(106 days)
The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
The Norlase Leaf device consists of a laser unit, a wireless control unit and a foot switch. The laser unit must be attached to the Doctors own compatible slit lamp to work as a full system. The Norlase Leaf Device is controlled by the wireless control unit that allows the Doctor to set the desired parameters for treatment. A shrouded foot switch is connected to the laser unit to control the emission of laser light.
The Doctor will use the user supplied slit lamp to identify the area to be treated and after setting the appropriate parameters, will target the ophthalmic tissue utilizing a visible red aiming laser. The foot switch will be pressed by the Doctor to deliver therapeutic green laser light to the target tissue. A mechanically fixed eye safety filter is built into the Laser Unit to protect the Doctor from any stray or reflected green laser light travelling along the visual path of the slit lamp.
The Norlase Leaf device consists of the following modules:
- -Laser unit + power supply + power cable
- Foot switch + cable -
- Control unit (Tablet computer with installed Software) + power supply + USB cable -
The wavelength of the treatment beam is centered around ~520 nm, and the maximum optical output power is 1.5W (to tissue). The laser is operated in continuous wave (CW) mode and electronically pulsing the laser output power to achieve durations from 50 usec to 1 second. Laser parameters are controlled by a Control Unit (tablet) User Interface that utilizes a touchscreen control to select or change a setting. Voice Control of selected parameters is an optional feature that can assist in the increment or selection of a parameter,
The provided text describes the Norlase Leaf Photocoagulator, a medical device, and its acceptance criteria as part of a 510(k) premarket notification to the FDA. The study presented focuses on demonstrating substantial equivalence to a predicate device through verification and validation testing against recognized standards.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Every specification of the Leaf Photocoagulator device has been verified and validated according to the company's documented development and test procedures." It then lists the standards used for testing without explicitly detailing specific numerical acceptance criteria. However, the completion of these tests with "successful results" implies that the device met the requirements outlined within those standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| General Safety and Performance | - Verified and validated according to Norlase ApS's documented development and test procedures. |
- Satisfactorily verified and validated all risk mitigations.
- Demonstrated that technological differences from the predicate did not result in new issues of safety or efficacy.
- Met design requirements and user needs. |
| Risk Management | - Identified potential risks according to ISO 14971. - Analyzed risks with regard to risk/benefit category.
- Implemented and tested mitigations as part of performance testing. |
| Electrical and Mechanical Safety | - Bench testing for electrical and mechanical safety completed successfully in compliance with ISO 15004-2, IEC 60601-1+, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ANSI Z136-1, and ANSI Z136-3. |
| Laser Performance | - Bench testing for laser performance completed successfully in compliance with ISO 15004-2, IEC 60601-1+, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ANSI Z136-1, and ANSI Z136-3. |
| Ophthalmic Device Specifics | - Bench testing specific to ophthalmic devices completed successfully in compliance with ISO 15004-2. |
| Software Performance | - Software testing completed successfully, including verification and validation in compliance with IEC 62304. - Included test cases related to off-the-shelf software and cybersecurity features. |
| Usability (Human Factors) | - Human factors testing completed successfully to demonstrate usability in a simulated use environment when used by healthcare professionals, in compliance with IEC 62366-1. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "sample size" in the context of patients or clinical data for testing the device's performance. It states that "Clinical data was not required for this type of device." The testing described is primarily laboratory-based (bench testing) and human factors testing in a simulated environment. Therefore, the "test set" consists of the device itself and its components, subjected to various engineering and usability tests, rather than a dataset of patient images or outcomes.
The "data provenance" is implied to be internal testing conducted by Norlase ApS, as described by "the company's documented development and test procedures." No specific country of origin or retrospective/prospective nature is applicable in the clinical sense, as no clinical data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Since no clinical data was used and the testing consisted of bench testing and human factors in a simulated environment, there was no need for expert ground truthing of clinical cases. The "ground truth" for these types of tests would be the specifications and requirements defined by the standards and the device's design documentation.
4. Adjudication Method for the Test Set
Not applicable. As no clinical data requiring expert adjudication was used, there was no adjudication method like 2+1 or 3+1. The assessment of test results would be based on comparison against predefined technical specifications and standards (e.g., whether a certain parameter falls within a specified range, or whether a safety feature functions as intended).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical data was not required for this type of device." Therefore, an MRMC comparative effectiveness study was not performed.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question seems to be more relevant to AI/CAD devices. The Norlase Leaf Photocoagulator is a direct treatment device, not an AI or diagnostic algorithm. Its performance is evaluated on its technical specifications and safety rather than algorithmic accuracy. The device's "standalone" performance would be its ability to emit laser light at specified parameters and its safety functions, which were evaluated through bench testing. Human factors testing, however, did involve human users (healthcare professionals) interacting with the device to assess usability, but this is distinct from "human-in-the-loop performance" in the context of an AI-assisted diagnostic task.
7. The Type of Ground Truth Used
The ground truth for this device's evaluation is primarily based on:
- Technical specifications and design requirements: The device's ability to operate within specified ranges for wavelength, power output, exposure time, etc.
- International and national standards: Compliance with standards like ISO 14971, ISO 15004-2, IEC 60601 series, IEC 60825-1, IEC 62304, IEC 62366-1, ANSI Z136-1, and ANSI Z136-3. These standards define acceptable performance and safety criteria.
- Usability metrics: Outcomes from human factors testing demonstrating that the device can be used safely and effectively by healthcare professionals in a simulated environment.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no training set as would be used for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.