(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.
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<023249
Abbreviated 510(k) Summary Alcon LADARWave" CustomCornea" Wavefront System
General Information I.
| a. Applicant: | Alcon2501 Discovery Drive, Suite 500Orlando FL 32826 |
|---|---|
| b. Contact Person: | Christy Stevens, OD |
| c. Telephone:Fax: | (407) 384-1600(407) 384-1699 |
| d. Summary Preparation Date: | September 27, 2002 |
II. Names
Alcon LADARWave™ CustomCornea® Wavefront System Device Name: Primary Classification Name: Ophthalmic Diagnostic Device Refractometer Class I 886.1760
III. Predicate Devices
Predicate Devices: As defined in the 21 CFR Sections 886.1350, 1760, 1770, and 1780, there are several diagnostic devices employed to measure the refractive power and any refractive errors of the eye. Some measure the corneal curvature (MMQ, HJA, 886.1350), some measure the refractive power of the eye by measuring light reflexes from the retina (HKO, 886.1760), some use lenses and subjective responses from the subject being measured (HKN, 886.1770) and some illuminate the retina and note the direction of movement of the light on the retinal surface to determine the refraction by the eye of the emergent rays (HKL, 886.1780). Each of these diagnostic devices provides some valuable information in assessing the refractive errors of the ocular system. However, no one product is available to date which is able to provide a comprehensive assessment of refractive errors.
The LADARWave" CustomCornea" Wavefront System has the following characteristics in common with other refractive diagnostic device products:
- . Each of the diagnostic devices, which serve as predicates to this device, measure refractive characteristics of the eye.
- Each of the diagnostic approaches operates on a similar principle of using some form of light energy reflected off an ocular structure (cornea, retina), which is then documented to communicate the degree from which the eve deviates from normal.
- Each of the diagnostic devices used to assess refractive errors of the eye pose no significant risk to the patient.
The LADARWave" CustomCornea" Wavefront System is substantially equivalent to prior aberrometers and the predicate model approved under K000637.
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Product Description IV.
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.
V. 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.
VI. Rationale for Substantial Equivalence
The LADARWave" CustomCorneas Wavefront System shares the same indication for use and similar design features as the predicate devices.
VII. Conclusion
The LADARWave" CustomCornea" Wavefront System is substantially equivalent to currently marketed aberrometers. The LADARWave" CustomCornea" Wavefront System shares the same intended use and indication for use and other basic system characteristics as the predicate systems. 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alcon Laboratories, Inc. c/o Christy Stevens, OD Director Clinical Affairs 2501 Discovery Drive, Suite 500 Orlando, FL 32826
OCT 1 8 2002
Re: K023249
Trade/Device Name: Alcon LADAR Wave™ CustomCornea® Wavefront System Regulation Number: 21 CFR 886.1760 Regulation Name: Ophthalmic Refractometer Regulatory Class: Class I Product Code: NCF Dated: September 27, 2002 Received: September 30, 2002
Dear Dr. Stevens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Christy Stevens, OD
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K023249
Alcon LADARWave™ CustomCornea® Wavefront System Device Name:
The LADARWave" CustomCornea® Wavefront System is used for Indications for Use: 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.
(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
§ 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.