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Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens maybe prescribed in spherical powers ranging from +20.00D to -20.00D.

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuty. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers 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 kalifilcon A material is made from a hvdrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with poloxamine, poloxamer 181, qlycerin, erythritol, and polyguaternium. A UV-absorbing 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. This lens is tinted blue with Reactive Blue Dye 246.

The Bausch + Lomb kalifilcon A Contact Lenses are to be prescribed for single-use disposable wear.

The physical properties of the lenses are:
Refractive index: 1.4011
Light transmission: 97%
Water Content: 55%
Specific Gravity: 1.029
Oxygen Permeability: 107 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method)

The lenses will be manufactured in spherical, toric and multifocal designs with the following parameters:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis: 0° to 180°
Add Power (Multi-Focal): +0.75D to +5.00D

The lenses are packaged in disposable blister packages containing phosphate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.

The provided text describes the acceptance criteria and a study for the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens. It is important to note that this is a 510(k) submission, meaning the device is being cleared as "substantially equivalent" to predicate devices, rather than requiring a full demonstration of novel safety and effectiveness through extensive new clinical trials. Therefore, the "study" demonstrating it meets acceptance criteria largely relies on equivalence to previously cleared devices and specific non-clinical and limited clinical testing.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative table for "performance" as one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this contact lens are implicitly met through demonstrating:

• Conformance to predetermined specifications: Physical properties, dimensional parameters, materials, and manufacturing processes.
• Functional performance: The device performs as expected.
• Safety and effectiveness equivalence: To predicate devices by showing identical lens material, manufacturing process, sterilization process, packaging, and that finished lens parameters fall within previously cleared ranges.
• Biocompatibility and toxicology: Showing the device is non-cytotoxic, not an ocular irritant, and not a sensitizing agent.

Here's a table summarizing the physical properties that are part of the device's specifications and performance:

The device performance aligns with these specifications, as the submission states that "The testing performed on the Bausch + Lomb kalifilcon A Contact Lens demonstrated that the device functions in a safe and effective manner" and its "finished lens parameters fall within the ranges previously cleared for the predicate device."

2. Sample size used for the test set and the data provenance

For this 510(k) submission, the "test set" to demonstrate safety and effectiveness for the subject device heavily relies on the clinical data from its predicate devices due to the identical lens material, manufacturing process, and sterilization. Therefore:

• Sample size used for the test set: Not directly provided for new clinical data specific to this submission. The clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528 (one of the predicate devices).
• Data provenance: The original clinical data for the kalifilcon A material comes from the predicate device K200528. This document does not specify the country of origin or whether it was retrospective or prospective, but clinical trials for medical devices are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Given that the clinical data is leveraged from a predicate device (K200528), the details about how clinicians or experts were involved in establishing "ground truth" (e.g., patient outcomes, visual acuity measurements) would be in the original K200528 submission. For a contact lens, "ground truth" often relates to objective measures of visual acuity, comfort, lens fit, and ocular health assessments by ophthalmologists or optometrists.

4. Adjudication method for the test set

This information is not provided in the document. As with the expert details, any adjudication methods for clinical outcomes would be found in the documentation for the predicate studies (K200528 and K210975).

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 is not applicable to this device. A contact lens is a medical device for vision correction, not an AI-assisted diagnostic or imaging device that would involve "human readers" or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to this device. It is a physical contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the referenced clinical data from K200528 (predicate device), the "ground truth" would primarily be outcomes data related to contact lens wear, including:

• Visual acuity measurements
• Lens fit assessments
• Measures of ocular health (e.g., absence of adverse events like infection, corneal staining, neovascularization)
• Patient comfort and satisfaction.

These outcomes would typically be assessed by eye care professionals.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/machine learning model that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable for the reason stated in point 8.

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