(57 days)
The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system was developed to utilize advancements in visible green semiconductor (diode) laser technology and to provide a compact design to be incorporated in a lightweight headset worn by the physician. The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system consists of an indirect ophthalmoscope headpiece, a headset laser enclosure/casing, a wireless user interface tablet, a footswitch with a battery, and a cable extending from the footswitch to the headset. The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system is controlled by the wireless user interface tablet that allows the physician to set the desired parameters for treatment. A shrouded footswitch is connected to the headset to control the emission of laser light and the battery to power the device illumination and laser source. The physician uses the headset to locate the area to be treated and after setting the appropriate parameters, targets the desired tissue utilizing a visible red aiming beam. The foot switch is pressed by the physician to deliver therapeutic green laser light to the targeted tissue. Eye safety filters are built into the laser unit to protect the physician's eyes while providing a clear view of the target area.
The document provided is a 510(k) summary for the Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator. It focuses on demonstrating substantial equivalence to predicate devices through engineering and bench testing, rather than clinical studies involving human patients or complex algorithms requiring extensive training and test sets.
Therefore, many of the requested categories related to medical AI/ML device studies (such as sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and specific ground truth types like pathology or outcomes data) are not applicable to the information provided in this document.
Here's a summary of the information available based on the provided document:
Acceptance Criteria and Device Performance
The device underwent verification and validation testing against several international standards. The acceptance criteria were met if the device demonstrated compliance with these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 14971: Application of risk management to medical devices | All identified potential risks were analyzed, and mitigations were implemented, verified, and validated satisfactorily. |
| ISO 15004-2: Ophthalmic instruments - Fundamental requirements and test methods - Part 1: Light hazard protection | Included in bench testing specific to ophthalmic devices; results demonstrated predetermined acceptance criteria were met. |
| IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance | Bench testing for electrical and mechanical safety was successfully completed. |
| IEC 60601-1-2: Electromagnetic disturbances | Bench testing for electrical and mechanical safety was successfully completed. |
| IEC 60601-2-22: Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment | Bench testing for laser performance was successfully completed. |
| IEC 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements | Bench testing for laser performance was successfully completed. |
| IEC 62304: Medical device software - Software life-cycle processes | Software testing, including verification and validation, was conducted in compliance with this standard, covering test cases related to off-the-shelf software and cybersecurity features. |
| IEC 62366-1: Application of usability engineering to medical devices | Human factors testing was conducted to demonstrate usability in a simulated use environment when used by healthcare professionals. |
| ANSI Z136-1: American National Standard for Safe Use of Lasers | Included in bench testing for laser performance; results demonstrated predetermined acceptance criteria were met. |
| ANSI Z136-3: American National Standard for Safe Use of Lasers in Health Care | Included in bench testing for laser performance; results demonstrated predetermined acceptance criteria were met. |
| 21 CFR Part 820.30: Design Control process | Verification and validation testing was completed in accordance with the company's Design Control process; results demonstrated that predetermined acceptance criteria were met. |
| Overall Safety and Efficacy (via Substantial Equivalence) | The device demonstrated substantial equivalence to predicate devices (Norlase LEAF Green Laser Photocoagulator K190083 and Iridex TruFocus LIO K170718) with no new issues of safety or efficacy identified. |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. The submission relies on engineering bench tests and simulated use environments, not a clinical test set with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for expert consensus is not relevant for this type of engineering and human factor testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI/ML device requiring MRMC studies for diagnostic or interpretive tasks.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical laser photocoagulator, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical gold standard. The "ground truth" here refers to the specifications and safety requirements defined by the various engineering and medical device standards (e.g., laser power output accuracy, electrical safety, software functionality, usability in a simulated environment).
- The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
Note: The 510(k) summary explicitly states that "Clinical data was not required for this type of device." This further confirms that the assessment of this device for substantial equivalence did not involve clinical studies with human participants that would generate the types of data requested in many of the prompts. The approval is based on engineering, safety, software, and human factors testing demonstrating compliance with established standards and equivalence to predicate devices.
§ 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.