(314 days)
The "OWL Contact Lens Case" and "DOG Contact Lens Cases" are a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
The "OWL Contact Lens Case" and "DOG Contact Lens Case" are medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing.
"OWL Contact Lens Case" has a well diameter of 27 mm, well capacity of 5.5 mL, and overall dimension of 71 x 38.5 x 17 mm (length x width x height). The case body is in blue color and case lids are in white and black colors. Inside of the lid has only white color and has no black color.
"DOG Contact Lens Case" has a well diameter of 25 mm, well capacity of 4.8 mL, and dimension of 69.5 x 38 x 14 mm (length x width x height). The case body is in blue color and case lids are in blue, black and white color. Inside of the lid has only blue color and has no white and black color.
Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right).
The applicant device of Contact Lens Case is made of Acrylonitrile - butadiene - styrene copolymer (ABS).
The provided text describes a 510(k) summary for "OWL Contact Lens Cases" and "DOG Contact Lens Cases." This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance and biocompatibility testing. It does not involve a study that would require the typical acceptance criteria and ground truth establishment methodology found in AI/ML device submissions.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and submission.
However, I can extract the relevant acceptance criteria and reported performance for the tests that were conducted:
Acceptance Criteria and Reported Device Performance
| Test Description | Acceptance Criteria | Reported Device Performance (OWL & DOG Contact Lens Cases) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5) | No cytotoxicity | No cytotoxicity |
| Eye Irritation (ISO 10993-10) | No Eye irritation | No Eye irritation |
| Systemic Toxicity (ISO 10993-11) | No systematic toxicity | No systematic toxicity |
| Performance | ||
| Leakage Test | No leakage | No leakage (all tests passed successfully) |
Study Details (Based on the provided 510(k) Summary)
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Sample size used for the test set and the data provenance:
- Leakage Test: 128 combinations of different tops and bottoms were tested.
- Data Provenance: The tests were conducted by the manufacturer, Ningbo Lishunda Electronics Co., Ltd., in China. The data would be considered prospective for the purpose of this submission, meaning these specific units were tested for this submission.
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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. These are non-clinical engineering and laboratory tests, not assessments requiring expert "ground truth" in the medical sense. The results are objective measurements against defined criteria.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The tests are objective and do not involve human adjudication for interpretation.
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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 not an AI/ML device nor does it involve human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are objective, measurable outcomes defined by established consensus standards (e.g., ISO 10993 for biocompatibility) and engineering principles for functional tests (e.g., absence of fluid leakage).
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The sample size for the training set: Not applicable. There is no AI/ML component, and therefore no training set.
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How the ground truth for the training set was established: Not applicable. There is no training set.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”