Search Results

For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfections only. DO NOT USE WITH HEAT.

The contact lens cases in submission are intended to be used to store soft (hydrophilic) and hard contact lenses during chemical disinfection only. These are not to be used in heat disinfection.

There are 2 parts to each contact lens case, the main body/base with two wells, and two screw-on lids. In order to store contact lenses with disinfection solution, the wells for storage need to be leak-proof, which is designed so by the screw construction of the lids.

The plastic that is used in all four contact lens cases is Acrylonitrile Butadene Styrene (Product Name: Polylac ® PA-707, manufactured by Chi Mei Corporation, please refer MSDS attached: Attachment 1), which is a durable plastic that is insoluble in water and can be used for at least two months continuous use.

The cat contact lens case is black, with white printed on the lids. The color pigment used in the case is PLASBLAK® UN2014 (Supplier: Cabot Plastics, please refer MSDS attached: Attachment 2). This pigment is insoluble in water.

The sunglasses contact lens case is white, with black labels on the lids. The color pigment used in the case is DuPont™ Titanium Dioxide Pigment - Plastics Grade/Type : R-350 (Supplier: DuPont, please refer MSDS attached: Attachment 3). This pigment is insoluble in water.

The 1st contact lens case is green, with clear uncolored lids. There are 2 color pigments used in the green body (1) PV Fast Green GNX (Supplier: Clariant Chemicals (India) Limited, please refer MSDS attached: Attachment 4) and (2) MACROLEX Yellow G Granulate (Supplier: Bayer AG, please refer MSDS attached: Attachment 5). These pigments are insoluble in water.

The Geeky eyes contact lens case is red with black glasses. The color pigment used in the red case is 13575 Orange Color Powder (Supplier: Summit Color Co., Ltd., please refer MSDS attached: Attachment 6). This pigment is insoluble in water.

The individual well capacity of each contact lens are: cat contact lens case 2.8ml, sunglasses contact lens case 2.5ml, 1* contact lens case 3ml, geeky eyes contact lens case 2.8ml. The capacities aforementioned are sufficient for a contact lens to be fully soaked in the disinfection liquid.

At the base of the cat contact lens case and the sunglasses contact lens case, in each well there is L and R embossed to help users differentiate the left and right lenses. The geeky eyes contact lens case also has the L and R markings on the side of the casing outer. The 1d contact lens case does not have L and R markings on it as the two wells are situated one above and one below the disc so it is unlikely to mix up the two wells during use.

Through use, the material of the contact lens case may come into contact with the user's eyes indirectly. The user will need to put contact lenses with chemical disinfecting liquid into the contact lens case for storage. Therefore we have used a plastic material and colorants that are insoluble in water so that it will not come in contact with one's eyes.

These contact lens cases are intended for the storage of soft (hydrophilic) and hard contact lenses. The case should ensure the fluids contained do not leak. These cases are for the storage of chemical disinfecting fluids with contact lenses only, they are not to be used in heat disinfection. These are not sold sterile, so the packaging should have instructions written on them to "Rinse the case thoroughly with clean solution before use".

It is recommended to replace the contact lens case at least every 3 months.

This document describes the premarket notification (510(k)) for several contact lens cases. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not directly applicable or available in this document.

However, I can extract the relevant information and indicate where data is not provided for questions that are typically relevant to AI/diagnostic device submissions.

The Device:

Ni Hau Industrial Co., Ltd. Contact Lens Cases (Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eyes Contact Lens Case)

Acceptance Criteria and Reported Device Performance

The document doesn't define quantitative acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI or diagnostic devices. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a legally marketed predicate device by fulfilling manufacturing, material, and functional requirements.

The "reported device performance" is implicitly that the device meets the same safety and performance characteristics as the predicate device. The comparison focuses on physical properties, intended use, and biocompatibility.

Study Information

The document describes a submission for substantial equivalence based on a comparison to a predicate device, not a de novo study demonstrating the clinical performance of a diagnostic or AI device. Therefore, many of the typical study parameters for such devices are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or algorithm output. The "test set" would implicitly refer to the contact lens case prototypes themselves. The provenance of the materials (ABS plastic, pigments) is provided by manufacturer and product name (e.g., Chi Mei Corporation, Cabot Plastics, DuPont), and the manufacturing location is Taiwan.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic output is not established here. Compliance with international standards (e.g., ISO 10993 for biocompatibility) is used as evidence of safety, which would be evaluated by qualified testing laboratories.

3. Adjudication method for the test set: Not applicable. No diagnostic outputs to adjudicate.

4. 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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established device safety and manufacturing standards, and demonstrated equivalence to a legally marketed predicate device. This includes:

   • Material specifications (e.g., ABS composition, insolubility of pigments).
   • Physical design specifications (e.g., screw lids for leak-proofing, well capacity).
   • Biocompatibility test results (passing ISO 10993-5, 10993-10, 10993-11). These lab tests provide objective data as "ground truth" for the material's biological safety.

7. The sample size for the training set: Not applicable. This is not an AI device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

The provided text is a 510(k) clearance letter from the FDA for "Non-prescription Sunglasses." This type of document is a regulatory approval, not a scientific study or a report detailing device performance and acceptance criteria.

Therefore, the input document does not contain any information related to:

• Acceptance criteria and reported device performance (in a table or otherwise)
• Sample size or data provenance for a test set
• Number/qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document simply states that the FDA has reviewed the 510(k) submission and determined the device (non-prescription sunglasses) is "substantially equivalent" to predicate devices, thus allowing it to be marketed. The "Indications For Use" section defines what the device is and its purpose, but not performance metrics or studies.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted. The document is an FDA 510(k) clearance letter for "Non-prescription Sunglasses," indicating that the device has been found substantially equivalent to a predicate device. It discusses regulatory matters such as marketing authorization, general controls, and compliance with regulations, but does not include any performance data or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosenstitzed lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosenstitzed lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

This document is a 510(k) clearance letter for "Non-prescription Sunglasses". It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses.

The provided text is a 510(k) clearance letter from the FDA for "Sunglasses." This document is a regulatory approval for the device and does not contain any information about acceptance criteria, device performance studies, or clinical trial details.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study information
6. Standalone performance information
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The letter focuses on the substantial equivalence determination to a legally marketed predicate device, allowing the sunglasses to be marketed. It confirms that the device meets the definition of sunglasses (nonprescription) intended for protection from bright sunlight, as per the "Indications For Use" statement.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, or any studies conducted to prove such criteria.

The provided text is a 510(k) clearance letter from the FDA for a product named "Sunglasses." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

The document does not contain any technical specifications, performance metrics, clinical study design, or results. It is a regulatory approval document, not a scientific report detailing device performance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria, as that information is not present in the provided input.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

The provided document is a 510(k) clearance letter for "Sunglasses" (non-prescription) and an "Indications For Use" statement. It does not contain information about acceptance criteria for a medical device or a study proving that a device meets such criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.

The document primarily focuses on:

• Device: Sunglasses (non-prescription)
• Regulatory Classification: Class I, Product Code 86 HQY
• Indication for Use: To protect eyes from bright sunlight, not for refractive corrections, usually available over-the-counter.
• Regulatory Decision: Substantially equivalent to pre-amendment devices, subject to general controls.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

The provided document is a 510(k) clearance letter from the FDA for non-prescription sunglasses. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for medical device performance evaluation.

This letter primarily focuses on the device's classification and its substantial equivalence to pre-amendment devices, allowing it to be marketed. It does not delve into the technical performance details or the studies conducted to establish that performance.

Therefore, I cannot provide the requested information based only on the input text. The information requested (acceptance criteria, study details, expert involvement, etc.) would be found in the 510(k) submission itself, not in the clearance letter.

Ask a specific question about this device

Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

Not Found

This document is a letter from the FDA regarding a 510(k) premarket notification for "Sunglasses." It primarily addresses the regulatory status and substantial equivalence of the device, rather than providing a study on performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance

• Cannot be extracted. The document is a regulatory approval letter, not a device performance study report. It does not list any specific acceptance criteria or performance metrics for the sunglasses.

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

• Cannot be extracted. No test set or data provenance is mentioned as this is not a study report.

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)

• Cannot be extracted. No ground truth establishment or expert involvement for a test set is discussed.

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

• Cannot be extracted. No adjudication method is mentioned.

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

• Cannot be extracted. This document predates widespread AI development for medical devices and does not describe any MRMC studies or AI involvement. The device is "Sunglasses," not an AI-powered diagnostic tool.

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

• Cannot be extracted. No algorithm or standalone performance is discussed.

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

• Cannot be extracted. No ground truth for performance evaluation is mentioned. The "ground truth" implied by the 510(k) process is the existence of legally marketed predicate devices that the new device is substantially equivalent to.

8. The sample size for the training set

• Cannot be extracted. No training set is mentioned.

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

• Cannot be extracted. No training set or its ground truth establishment is discussed.

Summary:

This document is solely an FDA 510(k) clearance letter confirming that "Sunglasses" manufactured by Elegance Optical Mfy. Ltd. are substantially equivalent to pre-amendments devices. It does not contain any information regarding performance studies, acceptance criteria, test sets, or ground truth establishment.

Ask a specific question about this device

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

This document is a 510(k) clearance letter for "Sunglasses" (K973526) from the FDA dated October 16, 1997. It is a regulatory approval document and does not contain information about acceptance criteria or performance studies for the device.

Specifically, the document states:

• The device is "substantially equivalent" to predicate devices marketed before May 28, 1976.
• The indications for use are: "Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter."

Therefore, based on the provided text, I cannot answer any of the questions about acceptance criteria or performance studies. This type of information is typically found in the 510(k) submission itself, not the clearance letter.

Ask a specific question about this device