(15 days)
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:
- A table of acceptance criteria and the reported device performance: This information is not in the document.
- Sample size used for the test set and the data provenance: This information is not in the document.
- 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.
- Adjudication method for the test set: This information is not in the document.
- 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.
- 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.
- The type of ground truth used: This information is not in the document.
- The sample size for the training set: This information is not in the document.
- 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.