(66 days)
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.
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.
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)
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.