(332 days)
The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.
The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components:
- A Laser Console
- A Fiber Port (for Delivery Devices)
- Control and Display Panels
- Operating Software
- Footswitch and Handswitch Delivery Controls
- Accessories
- A Cooling Sub-system
This document is a 510(k) summary for the Aura™ i Surgical Laser System & Accessories, indicating it's a submission for market clearance rather than a detailed study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for clinical performance studies.
Instead, this document focuses on establishing substantial equivalence to predicate devices based on shared indications for use, design, and functional features, and adherence to performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets that criteria based on the provided text. The document is essentially a regulatory filing for market clearance, not a clinical trial report.
However, I can extract information related to the device and its intended use:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as clinical performance metrics (e.g., reduction in lesion count by X% in Y% of patients). Instead, the regulatory acceptance criteria for this 510(k) submission are that the device is substantially equivalent to legally marketed predicate devices and conforms to federal regulations and performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).
- Reported Device Performance: The document states the device is "indicated to treat moderate inflammatory acne vulgaris." No specific clinical performance statistics (e.g., efficacy rates, adverse event rates, or comparative outcomes) are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This document does not describe a clinical study with a test set of patients for evaluating the device's efficacy or performance in a clinical setting. It's a regulatory submission for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. See point 2.
4. Adjudication Method for the Test Set:
- Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No. This document does not mention any MRMC study or any comparative effectiveness study with human readers (as would be relevant for diagnostic AI).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical surgical laser system, not an AI algorithm.
7. The type of ground truth used:
- Not applicable. As this is a medical device and not a diagnostic AI tool, the concept of "ground truth" for a test set in the same way is not relevant here. The "truth" for its claims relies on its physical and functional similarity to already cleared devices and adherence to laser safety standards.
8. The sample size for the training set:
- Not applicable. This document describes a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary: This 510(k) submission establishes the regulatory pathway for marketing the Aura™ i Surgical Laser System by demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards. It does not present clinical trial data or performance against specific clinical acceptance criteria in the format you requested.
§ 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.