(135 days)
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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 may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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 nondiseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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 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.
Lenses have the following physical properties:
Refractive Index: 1.411
Light Transmittance: 97.3%
Water Content: 46%
Specific Gravity: 1.048
Oxygen Permeability: 114 x 10 to the power of -11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
The lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis (Toric): 0° to 180°
Add Power (Multi-Focal): +0.75D to +5.00D
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, and its astigmatism and presbyopia variants.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Pre-established) | Reported Device Performance (Summary) |
|---|---|---|
| Non-Clinical Testing | Conformance to predetermined specifications (for physiochemical, biocompatibility, ocular irritation, stability, preservative uptake, extractables, solution compatibility tests). | All test results met the pre-established acceptance criteria. The testing demonstrates the lens is safe and effective and is substantially equivalent to the predicate device without adversely impacting safety and efficacy. |
| Clinical Testing (Safety) | Primary safety variable: biomicroscopy findings. No adverse events occurred. | Primary safety endpoint was achieved; no adverse events occurred during the study. |
| Clinical Testing (Efficacy) | Primary efficacy variable: visual acuity. Achieved. | Primary efficacy endpoint was achieved. |
| Overall Comparison | Substantial equivalence to predicate device (Bausch + Lomb PureVision (balafilcon A) Contact Lens). | Demonstrated substantial equivalence to the predicate device. The results demonstrated the lens is safe and effective and is substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): Not explicitly stated with a specific number of subjects. The text mentions "a prospective, three-month randomized clinical study utilizing adopted soft contact lens wearers."
- Data Provenance: The study was a prospective clinical study. The country of origin is not specified but is implied to be within the scope of FDA approval requirements (likely conducted in the US or under protocols acceptable to the FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. For a contact lens clinical study, the assessment of safety (biomicroscopy findings) and efficacy (visual acuity) would typically be performed by trained ophthalmologists, optometrists, or qualified clinical staff.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly mentioned. Clinical studies often involve multiple observers for key endpoints, but no specific adjudication method (e.g., 2+1, 3+1) is detailed in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or conducted. This would typically apply to diagnostic imaging devices where multiple readers interpret cases. For this contact lens, a clinical trial comparing the new lens to a predicate device in human subjects was performed.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as this is not an AI-assisted device.
6. If a Standalone (Algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is a contact lens and not an algorithm or AI device. The tests performed are on the physical device and its clinical performance with human users.
7. The Type of Ground Truth Used
- Ground Truth (Clinical Study): The ground truth for the clinical study was established through primary safety variables (biomicroscopy findings) and primary efficacy variables (visual acuity), along with additional variables like refraction, keratometry, and ratings of vision, comfort, and handling. This is essentially clinical observation and measurement by healthcare professionals.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is a physical contact lens, not a machine learning algorithm that requires a training set. The "testing" refers to non-clinical and clinical evaluation of the device itself.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: 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.