(88 days)
Spherical: ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.
Toric: ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.
The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.
ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are hemispherical shells of the lens material (phemfilcon A), which is a hydrophilic copolymer of 2hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate.
Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process.
Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.
This document does not describe an AI medical device or a study involving an AI algorithm. Instead, it is a 510(k) premarket notification for a traditional medical device: "ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear."
The document details the device's indications for use, its physical and mechanical properties, toxicology, and compares it to predicate devices to establish substantial equivalence. It does not mention any artificial intelligence, machine learning, or automated diagnostic capabilities.
Therefore, I cannot extract the information required for an AI-specific study report, as the provided text relates to a conventional contact lens and its regulatory clearance process.
To directly answer your numbered points based on the provided text, if we were to interpret "device performance" in a general sense for a medical device rather than an AI device:
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A table of acceptance criteria and the reported device performance:
The document establishes "substantial equivalence" as the primary acceptance criterion, comparing the ProSoft lenses to predicate devices. Specific quantitative acceptance criteria or detailed performance metrics are mentioned in the context of physical, mechanical, and safety properties but not in a consolidated table format with explicit acceptance criteria vs. results.Performance Aspect "Acceptance Criteria" (Implied by equivalence) Reported Device Performance Physical/Mechanical Properties Equivalent to current lathed DuraSoft 3 UV lenses. Measured properties show that the lathed lenses are equivalent to predicate lenses. Cytotoxicity Meet USP requirements (no cell lysis/toxicity). No evidence of causing cell lysis or toxicity. Test article met USP requirements. Systemic Injection Meet USP requirements (no mortality/systemic toxicity). No mortality or evidence of systemic toxicity from extracts. Each test article extract met USP requirements. Ocular Irritation Not irritant to ocular tissue (rabbit model). SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants. Residual Analysis No dye extractables detected. No dye extractables detected. Lens Compatibility (Care Regimen) Parameters within manufacturing tolerances; tint color evident after 30 cycles. Any changes in parameters through 30 cycles were within manufacturing tolerances. Tint color still evident. Light Transmittance No significant difference before and after cycling. All variances within experimental tolerance. No significant difference before and after cycling. Microbiology Sterilization identical to predicate device (DuraSoft 3 UV). Manufacturing, packaging, and sterilization are identical to predicate device. Overall Conclusion Substantially equivalent to DuraSoft® 3UV lenses and CustomEyes (bufilcon A) tinting. ProSoft lenses are substantially equivalent to DuraSoft® 3UV lenses (K965052) and CustomEyes tinting (P850057). -
Sample sizes used for the test set and the data provenance:
The document does not explicitly state numerical sample sizes for each test listed (e.g., cytotoxicity, systemic injection). It mentions "samples of lenses were extracted" for residual analysis. The data provenance is internal to Wesley Jessen Corporation's testing for regulatory submission to the FDA (USA). The studies are preclinical and aim for substantial equivalence rather than clinical efficacy trials with patient cohorts. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The "ground truth" here is based on laboratory-derived measurements and established safety standards (e.g., USP requirements) and comparisons to predicate devices, not expert consensus on medical images or diagnoses. -
Adjudication method for the test set:
Not applicable. The tests are laboratory measurements against established criteria, not expert adjudication of a test set. -
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, as this is not an AI device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI device. -
The type of ground truth used:
The ground truth for performance claims is based on laboratory measurements and established safety/material standards (e.g., USP standards for cytotoxicity, systemic injection, ocular irritation) and comparison to the physical/mechanical and safety profiles of legally marketed predicate devices. -
The sample size for the training set:
Not applicable, as this is not an AI device. There is no concept of a "training set" in the context of this device's development as described. -
How the ground truth for the training set was established:
Not applicable, as this is not an AI device.
§ 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.