(231 days)
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) and astigmatism in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.
The lenses may be prescribed for either conventional wear or planned replacement modalities, and may be disinfected with a chemical or heat disinfection system.
Not Found
Here's an analysis of the provided text regarding acceptance criteria and supporting study information.
IMPORTANT NOTE: The provided document is a 510(k) clearance letter from the FDA. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices, not typically to present original clinical study data or detailed acceptance criteria for a new device. Therefore, much of the requested information (especially specific performance metrics, sample sizes, expert qualifications, etc.) is not present in this type of document. The letter refers to the "premarket notification" which would contain such details, but the letter itself does not include them.
As such, I will extract what can be found and explicitly state when information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| This document does not contain specific quantitative acceptance criteria or reported device performance metrics. It focuses on the regulatory equivalence of the device. |
Detailed Breakdown of Missing Information and Assumptions Based on Document Type:
Regarding the remaining points, this document (a 510(k) clearance letter) does not typically contain the detailed study information you're asking for. Such information would be submitted to the FDA in a Pre-Market Notification (510(k)) application by the manufacturer, but is not present in the clearance letter itself.
Here's a breakdown of the requested information and why it's not in this document:
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2. Sample size for the test set and data provenance:
- Missing from document. Clinical study sample sizes and data provenance (e.g., country of origin, retrospective/prospective) are not included in this FDA clearance letter. These would have been part of the manufacturer's 510(k) submission.
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3. Number of experts used to establish the ground truth for the test set and qualifications:
- Missing from document. For soft contact lenses, performance is typically assessed through clinical trials involving patient wear rather than expert image interpretation. If any expert evaluation was performed (e.g., grading of ocular health), the number and qualifications of those experts would not be listed in this type of FDA letter.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Missing from document. This is typically relevant for image-based diagnostics where there's a need to resolve discrepancies between readers. Contact lens studies focus on physiological responses and visual acuity, which are measured directly or by an ophthalmologist/optometrist during follow-up visits.
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5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:
- Not applicable / Missing from document. MRMC studies are primarily for evaluating diagnostic imaging devices where human readers interpret images. This device is a soft contact lens. Its effectiveness is assessed by factors like visual acuity, comfort, and ocular health outcomes in wearers, not by human interpretation of its "output" aided by AI. There is no indication of AI assistance in this traditional contact lens clearance.
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6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Missing from document. This device appears to be a physical medical device (contact lens), not an algorithm or AI system. Therefore, "standalone algorithm performance" is not relevant.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing from document, but can be inferred for contact lenses. For contact lenses, "ground truth" often refers to clinical outcomes (e.g., measured visual acuity, slit lamp examination findings for ocular health, patient-reported comfort, incidence of adverse events). This information would be collected during clinical trials described in the 510(k) submission.
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8. The sample size for the training set:
- Not applicable / Missing from document. As this is a physical contact lens, there isn't a "training set" in the context of machine learning or AI models. Clinical trials for contact lenses involve a "study population" or sample size.
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9. How the ground truth for the training set was established:
- Not applicable / Missing from document. Similar to point 8, the concept of a "training set" and "ground truth establishment" for an algorithm does not apply to a physical contact lens. Clinical trial data collection methods would describe how outcomes (the closest equivalent to "ground truth" here) were established for the study population.
Summary regarding this particular document:
The provided document is an FDA 510(k) clearance letter confirming that the NOVAKONE Spherical and NOVAKONE Toric contact lenses are substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects and indications for use. It does not present any specific data, acceptance criteria, or details of clinical studies that would contain the performance metrics or ground truth information you've requested. Those details would be found in the original 510(k) premarket notification submitted by the manufacturer.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its wings and a wavy line representing its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alden Optical Labs., Inc. C/O Charles H. Creighton CEO 13295 Broadway Alden, NY 14004
APR 2 6 2011
Re: K102557
Trade/Device Name: NOVAKONE Spherical and NOVAKONE Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 22, 2011 Received: March 23, 2011
Dear Mr. Creighton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Charles H. Creighton
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| Device Names: | NOVAKONE SPHERICALNOVAKONE TORIC |
|---|---|
| Indications for Use: | The NOVAKONE SPHERICAL lens is indicated for dailywear for persons requiring keratoconus management forthe correction of refractive ametropia (myopia, hyperopia)in aphakic and not aphakic persons with otherwise non-diseased eyes. The lens may be worn by persons whoexhibit refractive astigmatism of 1.50 diopters or lesswhere the astigmatism does not interfere with visualacuity. |
| The NOVAKONE TORIC lens is indicated for daily wear forpersons requiring keratoconus management for thecorrection of refractive ametropia (myopia, hyperopia) andastigmatism in aphakic and not aphakic persons withotherwise non-diseased eyes and who possess refractiveastigmatism not exceeding 10 Diopters.The lenses may be prescribed for either conventional wearor planned replacement modalities, and may be disinfectedwith a chemical or heat disinfection system. | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Prescription Use ✔ | or Over the Counter Use |
signature
(Dission Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102557
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.