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The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.

The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion. The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling. The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a sterile, single-use device that consists of the following components: Needle Protector, Cannula, Hub, Wing, Antineedle Stick Protector "K-Shield", Tubing, Needleless Access Connector (NAC) Y-Site, Clamp, Blood Bag Unit Reservoir.

The provided text describes a 510(k) summary for the Kawasumi Laboratories Blood Drawing Kit (BDK) System. It lists various non-clinical performance tests conducted to demonstrate substantial equivalence to a predicate device, but it does not include acceptance criteria or reported device performance in a table format, nor does it detail a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML device.

The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device (K001043) by showing similar technological characteristics and by conducting standard performance and biocompatibility tests for medical devices. It does not describe a study that uses a 'test set' with 'ground truth' established by experts, as would be relevant for an AI/ML device's performance evaluation.

Therefore, many of the requested details (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set size, and ground truth establishment for training) are not applicable to the information provided in this document, which pertains to a traditional medical device (a blood drawing kit) rather than an AI/ML-powered one.

However, I can extract the information provided about the non-clinical performance testing which serves as the "study" for this device, and list the categories of tests that were performed.

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

The document does not provide a table of acceptance criteria with specific numerical targets and corresponding reported device performance values. Instead, it lists categories of non-clinical tests that were performed to demonstrate substantial equivalence. The implication is that the device passed these tests, thereby meeting the implicit acceptance criteria for each test type, which are typically defined by the referenced standards.

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

The document does not specify
sample sizes for the individual non-clinical performance tests nor the data provenance. These tests are typically conducted in a laboratory setting by the manufacturer or a contract research organization.

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)

Not applicable. The device is a traditional physical medical device (blood drawing kit), not an AI/ML device that requires expert-established ground truth for a test set.

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

Not applicable. This is not an AI/ML device for which adjudication methods for expert disagreement would be relevant.

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

Not applicable. This is a traditional medical device; MRMC studies relate to AI/ML image interpretation or diagnostic tools.

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

Not applicable. This is a traditional medical device; standalone algorithm performance is relevant for AI/ML devices.

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

For a blood drawing kit, "ground truth" would relate to meeting physical, chemical, and biological performance specifications outlined in recognized standards. This is demonstrated through objective laboratory testing rather than expert consensus on diagnostic outcomes. The "ground truth" is adherence to established engineering and medical device standards.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML device.

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