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The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.

The modifications to the Aurora SR 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.

The Aurora SR is indicated for superficial benign vascular and pigmented lesion treatment.

The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR 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 document is a 510(k) summary for the Aurora SR / SR Applicator, which is a device used for superficial benign vascular and pigmented lesion treatment. This is a "Special 510(k)" submission, which typically means the changes to the device (in this case, changing the light spectrum output) do not affect the intended use or alter the fundamental scientific technology.

Crucially, this document does not contain any information regarding clinical studies, acceptance criteria, or specific performance data derived from such studies. Special 510(k)s often rely on the established safety and effectiveness of the predicate device and demonstrate that the modifications do not introduce new safety or effectiveness concerns. They generally do not require new clinical studies if the changes are minor and do not alter the fundamental mechanism of action or intended use.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present in the document:

1. A table of acceptance criteria and the reported device performance: This information is not in the document.
2. Sample size used for the test set and the data provenance: This information is not in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not in the document.
4. Adjudication method for the test set: This information is not in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is not in the document. The device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a treatment device, not a diagnostic algorithm. This information is not in the document.
7. The type of ground truth used: This information is not in the document.
8. The sample size for the training set: This information is not in the document.
9. How the ground truth for the training set was established: This information is not in the document.

Summary based on the provided text:

The document states that the modifications to the Aurora SR (changing the light spectrum output) do not affect the intended use or alter the fundamental scientific technology, and raise no new issues of safety or effectiveness. This type of submission relies on the predicate device's existing clearance (K031993) and demonstrates that the modifications do not negatively impact the safety and effectiveness already established. There is no mention of new studies being conducted to prove new acceptance criteria or device performance for this specific special 510(k) submission.

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The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.

The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR 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.

This is a 510(k) summary for a Special 510(k) for the Syneron Medical Ltd. Aurora SR device. The provided document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document states that the modifications to the Aurora SR (an increase in RF energy output) "do not affect the intended use or alter the fundamental scientific technology of the device" and "raise no new issues of safety or effectiveness." This implies that the device's safety and effectiveness were considered established by the predicate device (K022266).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These details are typically found in a full efficacy study report, which is not part of this 510(k) summary. The purpose of a 510(k) Special submission is to demonstrate that a modified device is substantially equivalent to a legally marketed predicate device, often without requiring new clinical trials if the modifications do not significantly change safety or effectiveness.

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The Aurora SR is intended for use in dermatology for treatment of superficial benign vascular and pigmented lesion treatment.
The Aurora SR is indicated for treatment of superficial, benign vascular, and pigmented lesions.

The Aurora SR is a device that is used for treatment of superficial, benign vascular and pigmented lesions. The Aurora SR 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 pigmented and vascular lesions without damaging the surrounding tissues.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.

The document is a 510(k) premarket notification for the Aurora SR device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

The key information provided includes:

• Device Name: Aurora SR
• Intended Use: Treatment of superficial, benign vascular and pigmented lesions.
• Principle of Operation: Selective (electromagnetic) thermolysis using optical and RF energy.
• Predicate Devices: PhotoDerm VL, PhotoDerm PL, ThermaCool, Vnus Closure System.
• Conclusion: The manufacturer believes no significant differences exist and the device should raise no new issues of safety or effectiveness.
• FDA Response: The FDA determined substantial equivalence based on the provided indications for use.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth details, or study methodology as this information is not present in the provided text.

Ask a specific question about this device