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The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a safety shield and apparatus for connection to vacuum based collection vials.

The Kurin device is a sterile, single use blood culture collection set. The Kurin includes a winged needle with flexible tubing and an attached vial adapter intended for venipuncture to obtain blood culture samples. Kurin is identical in every way to existing sets used to collect blood culture samples except for the insertion into the tubing of the Kurin blood capture chamber. The Kurin blood capture device sequesters the initial draw of blood upon initial venipuncture. The set is provided with a safety shield for covering the used needle prior to disposal. The amount of blood diverted is very small, estimated at a fraction of 1 ml.

The provided document is a 510(k) premarket notification for a medical device called the "Kurin Blood Culture Collection Set." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than proving performance against specific acceptance criteria for diagnostic accuracy or effectiveness in a clinical context. Therefore, the information typically found in acceptance criteria and detailed study descriptions for AI/ML medical devices (like sensitivity, specificity, F1 score, sample size for test sets, expert qualifications, etc.) is not present in this document.

However, I can extract the non-clinical testing performed and present them as "acceptance criteria" and "reported performance" based on how they are described in the document as meeting specifications.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes non-clinical engineering and bench testing, not a clinical test set with patient data. No specific sample sizes for these tests (e.g., number of devices tested for flow rate, leakage, etc.) are provided in the summary. Data provenance is not applicable in the context of clinical populations as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this document describes non-clinical, bench testing, and engineering verification, not a study evaluating expert performance or ground truth established by experts. The "ground truth" here is determined by the specifications of the standards (e.g., ISO, ASTM) and the physical properties of the device.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

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 device is a blood collection set, not an AI/ML diagnostic tool, and no MRMC studies are mentioned.

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

Not applicable. This device is a physical medical device, not an algorithm, and its performance is assessed via non-clinical testing.

7. The type of ground truth used

The "ground truth" for the non-clinical tests described in this document is based on engineering specifications, compliance with international standards (ISO, ASTM), and predefined performance benchmarks (e.g., no leakage, specific flow rates, successful sterilization).

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no training set.

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

Not applicable. There is no training set for this type of device.

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The IMPROSAFE® Blood Collection Sets with Pre-attached to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.

The proposed devices are blood collection sets form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. They are available in different configurations as follows:
IMPROSAFE® Blood Collection Set with Pre-attached holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROSAFE® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., Safety Mechanism, Visible Flash Back
IMPROVACUTER® Blood Collection Set with Pre-attached Holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, N.A., Visible Flash Back
IMPROVACUTER® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., N.A., Visible Flash Back
IMPROSAFE® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, N.A.
IMPROSAFE® Multi Sample Needle (Flashback): Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROVACUTER® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., N.A., N.A., N.A.

The provided text is a 510(k) Summary for several blood collection devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving a device meets specific acceptance criteria through an independent clinical study for AI software.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not provided in this document, as it pertains to medical hardware (needles and collection sets) and not AI software.

However, I can extract information related to non-clinical tests and the general equivalence claims.

Here's the breakdown of the information provided in the document:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pre-defined manner for performance metrics. Instead, it refers to conformity with established international and ASTM standards. The "reported device performance" is essentially that the device "conforms" to these standards.

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

• Not provided. This document does not detail specific sample sizes for non-clinical tests or data provenance. The tests are general compliance tests for medical devices.

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/Not provided. This is not an AI device or a diagnostic device relying on expert interpretation for "ground truth." The tests are for physical/biological properties and compliance with engineering standards.

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

• Not applicable/Not provided. This concept is not relevant to the non-clinical testing of blood collection devices described.

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 device is a blood collection set/needle, not an AI-powered diagnostic tool, so MRMC studies are irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. The "ground truth" for this type of device is compliance with specific material, sterility, performance (e.g., seal strength, endotoxin limits), and biocompatibility standards, as measured by established laboratory test methods.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning device.

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

• Not applicable. There is no "training set" or corresponding ground truth for this type of device.

Summary of the Study (Non-Clinical Test Conclusion) from the document:

The non-clinical tests were conducted to verify that the proposed devices met all design specifications and were Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

• ISO 9626:1991+AMENDMENT 1 2001 (Stainless steel needle tubing)
• ISO 7864: 1993 (Sterile hypodermic needles for single use)
• ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals)
• ASTM F 88/F88M-09 (Seal strength of flexible barrier materials)
• ASTM F1929-12 (Detecting seal leaks in porous medical packaging by dye penetration)
• USP38-NF33 (Bacterial Endotoxins Limit)
• ISO 10993-5:2009 (Biological evaluation - Tests for in vitro cytotoxicity)
• ISO 10993-10:2010 (Biological evaluation - Test for irritation and delayed-type hypersensitivity)
• ISO 10993-11:2006 (Biological evaluation - Tests for systemic toxicity)
• ASTM F 756-13 (Assessment of hemolytic properties of materials)
• Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features

Clinical Test Conclusion:
"No clinical study is included in this submission."

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