(133 days)
The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called the "Ocular Response Analyzer (ORA)." This document primarily focuses on the regulatory clearance process, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain the detailed information necessary to describe acceptance criteria, a specific study proving those criteria were met, or any of the other requested information related to AI/algorithm performance, ground truth establishment, or sample sizes for testing and training datasets.
The 510(k) clearance process, as exemplified here, is about demonstrating substantial equivalence to a predicate device, not necessarily providing a de novo clinical study with specific performance metrics against pre-defined acceptance criteria in the manner typically required for novel AI/ML medical devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter. The letter confirms substantial equivalence but doesn't detail performance metrics against specific acceptance thresholds.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable or mentioned for this type of device and clearance. This is more relevant for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable or mentioned. The ORA is a physical device that measures properties of the eye.
- The type of ground truth used: Not available in this document.
- The sample size for the training set: Not applicable or mentioned, as this is not an AI/ML device in the context of the training sets typically discussed for such algorithms.
- How the ground truth for the training set was established: Not applicable or mentioned.
The document states the device's Indications for Use: "The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma." This is the primary functional statement provided.
To obtain the information you're asking for, you would typically need to refer to the 510(k) Summary or the full 510(k) Submission for K032799, which would contain detailed information about the design verification and validation studies performed, including any performance data used to demonstrate substantial equivalence to the predicate device. These documents are often publicly available through the FDA's 510(k) database.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the HHS logo, which is a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo.
Public Health Service
JAN 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reichert, Inc. C/O Frank Drexelius Regulatory Affairs Manager 3374 Walden Avenue Depew, NY 14043
Re: K032799
Trade/Device Name: Ocular Response Analyzer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX Dated: July 31, 2003 Received: September 9, 2003
Dear Mr. Drexelius:
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 cnclosure) 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 - Mr. Frank Drexelius
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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
Enclosure
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510(k) Number (if known): K032799
Device Name: __ Ocular Response Analyzer - ORA __
Revised 12/15/2002.
Indications for Use:
The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Hay R. Butteny DOED / DSDB
Division Sign-Off sion of Ophthalmic Ear, Nose and Throat Devises
Prescription Use
(Per 21 CFR 801.109)
510(k) Number
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.