(14 days)
The Applicant contact lens case is a lens care product to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
The applicant device of Contact Lens Case is a device intended to be used by the contact lens wearer or practitioner for storing contact lenses while not being worn. The applicant device is not sterile and not for heat-disinfection.
Applicant Device Variants: SL-295, SL-298, SL-326, SL-338, SL-316, SL-511, SL-800, SL-863, SL-884, SL-886, SL-869, SL-876, SL-880, SL-899
All the variant models as mention above follow the same design principle with the same intended use. The only difference is the dimension and appearance of each model, which do no effect on the usage and intended use and just for commercial purpose.
The applicant device of Contact Lens Case consists of 2 parts: case body and case cover. The case body is based with adjoining dual wells for the containment of fluid, and the cap is designed for screwing. All the variant models of the applicant device have a capacity of over 1.5 ml in each case well. And the inner height of the all well exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.
The applicant device of Contact Lens Case made of 2 types of material of Polypropylene (PP) and Acrylonitrile - butadiene - styrene copolymer (ABS) for each variant model.
The provided 510(k) summary is for a Contact Lens Case, which is a medical device. The summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing efficacy through a traditional clinical study with acceptance criteria for device performance in terms of diagnostic accuracy or impact on human readers.
Therefore, many of the typical bullet points for AI/diagnostic device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of device and submission.
Here's an analysis based on the information provided, tailored to a non-AI/diagnostic device and its substantial equivalence determination:
1. Table of Acceptance Criteria and the Reported Device Performance
For this type of device, "acceptance criteria" are primarily related to safety (biocompatibility) and functional equivalence, rather than a quantifiable performance metric like sensitivity or specificity. The "reported device performance" is framed in terms of meeting these safety standards and having comparable functionality to the predicate.
| Acceptance Criteria (Safety/Functionality) | Reported Device Performance |
|---|---|
| Biocompatibility of Materials: | |
| - In Vitro Cytotoxicity | - No Cytotoxicity (for Polypropylene, ABS, and PP with Carbazole violet) |
| - Delayed-type Hypersensitivity | - No delayed dermal contact sensitization (for Polypropylene, ABS, and PP with Carbazole violet) |
| - Eye Irritation / Intracutaneous Reactivity (for Systemic Toxicity test) | - No intracutaneous reactivity (for Polypropylene, ABS, and PP with Carbazole violet) |
| - Systemic Toxicity | - No systemic toxicity (for Polypropylene, ABS, and PP with Carbazole violet) |
| - Compliance with ISO 10993 "Biological Evaluation of Medical Devices" | - All conducted Biological Evaluation Tests are in compliance with ISO 10993. The compatibility of skin-contact component material meets biocompatibility requirements. |
| Functional Equivalence: | |
| - Capacity of each case well | - Over 1.5 ml (stated to be sufficient for full immersion of contact lenses) |
| - Inner height of well | - Exceeds 8.5 mm (stated to be sufficient for full immersion given typical contact lens thickness) |
| - Intended Use | - The same as the predicate device: storing soft, rigid gas permeable, or hard contact lenses with chemical disinfection (not heat disinfection). |
| - Design | - Two adjoining wells, screwed with screw top (similar to the predicate's screwed with integral hinged cap, deemed similar for intended use). |
| - Disinfection Type | - Chemical Disinfection, Not Heat-Disinfection (same as predicate). |
| - Indications | - Storage and Disinfection of Soft, Rigid Gas Permeable or Hard Contact Lenses (same as predicate). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for the individual biocompatibility tests (e.g., number of test specimens for cytotoxicity, number of animals for sensitization/irritation) are not detailed in this summary. The summary states that representative samples (SL-884 for PP, SL-800 for ABS, and SL-295 for PP with colorant) were used for testing their respective material types.
- Data Provenance: The origin of the raw test data is not explicitly stated beyond being "test results." Given the manufacturer's location in China, it is plausible the tests were conducted there or at labs compliant with ISO standards. This is a prospective assessment of newly manufactured materials/devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. This is a safety and functional equivalence submission, not a diagnostic accuracy study relying on expert interpretation of images or patient data. The "ground truth" here is objective laboratory measurements for biocompatibility (e.g., cell viability, dermal reactions) and physical dimensions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. There is no expert adjudication process for the types of tests conducted (biocompatibility, physical measurements). The results of these objective tests are generally interpreted against established criteria or controls.
5. 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 or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm or AI device. The tests performed are standalone evaluations of the physical device's characteristics and material safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" consists of objective laboratory measurements and internationally recognized standards. Specifically:
- Biocompatibility: Results of tests (cytotoxicity, delayed-type hypersensitivity, eye irritation, systemic toxicity) are compared against established biological responses and compliance with ISO 10993 standards.
- Physical Characteristics: Direct physical measurements (e.g., volume capacity, inner height) of the device.
8. The sample size for the training set
Not Applicable. This device uses standard materials and manufacturing processes; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI model, this question does not apply. The safety and effectiveness are established through direct testing against recognized standards and comparison to a legally marketed predicate 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.”