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510(k) Data Aggregation
(47 days)
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)
The Extreme H2O® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
Extreme H2O® 54% (hioxifilcon D) soft contact lenses are hemispherical shells and are available as spherical (G54 13.6 and G54 14.2) or toric (G54 Toric) lens designs. The Extreme H2O® 54% (hioxifilcon D) soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium borate. The lens is available with a blue visibility handling tint. phthalocyanato (2) - (copper).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.
Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Extreme H2O® 54% (hioxifilcon D) Soft Contact Lens for Daily Wear
1. Table of Acceptance Criteria and Reported Device Performance
The submission relies on a comparison to a predicate device (59% Extreme H2O® (hioxifilcon A) soft contact lens) and chemical/physical/toxicological testing to establish substantial equivalence. Direct "acceptance criteria" and "reported performance" for specific clinical outcomes are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" are implied by demonstrating that the new device's material properties fall within the range of, or are comparable to, already cleared materials and predicate devices.
| Property | Acceptance Criteria (Implied by Predicate/Cleared Materials) | Reported Device Performance (Extreme H2O® 54%) | Meets Criteria? |
|---|---|---|---|
| Material Classification | Hydrophilic Lens Group II | Hydrophilic Lens Group II | Yes |
| Method of Manufacture | Cast Molded | Cast Molded | Yes |
| Water Content | 59% ± 2% (Predicate) / Bracketed by cleared materials | 54% ± 2% | Yes |
| Refractive Index | 1.404 hydrated (Predicate) / Bracketed by cleared materials | 1.414 hydrated | Yes |
| Light Transmission | > 95% | > 95% | Yes |
| Specific Gravity | 1.308 (dry) (Predicate) / Bracketed by cleared materials | 1.300 (dry) | Yes |
| Oxygen Permeability (Dk units) | 28 (Predicate) / Bracketed by cleared materials | 21 | Yes |
| Systemic Injection Test (Toxicology) | No biological reaction (for cleared materials) | No biological reaction within mice | Yes |
| Agar Diffusion Test (Toxicology) | Non-cytotoxic (for cleared materials) | Non-cytotoxic | Yes |
| Primary Ocular Irritation (Toxicology) | Non-irritant (for cleared materials) | Non-irritant to rabbits | Yes |
| Clinical Performance (Safety & Effectiveness) | Substantially equivalent to predicate device | No clinical studies performed (justified) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical study. The "test set" here refers to the new device (Extreme H2O® 54%), which underwent material characterization and toxicology testing.
- Data Provenance: The toxicology tests were performed on the Extreme H2O® 54% material (hioxifilcon D). The document implies these were standard ISO tests. The country of origin and whether the data was retrospective or prospective is not specified for these specific tests, but they are generally carried out prospectively as part of product development.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth, in the sense of expert consensus on clinical findings, was not established for this submission. The "ground truth" for the material properties and toxicology was based on established scientific and regulatory standards for material characterization and pre-clinical safety testing (e.g., ISO standards for toxicology).
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a contact lens, not an AI algorithm. Its performance is inherent to the physical and chemical properties of the lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was based on:
- Material Characterization: Scientific measurements of properties like water content, refractive index, light transmission, specific gravity, and oxygen permeability.
- Toxicology Data: Results from standardized ISO safety tests (Systemic Injection Test, Agar Diffusion Test, Primary Ocular Irritation).
- Substantial Equivalence to Predicate Device: The established safety and effectiveness of the legally marketed predicate device(s) (59% Extreme H2O® (hioxifilcon A) and Benz-G 3X (hioxifilcon B)).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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