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The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the human cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.

The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.

The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

The provided document describes the modification of an existing contact lens product (OPTIMUM GP) to include a plasma surface treatment, and a UV blocker. The 510(k) summary focuses on demonstrating substantial equivalence to the predicate device.

The document does not contain acceptance criteria for a device's performance based on objective metrics (like sensitivity, specificity, accuracy) for a diagnostic algorithmic device. Instead, it focuses on the technological characteristics and physical properties of a medical device (contact lens) and demonstrates that a modified version maintains substantial equivalence to an existing predicate device.

Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth for an AI/algorithmic device are not applicable or cannot be extracted from this document.

However, I can extract the relevant information concerning the device's characteristics and the comparison made.

Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:

1. A table of acceptance criteria and the reported device performance

As mentioned, this document does not present acceptance criteria in terms of clinical performance metrics for an algorithm. Instead, it focuses on the physical and chemical characteristics of the contact lens. The "performance" assessment is around the reduction in contact angle after plasma surface treatment, indicating improved wettability.

• UVA (316-380mm): 95% average blocking |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document is for a medical device (contact lens) and is focused on demonstrating substantial equivalence through physical and chemical property comparisons and, for the plasma treatment, a lab-based assessment of wettability (contact angle). No clinical "test set" in the context of an AI algorithm is described. The contact angle measurements would have involved a sample size of lenses, but this specific number is not provided in the summary.

3. 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. This is not a study requiring expert-established ground truth for an algorithmic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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 not an AI/algorithmic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical and chemical characteristics, the "ground truth" would be established by standard analytical and material testing methods (e.g., spectrophotometry for UV blocking, goniometry for contact angle, chemical analysis for material composition). For the intended use and functionality, it relies on established clinical understanding of contact lens optics and patient outcomes, which are not detailed in this submission as it's a modification to an already cleared device.

8. The sample size for the training set

Not applicable. This is not an AI/algorithmic device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/algorithmic device.

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The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and rother competition I he OPT I MUM GF (fonulocon A, ronaloon D, ronis is indicated for daily wear for the correction of Spherical Rigid Cas Femicable (NOF) Connect roll it in in-diseased eyes with myopia of hyperopia. The lens may be disinfected with a chemical disinfection system only.

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual 1 orie Rigid Gas Penneable (KOT) Condict Dons is insectives with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and rother man the the The OF I Invitified Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the Munitional Mitocal Night Oas I cimically (1627) okic persons with non-diseased eyes with myopia or correction of visual actiry in apliatio and now tipm not exceeding 4 diopters and are presbyopic requiring liyferopia antivor possesses retraorre antegramar be disinfected with a chemical disinfection system only.

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) The OF TIMOM Of (Romatooon 14, romalovon act Lens is indicated for daily wear for promoted by atten Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the Correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When place on the eye, the lens acts as a refracting medium to focus light rays upon the retina.

The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.

The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methacrylaxypropyl Methyl methacrylate, 1,1,1,3,3,3 - Hexandovosoprops inc. L. 3,3-tectakis(trimethyl siloxy)disiloxane, 2Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropy))-1,1,3,3-tec Tris(trimethylslloxy) shalle, 1,3-bls(includer).com/propy.com/props/inked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

In the OPTIMUM GP Contact Least Collections of All Justhershappenhenene . The JV to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 "dimethoxybenzophenone. The UV to block UV radiation. The UV Blocker is 2,2 - Dibydroxy-4,4 "dimethoxy" (21 for to block UV radiation. The UV Blocker is 2,2 -Darydoxy ", Fennances - 1, 1 - 1 blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315mm and 95% in the UVA range of 316 - 380nm.

The provided text describes the 510(k) summary for the OPTIMUM GP Rigid Gas Permeable Contact Lens, but it does not contain information about an AI/ML device or a study proving its acceptance criteria in the context of an AI-powered medical device.

The document pertains to a physical medical device (contact lenses) and its safety and efficacy are demonstrated through preclinical testing (toxicology, packaging, shelf life, solution compatibility) and clinical testing on human subjects, rather than through an AI/ML model's performance metrics.

Therefore, I cannot fulfill the request to provide information based on your numbered criteria (1-9) as they are tailored for AI/ML device evaluations and are not applicable to the content provided. The document does not discuss acceptance criteria or studies related to AI performance, sample sizes for AI test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

If you have a document describing an AI/ML device, please provide that for analysis.

Ask a specific question about this device