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The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction

The Aurora DS is a device that is used for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) vascular and pigmented lesions without damaging the surrounding tissues.

The provided text describes a 510(k) summary for the Syneron Medical Ltd. Aurora DS / DS Applicator, which is a device used for hair removal. This document is a regulatory submission for a device modification, specifically changing the light spectrum output.

Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device performance.

The document states: "The modifications to the Aurora DS do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the light spectrum output. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness."

This suggests that the 510(k) submission is for a minor modification that is not expected to change the device's performance from its previously cleared version. Therefore, a new, extensive performance study with acceptance criteria, as one would expect for a novel or significantly modified device, is not presented or required in this particular 510(k) summary. The FDA's letter confirms substantial equivalence to a predicate device, which means the safety and effectiveness are considered to be similar to an already legally marketed device.

Therefore, I cannot provide the requested table and information, as the input document does not contain details about specific performance acceptance criteria or a study proving those criteria for the modified device.

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The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.

The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the hair follicle without damaging the surrounding tissues.

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request, particularly regarding specific acceptance criteria values, sample sizes, and expert qualifications for performance studies.

This is common for older 510(k) submissions, which often presented less granular data than more recent ones require. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

However, I will extract and infer information where possible based on the provided text.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for hair removal or reduction beyond indicating the device should "effect stable long-term, or permanent, hair reduction." It relies on substantial equivalence to predicate devices, implying that its performance is expected to be comparable.

Study Details

Given the context of a 510(k) submission primarily focused on substantial equivalence to predicate devices, detailed clinical study methodologies are not provided in this summary. The summary highlights that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present." This general statement suggests that any studies conducted were likely aimed at demonstrating this equivalence rather than establishing de novo performance metrics against specific criteria.

1. Sample Size used for the test set and the data provenance:
   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not specified.
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 hair removal system, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   • Not applicable as this is a device for hair removal, not an algorithm. Performance is inherent to the device's design and mechanism.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • Not explicitly stated. For hair removal devices, ground truth for efficacy would typically involve quantitative hair counts or subjective photographic assessments by clinicians and/or patients over time.
7. The sample size for the training set:
   • Not applicable, as this is a medical device for hair removal, not an AI/machine learning algorithm with a training set.
8. How the ground truth for the training set was established:
   • Not applicable.

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The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.

The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.

I'm sorry, but this document does not contain the information you requested about acceptance criteria and a study proving device performance. The provided text is a 510(k) summary for a medical device (Aurora DS) and a clearance letter from the FDA. It primarily focuses on the device description, its intended use, modifications from a predicate device, and the FDA's determination of substantial equivalence for market clearance.

Here's a breakdown of what is and is not in the document:

What is present:

• Device Name: Aurora DS
• Intended Use: Non-invasive hair removal.
• Predicate Device: Aurora DS cleared under K031988 (this is a Special 510(k) for modifications).
• Device Description: A device used for non-invasive hair removal based on selective thermolysis using optical and RF energy.
• Modification: An increase in light energy output.
• FDA Clearance: The device was cleared under K033586.

What is not present (and what you requested):

• A table of acceptance criteria and reported device performance.
• Details about sample size for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts for ground truth.
• Adjudication method.
• Information on MRMC comparative effectiveness studies or human reader improvement.
• Information on standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• How ground truth for training or test sets was established.

The document states that "The modifications to the Aurora DS do not affect the intended use or alter the fundamental scientific technology of the device... The device modifications raise no new issues of safety or effectiveness." This implies that the previous clearance for the predicate device would have established the fundamental safety and effectiveness, and the current submission is arguing that the changes do not change that. However, the details of those studies are not in this document.

Ask a specific question about this device

The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.

The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.

The provided text is a 510(k) summary for the Syneron Medical Ltd. AURORA DS device. It outlines the company, device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence for a modification (an increase in RF energy output) to an already cleared device. It explains that the modification does not affect intended use or fundamental scientific technology and raises no new safety or effectiveness issues.

Therefore, I cannot provide the requested table and study details as they are not present in the given input.

Ask a specific question about this device

The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.

The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.

The provided text includes a 510(k) summary for the Aurora DS device. However, it does not contain any information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, primarily for non-invasive hair removal.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as that information is not present in the provided text.

The closest information available is the intended use: "The Aurora DS is intended for use in dermatology for non invasive hair removal." This implies that the device's functional performance related to hair removal has been deemed acceptable for its regulatory submission, but no specific metrics or study details are provided.

Ask a specific question about this device