(83 days)
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Contact Lenses are composed of fluoro silicone acrylate copolymers wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BOSTON® EQUALENS® and BOSTON® EQUALENS® II RGP Contact Lenses:
The information provided is a 510(k) summary for RGP contact lenses, focusing on the stability of the lenses when wet-shipped and stored in a specific conditioning solution. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the studies described are primarily performance and safety tests, not clinical efficacy trials in the typical sense for a new drug or high-risk device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability/Compatibility (Physical) | Average changes for diameter, base curve, and power compared to DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses. | After soaking for thirty days, the silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses were determined to be physically compatible with Boston Advance Comfort Formula Conditioning Solution. |
| Microbiology (Bioburden) | 100 Colony Forming Units (CFU) per lens | Less than 10 Colony Forming Units (CFU) per lens (for both control and stored lenses). |
2. Sample Size Used for the Test Set and Data Provenance
- Stability/Compatibility Test Set: The sample size is not explicitly stated. The text refers to "Silicone acrylate (SA) and fluorosilicone acrylate (FSA) tinted rigid gas permeable contact lenses" being subjected to the test.
- Microbiology Test Set: The sample size is not explicitly stated, but it refers to "a set of test lenses" and "two sets of lenses" (one control, one stored).
- Data Provenance: The studies were performed by "The applicant," Polymer Technology. The location of the testing is not specified, nor is whether the data is retrospective or prospective. Given the nature of a 510(k) submission for device approval, these would be prospective tests conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For these types of physical and microbiological performance tests, the "ground truth" is typically established by laboratory measurements against defined standards or protocols, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The tests described are objective laboratory measurements, not subjective evaluations requiring adjudication.
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 type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human reading performance. The described studies are physical and microbiological performance tests for contact lenses.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the context of this device. A standalone algorithm performance study refers to the evaluation of an AI algorithm's performance without any human intervention. The device in question is a contact lens, and the studies performed are physical and microbiological tests, not AI algorithm evaluations.
7. The Type of Ground Truth Used
- Stability/Compatibility: The ground truth for physical compatibility (diameter, base curve, power changes) was established by comparison to the DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses. This is a recognized international standard for contact lens specifications.
- Microbiology (Bioburden): The ground truth for microbial contamination was established by quantitative measurement of Colony Forming Units (CFU) per lens against a defined numerical acceptance criterion.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of this device and study. Training sets are relevant for machine learning or AI models, which are not involved here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
§ 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.