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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.

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.

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For storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Use for storage during chemical disinfection only. Do not use during heat disinfection.

Polaris Contact Lens Case is a product for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. This device is intended for use with a contact lens solution to store the contact lenses, This product is not to be used in heat disinfection. This device is manufactured in two variations: #101 and #201. The variants follow the same design principles and have the same intended use. The only differences are the dimensions and appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The primary materials which compose the applicant device are ST757M and PT231M; they are produced by Taiwan Polypropylene Co., Ltd. ST757M is a translucent raw material and PT231M is an opaque white raw material. The Polymer 27A55 is produced by Kraton Polymers UK Ltd. The volume of each of the two chambers in the applicant device #101 contact lens case is 4.5ml. The volume of each of the two chambers in the applicant device #201 contact lens case is 3ml. Contact lenses can be fully immersed into the chamber; both models can accommodate all lenses currently on the market.

This submission describes the Polaris Contact Lens Case (models #101 and #201), a device intended for the storage of soft (hydrophilic), rigid gas permeable, or hard contact lenses with chemical disinfectants. The acceptance criteria and the study that proves the device meets them are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not specify a "test set" in the context of typical clinical or performance studies with separate training and testing data for an algorithm. Instead, the testing relates to biocompatibility and functional assessment.

• Biocompatibility Tests: The document details specific ISO standards used.
  • ISO 10993-5:1999 (Cytotoxicity): Tested on L929 colorectal carcinoma cells. The sample size for the test article (the contact lens case materials) would be determined by the standard's methodology for preparing extracts from the device for cell culture exposure. The specific number of cell cultures or replicates is not stated.
  • ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity): Tested on guinea pigs. The specific number of guinea pigs used for this test is not stated, but these studies typically involve a defined number of animals per group (e.g., 5-10 per group).
  • ISO 10993-11:2006 (Systemic Toxicity): The specific animal model and sample size for systemic toxicity are not stated, but similar to hypersensitivity, these studies involve a defined number of animals.
• Functional Assessment (Volume and Lens Immersion): This was a qualitative assessment based on physical dimensions of the device and known dimensions of contact lenses. No "sample size" in the statistical sense is applicable here.
• Leakage Tests: Performed on "each variant" (#101 and #201). The specific number of units tested is not provided.

Data Provenance: The studies were conducted by or on behalf of Reliance Design & Manufacture Corp., located in Taiwan. The data is prospective for the specific tests performed on the Polaris Contact Lens Case.

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)

This device is not an AI/ML device, and therefore, no experts were used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" for the performance criteria (biocompatibility, functional equivalence, leakage) is established by the international standards (ISO 10993 series) themselves and accepted scientific methodologies for assessing material safety and device function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device involving human interpretation of results. The assessment of test results (e.g., cytotoxicity, allergic reactions in animals) is typically performed by trained laboratory personnel following established protocols and criteria defined by the ISO standards.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

• Established scientific methodologies and criteria defined by the ISO 10993 series of standards for biocompatibility (e.g., absence of cytotoxicity, irritation, sensitization).
• Physical measurements and known specifications for functional aspects (e.g., device chamber volume, typical contact lens dimensions).
• Predicate device's established safety and effectiveness: The primary pathway for approval is substantial equivalence to a legally marketed predicate device (Ningbo Kaida Rubber & Plastic Technology Co., Ltd. Contact Lens Case K071081). The fundamental "ground truth" for safety and effectiveness is that it performs comparably to a device already deemed safe and effective by the FDA.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, there is no ground truth established for one.

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