Search Results

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

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.

Ask a specific question about this device