Search Results

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 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 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

Non-prescription sunglasses are for general use to protect eyes from strong sunlight

Not Found

The provided text is a 510(k) premarket notification approval letter from the FDA for "Sunglasses." This type of document is a regulatory approval, not a scientific study describing device performance and acceptance criteria.

Therefore, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, etc.) can be extracted from the provided text. The letter simply states that the device (sunglasses) is substantially equivalent to legally marketed predicate devices and can proceed to market.

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

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 related to a 510(k) premarket notification for "Venneto Sunglasses." This type of regulatory document, particularly for Class I devices like sunglasses, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with acceptance criteria, human-in-the-loop performance, or AI assistance.

Therefore, the input does not contain information about:

• Acceptance criteria and reported device performance in a table format.
• Sample sizes for test sets, data provenance, ground truth establishment, or training sets.
• The number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• The type of ground truth used (pathology, outcomes data, etc.).

The document solely confirms that the Venneto Sunglasses are classified as a Class I device and are substantially equivalent to pre-amendment devices, allowing them to be marketed under general controls.

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