(79 days)
The BAUSCH & LOMB® Softens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
Here's a breakdown of the acceptance criteria and study details for the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Endpoints) | Reported Device Performance |
|---|---|
| Safety: A difference of 10% in the proportions of total grade 2 or greater positive slit lamp findings, between the Test and Control lenses was considered significant. | No significant differences were seen between either Test lens modalities (daily and monthly replacement schedule) and the Control lens with respect to physiological response as determined by slit lamp examination. Therefore, the Safety endpoint of the study was achieved. |
| Efficacy: Test lens is not significantly different from the Control lens in the proportions of lens visual acuities at the level of 20/40 or better. | On eye, measured Snellen visual acuity data showed no difference between the Test and Control lenses, attaining the Efficacy endpoint. |
| Substantial Equivalence to Predicate Device (General) | Both the safety and efficacy endpoints were achieved. Almost all differences between the Test and Control lenses for other parameters were attributed to inadequate lens fit due to a lack of base curve choices with the Test lens. The Sponsor concluded substantial equivalence in safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 242 eyes (121 patients).
- Data Provenance: The document does not explicitly state the country of origin. The study was a "three month clinical study," implying a prospective design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications beyond stating that "10 investigators" participated in the study. These investigators would have performed the slit lamp examinations and visual acuity measurements.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method like 2+1 or 3+1. The assessment of safety (slit lamp findings) and efficacy (visual acuity) was likely performed directly by the investigators during patient visits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compared a new medical device (contact lens) to a predicate device, focusing on safety and efficacy in patients, rather than the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is a medical device, not an AI algorithm. The concept of "standalone performance" for an algorithm is not applicable here. The study assessed the performance of the contact lens itself when worn by patients.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established through:
- Clinical Observation/Assessment: Slit lamp examination findings (for safety) and Snellen visual acuity measurements (for efficacy) performed by clinical investigators. This represents a form of expert assessment based on established clinical practices.
8. The Sample Size for the Training Set
This information is not applicable. The study is a clinical trial for a physical medical device (contact lens), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no AI algorithm with a training set.
§ 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.