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Bausch + Lomb kalifilcon A 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 may be prescribed in spherical powers ranging from +20.00D to -20.00D.

Kalifilcon A Contact Lens for Astigmatism

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

The kalifilcon A contact 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 hydrophilic siloxane copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with 0.5% 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. This lens is tinted blue with Reactive Blue Dye 246.

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

The provided document is a 510(k) Premarket Notification from the FDA for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens and for Astigmatism. The document reviews the substantial equivalence of the new device to a legally marketed predicate device.

Based on the nature of this document (a 510(k) summary for a contact lens), it does not contain the detailed information typically provided for the acceptance criteria and study proving an AI/ML-based medical device meets those criteria. The information requested in the prompt (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, AI effect size, etc.) is specific to the validation of AI/ML algorithms.

This document describes the equivalence of a physical medical device (contact lens) and focuses on its physical properties, material composition, manufacturing, and clinical performance related to its function as a contact lens (e.g., correction of refractive error, comfort, safety like slit lamp findings).

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a clinical study for a standard medical device, not an AI/ML algorithm.

However, I can extract information related to the clinical study conducted for the contact lens, which might partially align with some general aspects of your request, but it won't be AI/ML-specific.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria with numerical thresholds for the contact lens's performance in the way an AI model's metrics (e.g., sensitivity, specificity, AUC) would be presented. Instead, it states the achievement of primary endpoints.

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

• Sample Size: "approximately 247 patients"
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). It was a "controlled clinical study," implying prospective data collection for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept (experts establishing ground truth) is not directly applicable in the context of a contact lens clinical trial in the same way it is for an AI algorithm interpreting images. The "ground truth" for contact lens performance is established through direct measurements, patient reported outcomes, and clinical assessments by optometrists/ophthalmologists involved in the study. The number of such clinicians and their specific qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/mentioned for a contact lens clinical trial in the context of diagnostic interpretation. Clinical trial data collection involves standardized examinations and measurements by clinicians. How disagreements among clinicians (if any) were handled 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. This was a clinical study comparing a new contact lens to a predicate contact lens, not an AI system. No human reader improvement with AI assistance is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For safety, the ground truth was based on slit lamp findings assessing ocular health (e.g., signs of inflammation, corneal issues). For efficacy, the ground truth was based on visual acuity measurements with the contact lenses. These are direct clinical observations and measurements.

8. The sample size for the training set:
Not applicable. This refers to the training of an AI model, not a physical device.

9. How the ground truth for the training set was established:
Not applicable. This refers to the training of an AI model, not a physical device.

In summary, as this document pertains to a conventional medical device (contact lens) and not an AI/ML algorithm, most of the specific questions regarding AI validation criteria cannot be answered.

Ask a specific question about this device