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Ophthalmic sponge drains are used during surgery to protect delica tissue from trauma, absorb fluids, and to act as a filter to aspirate.

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I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for the Ultracell Suction Sponge, which is a medical device used in ophthalmic surgery. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not include any details about:

• Acceptance criteria or reported device performance for a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Types of ground truth used.
• How ground truth for a training set was established.

This document is a regulatory approval, not a technical report on a device's performance study.

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Neuro sponge drains are used during surgery to protect brain tissue from trauma, absorb fluids and to act as a filter to aspirate.

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The provided documents are FDA letters regarding the 510(k) premarket notification for the "Ultracell Suction Sponge" (K972633 and K972634). These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The letters from the FDA specifically state that the devices are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. This type of FDA clearance (510(k)) generally relies on demonstrating substantial equivalence to a predicate device rather than on the detailed clinical performance data often required for new higher-risk devices or premarket approval (PMA).

Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval based on substantial equivalence, not on the detailed technical or clinical study data.

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Sponge drains are used during surgery to protect delicate tissue from trauma, absorb fluids and to act as a filter to aspirate

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Ultracell Suction Sponge" and indicates that the device has been found substantially equivalent to predicate devices. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.

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

Ask a specific question about this device