(90 days)
The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions.
The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins).
The Aramis Dermatologic Laser is an Er-glass 1.54 um system. The computer system consists of a laser unit, a cooler, a footswitch, and a 2mm or 4mm hand piece. The 4mm hand piece is gas-cooled to provide actual skin cooling. Laser parameters and other system features are controlled from the touch-buttons on top of the laser unit, which provides an interface to the system computer.
The provided text is a 510(k) summary for the Lumedics's Aramis Dermatologic Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device's technological characteristics, intended use, and indications for use to a previously approved device.
Crucially, this document does not contain acceptance criteria for device performance in a clinical study, nor does it detail a study performed to prove such criteria were met. Instead, it lists compliance with general electrical, laser, and quality standards.
Therefore, the requested information elements cannot be fully extracted from the provided text. However, based on what is available, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific clinical acceptance criteria are provided in the document. The submission focuses on substantial equivalence to a predicate device and compliance with general safety standards, rather than new performance criteria established for this specific device. | - Complies with 21 C.F.R. §§ 1040.10 and 1040.11 (Laser Product Performance Standards). |
- Complies with UL544 (Electrical Leakage).
- Complies with IEC 60-601-1 (Power Supply and Enclosure).
- Complies with IEC 60-825-01 (Safety of Laser Product).
- Complies with IEC 601-2-22 (Therapeutic Laser Equipment Safety).
- Complies with 93/42/EEC (European Directive).
- Complies with IEC 60-601-1-2 (Electromagnetic Compatibility). |
2. Sample size used for the test set and the data provenance
The document does not mention any clinical test set, sample size, or data provenance from a study specifically conducted for this 510(k) clearance. The submission relies on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with human ground truth establishment is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set or adjudication process is described.
5. 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 dermatologic laser, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human reader performance with and without AI assistance is not relevant to this device or its submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser for medical procedures, not an algorithm. Standalone performance as described in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical study requiring ground truth for validation is mentioned in this 510(k) submission.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no "training set" with established ground truth.
Summary of Device Approval Process as per the Document:
The Lumedics's Aramis Dermatologic Laser received 510(k) clearance based on its substantial equivalence to the predicate device, Palomar Medical Technologies, Inc. Aramis Dermatologic Laser. The submission details the technological characteristics, intended use, and indications for use, highlighting that "Any minor differences do not raise any new issues of safety or effectiveness."
Instead of presenting new clinical performance data against specific acceptance criteria, the document demonstrates compliance with recognized electrical, laser, and general safety standards (e.g., UL544, IEC 60-601-1, IEC 60-825-01). This type of submission relies on the established safety and efficacy of the predicate device, not on new clinical trials or performance assessments for the submitted device in a clinical setting.
§ 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.