(84 days)
Opera Evo laser device and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical Traditionalties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery and Arthroscopy.
The Opera Evo laser device includes a diode laser that emits a wavelength of 1940 nm and includes a diode laser that emits a wavelength of 1470 nm, with a combined cumulated laser output power up to 40W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 um. The main subsystems of the device are the two diode lasers, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch
This document is a 510(k) premarket notification for the Opera Evo laser device. It outlines the device's indications for use, technological characteristics, and compares it to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a direct table of reported device performance values against those criteria. Instead, it relies on demonstrating compliance with recognized consensus standards. The "performance" assessment is qualitative, asserting that the device meets safety and effectiveness standards.
| Acceptance Criteria (Inferred from standards) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1:2012, ed 3.1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014, ed 4 |
| Laser Specific Safety & Performance | Complies with IEC 60601-2-22:2012, ed 3.1 |
| Laser Product Classification & Safety | Complies with IEC 60825-1:2014, ed 3.0 |
| Usability | Complies with IEC60601-1-6:2013, ed 3.1 |
| Software Verification & Validation | Conducted and documented as per FDA guidance |
| Overall Safety and Effectiveness | Non-clinical testing supports safe and effective use |
| Substantial Equivalence | Technologies and indications are similar to predicate; differences do not raise new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance testing only. It does not refer to a "test set" in the context of patient data or clinical samples. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing was likely conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes non-clinical performance testing against engineering and safety standards, not a study involving human experts establishing ground truth on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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 such study was conducted or is referenced in this document. The Opera Evo is a surgical laser device, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical laser and doesn't involve an algorithm operating independently in a diagnostic or interpretive capacity. Its "performance" is about its physical characteristics and adherence to safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" refers to the established requirements and limits defined within the specified IEC and other consensus standards. For instance, ground truth for electrical safety would be adherence to specific voltage/current limits, or for laser safety, compliance with defined emission levels.
8. The sample size for the training set
This information is not applicable. The document describes a medical device, not a machine learning model that requires a training set. The "Software Verification and Validation Testing" refers to standard software development and testing practices, not the training of an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI/machine learning model 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.