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The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set intended for vempuncture to obtain blood specimens from patients. The device is connected to a syringe or evacuated blood collection tube for collection of the specimen.

The Ultraflo-R Push Button Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for patient populations over 2500 grams with consideration given to patient size, appropriateness for the solution being infused and duration of therapy.

After completion of the blood draw or infusion, the recommended use of the device is to depress the button on the top of the device to activate needle retraction into the device prior to removal from the venipuncture site. This is a one-handed activation of the safety feature. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needle-stick injury.

The device is not used for a diagnostic or treatment purpose.

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This FDA clearance letter for the UltraFlo-R Push Button Blood Collection Set (K220458) does not contain the information you've requested regarding acceptance criteria or the study that proves the device meets those criteria.

The provided document is a 510(k) clearance letter, which means the device has been determined to be substantially equivalent to a legally marketed predicate device. This determination is typically based on a comparison of technological characteristics and safety/effectiveness data to a predicate device, rather than a detailed presentation of novel clinical study results against specific performance acceptance criteria.

Here's why the requested information is absent:

• Type of device: The UltraFlo-R is a blood specimen collection device, which is a relatively low-risk device (Class II). For such devices, the FDA often relies on performance testing and comparison to predicate devices, rather than large-scale clinical trials with extensive ground truthing by experts.
• Nature of the document: This is a clearance letter, a summary of the FDA's decision, not the full 510(k) submission which would contain the detailed testing reports.
• Focus of the letter: The letter primarily focuses on the administrative details of the clearance, regulatory class, and general controls applicable to the device. The "Indications for Use" section (page 4) describes how the device is intended to be used but does not specify performance metrics or acceptance criteria for a study.

Therefore, I cannot extract the following from the provided text:

1. Table of acceptance criteria and reported device performance: This is not present in the clearance letter.
2. Sample size, data provenance, number of experts, qualifications, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, or how training ground truth was established: None of this information regarding specific studies or expert reviews is included in this document.

For this type of information, one would typically need to review the actual 510(k) submission, which is a much more detailed document submitted by the manufacturer to the FDA.

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