(83 days)
Focus® Excelens™ (Iotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Focus® Excelens™ Toric (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
Focus® Excelens™ Progressives (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
The material used for (lotrafilcon B) soft contact lenses is a modification to the lens material used for (lotrafilcon A) lenses. The lens material is 33% water and 67% lotrafilcon B, a silicone containing hydrogel which is surface treated.
Lotrafilcon B lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
● Center Thickness: varies with power (0.080 mm for -3.00D spherical)
Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.
Lenses have the following properties:
. Refractive index: 1.42 (hydrated)
● Light transmittance: > 96 %
. Water content : 33 % by weight in normal saline
. Oxygen permeability 110 x 10 *1 [(cm2 /sec)(ml O2 /ml+mmHg)] measured at 35°C (intrinisic Dk-Coulometric method)
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marked packaging System has boon domenstare effectively steam sterilized in a validated lens products, and puonagou lensors are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability and product oxpiration dater the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a twenty four (24) (ablity to maint of the for (lotrafilcon B) soft contact lenses in sealed blister pack containers. Shelf-life studies are ongoing to determine extension of expiration dating.
Here's an analysis of the provided text regarding the Lotrafilcon B Soft Contact Lenses to address your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) submission for substantial equivalence, not a detailed clinical study with specific quantitative acceptance criteria or performance metrics in a table format as you might expect from a rigorously designed clinical trial for a novel device. Instead, the "acceptance criteria" are implied by the demonstration of "safety and effectiveness" and "substantial equivalence" to a predicate device. The performance is reported in general qualitative terms.
Here's an interpretation based on the document:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical & Biocompatibility: | |
| 1. Non-toxic and non-irritating (material & extracts) | "The lens material and extracts are not toxic and non-irritating." |
| 2. Consistent physical and material properties (with industry standard and predicate) | "Lens physical and material properties are consistent with industry marketed lenses, and similar to lotrafilcon A lenses." Properties include: Refractive index (1.42), Light transmittance (> 96%), Water content (33%), Oxygen permeability (110 x 10^-11 [(cm^2/sec)(ml O2 /ml+mmHg)]) |
| 3. Compatibility with lens care products | "The lens material remains unaffected, with respect to lens properties, by exposure to common cleaning and disinfection systems, and is compatible with commonly available lens care products." |
| 4. Package integrity and sterility over shelf life | "The compatibility and package integrity of the blister pack packaging system has been demonstrated... and lenses are effectively steam sterilized in a validated system... Stability study data currently supports a twenty-four (24) month shelf-life for (lotrafilcon B) soft contact lenses..." |
| Clinical Performance (Daily Wear): | |
| 1. Safety (compared to predicate control lens) | "The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens." "Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions." |
| 2. Effectiveness (compared to predicate control lens) | "The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens." "Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions." Indications for Use cover spherical, toric, and progressive lenses for ametropia (myopia, hyperopia) and presbyopia, with specific astigmatism and add power limits. |
| 3. Substantial equivalence to predicate | "Results from all tests demonstrate the Substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses." "The (lotrafilcon B) contact lens is similar to other daily wear soft contact lenses in terms of water content (33% water) and ionic characteristics (FDA Group I: low water, nonionic polymer), optical performance, and indications for use." "Any differences which may exist... does not adversely effect the safety and effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size for the clinical test set (i.e., the number of patients or eyes enrolled in the "daily wear clinical study"). It only mentions "The one-month clinical evaluation was conducted..."
- Data Provenance: The study was a "daily wear clinical study," indicating it was prospective. The location is not specified, but the applicant (CIBA Vision Corporation) is located in Duluth, Georgia, USA. The study was conducted "in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812)," which are US regulations, suggesting the study was likely conducted in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided regarding "experts used to establish ground truth" in the context of typical diagnostic or image-based AI studies. This is a contact lens study, where clinical endpoints (vision, health, comfort, fit) are likely assessed by the investigating optometrists/ophthalmologists directly managing the patients in the trial, rather than independent experts reviewing data. The document does not detail individual expert qualifications or number for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable in the context of this type of clinical study for a contact lens. Clinical outcomes were assessed over time during the one-month evaluation.
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
Not applicable. This is a study evaluating the safety and effectiveness of a contact lens itself, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical study was the clinical assessment of safety and effectiveness parameters (vision, health, comfort, and fit) in patients wearing the contact lenses over a one-month daily wear period, particularly in comparison to a predicate device (lotrafilcon A). This would involve direct observation, patient-reported outcomes, and standard ophthalmic measurements. Non-clinical "ground truth" involved established toxicology, biocompatibility, and material property testing standards.
8. The Sample Size for the Training Set
Not applicable. There is no AI model or algorithm being trained described in this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI model or algorithm being trained described in this document.
§ 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.