(277 days)
The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.
- For the posterior segment, the Lumenis® Array™ LaserLink™ device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and severe and very severe nonproliferative diabetic retinopathy
- Macular edema associated with proliferative or nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion)
- Macular edema associated with Branch retinal vein occlusion
- Retinal tears and detachments
- And anterior segments as follows:
- Iridotomy in closed angle glaucoma
- Trabeculoplasty in open angle glaucoma
The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components:
- ArrayTM LaserLink™M module .
- . Console
- . Touchscreen display
- Remote touchpad .
The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue.
The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system.
The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control.
The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.
The provided 510(k) summary for the Lumenis® Array™ LaserLink™ describes a medical device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's the summary of the acceptance criteria and study findings based on the provided text:
Device: Lumenis® Array™ LaserLink™ (an ophthalmic laser delivery system)
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety | Compliance with IEC 60601 Series standards (electrical safety & EMC requirements). | "IEC Testing has been completed and reports received." and "been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing IEC 60601 Series." |
| Performance | Meet all determined design specifications. | "undergone protocol governed verification & validation to ensure the subject product met all determined design specifications." |
| Functional Testing | Functionality as intended. | Not explicitly detailed as a separate criterion, but implied by "performance and functional testing" and "met all determined design specifications." |
| Substantial Equivalence | Demonstrate substantial equivalence to cited predicate devices in intended use, technology, indications for use, principles of operation, method of energy delivery, critical materials, and basal design elements. | "The Lumenis® Array™ LaserLink™ device has equivalent intended use as the identified predicate device...and also employs the same fundamental scientific technology...service similar indications for use, equivalent principles of operation, method of energy delivery, critical materials, and basal design elements when directly compared." and "similar design features, functional characteristics, fundamental technology features, technical applications, service similar indications for use, and general modes of operation are substantially equivalent to cited predicate devices." |
No acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, F1 score, AUC, or other typical AI/ML metrics are present, as this is not an AI/ML device.
Study Details (as related to a non-AI/ML medical device)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable as the document describes a hardware medical device and its performance testing, primarily for electrical safety and functional equivalence, not a study involving patient data or a test set in the context of an AI/ML model. The testing mentioned is "side-by-side comparative performance assessment to competitive products" and "verification & validation to ensure the subject product met all determined design specifications," which refers to engineering and design validation, not a clinical study on a patient test set.
-
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 applicable. "Ground truth" in the context of an AI/ML model's performance on a test set is not relevant for this device. The "ground truth" for the device's design specifications would be defined by engineering standards and regulatory requirements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a test set is described, as this is not an AI/ML diagnostic or prognostic device.
-
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 device is a laser delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; there is no standalone algorithm. Its function is to deliver laser treatment through a slit lamp.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/ML evaluation. The "ground truth" for this device's performance is adherence to engineering specifications, safety standards (IEC 60601 Series), and functional requirements validated through engineering tests.
-
The sample size for the training set:
- Not applicable. There is no training set mentioned or implied for this non-AI/ML device.
-
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned or implied for this non-AI/ML 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.