(70 days)
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only
The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.
The provided document describes a 510(k) summary for the BOSTON® ESTM MULTIVISION (enflufocon A) Contact Lens. It references a clinical study conducted for a previous 510(k) for the same material (K943177) to support the current premarket notification. Therefore, the acceptance criteria and study details are derived from this referenced study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds. However, it implicitly uses visual acuity as a key performance indicator to demonstrate effectiveness.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Acuity | Satisfactory visual acuity (e.g., 20/30 or better) | 95.1% of acuities reported for completed eyes at 20/30 or better |
2. Sample size used for the test set and the data provenance
- Sample Size: 216 patients (432 eyes)
- Data Provenance: Not explicitly stated, but implies multi-site clinical study within the United States given it's a 510(k) submission referencing US regulatory context. It is a retrospective use of data for this specific submission, but the original study was a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts establishing ground truth. The "ground truth" here is the clinical endpoint of visual acuity as measured by standard optometric methods (e.g., Snellen chart readings).
4. Adjudication method for the test set
The document does not describe any specific adjudication method. Standard clinical trials for contact lenses would typically involve trained clinicians (e.g., optometrists, ophthalmologists) following a defined protocol to assess visual acuity.
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 is a contact lens approval, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contact lens approval, not an AI-powered diagnostic device.
7. The type of ground truth used
The ground truth used was clinical outcomes data, specifically:
- Visual acuity measurements (e.g., Snellen chart readings).
- Patient reports of wearing time.
- Discontinuation rates and reasons (absence of adverse reactions).
8. The sample size for the training set
The concept of a "training set" is not applicable as this is not an AI/machine learning device. The 216 patients (432 eyes) represent the clinical studycohort used to evaluate the device performance.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/machine learning device. The clinical study established the performance data through direct patient evaluation.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.