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510(k) Data Aggregation
(65 days)
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
The Multi-Spot Slit Lamp Laser Adapter has two functional modes available to the physician: a single spot mode and a Multi-Spot (4 spot) mode. When the a single spot mode is selected, the preexisting slit lamp laser apparatus is available for all treatment functions for which it was designed as a laser photocoagulator. The multi-spot mode is intended for use with "Green-Only" ine marcr bood me energy for panretinal photocoagulation in the treatment of proliferative retinopathy.
The multi-spot slit lamp laser adapter is a non-powered reusable optical system which, when connected between the laser fiber and the slit lamp 200m optics, generates four spots in a square pattern. Through a rotary mechanism the user can select between single or multiple spot patterns. The multi-spot laser adapter mechanically mimics the fiber cable and will not effect or deactivate any existing salety interlocks. The lens system of the multi-spot adapter provides a one-to-one image of the laser fiber, therefore the spot size indicator on the zoom lens systems is not effected. The selection of single or multiple spot patterns also applies to the aiming beam, this gives the user direct and unambiguous feedback on which mode is selected before treatment begins.
This document describes a 510(k) premarket notification for the Infinitech Multi-Spot™ Slit Lamp Laser Adapter. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria. Therefore, most of the requested information regarding detailed study design and acceptance criteria is not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or other quantifiable measures used in clinical studies for diagnostic or treatment devices). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is described qualitatively in the "Efficacy" section and through the comparison chart.
| Device Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Infinitech Multi-Spot Adapter) |
|---|---|---|
| Device Type | Ophthalmic Laser | Ophthalmic Laser |
| Ophthalmic Indications | Proliferative Retinopathy (Argon) | Proliferative Retinopathy (Argon) - "Green-Only" for multi-spot mode |
| Laser Energy Source | Doubled Nd: YAG (similar to predicate) | Doubled Nd: YAG |
| Laser Energy Delivery | Multi-Spot (4 spots) - This is the novel feature compared to predicates | Multi-Spot (4 spots) or Single Spot (pre-existing slit lamp functionality) |
| Spot Placement | Centered on Guide Beam | Centered on Guide Beam |
| Laser Energy Intensity | Selected by Physician | Selected by Physician (with adjustments needed for multi-spot mode as per manual) |
| Tissue Effect | Photocoagulation | Photocoagulation |
| Labeling per 21CFR 801.109 | YES | YES |
| Labeling per 21CFR 1040.10 | YES | YES |
| Reduced Procedure Time | Implicitly, faster than single spot due to 4 burns per exposure | "Greatly speeds up the procedure and should reduce user and patient fatigue." |
| Improved Burn Distribution | Implicitly, more uniform and repeatable than random single spot application | "A 4-spot pattern improves the repeatability of burn distribution." |
| Optical System | No unexpected shifts in focus; 1:1 image, spot size indicator not affected | "No unexpected shifts in focus regardless of zoom range." "spot size indicator on the zoom lens systems is not effected." |
| Safety Interlocks | Not affected or deactivated | "Will not effect or deactivate any existing safety interlocks." |
| Wavelength Use | Multi-spot optimized for 514-532nm (green only for proliferative retinopathy) | Manual reminds user "green only" for multi-spot; operates over 488-650nm in single spot. |
| Calibration | Requires laser console calibration after installation/removal | Manual informs user to have laser calibrated. |
| Output Power | Each spot ~1/4 of displayed energy in multi-spot; user compensation needed | User can compensate by increasing displayed power, exposure time, or decreasing spot size. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a formal clinical performance study or data-driven evaluation. The assessment is based on the design and functionality of the device in comparison to existing predicate devices. Therefore, there is no sample size or data provenance information provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided as there was no study requiring expert-established ground truth in the context of a clinical performance evaluation. The substantial equivalence argument relies on comparing technical and functional characteristics.
4. Adjudication Method for the Test Set
This information is not provided as there was no formal test set or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. The device is an optical accessory for a laser, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a mechanical/optical accessory, not an algorithm. Its performance is intrinsically linked to its use by a human operator with a laser and slit lamp.
7. The Type of Ground Truth Used
This information is not provided as no explicit performance study requiring ground truth was described. The "ground truth" for this 510(k) submission is the functional and safety characteristics demonstrated to be substantially equivalent to predicates.
8. The Sample Size for the Training Set
This information is not provided as there was no AI model or learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided as there was no AI model or learning algorithm requiring a training set and ground truth.
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