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510(k) Data Aggregation
(512 days)
Fiberion Ophthalmic Endolaser Probes are in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached
Fiberion endolaser probes are designed to be connected to ophthalmic laser photocoagulators and to transmit laser energy inside the patient's eye. One end of the probe contains a connector for attachment to the laser unit, the other, a tip section to be introduced inside the eye. Device components are an input connector, a glass fiber optic protected by a buffer coating, a protective tubing, an aluminum handle with a medical grade stainless steel needle. The illuminating endolaser probe has an additional illumination fiber optic.
This document describes the Fiberion Ophthalmic Endolaser Probe. Below is an anaylsis of its acceptance criteria and the study that proves the device meets the criteria.
Note: The provided document is a 510(k) summary for a medical device (Fiberion Ophthalmic Endolaser Probe). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, test sets, or expert evaluations as one might find for an AI/ML-based diagnostic device. Therefore, many of the requested fields cannot be directly answered from this document. The responses below are based on the information available and acknowledge the limitations.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench/Lab Testing) | Reported Device Performance |
|---|---|
| Laser Power Transmission: Equivalent to predicate device | Found to be equivalent to predicate device. |
| Beam Divergence: Equivalent to predicate device | Found to be equivalent to predicate device. |
| Beam Density Homogeneity: Equivalent to predicate device | Found to be equivalent to predicate device. |
| Illumination Intensity (for illuminating models): Equivalent to predicate device | Found to be equivalent to predicate device. |
| Illumination Area Diameter (for illuminating models): Equivalent to predicate device | Found to be equivalent to predicate device. |
| Safe Delivery of Intended Output Power: Verified performance | "Fiberion Ophthalmic Endolaser Probes were tested for safe delivery of the intended output power." |
| Sterility: Fulfil requirements | "Found to fulfil the requirements." |
| Biocompatibility (sections in contact with patient): Fulfil requirements | "Found to fulfil the requirements." |
| EO-ECH Residues: EO < 1.25 micrograms/device, ECH < 5 micrograms/device | EO levels determined to be < 1.25 micrograms per device, ECH levels < 5 micrograms per device. |
| Endotoxins: < 0.2 Endotoxin units/device | Endotoxin levels determined to be < 0.2 Endotoxin units per device. |
2. Sample size used for the test set and the data provenance
The document describes bench and laboratory testing, not a clinical study on patient data.
- Sample size for test set: Not specified in the document for the bench and lab tests. It's implied that "Fiberion Ophthalmic Endolaser Probes" (plural) were tested, but the exact number of units or replicates is not given.
- Data provenance: Not applicable in the context of patient data. The tests were performed on the manufactured devices themselves (bench and lab testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device's performance is based on physical and chemical measurements (e.g., laser power, chemical residues, sterility) against established standards or equivalence to a predicate device, not on expert medical interpretation of images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. This was not a study requiring human adjudication, but rather objective technical and laboratory measurements.
5. 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 an ophthalmic endolaser probe, which is a surgical tool, not an AI-based diagnostic or imaging device. Therefore, an MRMC study related to human readers and AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of this device is based on:
- Physical measurements (e.g., laser power, beam divergence, illumination intensity) against defined specifications or comparison to a predicate device's measured performance.
- Chemical analysis (e.g., EO-ECH residues, endotoxin levels) against regulatory limits and standards.
- Microbiological testing (sterility) against established standards.
8. The sample size for the training set
Not applicable. This is a hardware medical device and does not involve machine learning or a training set in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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