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The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is indicated for daily wear for the correction of refractive ametropia (myeropia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.

The lens may be prescribed for Frequent/Planned Replacement Wear in a power range of +20.00 to -20.00 diopters.

The Bausch + Lomb (samfilcon A) Multifocal for Astigmatism Contact Lens is 46% water and 54% samfilcon A material (a siloxane copolymer with N-vinyl pyrrolidone). This lens is tinted blue with Reactive Blue Dye 246 to make them easier to see when handling. The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine 1107 and a plastic coated aluminium lid stock. The disposable blister container and the lidstock are used in the predicate device. The packaged lenses are steam sterilized in a validated autoclave. Each lens is labelled with the lens parameters, lot number and expiration date.

This document is a 510(k) premarket notification for the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens. It asserts substantial equivalence to previously cleared predicate devices, using existing data for safety and effectiveness. Therefore, the information provided does not describe a new study conducted to establish acceptance criteria or device performance for this specific multifocal astigmatism lens. Instead, it leverages data from the predicate devices.

Based on the provided text, a new study for this specific device to establish acceptance criteria and device performance was not conducted. The provided text relies on the established safety and effectiveness of predicate devices and the material used. As such, direct answers to many of your questions regarding a new study's acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present.

However, I can extract the information related to the performance data and the basis for the declaration of substantial equivalence.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of a new study for the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens. Instead, it references conformance to "predetermined specifications and functional testing to verify that the device performs as expected without creating additional risk to the user" for the predicate device's material.

The physical properties of the new device are reported, which can be considered performance characteristics that would need to meet certain specifications.

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

The document explicitly states: "Due to the similarities between the subject device and the predicate device, the clinical study performed on the predicate device is applicable to the subject device and no additional clinical study was performed."

Therefore, there is no new test set sample size reported for the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens. The provenance of the data is based on the clinical study of the predicate device, Bausch + Lomb Ultra (samfilcon A) Contact Lens. The document does not specify the country of origin or whether the predicate study was retrospective or prospective.

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

As no new clinical study was performed for this specific device, this information is not provided in the document.

4. Adjudication method for the test set

As no new clinical study was performed for this specific device, this information is not provided in the document.

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 device is a contact lens and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

This device is a contact lens and not an algorithm. Therefore, a standalone performance study for an algorithm is not applicable and not mentioned.

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

For the predicate device's clinical study, the "ground truth" would implicitly be related to patient outcomes, visual acuity, comfort, and physiological responses associated with contact lens wear, which are typically assessed by eye care professionals. However, the exact type of ground truth and how it was established for the predicate study is not detailed in this 510(k) summary. The summary mentions "clinical performance data to confirm safety and effectiveness" of the samfilcon A lens material.

8. The sample size for the training set

This contact lens is not an AI algorithm, so there is no training set in the context of machine learning. The data used for establishing the safety and effectiveness of the material comes from a clinical study of the predicate device, but the sample size of that study is not detailed here.

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

As there is no training set for an AI algorithm, this question is not applicable. For the predicate clinical study, the safety and effectiveness data would have been collected and evaluated by relevant healthcare professionals. The specific methodology for establishing "ground truth" in that clinical study is not detailed in this document.

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