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Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

Light Drape (accessory to Neonatal Phototherapy Light)

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Light Drape." This document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device." This indicates that the FDA has found the device to be substantially equivalent to a predicate device, which means it likely does not require extensive new clinical studies or detailed performance metrics to be established for market approval.

The "Indications for Use" section (Image/page/2) merely states: "Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures." This is a functional description, not a performance claim that would necessitate specific acceptance criteria or a study with the details requested.

Therefore, I cannot populate the requested information from the provided document.

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Incubator Capes are designed to cover and enhance the outer appearance of an incubator.

Incubator Cover (accessory to Incubators)

The provided text is a 510(k) clearance letter from the FDA for an "Incubator Cape." This document does not contain information about acceptance criteria or a study proving device performance as described in your request.

The letter explicitly states: "we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing devices that it does not require a new study to prove its safety or effectiveness. The purpose of a 510(k) notification is to demonstrate substantial equivalence, not to provide new performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

If you have a different document that details performance studies and acceptance criteria for a medical device, please provide it, and I will do my best to extract the information you need.

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