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510(k) Data Aggregation
(148 days)
The Acuity 58™ (en:flufocon B) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. 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 lens may be disinfected using a chemical disinfection system only.
The Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- in the power range of -20.00 to +20.00 diopters for sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm
The lens material (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.
The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.
Here's an attempt to extract the requested information based on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Acuity 58™ enflufocon B) |
|---|---|---|
| Material | enflufocon B | enflufocon B (identical) |
| Production Method | Lathe Cut | Lathe Cut (identical) |
| UV Blocking | Yes | Yes (identical) |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm (identical) |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm (identical) |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface (identical) |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm (identical) |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D (identical) |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D (identical) |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D (identical) |
| Indications for Use | Effectively identical scope (myopia, hyperopia, presbyopia, astigmatism in aphakic/non-aphakic non-diseased eyes, irregular corneal conditions) | Effectively identical scope as predicate |
| Refractive Index | 1.429 | 1.429 (identical) |
| Oxygen Permeability | 58 | 58 (identical) |
| Specific Gravity | 1.23 | 1.24 (very close) |
| Hardness | 114 (Rockwell R) | 81 (Shore D) (Note: Different scales, not directly comparable without conversion. The document states "materials values meet minimum values required for use.") |
| Modulus | 1500 MPa | 1568 MPa (very close) |
| Tint | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) (identical) |
| Water Content | <1% | <1% (identical) |
| Lens Type | RGP | RGP (identical) |
| Biocompatibility | Meet requirements of FDA Daily Wear Contact Lens Guidance Document (May 1994) and ISO 10993-1 (2009) for a surface device, limited contact. | Tested and found to meet these requirements. |
| Chemical/Mechanical/Optical Characteristics | Comparable to predicate lenses. | Shown to be equivalent to predicate lenses. |
2. Sample Size Used for the Test Set and the Data Provenance
The submission states that no clinical studies were deemed necessary (Page 5, Section 13) because "no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material." Therefore, there isn't a specific "test set" in the context of a clinical trial with human subjects. The evaluation for substantial equivalence was based on non-clinical (bench) testing of the material and physical characteristics.
The data provenance for these non-clinical tests is not specified in terms of country of origin or retrospective/prospective nature, as they are laboratory tests performed by the manufacturer, Acuity Polymers, Inc., located in Rochester, NY, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As no clinical studies were performed, there was no "ground truth" derived from expert assessment of patient outcomes or conditions. The "ground truth" for material properties would be established by standard laboratory testing methodologies.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring expert adjudication.
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 rigid gas permeable contact lens, not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (contact lens), not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth was established by adherence to regulatory standards and guidance documents: FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.
For the chemical, mechanical, and optical characteristics, the "ground truth" for comparison was the properties of the predicate device material (Boston EO Material, enflufocon B). The new device's properties were compared against these established values to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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