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For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.

The applicant contact lens case is a lens care product used by the contact lens wearer or practitioner for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat. This device is manufactured in two variations: clear cap/blue cap and clear base and clear cap/green cap and clear base. The variants follow the same design and have the same intended use. The only difference is the color appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The right cap is labeled with the Letter 'R' to distinguish right and left lenses. The primary materials which compose the applicants device are M800E Polypropylene produced by Sinopec Shanghai Petrochemical Company Limited Plastics Division which is a translucent raw material and Heliogen Blue K6911D and Heliogen Green K8730 by BASF Corporation used as color additives. The applicant device of Contact Lens Case consists of 2 parts: case bottom (body) and case caps (covers). The volume of each of the two chambers in the applicant device is 3.8ml and the inner height of both wells is 10mm. The capacity of each well is sufficient for contact lens to be fully immersed under use conditions and can accommodate all lenses currently on the market.

This document describes the Sacks Holdings, Inc. Contact Lens Storage Case (K121030) and its substantial equivalence to a predicate device. It is a 510(k) summary, which focuses on demonstrating safety and effectiveness by comparing the new device to a legally marketed predicate device, rather than providing extensive clinical study data as might be found in a Premarket Approval (PMA) application for a novel, high-risk device.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML or efficacy studies are not applicable or detailed in this type of submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device, primarily through non-clinical biocompatibility testing and showing similar technological characteristics and intended use. The "performance" is reported in terms of meeting these biocompatibility standards and aligning with the predicate.

• ISO 10993-5: 1999 (Cytotoxicity): Test article considered non-cytotoxic.
• ISO 10993-10: 2002 (Irritation and Delayed-Type Hypersensitivity): Classified as non-irritating.
• ISO 10993-11: 2006 (Systemic Toxicity): Requirements of Acute Systemic Injection Test met.

The predicate device also underwent similar biocompatibility tests (In Vitro cytotoxicity, Delayed-type hypersensitivity, Eye irritation, Systemic toxicity). |
| Sterilization: Not sold sterile. | Met: Matches the status of the predicate device. |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in this context. The "testing" referred to is biocompatibility testing of the material, not a clinical study involving human subjects or a dataset of patient cases. The tests are performed on material samples.
• Data Provenance: The biocompatibility tests (ISO 10993 standards) are laboratory-based, non-clinical tests performed on the device materials. There is no country of origin for "data" in the sense of clinical cases, nor is it retrospective or prospective in that manner.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for biocompatibility is whether the material meets the established safety standards (e.g., non-cytotoxic, non-irritating) as determined by laboratory assays and observations by qualified toxicology/biology experts, but their number and specific qualifications are not detailed in the 510(k) summary.

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

Not applicable. Adjudication methods are typically for clinical outcome assessment or image interpretation, not for standard material biocompatibility testing. The results of the ISO 10993 tests are typically objective measurements or observations by a single, qualified lab technician/scientist and then interpreted against the standard criteria.

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 device is a physical contact lens case, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is a physical contact lens case, not an algorithm.

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

For this type of device, the "ground truth" for showing safety is adherence to established international standards for biocompatibility (ISO 10993 series). This is determined by laboratory test results (e.g., cell viability assays, skin irritation scores, systemic toxicity observations) compared against pre-defined thresholds within the standard, not by expert consensus on clinical cases, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is a physical non-AI/ML medical device. There is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth for this type of device.

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Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Use during chemical disinfection only. DO NOT USE WITH HEAT

The Pelican Products, Inc contact lens storage cases are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for heat disinfection.

The provided text describes a 510(k) summary for Pelican Products, Inc. contact lens storage cases. It does not contain information about an AI-powered device or a study involving AI performance. Therefore, I cannot generate the requested table and information about acceptance criteria and AI device study for this document.

The document discusses:

• Device: Contact lens storage cases (deep well cases, ultra clear single lens cases, billboard lens cases, curved lens cases, and lens vials).
• Intended Use: Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Specifically states "DO NOT USE WITH HEAT."
• Substantial Equivalence: Claimed to be substantially equivalent to Alcon contact lens case.
• Safety and Effectiveness Studies: Cytotoxicity, systemic toxicity, and ocular irritation studies were performed in accordance with FDA guidelines for "Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."
• Results: No evidence of cellular or systemic toxicity, or ocular irritation was found.

To summarize, this document pertains to a traditional medical device (contact lens storage cases) and not an AI-enabled medical device. Therefore, no information regarding AI performance, sample sizes for test/training sets for AI, ground truth establishment, or multi-reader multi-case studies can be extracted from the provided text.

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