(18 days)
The LADARWave" CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, 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.
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, a video subsystem, a probe beam subsystem, and a wavefront detection subsystem. These subsystems are all under control of the device software.
The provided document is a 510(k) summary for the Alcon LADARWave™ CustomCornea® Wavefront System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results or performance against specific acceptance criteria in the manner one might find for novel or high-risk devices.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, and ground truth establishment is not available in this document. The document confirms that the device is an aberrometer used for measuring, recording, and analyzing visual aberrations and displaying refractive error maps to assist in prescribing refractive corrections. It also states that the device can export data to a compatible treatment laser for wavefront-guided refractive surgery.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study designed to prove the device meets these criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The submission focuses on substantial equivalence to predicate devices rather than specific performance metrics. | Not explicitly reported in the document in terms of quantitative performance metrics against acceptance criteria. |
Study Details
The document does not describe a specific clinical study with test sets, ground truth, or statistical analysis in the way modern AI/ML device submissions would. It refers to the device's characteristics and its equivalence to other diagnostic devices.
2. Sample size used for the test set and the data provenance:
- Not available. The document does not describe a test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. Ground truth establishment is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available. Adjudication methods are not discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not available. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is a diagnostic tool designed to measure and analyze. Its function is inherently standalone in gathering the measurements, but the application of its output (prescribing corrections, guiding surgery) involves a human in the loop. The document doesn't detail a specific "standalone performance" study as would be expected for an AI algorithm. Its performance is based on the accuracy and reliability of its measurements compared to established methods.
7. The type of ground truth used:
- Not explicitly stated in the context of a "study" for acceptance. Given the nature of a refractometer, the "ground truth" for its measurements would typically be established through comparison with other accepted methods of refractive error measurement (e.g., subjective refraction, retinoscopy) or physical phaco-optics models, which the document alludes to by comparing it to predicate devices that measure refractive characteristics.
8. The sample size for the training set:
- Not applicable/Not available. This device predates the widespread use of large-scale machine learning and "training sets" in the modern sense. Its design and "knowledge" are based on optical physics and engineering principles, not statistical learning from a dataset.
9. How the ground truth for the training set was established:
- Not applicable/Not available. See point 8.
§ 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.