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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.

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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.

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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.

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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.

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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

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 the provided text is a 510(k) clearance letter for "Sunglasses" and an "Indications For Use" statement. It explicitly states that the device is "intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections."

This document does not contain information about:

• Acceptance criteria and reported device performance (beyond its intended use as sunglasses).
• Details of any study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details) that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested table or answer the questions based on the input. The document is primarily about regulatory clearance for a non-medical, over-the-counter item, not a device with complex performance metrics requiring such detailed study information.

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 "Sunglasses." This document is a regulatory approval for a medical device and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the letter states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the device was found to be similar enough to existing, legally marketed devices that it did not require extensive new testing to prove safety and effectiveness.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Results of a multi-reader, multi-case comparative effectiveness study.
• Results of a standalone (algorithm-only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

These elements are typically found in a clinical study report or a premarket approval (PMA) application, not in a 510(k) clearance letter for a Class I device like sunglasses, which often relies on established performance standards or comparison to predicates.

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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 marketing clearance letter from the FDA for sunglasses (K972850). It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for AI/device performance evaluation.

Therefore, I cannot provide the requested information based on the provided text. The letter is a regulatory approval, not a scientific study report.

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) premarket notification for "Sunglasses" (K971385). It confirms the device is substantially equivalent to devices marketed prior to May 28, 1976. However, the provided document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory approval letter from the FDA, and it focuses on:

• Acknowledging the 510(k) submission.
• Determining substantial equivalence to a predicate device.
• Outlining the general controls and regulations applicable to the device.
• Confirming permission to market the device.
• Providing contact information for regulatory inquiries.
• Stating the intended use of the sunglasses.

Therefore, I cannot provide the requested information based on 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 intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Sunglasses" and an Indications for Use statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided input. This document is a regulatory communication, not a performance study report.

Ask a specific question about this device