(95 days)
The Medical Diode Laser (Model: S1Pro) is indicated for use in surgical applications requiring the vaporization, incision. excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Headineck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: S1Pro) is further indicated for laser assisted lipolysis.
The Medical Diode Laser device incorporates a 1470nm wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 400um and 600um diameter respectively.
The provided text is a 510(k) premarket notification for a medical device called "Medical Diode Laser (S1Pro)". It describes the device, its intended use, comparison to predicate devices, and performance data from non-clinical testing.
However, the document does not contain information about a study that proves the device meets specific acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, accuracy) using a test set with ground truth established by experts, as implied by your detailed request. The device in question is a physical medical laser, not an AI software/algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI/algorithm metrics.
- Sample size and provenance for an AI test set.
- Number and qualifications of experts for AI ground truth.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study results for AI.
- Standalone performance of an AI algorithm.
- Type of ground truth for an AI test set.
- Sample size for an AI training set.
- How an AI training set's ground truth was established.
The document focuses on demonstrating substantial equivalence of the laser device to existing predicate devices based on:
- Similar Indications for Use: The uses of the S1Pro laser (e.g., vaporization, incision, coagulation of soft tissue in various surgical specialties, and laser-assisted lipolysis) are compared to those of the predicate devices.
- Similar Technology: It uses a 1470nm diode laser, similar to the predicate devices.
- Similar Output Parameters: While there are minor differences (e.g., Max Output Power, Pulse Duration, Repetition Rate), the document states these differences "do not raise new types of questions regarding the safety and effectiveness."
- Non-Clinical Performance Data: This primarily consists of compliance with recognized electrical safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
- Software Verification and Validation: This confirms the software (likely controlling the laser's operation) performs as intended, following FDA guidance for device software.
In summary, the provided text describes a medical laser device, not an AI-powered diagnostic or assistive tool. Thus, it does not contain the information required to answer your specific questions related to AI/algorithm acceptance criteria and studies.
§ 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.