(180 days)
The Aramis II Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II 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), and for the treatment of periorbital and perioral wrinkles.
The Aramis II Dermatological Laser emits a beam of coherent light at 1540 microns which is delivered to the hand pieces, including a cooling hand piece, through a fiber optic.
The provided text focuses on the 510(k) summary for the Aramis II Dermatological Laser, detailing its indications for use and substantial equivalence to predicate devices, rather than explicit acceptance criteria with numerical targets. Therefore, the requested information, particularly numerical acceptance criteria and a single study demonstrating adherence, is not fully present.
However, based on the provided text, we can infer some aspects and report what is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on the results of pre-clinical and clinical studies to demonstrate safety and effectiveness, leading to a conclusion of substantial equivalence.
| Performance Aspect | Inferred Acceptance Criteria (not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|---|
| Safety | Low incidence of adverse effects, controlled thermal effects | - Pre-clinical study in rats showed thermal effects need to be controlled to reduce risks of epidermal injury. |
- Clinical studies reported "no or only a low incidence of complications, such as pain, swelling, erythema, scabbing, or blisters."
- Brief erythema linked to cooling noted as the only "unwanted side effect."
- Higher doses led to "some erythema, swelling, blistering, and crusting," indicating a need for careful dose management, especially in periorbital areas. |
| Effectiveness (Wrinkle Treatment) | Progressive improvement of skin texture and wrinkles, new collagen synthesis | - Clinical studies showed "progressive improvement of the skin texture and the wrinkles." - Biopsies showed "significant increases in collagen."
- Remodeling progresses slowly over several months. |
| Effectiveness (General) | Incision/excision, ablation, coagulation, pigmented and vascular lesion removal | The device is deemed "safe and effective for these applications based on clinical studies" and is substantially equivalent to predicate devices for these indications. |
2. Sample size used for the test set and the data provenance
- Test set (Clinical Studies): A total of 76 patients were involved in the clinical studies.
- One study: 10 patients (dose-response study).
- Other two studies: 66 patients combined.
- Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical investigations as they involve follow-ups (e.g., 6 months, 14 months after treatment).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. The "researchers" and "investigators" are mentioned as reporting results and observations.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the clinical study results.
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
No MRMC study was described. This device is a laser system, not an AI-based diagnostic tool that would typically involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a laser for medical procedures, not an algorithm.
7. The type of ground truth used
- Clinical effectiveness: Clinical observations by "researchers" and "investigators" regarding improvement in skin texture and wrinkles, incidence of complications.
- Biological effect: Histological results (for animal study) showed new collagen synthesis and fibroblastic proliferation. Biopsies (in human studies) showed significant increases in collagen.
- Safety: Direct observation of adverse events like erythema, swelling, blistering, crusting.
8. The sample size for the training set
The concept of a "training set" is not directly applicable here as it relates to machine learning algorithms. The studies described are clinical investigations of a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.