(56 days)
BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to +5.00D.
Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The 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 BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a polymer of hydroxyethyl methacrylate (HEMA) and crosslinked with Ethyleneglycol Dimethacrylate (EGDMA), and is 38% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106.
The physical / optical properties of the lens are:
Specific Gravity: 1.15
Refractive Index: 1.4375
Light Transmittance: C.I.E. Y value - at least 96%
Water Content: 38%
Oxygen Permeability (Dk): 8.4 x 10 to the power of -11 [cm cubed O sub 2 (STP) x cm]/(sec x cm squared x mmHg)@35°C (Polarographic Method)
The BAUSCH & LOMB SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
Diameter: 13.5mm to 15.5mm
Center Thickness: 0.05mm to 0.75mm
Base Curve: 7.5mm to 9.5mm
Powers (Spherical): +20.00D to -20.00D
Add Power: +1.00D to +5.00D
Each BAUSCH & LOMB SofLens™ Multifocal (polymacon) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter, add (high/low) and expiration date.
The provided text describes a 510(k) summary for the BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens. The information largely focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a detailed report of acceptance criteria and a study proving device performance against those criteria in the way typically expected for an AI/software device.
However, I can extract the relevant information and structure it to the best of my ability based on the provided document.
Acceptance Criteria and Reported Device Performance
The study compares the SofLens™ MultiFocal (Test lens) to the Johnson & Johnson Acuvue® Bifocal Contact Lens (Control lens) in a randomized clinical study. The acceptance criteria and the "device performance" are framed in terms of achieving non-inferiority or statistical equivalence to the control lens.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (SofLens™ MultiFocal vs. Acuvue® Bifocal) |
|---|---|---|
| Safety | No statistical difference in the frequency of occurrence of total grade 2 or greater positive slit lamp findings between the study lenses. | "There were no significant differences between the Test and Control lenses with respect to the frequency of occurrence of total grade 2 or greater slit lamp findings. Therefore, the safety end-point defined in the protocol was achieved." |
| Efficacy | No statistical difference in the proportion of lens visual acuities worse than 20/40 between the Test and Control lenses. | "There were no significant differences in the proportion of lens visual acuities worse than 20/40 between Test and Control lenses. Therefore, the efficacy end-point defined in the protocol was achieved." |
| Conclusion | The Bausch & Lomb Castmold Bifocal Contact Lens is equivalent in safety and efficacy to the Johnson & Johnson Acuvue Bifocal Contact Lens. | "The Sponsor concludes, based on the data presented, that the protocol-specified endpoints were achieved, and that the Bausch & Lomb Castmold Bifocal Contact Lens is equivalent in safety and efficacy to the Johnson & Johnson Acuvue Bifocal Contact Lens, when worn on a daily wear basis." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: A total of 170 eyes (85 patients) were entered into the study. 166 eyes (83 patients) completed the study.
- Data Provenance: The study was a "one month, randomized clinical study" which implies a prospective clinical trial. The country of origin of the data is not explicitly stated but is implicitly within the scope of FDA approval for a US-based manufacturer (Bausch & Lomb, Rochester, NY).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states, "A total of 170 eyes (85 patients) were entered into the study by 6 Investigators." These investigators would be the experts assessing the clinical endpoints (slit lamp findings, visual acuity). Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but it's implied they are qualified eye care professionals capable of conducting such a clinical study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method. Data collection for slit lamp findings and visual acuity would typically be performed by the investigators directly.
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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 does not involve AI. It is a clinical comparison of two physical contact lenses.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This was not an AI or algorithmic device. It's a medical device (contact lens) where human clinical assessment (by investigators) is inherently part of the performance evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the safety endpoint was based on a "no statistical differences" finding in the frequency of "total grade 2 or greater positive slit lamp findings," which represent clinical observations made by the investigators.
- The "ground truth" for the efficacy endpoint was based on "no statistical difference in the proportion of lens visual acuities worse than 20/40," which are measured clinical outcomes.
- Therefore, the ground truth is clinical observations and measured visual acuity, assessed by qualified investigators.
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The sample size for the training set:
- This concept is not applicable, as this is a clinical study for a physical medical device, not an AI or machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of device.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.