(245 days)
Polaris 'Dial-A-Date' is a contact lens case for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses. Use for storage during chemical disinfection only. Not for use during heat disinfection.
The Polaris Dial-a-Date contact lens case is a device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. Contact lenses can be fully immersed into the chamber and accommodates all lenses currently being sold in the market. The contact lens case consists of a molded dual compartment bottom base and two screwdown lids. The bottom of each compartment is marked with L (left) and R (right). The lids are also labeled with L (left) and R (right), and include a dial with molded-in numbers from 0 to 3 and 0 to 9, respectively. The outer lids are colored to make the molded-in numbers of the dials visible at the 'dialed position'. The dials can be incrementally rotated to let the user set reminders (i.e. day of the month to replace the contact lenses). The outer lids and number dials do not come into contact with the lens care solution.
Here's a summary of the acceptance criteria and the study conducted for the Polaris Dial-a-Date Contact Lens Case, based on the provided 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of "acceptance criteria" with numerical targets for performance related to clinical outcomes or diagnostic accuracy (as would be typical for more complex diagnostic AI devices). Instead, the studies focused on demonstrating the safety and fundamental performance of the contact lens case to establish substantial equivalence to a predicate device. The "acceptance criteria" were implied by the successful completion and negative results (no adverse effects, no leakage) of the tests.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxic effects | Did not induce cytotoxic effects. |
| (ISO 10993-5) | ||
| Biocompatibility | No delayed dermal contact sensitization | Showed no evidence of causing delayed dermal contact sensitization. |
| (ISO 10993-10 - Skin) | ||
| Biocompatibility | No observable ocular irritation response | Did not cause any observable irritation response in vivo. |
| (ISO 10993-10 - Ocular) | ||
| Biocompatibility | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity. |
| (ISO 10993-11) | ||
| Leakage Testing | No leakage occurring after specified test conditions | None of the tested lens cases showed any leakage. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The specific sample sizes for animal testing (e.g., guinea pigs, NZW rabbits, ICR mice) are not explicitly stated as numerical counts in the provided text. The tests were performed "in vitro" (cytotoxicity) and "in vivo" (irritation, sensitization, systemic toxicity).
- Data Provenance: Not explicitly stated, but typically these tests are conducted in certified laboratories. The results are presented retrospectively as part of the submission.
- Leakage Testing:
- Sample Size: 192 combinations of different tops and bottoms.
- Data Provenance: Not explicitly stated but implies new product units from the manufacturer (Reliance Design & Manufacture Corp.) which is based in Taiwan. Retrospective, as the tests were performed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device and study. The "ground truth" for these tests (biocompatibility and leakage) is determined by the objective results of standardized laboratory tests and observation, not by subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, and results are typically evaluated against pre-defined criteria (e.g., cell viability, visual irritation scores, presence/absence of leakage) rather than subjective expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for a contact lens case. MRMC studies are typically used for diagnostic imaging devices where human reader performance (with and without AI assistance) is being evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "performance" of the device (contact lens case) itself in terms of biocompatibility and leakage was tested independently, without human interaction with the device during the testing phase, although human operators conducted the tests. There is no AI algorithm involved in this device.
7. The Type of Ground Truth Used
- Biocompatibility Testing: Ground truth was established through standardized biological assays and in vivo animal testing against established toxicity and irritation endpoints. For example, "did not induce cytotoxic effects" or "showed no evidence of causing delayed dermal contact sensitization."
- Leakage Testing: Ground truth was established through direct observation of the physical integrity of the device under stress conditions (filled with liquid, turned upside down).
8. The Sample Size for the Training Set
Not applicable. There is no AI or machine learning model that requires a training set for this device. The device is a physical product (contact lens case) with no AI components.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI or machine learning component requiring a 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.”