(194 days)
The Igel®56 (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 (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: 14 - 2mm Chord diameter: Center thickness: Sphere: 0.09mm (at-3.00 D) variable optic zone Optic Zone: with power Base Curve: 8.60mm -0.50D to -8.00D (in Power : 0.25D steps): -8.50D -12.00D (in to 0.50D steps); +0.50D to +6.00D (in 0.25D steps) Chord diameter: 14 - 6mm Toric: 0.15mm Center thickness: 8.45mm Optic Zone: 8.70mm Base Curve: Sphere: Plano to -8.00 D (in 0.25 D steps) Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cvlinder: 80, 90, 100, 160, 170, 180, 10 Axis: & 20° The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-vinyl pyrrolidinone. The blue tinted lens also contains D&C Green #6. The apparent color of the visibility tint may decrease slowly following repeated disinfection, but this will not affect the safety or performance of the lenses. When fully hydrated, the lens is 56% water by weight.
The provided document describes the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lens and its clinical evaluation for market clearance. The study aimed to demonstrate substantial equivalence to existing devices rather than meeting specific quantifiable performance benchmarks.
Here's an analysis of the acceptance criteria and study in the requested format:
Acceptance Criteria and Device Performance
The acceptance criteria for this device, as presented in the document, are primarily qualitative and focused on demonstrating clinical safety and efficacy comparable to already marketed predicate devices. Since this is a 510(k) submission, the primary goal is "substantial equivalence."
| Acceptance Criteria Category | Specific Criteria / Goal | Reported Device Performance |
|---|---|---|
| Safety - Adverse Events | No unanticipated serious adverse events. | "There were no adverse events during this study." |
| Safety - Slit Lamp Findings | Incidence comparable to baseline and/or predicate devices; findings manageable. | "No Findings" at final visit: 58.6% (Initial: 51.4%) |
| Reduction in Neovascularization, Staining, and Tarsal findings. Edema and Injection remained 0%. | ||
| Safety - Symptoms/Complaints | Incidence comparable to baseline and/or predicate devices; manageable. | "None" reported for 62.6% of visits. Lens awareness (14.5%), handling problems (8.4%), reading problems (7.9%). 2 subjects reported dryness, 1 reported torn lenses. |
| Safety - Discontinuations | Low rate of discontinuation due to device-related issues. | 2 out of 37 subjects (5.4%) discontinued the study. (Reason for discontinuation not specified as device-related). |
| Efficacy - Visual Acuity | Maintain or achieve appropriate visual acuity. | "All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity." "Appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision." |
| Efficacy - Wear Time | Sustained comfortable wear time. | "Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness." |
| Efficacy - Lens Cleanliness | Maintain acceptable clinical cleanliness. | 91% of test lenses were clinically clean (Rudko grades I and II) during the study. |
| Overall Conclusion | Substantially equivalent to currently marketed lenses in safety and efficacy. | "The data of the clinical trial confirm that the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lenses are substantially equivalent to currently marketed lenses in safety and efficacy." |
Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 37 subjects.
- Data Provenance: Prospective clinical trial conducted in the US (implied by FDA submission and approval process). The study was initiated July 11, 1997, and completed August 19, 1997.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "Two (2) investigators enrolled a total of 37 test subjects." It does not explicitly state their qualifications beyond being "investigators." In the context of a contact lens study, these would typically be optometrists or ophthalmologists. They would have performed the slit lamp examinations, assessed visual acuity, and recorded symptoms/complaints.
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Adjudication method for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1). The "investigators" collected and reported the data. It's implied that they themselves made the clinical judgments for slit lamp findings and efficacy measures.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a medical device (contact lens), not an AI diagnostic tool, so this type of study is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This study evaluates a physical medical device (contact lens) with human wearers, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the safety and efficacy outcomes was based on clinical observation and assessment by the investigators. This includes:
- Slit lamp findings: Direct observation and grading by the investigators.
- Symptoms, problems, and complaints: Subject self-report collected and categorized by investigators.
- Visual Acuity: Measured by standard clinical methods (e.g., Snellen chart) by the investigators.
- Lens Cleanliness: Evaluated by investigators using a "modified Rudko classification."
- Adverse events: Reported by investigators based on monitoring subjects.
- The ground truth for the safety and efficacy outcomes was based on clinical observation and assessment by the investigators. This includes:
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The sample size for the training set:
- This being a medical device (contact lens) study, there wasn't a "training set" in the machine learning sense. The "training" for the device's design and manufacturing would have been part of its development process, which is not detailed as a separate data set for a clinical trial.
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How the ground truth for the training set was established:
- Not applicable as there was no "training set" for a machine learning model. The development of the contact lens material and design would have relied on material science, engineering principles, and pre-clinical testing, which are distinct from establishing ground truth for clinical outcomes in a learning algorithm.
§ 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.