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Replacement battery for Spacelabs/ Squibb Vitatek Inc. 119-016-00 Patient Monitor 600 Series, 510(k) Number K844888.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Replacement battery for Spacelabs/ Squibb Vitatek Inc. 119-016-00 Patient Monitor 600 Series, 510(k) Number K844888.

This is a 510(k) clearance letter for a replacement battery, not a medical device that requires clinical performance studies with acceptance criteria, sample sizes, or ground truth. The letter establishes substantial equivalence to a predicate device, meaning it's deemed to have the same intended use and technological characteristics as a device already on the market, and therefore does not require the extensive validation described in your prompt.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and statistical analysis is not applicable to this document. The FDA's review for this device focused on its equivalence to a previously cleared product, as outlined in the letter.

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