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510(k) Data Aggregation
(273 days)
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made of hydrogel material, hioxifilcon A, with UV blocker available as spherical lens. The composition of the lens is 43% hioxifilcon A and 57% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121 is for handling visibility purpose. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) with isotonic buffered saline solution.
The provided text is a 510(k) Summary for the HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens. It outlines the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, but it explicitly states that no clinical study was conducted to prove the device meets acceptance criteria. Therefore, most of the requested information regarding a study, sample sizes, experts, adjudication, MRMC, and standalone performance cannot be provided as they are not applicable to this submission.
However, based on the provided "Technological characteristic" and "Performance Data" sections, we can infer some aspects of what would typically be considered "acceptance criteria" for a contact lens and how its performance was assessed non-clinically.
Here's a breakdown of the requested information, adapted to what is available in the text:
1. Table of acceptance criteria and the reported device performance:
Since no clinical study was performed with explicit acceptance criteria and corresponding performance metrics from that study, I will extract relevant technical specifications of the HydroSens A lens from the "Technological characteristic" and "Performance Data" sections, along with performance from non-clinical physiochemical studies. These values represent the device's intended performance.
| Criterion (Inferred from Technological Characteristics & Performance Data) | Acceptance Criteria (Implied / Design Specification) | Reported Device Performance (from Non-Clinical Tests) |
|---|---|---|
| Dimensional Characteristics: | ||
| Diameter Range | 13.0 to 15.0 mm, ±0.2mm | Stated as design specification |
| Base Curve | 8.0 to 9.2 mm, ±0.2mm | Stated as design specification |
| Center Thickness (-3.00D) | 0.08 mm, ± [0.010 mm + 0.10 tc] | Stated as design specification |
| Power Range (for | FL | ≤ 10.00 D) |
| Power Range (for 10.00 D < | FL | ≤ 20.00 D) |
| Material Properties: | ||
| Water Content | 57% | 57% |
| Light Transmittance | 95% | 95% |
| Refractive Index (hydrated) | N/A (compared to 1.404 for predicates) | 1.402 |
| Oxygen Permeability (Dk, 35°C) | N/A (compared to 18x10-11 for predicates) | 22x10-11 |
| Specific Gravity (hydrated) | N/A (compared to 1.136 for predicates) | 1.1300 |
| Modulus | N/A (compared to 0.34 Mpa for predicate) | 0.38 Mpa |
| Tensile Strength | N/A (compared to 36 gf/mm² for predicate) | 35.0 gf/mm² |
| Elongation at Break | N/A (compared to 128% for predicate) | 108% |
| Toughness | N/A (compared to 0.215 J/m3 for predicate) | 0.210 J/m3 |
| UV Protection: | ||
| UV-A Transmission (315-380 nm) | Less than 50% | Less than 50% |
| UV-B Transmission (280-315 nm) | Less than 5% | Less than 5% |
| Sterilization & Biocompatibility: | ||
| Sterility | Sterile in sealed blister packs | Demonstrated through testing against ISO17665-1/2 |
| Biocompatibility | Non-toxic and biocompatible | Demonstrated through testing against ISO 10993 series |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. No clinical study was performed. Non-clinical tests would have used various sample sizes per test (e.g., a batch of lenses for physical property testing, materials for biocompatibility), but specific numbers are not provided.
- Data Provenance: Not applicable for a clinical test set. Non-clinical tests were conducted by the manufacturer (Visco Vision Inc., Taiwan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical study for which experts would establish ground truth was conducted.
4. Adjudication method for the test set:
- Not applicable. No clinical study with adjudication was performed.
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:
- Not applicable. This is a contact lens, not an AI-powered diagnostic device, and no clinical study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens, not an algorithm.
7. The type of ground truth used:
- Not applicable for a clinical study. For non-clinical performance, the "ground truth" is based on established scientific and engineering standards and validated test methods (e.g., ISO 18369 for ophthalmic optics, ISO 10993 for biocompatibility) that define the acceptable range for physical, chemical, and biological properties of contact lenses.
8. The sample size for the training set:
- Not applicable. No machine learning algorithm requiring a training set was used.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning algorithm requiring a training set was used.
In summary: The submission for the HydroSens A contact lens relies on demonstration of substantial equivalence to legally marketed predicate devices through comparison of indications for use, technological characteristics, and non-clinical performance testing (biocompatibility, sterilization, stability, and physiochemical properties) to established standards, rather than a clinical study with acceptance criteria for patient outcomes.
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