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EASY DAY (methafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0 ~ - 12.00D. The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.

EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) contact lens is available as a single vision aspherical lens. The lens material, methafilcon A is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) cross-linked with ethylene glycol dimethacrylate (EGDMA) . The lens with visible tint is tinted blue using reactive blue 4K to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing buffered saline solution.

The provided 510(k) summary for the "EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear" focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against specific acceptance criteria with detailed metrics in a table.

However, based on the nonclinical studies section, we can infer some "acceptance criteria" through the reported device properties and comparability to the predicate. The "study" proving these are the nonclinical performance tests.

Here's an attempt to structure the information as requested, though some sections will highlight the lack of detailed quantification regarding "performance" against explicit "acceptance criteria" as would be seen in an AI/software device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of device (contact lens), the "acceptance criteria" are largely derived from established standards for contact lens properties and biocompatibility, and by demonstrating equivalence to a legally marketed predicate device. Specific numerical acceptance thresholds beyond what is shown are often found in the detailed test protocols which are not included in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Study: At least 30 evaluable subjects' eyes were tested separately for 1 month.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given the submitter's location (Jiangsu, China), it is highly probable the clinical study was conducted in China. The "summary of clinical study" describes an evaluation over a month, suggesting a prospective study.
• Nonclinical Studies: No explicit sample sizes are provided for individual nonclinical tests (e.g., irritation, cytotoxicity). For technological characteristics, it is implied that representative samples of the manufactured lenses were tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Clinical Study: Not applicable in the sense of expert consensus for ground truth as would be used for diagnostic imaging devices. The study assessed patient-reported outcomes (satisfaction) and vision correction, likely measured by optometrists or ophthalmologists, but their number or specific qualifications are not detailed.
• Nonclinical Studies: Not applicable. These involve laboratory testing against established physical, chemical, and biological standards, not expert consensus on findings.

4. Adjudication Method for the Test Set

• Clinical Study: Not applicable for adjudication in the context of diagnostic ground truth. Clinical outcomes (vision correction, satisfaction) were likely recorded directly.
• Nonclinical Studies: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not conducted. This type of study is typical for diagnostic algorithms (e.g., AI in radiology) where human readers interpret cases with and without AI assistance. This submission pertains to a medical device (contact lens), not a diagnostic algorithm.

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. This category is not relevant for a contact lens.

7. The Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study was based on:
  • Patient outcomes: Corrected vision (measured objectively).
  • Patient satisfaction: Subjective feedback on lens wearing and care.
  • General safety: Observation for adverse events or complications.
• Nonclinical Studies: The "ground truth" (or reference) for these tests involved:
  • Industry standards and guidelines: For properties like oxygen permeability, light transmittance, water content, sterility, etc.
  • Reference materials/controls: In biocompatibility and leachability testing.
  • Predicate device characteristics: For comparison of technological characteristics.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical product (contact lens), not an AI algorithm, so there is no "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device.

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