(71 days)
Doctor Diode Laser Family including Doctor Smile, Doctor Surgery and Helios are available at 810 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 10w and 15w; at 940 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w; at 980 wavelength with variable power of 500mw, 2w, 2,5w , 5w, 7w, 8w, 10w and 15w and at 1064 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
The Doctor Diode Laser Family are portable instruments which transmit laser energy via a contact fiber optic delivery system and each unit is composed of the following main components: -a laser system console (including display panel, software and control); -a fiber optic delivery system; -one or more handpieces -protective eye ware -optical tips
The provided text is a 510(k) summary for the LAMBDA S.p.A. Doctor Diode Laser Family. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through clinical studies involving human patients or complex AI algorithms. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and multi-reader multi-case studies is not applicable to this document.
The document focuses on compliance with established safety and performance standards for medical lasers and demonstrating substantial equivalence to previously cleared devices.
Here's a breakdown of the relevant information from the document based on your request, with an explanation of why other sections are not applicable:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria (Standards Complied With) Reported Device Performance IEC 60601-1:1998+A1:1991+A2:1995 (Implicitly meets these standards through compliance statement.) IEC 60601-2-22:1995 (Implicitly meets these standards through compliance statement.) IEC 60825-1:1993+A1:1997+A2:2001 (Implicitly meets these standards through compliance statement.) 21 CFR 1040.10 and 1040.11 (Implicitly meets these standards through compliance statement.) Explanation:
The document states that "The Doctor Diode Laser Family comply with the following standards." In a 510(k) submission for a non-AI/diagnostic device like a laser, compliance with recognized performance and safety standards is the acceptance criteria. The "reported device performance" is essentially that the device meets these technical standards. There are no clinical performance metrics like sensitivity or specificity reported, as this is a physical medical device, not a diagnostic or AI-powered analytical tool. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This device is a surgical laser, and the submission focuses on its physical and electrical safety, and its substantial equivalence to predicate devices, rather than clinical performance data from a "test set" of patient data. Performance is evaluated against engineering and safety standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. As above, no clinical "ground truth" derived from expert review of patient data is part of this submission for a surgical laser.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication by experts is described.
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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
- N/A. This is a physical medical device (surgical laser), not a diagnostic tool or AI algorithm, so MRMC studies involving human readers are not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a physical medical device (surgical laser), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No clinical "ground truth" is used for evaluating this type of device in a 510(k) submission. The "ground truth" for the device's acceptability is its compliance with international and federal safety and performance standards for medical lasers, and its substantial equivalence to legally marketed predicate devices.
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The sample size for the training set
- N/A. This is a physical medical device, not an AI algorithm. There is no training set in the context of machine learning.
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How the ground truth for the training set was established
- N/A. As above, this is not an AI algorithm.
§ 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.