(196 days)
The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.
The NAVILAS Laser System is a retinal laser photocoagulator with an integrated digital fundus camera. The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.
The NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform intended to be used to capture display, store and manipulate images captured by the fundus camera.
Like the predicate devices, laser photocoagulation with the NAVILAS is performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode). All treatment-related information and images are continuously displayed on the monitor to provide the physician an optimal platform for the photocoagulation procedure.
The provided 510(k) summary for the NAVILAS Laser System primarily focuses on demonstrating substantial equivalence to predicate devices and verifying that the device complies with specifications through internal testing. It does not present a clinical study with detailed acceptance criteria and reported device performance metrics typically found in AI/ML device submissions.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this device, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the document.
The document discusses "Performance Data" in a general sense:
Performance Data Summary (as per the document):
"Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the NAVILAS Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the NAVILAS Laser System. All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements."
This statement indicates that internal engineering and bench testing was performed to ensure the device met its design specifications, but it does not detail specific acceptance criteria for a human-interpretable performance metric (like sensitivity, specificity, accuracy) derived from a clinical trial or expert review.
Here's what can be extracted based on the provided text, with many fields noted as "Not Applicable" or "Not Provided" due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. | "All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements." (This refers to internal verification and validation testing, not clinical performance metrics.) |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not provided. The testing described appears to be internal engineering and bench testing, not a clinical study with a patient test set.
- Data Provenance: Not provided.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not applicable/Not provided. The submission focuses on device engineering specifications and functionality, not diagnostic accuracy requiring expert ground truth in a clinical context.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for Test Set:
- Adjudication Method: Not applicable/Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable. (The NAVILAS Laser System is a photocoagulator and imaging system, not an AI-diagnostic assistant that would typically be evaluated in an MRMC study for reader improvement.)
6. Standalone (Algorithm Only) Performance Study:
- Was a standalone study done? Not in the sense of an algorithm's diagnostic performance. The document describes "software and hardware verification & validation testing, along with system level bench testing," which functions as a standalone performance evaluation of the device's operational specifications, but not its diagnostic or clinical efficacy in terms of specific performance metrics against a clinical ground truth.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for a clinical performance evaluation. The "ground truth" for the verification and validation testing would be the engineering specifications and functional requirements of the device itself (e.g., laser power output accuracy, image resolution, software functionality).
8. Sample Size for Training Set:
- Sample Size: Not applicable/Not provided. This device is not described as involving machine learning or AI that would require a 'training set' in the modern sense.
9. How Ground Truth for Training Set was Established:
- How Ground Truth was Established: Not applicable/Not provided.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.