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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:

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.

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.

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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:

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.

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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The Intended Use for Ellipse I2PL is:

Ellipse 12PL. 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 (diffuse redness).

The Indications for Use for Ellipse I2PL are:

Ellipse If PL 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 and diffuse redness 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 555 nm - 950 nm.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL system:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about specific study designs, sample sizes, ground truth establishment, and expert involvement are not explicitly present in this type of document. 510(k) clearances are often based on performance testing to ensure safety and functionality, and comparison to legally marketed predicate devices, rather than large-scale clinical trials proving efficacy against predefined acceptance criteria in the same way a PMA would require.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are not framed as specific performance thresholds that the device had to meet in independent clinical trials. Instead, the acceptance criteria are implicitly that the device's technical specifications and intended uses are substantially equivalent to legally marketed predicate devices. The "reported device performance" is essentially the device's capabilities and parameters, which are then compared to those of the predicate devices.

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which primarily relies on comparison and demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with specific performance endpoints. The conclusion explicitly states: "Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S believes that no significant differences exist. The Ellipse I-PL 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 Data Provenance

• Sample Size for Test Set: Not explicitly stated. 510(k) submissions generally do not include detailed clinical study reports with patient sample sizes. The "test set" here refers to the parameters and specifications of the device being compared to predicates. Performance claims for the device would have been supported by internal testing and possibly limited clinical data, but the specifics are not in this summary.
• Data Provenance (country of origin, retrospective/prospective): Not specified in this 510(k) summary. Given the manufacturer is Danish, internal testing might have been done in Denmark or in collaboration with clinical sites.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• For a 510(k) based on substantial equivalence, ground truth for device performance is often established by engineering and medical professionals within the company and/or by referring to published literature and the established performance of the predicate devices. Clinical efficacy data, if used, would typically refer to assessments by qualified dermatologists or medical practitioners.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. This level of detail regarding clinical study methodology (like adjudication) is typically not found in a 510(k) summary unless a specific clinical study was a critical part of the equivalence claim, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, the provided 510(k) summary does not indicate that an MRMC comparative effectiveness study was performed. The evaluation focuses on the device's technical specifications and intended use in comparison to predicate devices, not on human reader performance with or without AI assistance.
• Effect size of AI improvement: Not applicable, as no MRMC study with AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Not explicitly stated in terms of a formal standalone clinical study report. The device itself (an IPL system) is a standalone technology, meaning it operates independently of "human-in-the-loop" performance in the context of an algorithm or AI. The performance of the device's energy output, pulse duration, and other physical parameters would have been characterized through engineering bench testing and system verification, which could be considered a form of standalone performance evaluation for the device's technical specifications.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the device's claims of safety and effectiveness in a 510(k) context is primarily established by:
  • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices for similar indications.
  • Technical Specifications: Engineering measurements and verification of the Ellipse I2PL's physical parameters (energy, wavelength, pulse duration) to ensure they are within safe and effective ranges comparable to predicates.
  • Clinical Literature/Experience: General dermatologic understanding of IPL technology for hair removal and lesion treatment.
  • If any minimal clinical data was included to support the claim, then patient outcomes (e.g., hair reduction, lesion clearance) would have been the ground truth, likely assessed by clinicians. However, no such data is detailed here.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is an IPL system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physics of light-tissue interaction.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this type of medical device.

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