(29 days)
Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.
The SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.
Here's an analysis of the provided 510(k) summary for the SAUFLON Flat Coloured Contact Lens Cases, focusing on the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Cytotoxicity | No evidence of cellular toxicity |
| Systemic Toxicity | No evidence of systemic toxicity |
| Ocular Irritation | No evidence of ocular irritation |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample sizes used for the cytotoxicity, systemic toxicity, or ocular irritation studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, given that Sauflon Pharmaceuticals Ltd. is based in the UK, it's reasonable to infer the studies likely involved testing done in the UK or under UK/European standards at the time, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The 510(k) summary does not mention the use of experts to establish ground truth for the test set. The reported performance is based on the laboratory study results (cytotoxicity, systemic toxicity, ocular irritation). These types of studies typically involve scientific methodologies and instrumentation rather than expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The testing performed (cytotoxicity, systemic toxicity, ocular irritation) are laboratory-based studies that produce objective results, not requiring an adjudication process commonly used for subjective interpretation tasks (e.g., image reading).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, often clinical imaging, to assess reader performance with and without AI assistance. The Sauflon contact lens case is a physical medical device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Sauflon Flat Coloured Lens Case is a physical product for storing contact lenses during chemical disinfection. It does not involve an algorithm or AI functionality, so the concept of standalone performance (algorithm-only) does not apply. The "standalone" performance here relates to the inherent safety and effectiveness of the material and design as tested in the mentioned studies.
7. The Type of Ground Truth Used
For the studies mentioned:
- Cytotoxicity: The ground truth would be established through laboratory assays (e.g., cell viability, cell proliferation) comparing the device's extract/material exposure to control substances, with scientific criteria defining what constitutes cellular toxicity.
- Systemic Toxicity: The ground truth would be established through animal models (e.g., using extracts of the material) with predetermined endpoints and measurements to assess systemic adverse effects, using established toxicological protocols.
- Ocular Irritation: The ground truth would be established through in-vitro or in-vivo testing (e.g., using extracts applied directly to ocular tissues or cell lines, or in animal models) using established protocols to evaluate irritating effects on the eye.
The ground truth in all these cases is based on objective scientific/laboratory measurements and established biological assays/protocols, rather than expert consensus, pathology, or outcomes data in the context of clinical trials.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical contact lens case, not an AI/machine learning model that requires a training set. The safety and effectiveness were demonstrated through direct testing of the device's materials, not through a learning algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for this device.
§ 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.”