(57 days)
The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.
The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to -12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps). The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
The provided text describes the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lens and its clinical study for substantial equivalence to other marketed lenses. However, it does not explicitly state "acceptance criteria" in a tabulated format with corresponding "reported device performance" as requested in point 1. The document primarily focuses on establishing substantial equivalence based on safety and efficacy, assessed through the absence of adverse reactions, improvement/maintenance of slit lamp findings, resolution of symptoms, and maintenance of visual acuity and lens cleanliness.
Here's an attempt to extract and infer the closest information to
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from clinical findings) | Reported Device Performance |
|---|---|
| Safety: | |
| - Absence of unanticipated adverse device effects | - "There were no adverse events during this study." |
| - Slit lamp findings not worsening significantly (e.g., no findings greater than Grade 2) | - "The Trend Analysis Profile showed no reports of positive slit lamp findings greater than Grade 2." |
- Initial "No Findings" (51.4%) increased to "No Findings" (58.6%).
- Neovascular decreased from 18.9% to 11.4%.
- Tarsal decreased from 48.6% to 40.0%. |
| - Resolution or non-worsening of symptoms, problems, and complaints (e.g., lens awareness, handling, reading problems) | - "Symptoms, problems and complaints were reported by the investigators at each visit." - "NONE" (62.6%). Other reported: "Lens Awareness" (14.5%), "Handling Problems" (8.4%), "Reading Problems" (7.9%). The document implies these were not considered disqualifying for substantial equivalence. "The 'other' symptoms were dryness (reported by 2 subjects); torn lenses reported by 1 subject." |
| - Low discontinuation rate | - "Throughout the study, 2 subjects (5.4%) were discontinued." (Implied acceptable for substantial equivalence). |
| Efficacy: | |
| - Maintenance of visual acuity (within 1 line of initial best corrected acuity, where appropriate) | - "All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity. The appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision." |
| - Acceptable wear time | - "Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness with the investigational solution." |
| - Good lens cleanliness (e.g. clinically clean) | - "91% of test lenses were clinically clean during the study. (Rudko grades I and II are considered clinically clean.)" |
2. Sample size used for the test set and the data provenance:
- Sample Size: 37 subjects. 35 (94.6%) completed 1 month of wear.
- Data Provenance: The study was conducted from July 11, 1997, to August 19, 1997. The location is not explicitly stated, but the submission is from "Igel Vision Care PTE, Ltd, Singapore" with an agent in Chicago, IL, USA. This suggests a prospective clinical trial, although the specific country of origin of the subjects is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: The study involved two (2) investigators.
- Qualifications of experts: The document does not specify their exact qualifications (e.g., "radiologist with 10 years of experience"). However, being "investigators" in a clinical trial for contact lenses implies they are qualified eye care professionals (e.g., optometrists, ophthalmologists) capable of conducting such assessments, measuring visual acuity, and interpreting slit lamp findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method for the test set. Findings and symptoms were "reported by the investigators at each visit." It appears the assessments were made by the two investigators, but there's no mention of a consensus or arbitration process if their findings differed.
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:
- No, an MRMC comparative effectiveness study was not done. This study is a clinical trial assessing the safety and efficacy of a contact lens for daily wear, not an AI-assisted diagnostic device. The document does not mention any AI component or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. The device in question is a contact lens, which is physically worn by humans, and its performance is assessed through clinical observations by human investigators. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the safety and efficacy assessments was based on clinical observations and measurements by investigators, including:
- Slit lamp findings (presence/absence and grade of conditions like edema, neovascularization, staining, injection, tarsal, etc.)
- Patient-reported symptoms, problems, and complaints (lens awareness, handling, reading issues, dryness, torn lenses)
- Visual acuity measurements
- Wear time
- Lens cleanliness scores (modified Rudko classification)
- Adverse reaction reports.
- This can be categorized as expert clinical assessment and patient-reported outcomes data.
8. The sample size for the training set:
- The document describes a clinical trial for the new device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm. The clinical trial data (37 subjects) serves as the basis for demonstrating substantial equivalence.
9. How the ground truth for the training set was established:
- As there is no training set for a machine learning model, this question is not applicable. The clinical study's "ground truth" (as described in point 7) was established through the professional assessments and observations of the two clinical investigators during the 4-week trial.
§ 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.