(17 days)
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.
MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have - 10.00 diopters of astigmatism or less.
MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.
The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.
When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
The provided text is a 510(k) summary for the MyDay (stenfilcon A) Soft (hydrophilic) Daily Disposable Contact Lens. It outlines testing performed and conclusions regarding its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance.
The document mainly focuses on:
- Device Description: Material, physical parameters, and optical properties of the contact lens.
- Performance Testing (Non-clinical): A battery of tests performed according to ANSI, ISO, and ASTM standards to characterize physical/mechanical/optical properties (e.g., contact angle, light transmittance, water content, mechanical properties, refractive index, total extractables, non-polymeric residuals).
- Biocompatibility Testing: Extractable residual analysis to compare current and modified stenfilcon A formulations.
- Clinical Testing: A statement that clinical performance data was not required because the subject device and predicate device are equivalent in technical characteristics, manufacturing, and sterilization processes, and the non-clinical performance testing demonstrates equivalence.
Therefore, I cannot provide the requested information because the document describes a contact lens and its regulatory submission, not an AI/ML-driven device with diagnostic performance criteria and a study to prove it meets them.
If this were a document about an AI/ML device, the requested information would typically include:
- Table of Acceptance Criteria and Reported Device Performance: This would list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, accuracy, or other relevant AI performance indicators, along with the predefined acceptance thresholds and the actual performance achieved by the device in a validation study.
- Sample Size for Test Set and Data Provenance: Details on the number of cases/samples in the independent test set used to evaluate the AI, and information about where this data came from (e.g., specific hospitals, countries, whether it was collected retrospectively or prospectively).
- Number of Experts and Qualifications: How many human experts reviewed the test data to establish the ground truth, and their professional qualifications (e.g., board-certified radiologists, pathologists, clinical specialists, with specified years of experience).
- Adjudication Method: The process used to reconcile disagreements among experts when establishing ground truth (e.g., a "2+1" method where two experts agree, or a third expert resolves disagreements; a "3+1" method; or if no adjudication was used).
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Whether a study was performed to compare human performance with and without AI assistance, and if so, the effect size (e.g., how much the readers' sensitivity or specificity improved, or reduction in reading time).
- Standalone Performance: Whether the AI algorithm's performance was evaluated independently without human intervention.
- Type of Ground Truth: How the definitive diagnosis or reference standard was established for the test set (e.g., consensus of multiple experts, pathological confirmation, long-term clinical outcome data, surgical findings).
- Sample Size for Training Set: The number of cases/samples used to train the AI model.
- How Ground Truth for Training Set was Established: The method used to label or annotate the data used for training the AI model (often similar to the test set ground truth establishment but might involve different scales or processes).
§ 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.