(85 days)
The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Spherical Soft Contact Lens are indicated for daily wear for the correction of hyperopia in pediatric aphakic persons. The lens may be disinfected with chemical (not heat) disinfection system.
The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Soft Contact Lens for Daily Wear (lathecut) is fabricated from ocufilcon B 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. The aphakic lens designs are made for daily wear for the correction of refractive hyperopia in pediatric aphakic persons. The design elements of the OCU-FLEX PEDIATRIC APHAKIC (ocufileon B) Soft Contact Lens for Daily Wear (lathe-cut) is intended to accommodate pediatric patients. The lens design has a higher power range and smaller lens to compensate for the increased power. In the hydrated state, the lens conforms to the curvature of 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 non-ionic lens material, ocufilcon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) methacrylic acid and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 47% ocufilcon B and 53% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Reactive Blue 21.
The provided text is a 510(k) summary for a medical device (soft contact lens) and does not contain information about acceptance criteria, study details, or performance metrics in the way that would typically be described for an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's an attempt to address the points based on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit acceptance criteria or a reported device performance table in the context of a "study" as one would expect for an AI/ML device. Instead, it implies acceptance through "substantial equivalence" to a predicate device based on characteristics like indications, material, design, and physical parameters.
| Characteristic | OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Spherical Soft Contact Lens for Daily Wear | Predicate Device (X-Cel Contacts Flexlens Pediatric Aphakic) |
|---|---|---|
| INDICATION | Daily wear, Soft Contact Lens | Daily wear, Soft Contact Lens |
| INTENDED USE | Correction of hyperopia in pediatric aphakic persons. | Correction of visual refractive ametropia and specialized uses such as atypical ametropia, including adult and pediatric aphakia and irregular astigmatism. |
| MATERIAL | HYDROPHILIC (ocufilcon B) | HYDROPHILIC (methafilcon A) |
| dk/l (Oxygen Transmissibility) | 18.1 | 18.8 |
| DESIGN | Aphakic Spherical | Aphakic Spherical |
| Base Curve (mm) | 6.0 mm to 8.5 mm | 6.0 mm to 10.8 mm |
| Dia (mm) | 8.0 mm to 11.0 mm | 10.0 mm to 16.0 mm |
| Powers Available | +10.00 to +40.00 diopters | Plano to +30.00 diopters |
| Thickness | Varies with power | Varies with power |
| Optical Zone | 4.5mm - 8.0mm | 4.5mm - 8.0mm |
Note: The "acceptance criteria" here are implicitly that the new device's characteristics are comparable to or fall within an acceptable range relative to the predicate device to establish substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The document refers to "Pre-clinical performance data" for the material (ocufilcon B) referenced in a PMA (P820051) and a previous 510(k) (K960291) for the tint. It does not describe a clinical performance study with a specific test set.
- Data Provenance: Not specified for any explicitly described "test set". The pre-clinical data is referenced from previous submissions, implying it would be related to material properties rather than clinical performance with a specific patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided in the document, as it does not describe a study involving expert-established ground truth for a test set. This type of information is typically related to diagnostic or prognostic AI/ML devices.
4. Adjudication method for the test set
- This information is not applicable and not provided. As no test set and ground truth establishment by experts is described, no adjudication method would be detailed.
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, a MRMC comparative effectiveness study was not done. This document describes a soft contact lens, not an AI-powered diagnostic or assistive tool. Therefore, effects on human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done. The device is a physical medical device (contact lens), not an algorithm.
7. The type of ground truth used
- This information is not applicable and not provided. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for diagnostic/prognostic studies, which are not described here. The "truth" demonstrated in this submission is the physical and material properties of the contact lens.
8. The sample size for the training set
- Not applicable and not provided. This device is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not provided. As there is no AI/ML model or training set, this information is irrelevant.
Summary of what the document does provide regarding device evaluation:
The document primarily focuses on demonstrating substantial equivalence to an existing legally marketed predicate device (Flexlens Pediatric Aphakic). This is achieved by comparing:
- Indications for Use: Both for daily wear, soft contact lenses, for pediatric aphakic persons.
- Material: Both hydrophilic, with similar oxygen transmissibility (dk/l).
- Design: Both Aphakic Spherical.
- Parameters: Comparable ranges for base curve, diameter, powers available, thickness, and optical zone.
Pre-clinical data for the ocufilcon B material (cytotoxicity, systemic injection, ocular eye irritation) and for the Reactive Blue 21 tint are referenced from previously accepted FDA submissions (PMA #P820051 and 510(k) K960291, respectively), indicating that the safety of the materials has been previously established.
The evaluation method relies on comparison with a predicate device and referencing existing safety data for the materials, rather than conducting new clinical performance studies with specific patient cohorts and ground truth for the specific application of AI/ML or diagnostic devices.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.