects: mild to moderate edema and erythema, resolving within 1-7 days.
• One instance of Post Inflammatory Hyperpigmentation (PIH) noted with 5 mJ energy setting and unusually high coverage (77.9%), which is significantly higher than recommended settings (20-35% for off-face treatment in Fitzpatrick skin type I-III). |
  | Compliance with Regulatory and Safety Standards | - Standards: US FDA 21 CFR 1040.10 and 1040.11, IEC 60601-1, UL 60601-1, CSA C22.2 No. 601.1, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-2, European Medical Device Directive 93/42/EEC (Annex II), ISO13485, US FDA 21CFR Part 820.
• Reported Performance: The device has been tested according to and complies with all listed standards. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): 3 subjects for the in-vivo histological healing response study.
• Data Provenance: Prospective, controlled, in-vivo study of human abdominal skin. The country of origin for the study is not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The text mentions that "a theoretical analysis has been established showing negligible difference in chromophore absorption at the 2 wavelengths, supported by a statement from a Professor of Dermatology." This indicates one Professor of Dermatology was involved in supporting part of the non-clinical evaluation related to wavelength differences.

For the clinical study, the judgment of "complete healing with no significant adverse events" and observations of edema, erythema, and PIH would have been made by clinical investigators, but their specific number, qualifications, and role in establishing a formal "ground truth" are not detailed beyond being integral to the study's execution.

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

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the clinical outcomes in the test set. Clinical observations and histological assessments would have been made by the study investigators.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
• This device is a laser system for dermatological procedures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no mention of human readers or AI assistance in the context of this 510(k) submission.

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

• This question is not applicable. The device is a physical laser system, not a software algorithm. The "standalone" performance would refer to the laser system's (Frax 1940) inherent performance specifications, which were assessed through non-clinical beam diameter measurements, wavelength analysis, and clinical histological studies.

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

The ground truth for the clinical safety performance (healing process) was primarily established through:

• Histology: "in-vivo histological healing response study of human abdominal skin."
• Clinical Observation/Outcomes Data: Observations of "complete healing with no significant adverse events," resolution of edema and erythema, and instances of PIH.

For the non-clinical comparison of wavelength absorption, the ground truth was supported by expert opinion (statement from a Professor of Dermatology) on theoretical analysis.

8. The sample size for the training set

The document does not describe a "training set" in the context of a machine learning algorithm. This 510(k) submission is for a physical medical device, not an AI/ML product that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned or implied for this physical medical device.

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Ellipse Ydun system is intended to be used in dermatology, as tabled below:

• Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Ydun is a platform/console capable of driving the Ellipse Frax 1550 applicator, which is a 1550 nm Laser diode-based applicator cleared by FDA under K161162.

The Ydun system consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1550 applicator connects to the system and have built in Laser diodes emitting 1550 nm light in a fractionated pattern.

The provided text describes a 510(k) premarket notification for the Ellipse Ydun system, a laser surgical instrument. The document focuses on demonstrating substantial equivalence to a predicate device (Ellipse Nordlys with Frax 1550) rather than presenting a performance study with acceptance criteria for an AI/algorithm-driven device.

Therefore, the information required to populate a table of acceptance criteria and reported device performance (especially for an AI algorithm), details on test set provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in the provided text.

The document primarily outlines:

• Device Name: Ellipse Ydun
• Regulation Number: 21 CFR 878.4810 Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Code: GEX
• Intended Use/Indications for Use: "Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures."
• Technological Comparison: The Ellipse Ydun is described as being "identical to the predicate device in that the Frax 1550 applicator/handpiece being used is the same as used by the predicate device and the Ellipse Ydun console driving the Frax 1550 is of the same technological design."
• Performance Standards: The device was tested according to and complies with various electrical safety, laser product, and quality management standards (e.g., US FDA 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60825-1, ISO13485).

Conclusion:

Based on the provided text, there is no information about an AI/algorithm-driven device, acceptance criteria or performance studies of the kind typically performed for software/AI-based medical devices. The submission is for a hardware device (laser instrument) seeking substantial equivalence based on its technological similarity to an existing predicate device and compliance with relevant safety and performance standards for hardware.

Therefore, I cannot fulfill the request for the table or other detailed information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as such information is not contained within this document.

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Ellipse Nordlys system is intended to be used in dermatology, as tabled below:
• Permanent Hair Reduction (defined as the 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) (overall 600-950nm).

• · Treatment of Telangiectasias (530-750nm or 555-950mm).
• · Treatment of Port Wine Stains (530-750nm or 555-950nm).
  · Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (ex Diffuse Redness) (530-750nm or 555-950nm).
• · Treatment of Rosacea (530-750nm or 555-950nm).
• · Treatment of Poikiloderma of Civatte (530-750nm or 555-950mm).
• · Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
• · Treatment of Inflammatory Acne Vulgaris (530-750mm).
  Using Nd:YAG Laser, (1064 nm):
• · Treatment of Leg vessels (0.1 -3.0 mm diameter).
• · Treatment of Benign Vascular Lesions.
• Treatment of Venous Lakes.
• · Treatment of Port Wine Stains.
• · Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g.,
  dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
• · Treatment of benign cutaneous lesions, such as warts.
• · Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including:
  • Matrixectomy.
  • Periungal and subungal warts
  • Plantar warts.
    Using Frax 1550 Laser, (1550 nm):
    · The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Nordlys is an Intense Pulsed Light (IPL) and Laser system (Nd:YAG 1064 nm and Fractional 1550 nm) 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, 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:Y AG hand piece (1064 nm) and a Fractional (1550 mm) hand piece can be connected to the Ellipse Nordlys for treatment of: Vascular lesions as stated below under Intended Use/Indications for Use for the Nd: YAG and fractional treatments for non-ablative skin resurfacing for Frax 1550 as stated below.

The provided text is a 510(k) summary for the Ellipse Nordlys system with the Frax 1550 hand piece. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It does not contain a detailed study report with specific acceptance criteria and performance data for a new AI/algorithmic device.

Instead, it states that the device complies with various performance standards and that technical parameters are "as safe and effective as the predicate devices."

Therefore, I cannot extract the requested information in the format provided because the document describes a laser device and its regulatory clearance process, not an AI or algorithmic medical device that would have specific performance metrics like sensitivity, specificity, or ROC AUC from a clinical study.

The document mentions:

• Performance Standards utilized: IEC 60601-1, IEC 60601-2-57, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-2, US FDA 21 CFR 1040.10 and 1040.11 for Class IV Laser Products, European Medical Device Directive 93/42/EEC (Annex II), and ISO13485 Quality Management System.
• Performance Data: "Testing certificates by UL International and Delta according to above listed Performance Standards were provided which demonstrates that Ellipse Nordlys with the listed applicators/handpieces utilize technical parameters which are as safe and effective as the predicate devices."
• Study for Frax 1550 settings: "The default start settings for the Frax 1550 are based on the most relevant clinical investigations found to be safe and effective in the Ellipse literature study (RA18704, appendix 2) and equivalent to what are used as standard settings for the same treatments for Frax SR1550 (K130193) and Icon Lux1540 (K142376)." This refers to a literature study to justify parameter settings, not a new clinical study.

Without a detailed clinical study report specifically for an AI/algorithmic device, I cannot fill in the requested table and details.

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Ellipse Nordlys system is intended to be used in dermatology, as tabled below:

•Permanent Hair Reduction (defined as the 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) (overall 600-950nm).

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

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

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

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

· 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: Y AG 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

• Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g.,

dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

· Treatment of benign cutaneous lesions, such as warts.

• •Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including
• Matrixectomy.
• Periungal and subungal warts
• Plantar warts.

Ellipse Nordlys is an Intense Pulsed Light (IPL) and Nd:YAG Laser 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, 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 Nordlys for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

This document, a 510(k) Summary for the Ellipse Nordlys device, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. In a 510(k) submission, the FDA often receives evidence that a new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics, performance, and intended use.

Here's a breakdown of why the requested information is not present and what the document does provide:

Missing Information (and why it's missing in a 510(k) Summary like this):

1. A table of acceptance criteria and the reported device performance: This would be found in a more detailed clinical or performance study report, which is usually part of the full 510(k) submission but not typically summarized in this public-facing document. The 510(k) summary focuses on equivalence to existing devices rather than a direct, quantitative performance validation against novel acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not mentioned. This would be part of a specific study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 a laser/IPL system, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
8. The sample size for the training set: Not applicable for a device that is not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable for a device that is not an AI/ML algorithm.

What the document does provide regarding "performance standards" and "equivalence" (which is the closest it gets to your request):

The document explicitly states that the Ellipse Nordlys system has been tested according to and complies with a list of regulatory and safety standards. These standards implicitly set "acceptance criteria" for the device's fundamental safety and electrical performance.

Performance Standards (serving as implicit "acceptance criteria" for safety and basic function):

• US FDA 21 CFR 1040.10 and 1040.11: For class IV Laser Products (This relates to laser product performance, safety, and labeling requirements).
• IEC 60601-1 3rd edition, UL 60601-1 and CSA C22.2 No. 601.1: Medical electrical equipment - General requirements for basic safety and essential performance.
• IEC 60601-2-57: Particular requirements for the basic safety and essential performance of laser devices for dermal and aesthetic applications.
• IEC 60825-1 and IEC 60601-2-22: Safety of laser products and particular requirements for surgical, therapeutic and diagnostic laser equipment.
• IEC 60601-1-2: Electromagnetic compatibility.
• Complies with the European Medical Device Directive 93/42/EEC (Annex II): A broad directive for medical devices in Europe.
• Manufactured under ISO 13485 Quality Management System certified by Presafe/DGM and QMI and also complies with the US FDA 21CFR Part 820: Demonstrates a robust quality management system in place.

The "study" or evidence provided to meet these criteria is the compliance with these standards. This means the manufacturer has conducted tests (e.g., electrical safety tests, electromagnetic compatibility tests, laser output parameter tests) and demonstrated that the device meets the specifications and safety requirements outlined in these standards. The specific results of these tests are not detailed in this summary but would be part of the full submission.

Substantial Equivalence Conclusion:

The core "study" mechanism here is the comparative analysis for substantial equivalence. The manufacturer concluded: "The Ellipse Nordlys system are substantially equivalent in terms of technological characteristics, performance, intended use/indications for use to the predicate devices listed on page 1 of this document." This means they presented data (likely including design specifications, output parameters, and sometimes clinical literature for the predicate devices) to convince the FDA that the Nordlys performs comparably to the already approved predicate devices. They explicitly state, "Based on this analysis of the overall performance of the mentioned predicate devices Ellipse A/S believes that no significant differences exist. The Ellipse Nordlys system should not raise new issues of safety or effectiveness."

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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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Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of:

• Skin Resurfacing .
• Wrinkles, Rhytides, and Furrows .
• Acne Scars .

The Ellipse Juvia system comprises the following major parts:

• A laser console containing a CO2 laser module capable of providing a laser beam having a . wavelength of 10,600 nm.
• A scanner that is intended to manipulate and place a pulsed beam received from the laser . console in a pre-specified pattern on the skin being treated.
• An optical fiber providing a beam path from the laser to the scanner. .

The Ellipse Juvia laser system received 510(k) clearance (K072023) based on substantial equivalence to predicate devices, not on a study demonstrating that it meets specific acceptance criteria. The submission focuses on comparing the new device's technical specifications and intended uses to those of already cleared devices to establish that the Ellipse Juvia does not raise new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this 510(k submission, as it is not a requirement for substantial equivalence pathways where direct performance studies against pre-defined criteria might not be conducted.

However, based on the provided text, we can infer the "acceptance criteria" as substantial equivalence to the predicate devices and the "study" as a detailed comparison table of technical specifications and indications for use.

Here's an analysis based on what is provided:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. The submission does not describe a clinical study with a "test set" in the traditional sense of evaluating device performance on a sample of patients or images. The "test" here is a technical comparison against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No expert ground truth establishment for a test set is mentioned, as this was not a clinical performance study. The "truth" for substantial equivalence is based on the technical specifications and intended uses of legally marketed predicate devices.

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

• Not applicable. No adjudication method is mentioned, as there was no test set requiring expert review.

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

• No. This is a medical device for dermatological and plastic surgery procedures, specifically a laser system, not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant and not mentioned.

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

• Not applicable. This is a laser system, not an algorithm. Standalone performance as typically described for AI algorithms is not relevant here. The "standalone" performance would be its physical output (wavelength, power, spot size), which is characterized by its technical specifications but not presented as a "study" in the provided document.

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

• The "ground truth" for this 510(k) submission is the pre-existing FDA clearance of the predicate devices (Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and SLIM Evolution Family of CO2 Lasers). The equivalence claim is based on the comparison of specifications and indications to these already-cleared devices, implying that their safety and effectiveness are established.

8. The sample size for the training set

• Not applicable. There is no "training set" mentioned, as this is a medical device clearance based on substantial equivalence, not a machine learning model.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set, there's no ground truth establishment for it.

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