(267 days)
THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES TO MEASURE INTRACCULARY RESURE, NOORDING TO MEINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA. IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE.
Not Found
This document is a 510(k) substantial equivalence determination letter from the FDA for a medical device called the "Haag-Streit Goldmann Manual Tonometer." This type of letter generally does not contain the detailed acceptance criteria and study results you are asking for.
Here's why and what information can be gleaned:
- 510(k) Process: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparisons of design, materials, indications for use, and performance data (often bench testing) to show that the new device is as safe and effective as the predicate. It does not usually involve extensive clinical trials with the kind of detailed statistical analysis, ground truth establishment, and expert adjudication you describe for AI/software-as-a-medical-device (SaMD) clearances.
Therefore, I cannot provide a response filling in all categories of your request based on the provided text. However, I can extract the relevant information and explain what is missing:
Information from the document:
- Device Name: Haag-Streit Goldmann Manual Tonometer (also referred to as "GOLDMAN MANUAL TONOMETER")
- Indications for Use: "THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES TO MEASURE INTRAOCULAR PRESSURE, ACCORDING TO THE GOLDMAN METHOD. IT IS USED TO MEASURE INTRAOCULAR PRESSURE AND TO MAINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA. IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE."
- Regulation Number/Name: 886.1930 / Tonometer and accessories
- Regulatory Class: Class II
- Product Code: HKY
- Type of Submission: 510(k) Premarket Notification (K981432)
Detailed Breakdown of Missing Information (and why it's missing in a 510(k) for this type of device):
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A table of acceptance criteria and the reported device performance
- Missing: The document does not specify quantitative acceptance criteria or detailed performance metrics. For a manual tonometer, performance is typically assessed through manufacturing specifications (e.g., accuracy, precision) that would be compared to a predicate device, but these are not disclosed in this summary letter.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: This information is not typically part of a 510(k) determination letter for a physical medical device like a tonometer. If any performance testing was done, it would likely be laboratory or bench testing, not a "test set" in the sense of clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing: This concept of "ground truth" and expert adjudication is more pertinent to diagnostic AI/SaMD devices. For a manual tonometer, the "ground truth" is typically a known physical pressure or a reference standard device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: Not applicable for a manual tonometer's 510(k).
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Missing: Not applicable. This device is a manual tonometer, not an AI or software-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing: Not applicable. This device is a manual tonometer, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing: For a tonometer, the "ground truth" would relate to the accuracy of intraocular pressure measurement against a known standard. The document does not specify how this was established or measured.
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The sample size for the training set
- Missing: Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established
- Missing: Not applicable. This is not an AI/machine learning device.
In summary: The provided document is an FDA 510(k) clearance letter for a manual tonometer, a physical medical device. The type of detailed study information requested (especially regarding AI/ML, ground truth, experts, and adjudication) is not applicable to this device or typically found in such a clearance letter. This information would be required for a Software as a Medical Device (SaMD) or AI-powered device, which this is not.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Golden Vision, Inc. Mr. Andres R. Quiroz, President 7436 S.W. 117th Ave, Suite 103 Miami, FL 33183
Re: K981432
Trade/Device Name: Haag-Streit Goldmann Manual Tonometer Regulation Number: 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: II Product Code: HK Y Dated: October 9, 1998 Received: October 15, 1998
Dear Mr. Quiroz:
This letter corrects our substantially equivalent letter of January 12, 1999.
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 (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 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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This letter will allow you to continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Everett T. Beers PhD
Malvina B. Eydelman, 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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ATTACHMENT 4
GOLDEN VISION, INC.
7436 S.W. 117th AVE., SUITE 103 MIAMI, FLORIDA 33183 PHONE (305) 270-0877 FAX (305) 270-8373
ATTACH. 4
510(k) 981432
DEVICE NAME:
GOLDMAN MANUAL TONOMETER
INDICTIONS FOR USE: THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES INDICTIONS FOR USE. THE GOEDRANTS ACCORDING TO THE GOLDMAN METHOD. THE TO MEASURE INTRACCULARY RESURE, NOORDING TO MEINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA.
IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE.
.L.B. hicholas
Division Sign-Off) Division of Ophthalmic Devices K981432 10(k) Number _
Prescription Use
(Per 21 CFR 801.109)
/s/ B Nicholas
(Per 21 CFR 801.109)
§ 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.