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510(k) Data Aggregation
(322 days)
The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.
The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.
This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.
| Characteristic | Oxfore®100 (hexafocon A) RGP Lens (New Device) | Boston XO™ (hexafocon A) RGP Lens (Predicate Device) | Implicit Acceptance Criteria (Achieved) |
|---|---|---|---|
| Material | hexafocon A | hexafocon A | Same material (hexafocon A) |
| Production method | Lathe Cut | Lathe Cut | Same production method |
| Actions/Operational Principles | When placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuity | When placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuity | Same fundamental mechanism of action |
| Product Code | HQD | HQD | Same FDA product code |
| Common Name | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable | Same classification |
| Device Class | II | II | Same device class |
| CFR Reference | 21 CFR 886.5916 | 21 CFR 886.5916 | Same regulatory classification |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | Same FDA material group |
| Indications for Use | Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. Disinfected using chemical disinfection system only. | Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia), management of irregular corneal conditions (keratoconus, etc.), and therapeutic use for ocular surface disease. Disinfected using chemical disinfection system only. | Partially equivalent, with predicate having broader therapeutic indications not claimed by the new device. However, the core refractive correction indication is equivalent. |
| Refractive Index (RGP) | 1.415 | 1.415 | Identical |
| Oxygen Permeability (RGP Center) | 100 | 100 | Identical |
| Specific Gravity (RGP) | 1.27 | 1.27 | Identical |
| Hardness (Shore D) | 81 | 81 | Identical |
| Modulus (MPa) | 1500 | 1500 | Identical |
| Tint | Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18, D&C Red No. 17) | Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18) | Largely similar, with new device having one additional tint (D&C Red No. 17). This is considered a minor difference. |
| Water Content (Soft Skirt) | <1% | <1% | Identical (for RGP material, this is typically very low) |
| Lens Type | RGP | RGP | Same lens type |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Non-Clinical" testing and evaluation.
- Conclusion: "Based on the data generated from the chemical/physical testing (See Side by Side Comparison) of Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lens, it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston XO™ (hexafocon A) Daily Wear Contact Lens."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The "testing" appears to refer primarily to characterization of the material itself (hexafocon A) rather than a large-scale clinical trial with patient-specific "test sets."
- Data Provenance: Not explicitly stated, but the testing would have been conducted by Paragon Vision Sciences, Inc. or a contracted lab. This is a premarket notification, so the data is prospective in the sense that it was generated for this submission, but not necessarily a long-term clinical prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the evaluation is based on chemical/physical properties and biocompatibility, not expert interpretation of clinical outcomes or images. The "ground truth" for material properties is established through standardized laboratory methods.
4. Adjudication Method for the Test Set
- Not applicable for chemical/physical testing.
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 device is a contact lens, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a contact lens.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the non-clinical testing appears to be the established scientific and regulatory standards for contact lens materials, including:
- Specific values for physical properties (refractive index, oxygen permeability, specific gravity, hardness, modulus, water content).
- Biocompatibility requirements outlined in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009) for a surface device, limited contact.
- The characteristics of the legally marketed predicate device (Boston XO™).
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI-based device. "Training set" is not relevant here.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
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