(733 days)
The Aurolase Therapy, Laser Delivery Device is a fiber-optical laser delivery device to be used with a compatible 810nm laser device for laser-based applications and procedures that are cleared for the compatible laser.
Laser light generated by the Laser Module is delivery Device (LDD) Assembly, that is comprised of three components: the Laser Catheter Assembly (LCA), the Optical Fiber Diffuser (OFD), and the Coolant Supply Set (CSS). The LCA and OFD transmit laser energy to the tissue situated at their distal regions, to achieve the desired effect of the intended use. The use of coolant provides cooling for the surfaces of the CSS in contact with both the tissue and the LCA.
The provided text is a 510(k) summary for the Aurolase Therapy, Laser Delivery Device (LDD). It discusses the device's classification, intended use, technological characteristics, and a comparison to a predicate device. However, this document does not contain information about acceptance criteria, detailed study designs, performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies, which are typically found in a clinical study report or a more detailed section of a 510(k) submission regarding performance data.
The document states: "The results of testing, including rigorous physical and environmental use studies, sterility, and biocompatibility tests, support a conclusion that the Aurolase Therapy LDD satisfies the requirements of performance to achieve its intended effect within its indication for use, and have not produced any additional risks of hazard leading to harm of the user and/or the patient within its intended use." This broadly refers to non-clinical performance data, but does not provide specific metrics or acceptance criteria for device performance in a clinical context (e.g., related to an AI/ML algorithm's diagnostic or predictive capabilities).
Therefore, I cannot fully answer your request based on the provided text. The questions you posed, particularly those related to acceptance criteria, diagnostic performance studies (like MRMC, standalone), ground truth, and sample sizes for training/test sets, typically apply to devices that involve AI/ML algorithms or interpretative functions. The Aurolase Therapy LDD, as described, appears to be a delivery device for laser energy, rather than a diagnostic device or one that incorporates AI/ML for analysis or interpretation. Its "performance" would likely be evaluated on optical, mechanical, and safety specifications, not on diagnostic accuracy metrics.
Here's a breakdown of why the information is not present and what types of information would typically be provided for the type of study you're asking about:
- Acceptance Criteria & Reported Device Performance Table: This would typically apply to a diagnostic device or an AI algorithm. For a laser delivery device, acceptance criteria would be for things like power output accuracy, wavelength, fiber integrity, cooling efficiency, etc. These are not detailed in the provided summary.
- Sample size and Data Provenance: Not applicable in the context of clinical performance evaluation for this type of device based on the provided document.
- Number of Experts & Qualifications / Adjudication Method / MRMC / Standalone performance / Type of Ground Truth: These are all highly relevant for AI/ML-based diagnostic devices where human readers or algorithms interpret medical images or data. They are not relevant for a passive laser delivery device like the Aurolase LDD as described in this 510(k) summary. The "ground truth" for this device would be its physical and optical characteristics meeting specifications, not clinical outcomes related to diagnosis or prediction.
- Training Set Sample Size & Ground Truth for Training: Applicable to AI/ML devices. Not relevant for this device.
In summary, the provided document for the Aurolase Therapy, Laser Delivery Device (LDD) does not contain the type of clinical performance study data (e.g., diagnostic accuracy, reader studies, AI/ML algorithm performance) that your questions refer to. The 510(k) largely focuses on the device's physical characteristics, its role as an accessory, and its substantial equivalence to a predicate device based on non-clinical testing (sterility, biocompatibility, physical performance).
§ 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.