(51 days)
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20,00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
Specific Gravity: 1.068
Refractive Index: 1.38
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 70%
Oxygen Permeability (Dk): 33 x10-11[cm3O₂(STP) x cm]/(sec x cm2 x mmHg)@35°C(Polarographic Method)
The BAUSCH & LOMB SofLens™one day disposable (hilafilcon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D
Each BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date.
The provided text describes a 510(k) premarket notification for a contact lens, focusing on demonstrating substantial equivalence to a predicate device rather than a study with acceptance criteria and device performance in the typical sense of a diagnostic or treatment effectiveness study.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present "acceptance criteria" for clinical performance in the way a diagnostic device might (e.g., sensitivity, specificity thresholds). Instead, it aims to show substantial equivalence to an existing predicate device based on physicochemical properties and toxicology. Therefore, the "acceptance criteria" are implicitly that the new device's properties are "equivalent" to the predicate, and toxicity is "none."
| Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Physicochemical Properties | Equivalent to currently marketed predicate device | "The physicochemical properties... are equivalent to the currently marketed predicate device." |
| Toxicity / Irritation | No significant quantities of monomer components; no toxicity or irritation | "The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens material demonstrated no toxicity or irritation." |
| Material Classification | Same FDA material classification grouping (Group II) as predicate | "Both fall into the same FDA material classification grouping (Group II)." |
| Manufacturing Process | Same manufacturing process (cast molding) as predicate | "Both are manufactured by the same manufacturing process (cast molding)." |
2. Sample Size Used for the Test Set and Data Provenance:
The study described is preclinical testing (in vitro and in vivo toxicology) and comparison to a predicate device. It is not a clinical study involving human subjects or a "test set" of patient data in the typical sense for evaluating device performance metrics like sensitivity/specificity.
- Sample Size: Not specified for the preclinical testing. The focus is on material properties and toxicology rather than a patient-based test set.
- Data Provenance: The preclinical tests were conducted in accordance with FDA guidelines and involved in vitro and in vivo studies. Specific country of origin or whether it was retrospective/prospective is not mentioned, but "preclinical" generally implies laboratory-based, controlled studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not a study that establishes "ground truth" through expert consensus for a diagnostic outcome. The "truth" in this context is the safety and functional properties of the material, assessed through laboratory tests.
4. Adjudication Method:
Not applicable. As this is not a study requiring human interpretation or consensus for a "ground truth," there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a contact lens, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
Not applicable. The device is a physical medical device (contact lens), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" in this context is based on preclinical testing results (physicochemical properties, toxicology) and comparison to the known characteristics of a legally marketed predicate device. It's about demonstrating safety and equivalence in material properties and manufacturing.
8. Sample Size for the Training Set:
Not applicable. The device is a physical contact lens, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
§ 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.