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Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.

The Subject device is a sterile, single-use device that consist of a pressure-rated extension set and the blood culture collection set. The blood culture collection set incorporates a luer connection, flexible tubing, blood lock mechanism, and blood collection holder. The pressure-rated extension set is connected to the blood collection set via the luer connection. The Subject device is provided to the healthcare facility in this configuration. The Peripheral IV (PIV) catheter is connected to the pressure-rated extension set via luer connection. Blood travels through the lumen of the Subject device into the blood lock mechanism where the initial draw of blood (approximately 1ml) is diverted and sequestered. The purpose of the sequestration is to automate the discard volume method (DVM). Once the sequestered volume is diverted and retained, the blood continues travel to the blood collection holder where the blood culture sample is obtained. Once the blood draw process is completed, the blood collection set of the Subject device is disconnected from the pressure-rated extension set and discarded. The pressure-rated extension set is utilized as an infusion system to administer IV fluids, medications, blood and blood products to the patient's vascular system. The pressure-rated extension set is rated to 325 PSI. Various blood collection holders are incorporated with the Subject device to interfaces with marketed blood culture bottles and vails. These blood collection holders are cleared under K912563 (Biomerieux Shield), K950432 (BD Vacutainer), and K081229 (Short Saf-T Holder). The blood collection holder incorporates a needle that is covered by elastomer boot. The culture bottle is inserted into the blood collection holder where the needle punctures the elastomer cap and provides a pathway for the blood to traveling into the culture bottle. The vacuum of the culture bottle pulls the blood. Once completed, the culture bottle is removed and the elastomer boot covers the needle and seals to fluid path.

The provided document is a 510(k) summary for the Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. While it summarizes non-clinical tests performed, it does not include acceptance criteria or a study proving that the device meets specific performance criteria related to diagnostic accuracy, sensitivity, or specificity in the way an AI/ML device study would.

The document details engineering and performance tests relevant to the device's function as a blood collection and infusion system. It confirms that these tests demonstrate substantial equivalence to predicate devices, but it does not present acceptance criteria for diagnostic performance or present a study to meet those criteria.

Therefore, the requested information specifically about acceptance criteria and a study proving achievement of those for a diagnostic device cannot be extracted from this document, as this is a physical medical device clearance, not an AI/ML diagnostic software clearance. Many of the requested fields are not applicable or cannot be found within this document.

However, I can extract information related to the non-clinical tests performed to demonstrate safety and performance of the physical device to establish substantial equivalence.

Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable for this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format for all tests, nor does it detail the specific reported device performance values for each test, other than qualitative statements of substantial equivalence. It lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary. The document describes "non-clinical tests" which typically refer to bench or lab testing, not patient-based studies. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a physical medical device (blood collection and infusion set), not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of bench and performance testing described for this physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as this is a physical medical device, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be the engineering specifications and established performance standards that the device needs to meet (e.g., sterilization efficacy, mechanical strength, flow rates). These are not expert consensus, pathology, or outcomes data, but rather measurable physical properties.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

This is not applicable as this is a physical medical device, not an AI/ML device.

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