(421 days)
The HOY A Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The HOY A Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D. The lenses may be worm by persons who exhibit astigmatism of up to 2.75 diopters that does not interfere with visual acuity.
The HOY A Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D with add power ranging from +0.50D to +2.50D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The sorafilcon A contact lenses are to be prescribed for single-use disposable wear and are to be discarded upon each removal.
The HOY A sorafilcon A material is made from a hydrophilic siloxane copolymer of N-vinyl pyrrolidone and is 48% water by weight when immersed in a sterile phosphate buffered saline packaging solution. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280 nm to 315 nm and less than 50% in the UVA range of 316 nm to 380 nm.
The HOYA sorafilcon A Contact Lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
Refractive Index: 1.408
Light Transmittance: ≥ 95%
Water Content: 48%
Specific Gravity: 1.123
Surface Character: Hydrophilic
Oxygen Permeability: 112 x 10-11 (cm²/sec)(cm³O₂)/(mL x mmHg) @ 35 °C (polarographic method).
The lenses will be manufactured with the following parameters:
Diameter: 14.0 mm to 14.7 mm
Center Thickness: 0.062 mm to 0.330 mm
Base Curve: 8.40 mm to 9.20 mm
Power Range: +5.00D to -12.00D
Cylinder Power (Toric): -0.75D to -2.75D
Cylinder Axis: 0 o to 180 o in 10 o increments
Add Power Range: +0.50D to +2.50D
The provided text describes the 510(k) premarket notification for HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, and HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens. The document outlines acceptance criteria and the study conducted to prove the device meets these criteria, primarily focusing on demonstrating substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a numerical table format for device performance metrics for the clinical study. Instead, it discusses the meeting of "primary safety hypotheses" and "primary efficacy hypotheses." The non-clinical testing section lists various tests conducted and states that "All test results met the pre-established acceptance criteria." However, the document does not provide the numerical values for these pre-established acceptance criteria for each test, nor the specific numerical results of the subject device for each non-clinical test.
For the clinical study, the acceptance criteria relate to non-inferiority for safety and visual acuity targets for efficacy.
Clinical Performance (Efficacy and Safety):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Safety | Non-inferiority to control lens with respect to percentage of eyes with ocular adverse events across all follow-up visits, with a non-inferiority margin of 5%. | "The low incidence of ocular adverse events ensured that both of the primary safety hypotheses were met." "No serious or significant ocular adverse events were reported." (20 reported adverse events in 17 subjects, 5 ocular AEs in 4 subjects, 2 lens-related ocular AEs - bilateral redness, all classified as non-significant). |
| Efficacy (Visual Acuity) | Proportion of eyes with VA with contact lenses and best sphere-correction corrected to 1.0 (0.0 logMAR, 20/20) or better to meet a target threshold of 90% at each visit. | VA to the nearest line: 94% to 99% for test lens, 94% to 100% for control lens. ("Both lenses achieved the target threshold of 90% at each visit.") |
| Efficacy (Visual Acuity) | VA to the nearest letter: 83% to 93% for test lens, 83% to 91% for control lens. (Note: "with habitual lenses, the proportion was also below the target threshold of 90%: 77% of test eyes and 91% of control eyes.") | |
| Mean sphere-corrected VA at follow-up (13 weeks) to have upper and lower limit values of the 95% confidence intervals better than 0.0 logMAR (1.0 decimal, 20/20). | Mean sphere-corrected VAs at follow-up were 0.07 logMAR for test lens and -0.06 logMAR for control lens. ("At each visit, the upper and lower limit values of the 95% confidence intervals were better than 0.0 logMAR... and, therefore, a primary efficacy hypothesis was met.") |
Non-Clinical Testing: The document states that "All test results met the pre-established acceptance criteria," for various tests (e.g., lens shape, water content, light transmittance, biocompatibility). However, the specific numerical acceptance criteria and the actual numerical results are not provided in the text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): A total of 133 subjects were enrolled. 80 subjects completed the study as per protocol (59 subjects wearing test lenses, 21 subjects wearing control lenses).
- Data Provenance: The clinical trial was a multicenter study conducted in USA and UK. It was a prospective trial, described as a "three-month, double-masked (subject and investigator), bilateral, randomized clinical trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study design does not appear to involve human experts interpreting data for a "ground truth" in the way it might for an AI diagnostic device. Instead, the ground truth for safety and efficacy in this clinical trial would be derived from objective measurements (e.g., visual acuity, recorded adverse events) and clinical assessments by the investigators and subjects themselves, rather than a consensus of independent experts adjudicating outcomes.
4. Adjudication Method for the Test Set
The document describes a clinical trial for contact lenses. The concept of "adjudication method (e.g., 2+1, 3+1)" is typically specific to image-based diagnostic studies where multiple readers interpret images to establish a consensus ground truth. This type of adjudication method is not applicable and therefore not mentioned in the context of this contact lens clinical trial. Safety and efficacy outcomes were assessed via standard clinical trial methodologies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. An MRMC study is relevant for evaluating the performance of diagnostic devices, especially those involving human interpretation of images, and often assesses the impact of AI assistance on human readers. This study evaluates the safety and efficacy of a contact lens itself. The "control lens" served as a comparator for the device's performance directly, not as an unassisted human reading condition in an MRMC setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable for a contact lens. The device is a physical contact lens, not a software algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. The study assessed the device's performance in human subjects.
7. The Type of Ground Truth Used
The ground truth used for this clinical study was based on:
- Clinical Measurements and Observations: Visual acuity measurements (logMAR, decimal, 20/20), and objective and subjective reporting of ocular adverse events by study investigators and subjects.
- Comparison to Predicate Device: The study's conclusion of "substantial equivalence" implies that the performance of the HOYA Illumina lenses (test device) was compared directly to that of the MyDay® (stenfilcon A) Soft Daily Disposable Contact Lens (control/predicate device) as the de facto "ground truth" for proving equivalence in a regulatory context.
8. The Sample Size for the Training Set
This information is not applicable. Contact lenses are physical medical devices, not AI/ML algorithms that require a "training set" of data in the computational sense. The clinical study was a product evaluation, not an algorithm development process.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for a physical medical 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.