(228 days)
SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers for surgical incision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and gland) laser assisted lipolysis and the treatment of primary axillary hyperhidrosis.
The Cynosure 1440nm Wavelength laser is solid state Nd: YAG laser, having a neodymium rod as a lasing medium. Laser activation is by footswitch. Overall weight of the laser is 220lbs, and the size is 38.6"x16.5"x35.5" (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. SideLaze800™ Laser Beam Delivery Accessory is an optional side-firing fiber optic accessory used with the Cynosure Lasers with 1440nm wavelength. The SideLaze800™ option is intended to offer physicians a convenient accessory.
This document describes the SideLaze800™ Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers, and its application for the treatment of primary axillary hyperhidrosis. Since this is a medical device submission, the "acceptance criteria" discussed are related to demonstrating safety and effectiveness for a new indication for use rather than statistical performance metrics typical of AI/ML devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are implied by the clinical study's objective: demonstrating the device is safe and effective for treating primary axillary hyperhidrosis. The reported device performance focuses on the clinical outcomes observed in the study.
| Acceptance Criteria (Implied by Clinical Study Objective) | Reported Device Performance (Clinical Study Findings) |
|---|---|
| Safe for treating primary axillary hyperhidrosis | No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs) reported. |
| Effective in treating primary axillary hyperhidrosis | All subjects demonstrated a reduction, ablation, and fragmentation of the sweat glands. Treatment effectiveness assessed through: |
- Subject-rated Hyperhidrosis Disease Severity Scale (HDSS) scores
- Physician Satisfaction Scale (PSS)
- Blinded evaluation of pre and post photographs from starch iodine test results |
2. Sample Size and Data Provenance
- Sample Size (Test Set): 59 subjects
- Data Provenance: The study was conducted at 4 study centers. The location of these centers (e.g., country of origin) is not specified. The study appears to be prospective as subjects underwent treatment and were followed up for 12 months.
3. Number of Experts and Qualifications
The document mentions "Physician Satisfaction Scale (PSS)" and "blinded evaluation of pre and post photographs from starch iodine test results." It does not explicitly state the number or specific qualifications of the physicians or experts involved in these evaluations. It can be inferred that these evaluations were performed by qualified medical professionals.
4. Adjudication Method
The document mentions "blinded evaluation of pre and post photographs from starch iodine test results." This implies a form of adjudication for objective assessment, but the specific method (e.g., how disagreements were resolved, 2+1, 3+1) is not detailed. It's only stated that the evaluation was "blinded."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance was mentioned. This device is a laser-based medical device, not an AI/ML diagnostic tool.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth for effectiveness was established through a combination of:
- Clinical outcomes:
- Subject-rated Hyperhidrosis Disease Severity Scale (HDSS) scores.
- Physician Satisfaction Scale (PSS).
- Blinded evaluation of pre and post photographs from starch iodine test results (an objective measure of sweat production).
- Direct observation of "reduction, ablation and fragmentation of the sweat glands" (likely from biopsy or other imaging, though not explicitly stated how this was observed in all subjects).
- Safety data: Adverse event reporting.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML system requiring a training set in the conventional sense. The "training" or development of the device likely involved engineering and preclinical testing before the clinical study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no "training set" for an AI/ML algorithm. The safety and effectiveness for a medical device are established through a combination of engineering design, preclinical testing, and clinical trials. The previous clearance of the SideLaze800™ for other soft tissue applications (K121127) also provided a foundation for its known performance characteristics, with this submission specifically adding the hyperhidrosis indication based on the clinical study.
§ 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.