(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.
§ 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.