(157 days)
The SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopia (nearsighted) and may exhibits refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement. The contact lens may be disinfected using heat (not chemical), hydrogen peroxide, or chemical (not heat) disinfection system.
SuperView (polymacon) soft (hydrophilic) contact lens for daily wear with water content (38.5%) when immersed in a sterile saline solution. It consists of a polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with Ethylene Glycol Dimethacrylate (EGDMA) served as crosslinker. The lenses are produced by spin-casting method to form non-spherical flexible surface, which covers the cornea. The SuperView Contact lens with visible tint is tinted blue using C.) Reactive blue 19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister PP cup containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister cup packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave.
Here's a breakdown of the acceptance criteria and study information for the SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (SuperView Lens) | Predicate Device Performance (Optima FW / SeeQuence) |
|---|---|---|
| Material / Design Characteristics | ||
| Diameter Range | 13.7 to 14.1 mm | Equivalent/Comparable |
| Power Range | Plano to -12.00 D | Equivalent/Comparable |
| Center Thickness (for -3.00D) | 0.08 to 0.12 mm | Equivalent/Comparable |
| Refractive Index (hydrated) | 1.437 | Equivalent/Comparable |
| Light Transmittance | >93% | Equivalent/Comparable |
| Water Content | 38.5% | Equivalent/Comparable |
| Oxygen Permeability (edged corrected) @ 35°C | 8.6 x 10^-11 [(cm²/sec)(ml O3/ml-mmHg)] | Equivalent/Comparable |
| Biocompatibility (Irritation Test in Rabbit Eye) | Non-toxic, non-irritated | Not explicitly detailed, assumed predicate equivalence |
| Biocompatibility (Systemic Toxicity in Mouse) | Non-toxic | Not explicitly detailed, assumed predicate equivalence |
| Biocompatibility (Cytotoxicity) | Not cytotoxic | Not explicitly detailed, assumed predicate equivalence |
| Sterilization (SAL) | Minimum SAL of 10^-6 (via steam sterilization) | Not explicitly detailed, assumed predicate equivalence |
| Shelf-Life Sterility | Remains sterile through 3 years expiration date | Not explicitly detailed, assumed predicate equivalence |
| Leachability (monomers & addictive residues) | No leachable monomers and addictive residues at detectable levels | Not explicitly detailed, assumed predicate equivalence |
| Clinical Performance | ||
| Visual Acuity Correction | Nearly a hundred percent of participants' vision was corrected | Not explicitly detailed, assumed predicate equivalence |
| Patient Satisfaction (lens wearing and care) | Nearly all were satisfied | Not explicitly detailed, assumed predicate equivalence |
| Safety (No severe complications observed in daily wear users worldwide) | Generally stable condition without severe complication | Not explicitly detailed, assumed predicate equivalence |
| Appropriateness of Fit | Good fit for human eyes | Not explicitly detailed, assumed predicate equivalence |
| Intended Use | Correction of visual acuity in not-aphakic persons with non-diseased eyes, myopia (nearsighted) and up to 2.00 diopters refractive astigmatism that does not interfere with visual acuity. | Same as predicate devices |
| FDA Material Classification Group | Group 1 | Same as predicate devices (Group 1) |
| USAN Name | Polymacon | Same as predicate devices (Polymacon) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 60 human eyes (for the clinical study).
- Data Provenance: The document does not explicitly state the country of origin for the clinical study participants. It mentions the lenses have been "wide-used around the world, including Taiwan, China, Europe, Japan, etc.," but the specific clinical study's origin isn't detailed. The study appears to be a prospective clinical trial, as it describes testing the lenses "within 6 months" and ophthalmologists making conclusions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document states that "The ophthalmologists concludes, based on the specified clinical protocol..." This implies that the ground truth for safety and effectiveness, including visual acuity correction, patient satisfaction, and fit, was established by multiple ophthalmologists.
- Qualifications of Experts: They are referred to as "ophthalmologists," implying they are medical doctors specializing in eye and vision care. No further specific qualifications (e.g., years of experience) are provided.
4. Adjudication Method for the Test Set
- The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states "The ophthalmologists concludes," suggesting a consensus among the involved ophthalmologists or a lead investigator's final determination.
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 MRMC comparative effectiveness study was done. This device is a contact lens, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm only) performance study was done. Again, this is a physical medical device (contact lens), not a standalone algorithm.
7. The Type of Ground Truth Used
- The ground truth for the clinical study appears to be a combination of:
- Expert Consensus/Clinical Judgment: Based on the assessments and conclusions of the ophthalmologists regarding safety, effectiveness, visual acuity, and fit.
- Patient-Reported Outcomes: Patient satisfaction with wearing and care.
- Observed Outcomes: Lack of severe complications.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" as it would for a machine learning model. For this type of device, the "training set" would implicitly refer to all the research and development, materials testing, and previous predicate device data that informed the design and manufacturing of the SuperView lens.
- However, if we strictly consider explicit "set" sizes, the large-scale "wide-used around the world" population (Taiwan, China, Europe, Japan, etc.) with "all the procedure was in generally stable condition without severe complication to be observed" could be seen as an informal "real-world training/validation set" demonstrating long-term safety, though not a formally controlled study.
9. How the Ground Truth for the Training Set Was Established
- As there isn't a formal "training set" described in the context of an algorithm, the ground truth for the general development and underlying knowledge base for this contact lens was established through:
- Established scientific principles in polymer chemistry and ophthalmology.
- Non-clinical performance tests (material characteristics, biocompatibility, microbiology, leachability) which have their own established performance standards and methods.
- Historical data and experience from predicate devices and similar contact lenses, whose safety and effectiveness profiles are well-understood and supported by previous regulatory approvals. This forms a foundational "ground truth" that guides the design and testing of new, substantially equivalent devices.
§ 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.