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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 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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INTENDED TO BE WORN BY CHILDREN TO PROTECT THE EYES FROM SUNLIGHT.

Not Found

The provided FDA document is a 510(k) clearance letter for "Sunglasses" (K972014), issued in 1997. This type of document confirms that a device is substantially equivalent to a legally marketed predicate device, meaning it's generally safe and effective for its intended use.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Here's why this information is absent:

• Device Type: Sunglasses, especially those intended for children, are generally considered low-risk devices. For such devices, the FDA typically relies on substantial equivalence to predicate devices rather than requiring extensive clinical trials or performance studies with detailed statistical metrics as would be expected for high-risk medical devices or AI/ML-driven diagnostics.
• 510(k) Process: The 510(k) pathway primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. While some performance data might be submitted, it's often related to basic safety standards (e.g., UV protection levels, material safety) and not the kind of detailed clinical performance data (sensitivity, specificity, AUC) typically found in submissions for AI-based medical devices or more complex diagnostics.
• Date of Document: The document is from 1997, predating the widespread use and regulation of AI/ML in medical devices. The methodologies for evaluating AI performance (e.g., test set sizes, ground truth establishment with multiple experts, MRMC studies) were not relevant to the review of sunglasses at that time.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The document confirms market clearance for a device based on substantial equivalence, but it does not detail the specific performance metrics or studies you've inquired about, which are more pertinent to advanced medical technologies, particularly those involving AI.

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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 text describes a 510(k) submission for "Sunglasses" (K971707) and the FDA's determination of substantial equivalence. However, it does not contain the specific information required to answer your questions about acceptance criteria, device performance, study details, or ground truth establishment.

This document is a regulatory approval letter, not a technical report or clinical study summary. It confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed but does not provide details about performance testing or validation studies with specific metrics.

Therefore, I cannot populate the table or provide answers to the questions based solely on the provided text.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device