(233 days)
The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethy) methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are tinted using Vat Blue #6 in an entrapment tinting process during polymerization of the lens.
Here is an analysis of the acceptance criteria and study information for the Specialty 55 Multifocal and Specialty 55 Single Vision Contact Lenses, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests. Therefore, the "acceptance criteria" are implied to be meeting the performance characteristics of the predicate devices. The table below presents the physicochemical properties of the new device and its predicate devices, where "reported device performance" refers to the values stated for the Specialty 55 lenses.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Specialty 55) |
|---|---|---|
| Material | methafilcon A or hefilcon C | methafilcon A |
| Material Classification | Hydrophilic Lens Group 4 (methafilcon A predicates) or Group 2 (hefilcon C predicate) | Hydrophilic Lens Group 4 |
| Indication for Use | Correction of myopia, hyperopia, and presbyopia (multifocal predicate) or myopia, hyperopia, and astigmatism (IGEL 56) | Myopia, hyperopia, and presbyopia (multifocal); myopia, and hyperopia (single vision) |
| Water Content | 55% (methafilcon A predicates) or 56% (hefilcon C predicate) | 55% |
| Light Transmittance | 90 to 97% (methafilcon A predicates) or 90 to 94% (hefilcon C predicate) | 98% |
| Dk (35° C) | $19.7 \times 10^{-11}$ (hefilcon C predicate) or $18.8 \times 10^{-11}$ (methafilcon A predicate) | $18.8 \times 10^{-11}$ |
| Powers | +20.00 to -20.00 Diopters (methafilcon A predicates) or +6.00 to -12.00 Diopters (hefilcon C predicate) | +20.00 to -20.00 Diopters |
| Color | Blue visibility | Blue visibility |
| Refractive Index | 1.41 (predicates) | 1.42 |
| Specific Gravity | 1.09 (methafilcon A predicate) or 1.16 (hefilcon C predicate) | 1.06 |
| Method of Manufacture | Molded | Molded |
| Tint | Vat Blue #6 (Specialty 55) or Reactive Blue #4 (Specialty Progressive/Choice AB) | Vat Blue #6 |
| Tint Process | Entrapment process during polymerization (Specialty 55, IGEL 56) or Wet lens tinting process (Progressive/Choice AB) | Entrapment process during polymerization |
| Systemic Toxicity | Non-toxic | Non-toxic (from Systemic Injection test) |
| Ocular Irritation | Non-irritating | Non-irritating (from Primary Ocular Irritation test) |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic (from Cytotoxicity test) |
| Solution Compatibility | Compatible with chemical and hydrogen peroxide regimens | Compatible with chemical and hydrogen peroxide regimens (from Solution Compatibility test) |
| Dye Leachability | No detectable leachability of dye | No detectable leachability of dye (from Extraction test for Vat Blue #6) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a clinical trial with human subjects for the current device. The studies described are preclinical (laboratory-based) tests. Therefore, information regarding sample size, data provenance, ground truth experts, and adjudication methods for a human subject test set is not provided.
The document mentions that "A series of preclinical tests were performed to demonstrate the safety and effectiveness of the Specialty 55 Multifocal and Specialty 55 (methafilcon A) Single Vision Contact Lenses for Daily Wear". These tests include:
- Systemic Injection
- Primary Ocular Irritation
- Cytotoxicity
- Solution Compatibility
- Dye Extraction for leachability of Vat Blue #6
- Physicochemical testing (e.g., water content, Dk, light transmittance, refractive index, specific gravity)
The provenance of this preclinical data is not explicitly stated but is implied to be from laboratory testing supporting the manufacturer's submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as a human clinical trial "test set" with expert adjudicated ground truth is not described. The ground truth for the preclinical tests would be based on validated laboratory methods and standards.
4. Adjudication Method for the Test Set
Not applicable, as a human clinical trial "test set" with expert adjudication is not described.
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. The device is a soft contact lens, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a soft contact lens, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the safety and effectiveness claims is established through:
- Physicochemical Measurement Standards: For parameters like water content, Dk, light transmittance, refractive index, specific gravity, and powers, the ground truth is based on established scientific and industry standards for contact lens properties.
- Biocompatibility Standards: For systemic injection, primary ocular irritation, and cytotoxicity tests, the ground truth is based on recognized biocompatibility testing standards to determine non-toxicity and non-irritation.
- Chemical Analysis: For dye leachability, the ground truth is established through chemical analysis methods to detect the presence or absence of the dye.
- Compatibility Protocols: For solution compatibility, the ground truth is established via protocols demonstrating material integrity and performance after disinfection with specified solutions.
The overall "ground truth" for the submission is the substantial equivalence to predicate devices that have already been cleared for marketing. This means the new device is deemed safe and effective because its characteristics are sufficiently similar to devices already on the market.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/algorithm-based device and therefore does not have a "training set" in that context. The preclinical tests described would involve specific numbers of lenses or biological samples according to the testing protocols, but these are not considered a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.