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510(k) Data Aggregation
(94 days)
X-CEL CONTACTS, A WALMAN CO.
The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty.
The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
The lens may be disinfected with a chemical (not heat) disinfection system.
The Flexlens and Harrison Post Refractive Surgery (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) is fabricated from one of the above materials which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eve 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided text describes a 510(k) submission for new contact lens materials, not a study proving device performance against acceptance criteria in the typical sense of a clinical or AI performance study. The submission focuses on demonstrating substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable to this type of regulatory submission.
Here's a breakdown of the relevant and non-applicable information based on the provided text:
Acceptance Criteria and Device Performance
The "acceptance criteria" in this context are the characteristics and performance values that demonstrate substantial equivalence to legally marketed predicate contact lenses. The device performance is assessed by comparing these characteristics of the new materials to those of the predicate materials.
| Characteristic | Acceptance Criteria (Predicate Device Range) | Reported Device Performance (New Materials: hioxifilcon A, B; acofilcon A, B) |
|---|---|---|
| INDICATION | Daily wear, Soft Contact Lens | Daily wear, Soft Contact Lens |
| INTENDED USE | Correction of refractive ametropia and specialized use for daily wear. | Correction of refractive ametropia and specialized use (e.g., aphakia, irregular astigmatism due to keratoconus, trauma, post keratoplasty; and following corneal refractive surgery) for daily wear. (Matches predicate for both Flexlens and Harrison PRS) |
| PRODUCTION METHOD | Lathe-Cut | Lathe-Cut |
| HYDROPHILLIC MATERIAL/ | ||
| USAN | (methafilcon A), (hefilcon A) | (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) |
| Water Content | (methafilcon A) - 55% | |
| (hefilcon A) - 45% | (hioxifilcon A) - 59% | |
| (hioxifilcon B) - 48% | ||
| (acofilcon A) - 58% | ||
| (acofilcon B) - 49% | ||
| Specific Gravity | (methafilcon A) - 1.090 | |
| (hefilcon A) - 0.979 | (hioxifilcon A) - 1.18 (hydrated) | |
| (hioxifilcon B) - 1.136 (hydrated) | ||
| (acofilcon A) - 1.103 (hydrated) | ||
| (acofilcon B) - 1.142 (hydrated) | ||
| Oxygen Permeability* | (methafilcon A) - 18.8 | |
| (hefilcon A) - 16.0 | (hioxifilcon A) - 18.0 | |
| (hioxifilcon B) - 15.0 | ||
| (acofilcon A) - 25.5 | ||
| (acofilcon B) - 15.8 | ||
| Light Transmittance | (methafilcon A) - >95% | |
| (hefilcon A) - >95% | (hioxifilcon A) - >95% | |
| (hioxifilcon B) - >95% | ||
| (acofilcon A) - >93% | ||
| (acofilcon B) - >96% | ||
| Refractive Index | (methafilcon A) - 1.40 (hydrated) | |
| (hefilcon A) - 1.43 (hydrated) | (hioxifilcon A) - 1.40 (hydrated) | |
| (hioxifilcon B) - 1.40 (hydrated) | ||
| (acofilcon A) - 1.40 (hydrated) | ||
| (acofilcon B) - 1.42 (hydrated) |
*Note: Oxygen Permeability units are (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).
Study Details Table
This submission is a 510(k) Pre-Market Notification for substantial equivalence for new materials for an existing device, not a performance study (e.g., clinical trial) in the traditional sense that would generate new patient-specific data for acceptance criteria. The "study" here is primarily a comparison of material properties and intended uses to predicate devices.
| Question | Information from Text |
|---|---|
| 2. Sample size used for the test set and the data provenance | Not applicable. This is not a study with a "test set" of patient data. The "test" is a comparison of physical properties of the new materials to the established properties of predicate materials. The "data provenance" for the pre-clinical performance data (cytotoxicity, systemic injection, ocular eye irritation) for the new materials is by reference to previous 510(k) submissions from the material manufacturers (Benz Research and Development for hioxifilcon A and B; Contamac Ltd. for acofilcon A and B). These previous submissions would contain data from their respective studies. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | Not applicable. There is no "test set" requiring ground truth established by experts. The properties presented (e.g., water content, oxygen permeability) are measured physical properties of the materials themselves, likely determined by standardized laboratory methods, not subjective expert assessment of clinical data. |
| 4. Adjudication method for the test set | Not applicable. No "test set" requiring adjudication. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improve with AI vs without AI assistance | Not applicable. This is not an AI device, nor a comparative effectiveness study involving human readers. |
| 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not applicable. This is not an AI algorithm. |
| 7. The type of ground truth used | Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the material properties are the experimentally measured physical and chemical characteristics of the materials, which are then compared to the established properties of the predicate devices for demonstrating substantial equivalence. For pre-clinical safety data, the "ground truth" refers to the results of standard biocompatibility tests (cytotoxicity, systemic injection, ocular irritation) referenced from prior 510(k)s. |
| 8. The sample size for the training set | Not applicable. This is not a machine learning/AI device, so there is no training set. |
| 9. How the ground truth for the training set was established | Not applicable. There is no training set. |
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