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510(k) Data Aggregation
(123 days)
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) ± 0.18 (5 to = 10.0D) ± 0.25 (10 to = 15D) ± 0.37 (15 to = 20D) ± 0.50 (over 20D) |
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D) ± 0.37 (2 to = 4D) ± 0.50 (over 4D) |
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | Lenses should be clear with no surfacedefect |
The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
|---|---|
| Refractive Index | 1.430 |
| Modulus (MPa) | 1194 |
| Hardness (Shore D) | 78 |
| Specific Gravity | 1.18 |
| Oxygen Permeability(Dk) | 200 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 |
This document describes the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and its substantial equivalence to predicate devices, focusing on its expanded indications for use.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission for a medical device (contact lens) and not an AI/software device. The primary "acceptance criteria" for such a device effectively revolve around demonstrating substantial equivalence to legally marketed predicate devices and proving its safety and effectiveness for its intended use and expanded indications.
The reported device performance is primarily qualitative and based on the outcomes of a retrospective clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Original Indications | Demonstrated through previous 510(k) clearances. Substantial equivalence to predicate for its original indications (correction of refractive error in non-diseased eyes). |
| Safety and Effectiveness for Expanded Indications | In a retrospective clinical study (41 patients, 66 eyes), "irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses." No serious adverse reactions reported over 13,760 total days of wear. This demonstrates safety and effectiveness for management of irregular corneal conditions. |
| Physical and Chemical Properties Equivalence | Refractive Index, Modulus, Hardness, Specific Gravity, and Oxygen Permeability (Dk) are provided for the Acuity 200 and are comparable to predicate devices in terms of material group. |
| Manufacturing and Design Equivalence | Lathe-cut production method, daily wear intended use, <1% water content, and UV absorber availability are equivalent to predicate devices. |
| Material Equivalence | Same USAN material (fluoroxyfocon A) as one predicate, and within the same FDA material group (Group #3 Fluoro Silicone Acrylate) as all predicates. |
| Compliance with General Controls and Regulations | Implicitly met as part of the 510(k) clearance process. |
2. Sample size used for the test set and the data provenance
- Sample Size: 41 patients (66 total eyes).
- Data Provenance: The data was obtained from a retrospective review of medical charts. The country of origin of the data is not explicitly stated, but the submitter (Acuity Polymers, Inc.) is based in Rochester, NY, United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Four (4) independent practitioners.
- Qualifications of Experts: The document refers to them as "independent practitioners" but does not specify their exact qualifications (e.g., ophthalmologists, optometrists, or years of experience).
4. Adjudication method for the test set
- The document does not specify an adjudication method. It states that "Four (4) independent practitioners retrospectively reviewed medical charts," but it does not detail how potential discrepancies or disagreements among these practitioners were resolved or if their findings were aggregated. It appears each practitioner's assessment of their own patients' outcomes was used.
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
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a contact lens submission, not an AI-assisted diagnostic or interpretative device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The Acuity 200™ is a physical medical device (contact lens) and does not involve any algorithm or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was based on clinical outcomes data derived from the medical charts reviewed by the independent practitioners. Specifically, it focused on whether "irregular corneal conditions and vision remained stable or improved."
8. The sample size for the training set
- Not applicable. This device is a physical contact lens, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The safety and effectiveness of the material and design were established through previous clearances and the clinical study mentioned.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an algorithm, this question is not relevant to this device submission.
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