(30 days)
The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.
The AURIGA is a pulsed solid-state Holmium YAG-Laser System with a wavelength of approx. 2080 nm. The system is suitable for interdisciplinary use in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures) , ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.
The provided document is a 510(k) summary for the AURIGA Holmium Laser System. It focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use. Crucially, the document explicitly states "Performance Data not presented" and does not include any studies proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document only provides the following:
1. A table of acceptance criteria and the reported device performance:
- No acceptance criteria or reported device performance are presented in the document. The document states "Performance Data not presented."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No test set data or provenance is mentioned.
3. 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):
- Not provided. No information on ground truth establishment for a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. No adjudication method for a test set is mentioned.
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 done or reported. This device is a surgical laser, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No ground truth information is available as no performance data or studies are presented.
8. The sample size for the training set:
- Not provided. No training set is mentioned as no algorithm or AI is discussed.
9. How the ground truth for the training set was established:
- Not provided. No training set or ground truth establishment for it is mentioned.
§ 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.