(112 days)
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens is made from nesofilcon A material, a hydrophilic copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone. The lens is 78% water by weight when immersed in a sterile borate buffered saline with poloxamine solution. A UVabsorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. The lenses are tinted blue for visibility with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106.
The lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
Refractive index: 1.374
Light transmission: 99%
Water Content: 78%
Specific Gravity: 1.039
Oxygen Permeability: 42 x 10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
The lens will be manufactured in the following parameter ranges:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Add Power: +0.75D to +5.00D
The lens is packaged in disposable blister packages containing borate buffered saline solution with poloxamine and provided sterile. Blister packages are labeled with the lot number, expiration date and applicable lens parameters.
The provided text describes a 510(k) premarket notification for a contact lens, not an AI device. As such, most of the requested information regarding AI device acceptance criteria and study particulars (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable.
However, I can extract information related to the device's characteristics, performance, and the basis for its approval, which is substantial equivalence to predicate devices, rather than meeting specific performance criteria demonstrated by an independent clinical study for the new device itself.
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a medical device like a contact lens, "acceptance criteria" and "reported device performance" are often tied to demonstrating safety and effectiveness based on established standards, comparison to predicate devices, and specific physical/functional properties. The document explicitly states that the safety and effectiveness were demonstrated through preclinical testing and the applicability of a clinical study performed on a predicate device due to substantial equivalence.
| Acceptance Criteria (Demonstrated via Preclinical & Predicate Device Clinical Data) | Reported Device Performance (as per specifications and comparison) |
|---|---|
| Material Safety & Biocompatibility: Performed according to FDA guidance "Premarket Notification (510(k)) Guidance document for Daily Wear Contact Lenses, May 1994" and GLP regulation 21 CFR part 58. Includes: |
- Leachables
- Ocular Irritation (Lens device, Packaging, Lens Mold)
- Sensitization
- Systemic Toxicity (Lens device, Packaging, Lens Mold) | Demonstrated to be safe and effective through a series of in vitro and in vivo preclinical toxicology and biocompatibility testing for nesofilcon A material. The subject device uses the identical lens material, manufacturing process, sterilization process, and packaging as the predicate device (Bausch + Lomb nesofilcon A contact lens, K113703), and its finished lens parameters fall within previously cleared ranges. |
| Functional Performance: Conformance to predetermined specifications and verification that the device performs as expected without creating additional risk to the user. | The device functions as a refractive medium to focus light.
Physical properties: Refractive index: 1.374, Light transmission: 99%, Water Content: 78%, Specific Gravity: 1.039, Oxygen Permeability: 42 x 10-11.
Parameter ranges: Diameter: 13.5mm-15.0mm, Center Thickness: 0.05mm-0.75mm, Base Curve: 7.8mm-9.5mm, Power Range: +20.00D to -20.00D, Add Power: +0.75D to +5.00D. These are stated as conforming to specifications. |
| Stability: Demonstrated product stability over its intended shelf-life. | Stability testing (real-time and accelerated aging) demonstrated the product is stable for four years. |
| Clinical Safety & Effectiveness: Confirmation of safety and effectiveness of the nesofilcon A lens material in the daily disposable modality. | Clinical performance data was obtained via a clinical study of the predicate device (Bausch + Lomb nesofilcon A contact lens). Due to the similarities between the subject device and the predicate device, this clinical study was deemed applicable, and no additional clinical study was performed for the subject device. The predicate device's study demonstrated safe and effective functioning. |
| Indications for Use: Ensure the new device aligns with the predicate device's indications or is otherwise justified. | Indications for Use for the new device are "Same as predicate" (BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens, K050948). The new device is indicated for daily wear for correction of refractive ametropia and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for the clinical study that was referenced. The document only states that "clinical performance data... was obtained via a clinical study of the Bausch + Lomb nesofilcon A contact lens" (which is the predicate device for material, not the multifocal predicate). It does not specify the sample size, country of origin, or if it was retrospective or prospective.
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)
This information is not applicable/not provided. The device is a contact lens, and its clinical performance was established by reference to a prior study on a similar device. There's no mention of "ground truth" adjudicated by experts in the context of an AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. This refers to methods for establishing ground truth in AI studies, which is not relevant here.
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
This information is not applicable/not provided. This relates to AI system evaluation, which is not the subject of this 510(k). The device is a contact lens.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This relates to AI system evaluation, which is not the subject of this 510(k).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As it is a contact lens, the "ground truth" (or evidence of safety and effectiveness) for the clinical performance was based on the outcomes data from a clinical study on a predicate device (Bausch + Lomb nesofilcon A contact lens). This study demonstrated that the predicate device functions in a safe and effective manner.
8. The sample size for the training set
This information is not applicable/not provided. This is an AI-specific term and not relevant to a contact lens approval via substantial equivalence.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This is an AI-specific term and not relevant to a contact lens approval via substantial equivalence.
§ 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.