(53 days)
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-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 in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D.
The 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 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline solution with poloxamine, poloxamer 181, glycerin, and erythritol. A UV-absorbing 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 multifocal lenses will be manufactured with the following parameters: Diameter 13.5mm to 15.0mm, Center Thickness 0.05mm to 0.75mm, Base Curve 7.8mm to 9.5mm, Power Range +20.00D to -20.00D, Add Power (Multifocal) +0.75D to +5.00D. The lenses are packaged in disposable blister packages containing phosphate buffered saline solution.
I'm sorry, but this document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter and synopsis for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a specific study's methodology and results against defined acceptance criteria.
Here's what I can extract and what's missing based on your request:
What is available:
- Device Performance (from "Physical, Chemical and Spectral Properties"):
- Refractive index: 1.4011
- Light transmission: 97%
- Water Content: 55%
- Specific Gravity: 1.029
- Oxygen Permeability: 107 x 10-11 [cm³O2(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
- Non-Clinical Performance Data Overview: The document states that "Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user." It also lists the types of non-clinical tests conducted on the predicate device (K200528), which are deemed applicable to the subject device because it uses the identical lens material, manufacturing process, sterilization process, and packaging. These tests include:
- Toxicology / Biocompatibility (In-Vitro Cytotoxicity, Ocular Irritation Study, Systemic Toxicity)
- Chemistry / Leachables (Leachable Monomer and Additives)
- Physical, Chemical and Spectral Properties (as listed above)
- Clinical Performance Data Overview: The document states, "Clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528. Because the subject device is of the identical lens material, kalifilcon A, the clinical study performed on the predicate device is applicable and no additional clinical study was performed."
What is missing from the provided text:
- Detailed Acceptance Criteria Table: While mechanical and physical properties for the lens are listed, specific acceptance criteria (e.g., "oxygen permeability must be greater than X") and a direct side-by-side comparison to explicitly stated acceptance criteria are not provided. The document implies "conformance to predetermined specifications" but doesn't list them.
- Sample Size for the Test Set: This information is not provided for either non-clinical or clinical studies.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
- Number of Experts and Qualifications: This would typically be relevant for clinical studies involving expert assessment, which isn't detailed here.
- Adjudication Method: Not applicable or provided in this context.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is not applicable to a contact lens approval and is not mentioned.
- Standalone Performance (algorithm only): Not applicable as this is a physical medical device, not an AI/algorithm.
- Type of Ground Truth Used: Not explicitly stated beyond "clinical performance data to confirm safety and effectiveness" for the predicate device.
- Sample Size for the Training Set: Not applicable as this is not an AI/machine learning device.
- How Ground Truth for Training Set was Established: Not applicable.
To get the specific acceptance criteria and detailed study methodologies, one would typically need to refer to the full 510(k) submission (K210975) and its referenced predicate (K200528), which are usually much more extensive documents than the clearance letter and summary provided.
§ 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.