(206 days)
The Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A), and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for the correction of refractive ametropia in aphakic and nonaphakic patients with keratoconus or following penetrating keratoplasty who may be disabled by conventional contact lenses or spectacles.
Not Found
This document is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a previously marketed predicate device.
Therefore, most of the requested information cannot be extracted from this document, as it describes a regulatory approval process for a contact lens based on equivalence, not a performance study against specific acceptance criteria.
Here's an attempt to address the points based on the available information, noting where data is absent:
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A table of acceptance criteria and the reported device performance
- Not Applicable. The document explicitly states: "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 ... to legally marketed predicate devices." This means the device's performance is accepted because it is deemed to be as safe and effective as existing, legally marketed devices, not because it met specific, predefined quantitative performance metrics in a study. The document does not provide acceptance criteria or performance metrics for this specific device.
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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)
- Not Applicable. No test set or data provenance related to a performance study is mentioned.
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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)
- Not Applicable. No ground truth establishment for a test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is mentioned.
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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
- Not Applicable. This is a contact lens, not an AI/ML diagnostic or assistive device. No MRMC study or AI assistance is relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to a physical contact lens, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for device performance as typically defined for diagnostic or AI devices is mentioned. The "ground truth" for this 510(k) clearance is the established performance and safety of its predicate devices.
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The sample size for the training set
- Not Applicable. No training set is mentioned as this is a physical device, not an AI/ML model.
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How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it is mentioned.
In summary: This document is a regulatory approval based on the concept of "substantial equivalence" of a medical device (contact lens) to existing, legally marketed devices. It is not a report detailing a clinical performance study with specific acceptance criteria as you would typically find for a diagnostic device or an AI/ML product.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized birds in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2002
Mr. Ian Jennings Rose K. International, LTD 60 St. Andrews TCE Hamilton, New Zealand
Re: K013646
Trade/Device Name: Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A or enflufocon B)
Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: May 14, 2002 Received: May 16, 2002
Dear Mr. Jennings:
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 aso button in all encreates) of the Medical Device Amendments, or to devices that provision in they 20, 1978, and cordance 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 rr your de rive to such additional controls. Existing major regulations affecting your device can be finar of subject to sten acant 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. Ian Jennings
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotes with are way of substantial equivalence of your device of your device to a legally promated nodicate 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 vours,
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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Name and Address of Company
P.O. Box 9307 HAMILTON NEW ZEALAND. ROSE K INTERNATIONAL LTD Indications for Use Statement
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K013646 |
| Device Name: | THE ROSE K POST GRAFT (hexaforon A or Enflufocon B)RIGID GAS PERMEABLE CONTACT LENS |
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510(k) Number K013646
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.