Search Results

Samfilcon B Contact Lens: Bausch + Lomb Samfilcon B Contact Lens for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Samfilcon B Contact Lens for Astigmatism: Bausch + Lomb Samfilcon B Contact Lens for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia and/or astigmatism) in aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters.

Samfilcon B Contact Lens for Presbyopia: Bausch + Lomb Samfilcon B Contact Lens for Presbyopia for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Samfilcon B Contact Lens Multifocal for Astigmatism: Bausch + Lomb Samfilcon B Contact Lens Multifocal for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters.

When prescribed for frequent planned replacement wear, the contact lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

The Samfilcon B Contact Lens is available for a frequent/planned replacement modality.

The Bausch + Lomb Samfilcon B Contact Lens is made from a silicone hydrogel material and is approximately 41% water by weight when immersed in a sterile phosphate buffered saline solution. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms with 21 CFR Part 73.3106.

The Bausch + Lomb Samfilcon B Contact Lens is to be prescribed for daily wear.

The custom-made lenses will be manufactured in spherical, toric, multifocal and toric multifocal designs with the following parameters:
Diameter: 10.0 mm to 16.0 mm
Base Curve: 6.5 mm to 9.7 mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): 0D to -10.00D
Cylinder Axis: 1° to 180°
Add Power (Multifocal): +0.50D up to +4.00D

The lenses are packaged in borosilicate USP Type 1 glass vials containing phosphate buffered saline solution. A silicone vial stopper and aluminum crimp cap secure the lenses in the vial. Vials 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 510(k) premarket notification for the Samfilcon B Contact Lens. It includes information about the device's technical specifications, comparison to predicate devices, and summaries of non-clinical and clinical testing. However, it does not explicitly detail a "study that proves the device meets the acceptance criteria" in the format of specific acceptance criteria.

Instead, the document states that "The primary safety endpoint was statistical non-inferiority with respect to the proportion of eyes with slit lamp findings Grade >2 at any follow-up visit between the test and control lenses. And the primary effectiveness endpoint was statistical non-inferiority with respect to mean distance high-contrast logMAR lens visual acuity for each eye between the test and control lenses." These are the endpoints used to demonstrate substantial equivalence, rather than a direct set of acceptance criteria with reported performance against them in a table format.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text because these specific criteria and their direct outcomes are not explicitly listed in that manner.

Below is the information that can be extracted from the provided text regarding the clinical study:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, a direct table of specific acceptance criteria and detailed reported performance is not explicitly provided in the text. However, the primary endpoints of the clinical study, which serve as the basis for proving effectiveness and safety, are stated.

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

• Sample Size for Test Set (Clinical Study):
  • Enrollment: 56 for Investigational Device (Samfilcon B Contact Lens), 28 for Control Device, Total = 84 subjects.
  • Primary Safety Endpoint Analysis: 56 for Investigational Device, 28 for Control Device, Total = 84 subjects.
  • Primary Effectiveness Endpoint Analysis: 46 for Investigational Device, 21 for Control Device, Total = 67 subjects.
• Data Provenance: The clinical study was a "multicenter, clinical study in the US." It was active-controlled, randomized, and double-masked.

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 text.

4. Adjudication method for the test set:

This information is not provided in the text. The study was double-masked, which suggests a controlled environment, but a specific adjudication method beyond that is not mentioned.

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 was not an MRMC study, and it does not involve AI assistance. The study compared the Samfilcon B contact lens to a control lens.

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

This was not a standalone (algorithm only) study, as it involved human subjects wearing contact lenses.

7. The type of ground truth used:

For the clinical study, the "ground truth" was established through clinical observations and measurements by eye care professionals, specifically regarding:

• Slit lamp findings (for safety)
• Distance high-contrast logMAR lens visual acuity (for effectiveness)

8. The sample size for the training set:

There is no mention of a "training set" in the context of this contact lens clinical study. This term is typically used in machine learning or AI development, which is not applicable here. The study involved a test set of human subjects.

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

As there was no "training set" in the machine learning sense, this question is not applicable.

Ask a specific question about this device