Search Results

OcuMet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent.

Ocumet Beacon is a scanning LED based ophthalmoscope which uses infrared and blue light to obtain confocal images of the retina. Multiple retinal fields can be captured using a programmable internal fixation target. The device integrates a tablet and is provided with an external power supply. The device works with a dedicated software application and operates as a standalone unit.

Ocumet Beacon offers two different acquisition modalities:

• black and white reflectance images of the retina obtained using infrared illumination;
• black and white fluorescence images of the retina obtained using blue illumination (peak at 458 nm) and a barrier filter to select only autofluorescent emission between 520 and 540 nm.

Clinician Report Generator Software is required to open, review, analyze, and print images obtained from Ocumet Beacon. The software runs on a standalone laptop.

The total light exposure is qualified as Group 1 under ANSI Z80.36-2016

Clinician Report Generator Software is required to open, review, analyze and print a co-registered version of both the infrared and visible wavelength images obtained from Ocumet Beacon. The software runs on a standalone Windows 10 or 11 based laptop computer.

The clinical interpretation of the images acquired by Ocumet Beacon is restricted to licensed eye care practitioners. A device specific training is required for any operator to become able to use the system and certification training is available for operators who will be capturing images in a clinical trial. The interpretation and use in clinical practice is as an adjunctive modality for the clinician to optionally combine with other structural images, and functional studies.

I am sorry, but the provided text from the FDA 510(k) clearance letter for OcuMet Beacon (K241931) does not contain specific details regarding acceptance criteria, study design, or performance metrics from a clinical study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (EIDON FA/AF) and a reference device (Heidelberg Spectralis HRA+OCT) based on:

• Indications for Use: Stating they are similar.
• Device Type: Describing both as confocal scanning ophthalmoscopes.
• Operational Modalities: Comparing features like IR and AF imaging.
• Technical Specifications: Such as field of view (where OcuMet Beacon has a reduced FoV, noted as "Similar" but explainable by multiple acquisitions), light sources, electrical safety, and physical dimensions.
• Safety Standards: Compliance with IEC 60601-1, IEC 60601-1-2, ANSI Z80.36-2016, and ISO 15004-2:2007 (for light hazard).
• Biocompatibility: Stating patient contact points meet requirements.
• System Verification and Validation: Broadly stating the system "was tested and passes."

Crucially, the document does NOT include:

• A table of acceptance criteria with specific quantitative targets (e.g., sensitivity, specificity, accuracy thresholds).
• Reported device performance data against those criteria.
• Details on the sample size used for any test set or the provenance of data (e.g., retrospective/prospective, country of origin).
• Information on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including human reader improvement with/without AI assistance.
• Data on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, expert consensus).
• The sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The 510(k) summary provided here focuses on demonstrating substantial equivalence, not on presenting results from a comprehensive clinical performance study with specific acceptance criteria and performance data. Such information would typically be found in a more detailed clinical study report or a different section of the 510(k) submission, which is not included in this excerpt.

Ask a specific question about this device