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510(k) Data Aggregation
(53 days)
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.
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 Astigmatism (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
Cylinder Powers: -0.75D to -5.00D
Cylinder Axis: 0° to 180°
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 document describes the Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device.
However, interpreting the request to extract information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this contact lens submission, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" in the way one might expect for an AI/ML device (e.g., target accuracy metrics). Instead, it lists physical properties and functional characteristics that the device is designed to meet, which serve as its "performance." The comparison is made against the predicate device.
| Property/Characteristic | Acceptance Criteria (Implied from Predicate/New Device Specifications) | Reported Device Performance (New Device) |
|---|---|---|
| Material Group | Group II (high water, no ionic polymers) | Same as predicate (Group II) |
| USAN Name | nesofilcon A | Same as predicate (nesofilcon A) |
| Water Content | 78% | 78% |
| UV Blocker | Present | Present (transmittance <5% UVB, <50% UVA) |
| Sterilization | Air over steam | Same as predicate (Air over steam) |
| Packaging | Polypropylene blister with plastic-coated aluminum foil | Same as predicate |
| Packaging Solution | Borate buffered saline with poloxamine | Same as predicate |
| Design | Toric | Same as predicate (Toric) |
| Refractive Index | Not explicitly stated for predicate in table, but 1.374 for new device | 1.374 |
| Light Transmission | Not explicitly stated for predicate in table, but 99% for new device | 99% |
| Specific Gravity | Not explicitly stated for predicate in table, but 1.039 for new device | 1.039 |
| Oxygen Permeability | Not explicitly stated for predicate in table, but 42x10^-11 for new device | 42 x 10^-11 [cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C |
| Diameter | Within 13.5mm to 15.0mm range | 13.5mm to 15.0mm |
| Center Thickness | Within 0.05mm to 0.75mm range | 0.05mm to 0.75mm (varies with power) |
| Base Curve | Within 7.8mm to 9.5mm range | 7.8mm to 9.5mm |
| Power Range | Within +20.00D to -20.00D range | +20.00D to -20.00D |
| Cylinder Powers | Within -0.75D to -5.00D range | -0.75D to -5.00D |
| Cylinder Axis | Within 0° to 180° range | 0° to 180° |
| Functionality | Acts as a refractive medium to focus light rays | Same as predicate |
| Modality | Daily wear contact lens | Same as predicate |
| Manufacturing Method | Cast Molded | Same as predicate |
| Stability | Demonstrates stability for four years | Stable for four years (real-time and accelerated aging) |
| Safety and Effectiveness | Safe and effective (demonstrated by predicate testing) | Assumed safe and effective due to identical material, manufacturing, sterilization, packaging, and parameter ranges within cleared limits of predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that a clinical study was performed on the predicate device (Bausch + Lomb nesofilcon A Contact Lens) to confirm the safety and effectiveness of the nesofilcon A lens material in the daily disposable modality. This study's results were considered applicable to the new device.
- Sample size for test set: Not explicitly stated for the predicate device's clinical study.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective) for the predicate device's clinical study.
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 and therefore not provided, as the submission is for a physical medical device (contact lens) and not an AI/ML device requiring expert-labeled ground truth for an algorithm. The "truth" for a contact lens involves physical properties and clinical performance in human subjects, not image interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to expert consensus for AI/ML ground truth, not the evaluation of a physical contact lens.
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 a contact lens, not an AI-assisted diagnostic device evaluated via MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical contact lens, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study of the predicate device (which is deemed applicable to the new device), the "ground truth" would be the clinical outcomes data gathered from human subjects wearing the contact lenses. This typically includes measures of visual acuity, comfort, ocular health, and adverse events, as assessed by ophthalmologists or optometrists during follow-up visits.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device submission.
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