(98 days)
The Reliant Technologies Laser System II is intended for:
-Dermatological procedures requiring the coagulation of soft tissue;
-Treatment of periorbital wrinkles;
-Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia.
The Reliant Laser System II consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatological procedures. The system includes scanning and focusing optics to deliver a pattern of microscopic treatment zones (MTZs) to the epidermis and upper dermis. Device attachments and pre-treatment solution are also included.
The provided document is a 510(k) summary for the Reliant Laser System II. It describes the device, its intended use, and states that clinical performance data was used to demonstrate its function and safety. However, it does not contain specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
Here's a breakdown based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Information provided in the document:
The document states: "Results of clinical evaluations were used to demonstrate that the Reliant Technologies Laser System II functioned as intended. Sufficient data have been gathered from clinical studies to determine that the Reliant Laser System II performs as clinically intended, and no issues of safety and effectiveness are introduced."
Missing Information:
- Specific Acceptance Criteria: The document does not define any quantitative or qualitative acceptance criteria that the device was tested against (e.g., a specific percentage reduction in wrinkles, a certain lesion clearance rate, or a defined safety threshold).
- Reported Device Performance: While it states the device "functioned as intended" and "performs as clinically intended," it does not provide any specific metrics, data, or results from the clinical evaluations to substantiate this claim.
2. Sample Size for the Test Set and Data Provenance
Missing Information:
- Sample Size: The document does not mention the number of subjects or cases included in any clinical evaluation or test set.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only generically refers to "clinical evaluations" and "clinical studies."
3. Number of Experts and their Qualifications for Ground Truth
Missing Information:
- The document does not describe the establishment of a "ground truth" using experts for any test set.
- It does not mention the number or qualifications of any experts involved in reviewing the clinical outcomes or data for the studies.
4. Adjudication Method for the Test Set
Missing Information:
- Since the document doesn't detail a test set or ground truth establishment process involving experts, an adjudication method is also not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Missing Information:
- The document does not mention any MRMC comparative effectiveness study, nor does it discuss human readers, AI assistance, or an effect size. Laser devices like this typically focus on direct physiological effects rather than diagnostic interpretation assisted by AI.
6. Standalone (Algorithm Only) Performance Study
Missing Information:
- This is a standalone device in the context of a laser system, meaning it functions directly on the patient, not as a diagnostic algorithm that processes data. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as it relates to AI algorithms is not applicable here and no such study is mentioned or implied.
7. Type of Ground Truth Used
Missing Information:
- The document does not specify the type of ground truth used. For a laser device, "ground truth" would typically refer to clinical outcomes validated through physician assessment, patient satisfaction, or objective measurements (e.g., imaging, biopsies for lesion clearance), but no specifics are provided.
8. Sample Size for the Training Set
Missing Information:
- The document does not refer to any "training set." This term is specific to machine learning algorithms, which is not the nature of this medical device (a laser system).
9. How the Ground Truth for the Training Set Was Established
Missing Information:
- As there is no mention of a "training set" (due to the nature of the device), there is no information on how its ground truth was established.
In summary, the provided 510(k) summary for the Reliant Laser System II broadly states that clinical evaluations demonstrated the device performs as intended and is safe and effective. However, it lacks the detailed information required to answer most of the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment. This level of detail is typically found in the full 510(k) submission, not necessarily in the publicly available summary.
§ 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.