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Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, CooperFlex a 1. Onevue are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes.
The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with usual acuity.
Frequency 55 lenses with UV absorbing monomer helps protect against transmission of harmful UV radiation to the cornea and into the eye.

Encore Toric lenses are indicated for daily for the correction of refractive (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

Device Description

Frequency 55, Frequency 55 Aspheric, Encore, CooperFlex and Onevue (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Encore Toric (methafilicon A) Soft (hydrophilic) Contact Lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylic acid. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.

Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzotriazole UV absorbing monomer is used to block UV radiation. the average transmittance characteristics are less than 10% in the UVB range if 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert involvement, adjudication methods, or MRMC studies.

The document is a 510(k) premarket notification for contact lenses. It states explicitly:

"No Non-Clinical or Clinical tests were performed. The lenses are the same as those cleared in the above premarket notifications."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as no such study was conducted for this specific submission. The approval is based on substantial equivalence to previously cleared devices.

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K Number

K980218

Device Name

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Manufacturer

BIOCOMPATIBLES EYEWEAR, INC.

Date Cleared

1998-03-23

(66 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K941877

Predicate For

N/A

Intended Use

LL-55 (methafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Device Description

The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Biocompatibles Evecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses (LL-55):

This submission is a Parametric Release 510(k), which means it focuses on the sterility release mechanism rather than a new device design or clinical performance. The key point is that the lenses themselves remain unchanged from a previously approved 510(k) (K941877). Therefore, the "acceptance criteria" and "device performance" discussed here specifically pertain to the sterilization process validation for parametric release, not the clinical effectiveness or safety of the contact lens as a medical device in terms of vision correction or wear.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Steam Sterilization Process: Capable of achieving more than a 10^-6 sterility assurance level (SAL).	Achieved more than a 10^-6 SAL upon completion of a calculated exposure time of 20 minutes and an exposure temperature of 121°C on normal finished product lenses.
Product Bioburden: Pre-sterilization bioburden consistently and significantly below 1000 vegetative CFU and 40 spore-forming CFU.	Monthly average CFU per pre-sterilized product unit for 5 months (July 1997 to November 1997) ranged from a high of 294 to a low of 29 vegetative CFU, and less than 1 spore-forming CFU.
Bioburden Monitoring Technique Validity: Adequacy of microorganism removal, enumeration, microbiological counting, culture conditions, and recovery efficiency established.	Validation of the process used to determine bioburden included assessment of adequacy of removal, enumeration, counting techniques, culture conditions, and establishment of recovery efficiency for correction factor calculation.
Laminar Flow Workstation Bioburden Level (Airborne): Consistently low results on settle plates.	Results are consistently low.
Laminar Flow Workstation Bioburden Level (Surface): Consistently low results on surface touch plates.	Results are consistently low.
Steam Sterilizer Calibration: Operating within manufacturer design specifications; capable of regulating temperature and displaying/recording pressure.	Sterilizer successfully demonstrated capability to regulate temperature. Pressure gauge successfully demonstrated ability to display and record pressure.
Data Logger Calibration: Output temperatures from 10 validation thermocouple readings deviated less than 1°C from setpoint.	All output temperatures from the 10 validation thermocouple readings deviated less than 1°C from the setpoint.
Pressure Monitoring during Cycle: Pressure held to 15 psi ± 0.5 psi during timing portion of the cycle.	Pressure was held to 15 psi ± 0.5 psi during the timing portion of the cycle.
Annual Sterilizer Calibration & Validation: Verify consistent parameter measurement recordings, consistent operations to specifications, and adequacy of cycle times to achieve 10^-6 SAL.	Annual calibration and validation are performed; recent validation demonstrated compliance with operating specifications and cycle time exceeding time necessary to achieve 10^-6 SAL.
Annual Laminar Air Flow Workstation Certification: Compliance with Federal Standard 209E to Class 100 requirements.	Recent certification demonstrated compliance with Federal Standard 209E to Class 100 requirements.

Study Details (Focusing on Sterilization Validation)

Sample size used for the test set and the data provenance:
- Steam Sterilization Validation: "Normal finished product lenses" were used, but a specific sample size for this part of the test is not explicitly stated. The validation demonstrated the process's capability.
- Product Bioburden Monitoring: Bioburden results were obtained "monthly over a 5 month period" (July 1997 to November 1997). The number of product units sampled per month for bioburden is not specified, only the average CFU per unit.
- Thermocouple Readings: 10 validation thermocouple readings were used for data logger calibration.
- Data Provenance: Retrospective, based on internal validation and monitoring data from Biocompatibles Eyecare Inc. (USA). This is typical for process validation data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a process validation study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" here is objective physical and microbiological measurements demonstrating sterility assurance.
Adjudication method for the test set:
- Not applicable. This is a scientific and engineering validation of a sterilization process, relying on quantifiable measurements and established standards (e.g., SAL). There is no "adjudication" in the sense of resolving discrepancies between human readers.
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 sterilization process validation for a contact lens, not a diagnostic AI device requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is about the process of sterilization and its parametric release, not an algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on scientific and engineering measurements against established standards for sterilization (e.g., 10^-6 SAL, specific temperature, pressure, and time parameters), and microbiological assays to quantify bioburden.
- It relies on calibrated equipment and validated microbiological testing methods.
The sample size for the training set:
- Not applicable. This is a process validation, not a machine learning model's development. There is no "training set" in this context. The underlying principles for determining sterilization parameters are based on extensive scientific literature and regulatory guidelines, not a specific training dataset for this device.
How the ground truth for the training set was established:
- Not applicable. See point 7.

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