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The Ivalon® Instrument Wipe and PVA Knife Cleaning Block are used to clean surgical instruments and knives.

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The provided document is a 510(k) clearance letter from the FDA for the Ivalon Instrument Wipe and Ivalon Knife Cleaning Block. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a notification of an administrative change related to a previous substantial equivalence (SE) determination, and the initial SE letter itself. These documents confirm that the devices are substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices, and therefore can be marketed. They discuss regulatory compliance such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information as it is not present in the given text.

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The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.

The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.

I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, ground truth, or an MRMC comparative effectiveness study.

The document consists of a 510(k) premarket notification letter from the FDA to Shippert Medical Technologies Corporation regarding their EXPANDACELL™ Instrument Wipe. It primarily addresses the device's regulatory classification and substantial equivalence to existing devices.

The key points from the provided text are:

• Device Name: EXPANDACELL™ Instrument Wipe
• Regulatory Classification: Class I
• Product Code: GEC (Manual surgical instrument for general use)
• Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
• Basis for Equivalence: The summary of safety and effectiveness information (page 4) states that the device is "identical to existing medical devices" (K920355, K791736, and others by Ultracell, SomedMerocel, and Smith and Nephew) and is "identical in intended use, materials, anatomic model... population, physical safety, biocompatibility and performance to the predicate device."
• Indication for Use: "The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure."

The document does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or detailed performance metrics. It relies on the claim of substantial equivalence to previously cleared devices rather than providing new performance study data.

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