(18 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional optical and software control methods for wavefront sensing.
No.
The device is used for measuring, recording, and analyzing visual aberrations and displaying refractive error maps to assist in prescribing refractive corrections. It is a diagnostic and measurement device, not one that provides therapy or treatment.
Yes
The device is used for measuring, recording, and analyzing visual aberrations and displaying refractive error maps of the eye to assist in prescribing refractive corrections, which falls under the definition of diagnosing eye conditions.
No
The device description explicitly states it contains four major optical subsystems (fixation, video, probe beam, and wavefront detection) which are hardware components, even though they are controlled by software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LADARWave CustomCornea Wavefront System measures visual aberrations and refractive errors directly in the eye using optical sensing (Hartmann-Shack wavefront sensing). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure and analyze visual aberrations and refractive errors of the eye to assist in prescribing refractive corrections and for wavefront-guided refractive surgery. This is a direct measurement of a physiological characteristic of the eye, not an analysis of a biological sample.
Therefore, the device falls under the category of an ophthalmic diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LADARWave" CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.
Product codes (comma separated list FDA assigned to the subject device)
NCF
Device Description
The LADARWave" CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-Shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination.
- A fixation subsystem provides the patient with an unambiguous point of fixation. . Optics in this path adjust automatically to correct for the patient's spherocylindrical error so that the target is clearly observed.
- A video subsystem provides the device operator with a view of the eye at the . measurement plane. The operator uses the video imagery to position the eye for the measurement and to record the geometry of the wavefront relative to anatomical features.
- A probe beam subsystem directs a narrow beam of eye-safe infrared radiation into the . eye to generate the re-emitted wavefront.
- A wavefront detection subsystem images the re-emitted wavefront onto the entrance ● face of the Hartmann-Shack wavefront sensor.
These subsystems are all under control of the device software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Wavefront sensing
Anatomical Site
Eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 886.1760 Ophthalmic refractometer.
(a)
Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (Per 21 CFR 801.109)
Over the Counter Use:
Enether Beem
Or
wision Sian-Off Division of Ophthalmic Ear, Nose and Throat Devises
Optional Format 1-2-96
510(k) Number Y023249