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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 blood collection holder for connection to vacuum-based collection vials.

The Subject Device is a sterile, single-use blood culture collection set. The blood collection set incorporates a venipuncture needle assembly that is connected with flexible tubing to a blood lock mechanism that is connected by flexible tubing to a blood collection holder. Blood collection is accomplished by inserting the venipuncture needle into the patient's peripheral vascular system. Blood will travel up the lumen into the blood lock mechanism where the initial draw of blood (approximately 0.15 ml) is held in a side chamber. The purpose of the side chamber is to automate the initial specimen diversion volume method (ISDVM). Once the side chamber volume is retained, the blood upon connection to a vacuum bottle continues to travel up the lumen to the blood collection holder into the attached blood culture bottle/vial.

The Subject Device's venipuncture needle assembly incorporates an active, semi-automatic needlestick safety design where the safety mechanism is activated via a button on the needle hub. When the safety mechanism is activated, a protective shield is deployed. It advances distally to cover the entire length, including the distal tip, of the venipuncture needle. The protective shield is locked in this position protecting the clinician/patient from needlestick injuries. Silicone coating is applied to the outside of the venipuncture needle, which aids in the insertion into the peripheral vascular system.

The Subject Device incorporates various blood collection holders to interact with various types of vacuum-based collection vials.

The Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle, has undergone various evaluations to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a formal table of specific, quantified acceptance criteria for each test. Instead, it lists the types of evaluations performed and implies that the performance met acceptable standards for demonstrating substantial equivalence. The "Reported Device Performance" column below is based on the conclusion stated in the document that the device "has demonstrated it is substantially equivalent... based on the intended use and performance testing conducted."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices or tests performed) for each individual test conducted to support the 510(k) submission. It broadly states that "evaluations were conducted."

The data provenance is implicit: the tests were conducted by Kurin, Inc. to support their premarket notification. Therefore, this would be considered prospective data collected specifically for regulatory submission. There is no information provided about the country of origin for the data collection, but given the company's address in San Diego, California, it is reasonable to infer the testing was likely conducted in the United States or under conditions compliant with U.S. regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number and qualifications of experts for ground truth establishment) is typically not applicable to the evaluation of mechanical or material performance of a blood collection device, which relies on standardized engineering and biological tests rather than expert interpretation of complex clinical data. The "ground truth" for these tests is defined by the passing criteria of the relevant ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are usually relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. For the types of performance and material tests described for this device, which are objective and quantitative, an adjudication method is not applicable. The results are typically pass/fail based on pre-defined criteria from recognized standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided text. MRMC studies are typically employed for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) is compared. This device is a blood specimen collection device, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not done or mentioned. This device is a physical medical device for blood collection, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the various evaluations conducted for this device was established based on recognized industrial standards, international standards (ISO), and FDA guidance documents.

Examples of ground truth sources include:

• AAMI TIR 28 for sterilization.
• ISO 10993-1:2018 for biocompatibility.
• ISO 1135-3:2016 for blood-taking sets.
• ISO 7864:2016 and ISO 9626:2016 for sterile hypodermic needles.
• ISO 23908:2011 for sharps injury protection.
• ISO 11135:2014 for ethylene oxide sterilization.
• ISO 11607-1:2006 for packaging integrity.
• FDA Guidance documents (e.g., Medical Devices with Sharps Injury Prevention Features).

The outcomes of these tests are objective measurements against the specified criteria within these standards.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to the evaluation of this medical device. Training sets are used in machine learning and AI development. The evaluations performed here are for a physical product and its constituent materials and mechanisms.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device evaluation, this question is not applicable.

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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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The Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick.

The safety needle portion of the Angel Tip Safety Intravascular Needle Set will be available in diameters ranging from 14 to 18 Ga and lengths of 1.0 to 1.5 inches.

The Angel Tip Safety Intravascular Needle Sets are sterile, single use devices designed to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick. The Angel Tip Safety Intravascular Needle Set consists of a needle attached to a winged hub, microbore or macrobore tubing, adapter and adapter cap and a safety enclosure that attaches to the winged hub.

As the needle is removed from the patient's vessel, the user's finger actively slides the safety enclosure until it latches onto the needle using a one- or two-handed technique. The user will know the needle is engaged based on the tethers being fully extended and hearing an audible click. The safety enclosure is designed to allow the user's fingers to remain behind the needle point so that the risk of needle stick injury is minimized. The enclosure is clear so the user has a visual means of knowing the needle is captured.

This document does not contain the information required to populate all sections of the request. It primarily pertains to a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed clinical study data with acceptance criteria and reported performance metrics.

Specifically, the document focuses on non-clinical testing for performance aspects like tensile strength, leakage, Luer compatibility, corrosion, force to activate, and force to override, rather than clinical performance for diagnostic or therapeutic accuracy that would require an AI-driven device analysis.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "performance testing (tensile, leakage, Luer, corrosion, force to activate and force to override)" and states these tests "demonstrate that the Angel Tip Safety Intravascular Needle Set is as safe, as effective and performs comparably to the predicate devices." However, it does not provide specific acceptance criteria values or the reported performance data for these tests. Therefore, a table cannot be fully constructed.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not present. The document mentions "nonclinical testing" but does not specify sample sizes for these engineering/material tests, nor does it refer to a "test set" in the context of human or patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not present. The approval is based on substantial equivalence to predicate devices, supported by non-clinical engineering tests, not on an evaluation by experts establishing ground truth for a diagnostic or therapeutic outcome.

4. Adjudication Method:

This information is not present. Adjudication methods are typically relevant for studies involving human interpretation or challenging cases, which is not the nature of the testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not present. This type of study is for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device (needle set) that does not incorporate AI.

6. Standalone (Algorithm Only) Performance:

This information is not present. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests described, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ASTM standards for tensile strength, ISO standards for Luer connections). However, the document does not explicitly state the specific standards or the "ground truth" labels. It implies compliance with predicate device performance.

8. Sample Size for the Training Set:

This information is not present. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not present as there is no training set for this device.

Summary of Available Information (from the document):

• Device Name: Angel Tip Safety Intravascular Needle Set
• Purpose of Review: 510(k) Premarket Notification for substantial equivalence.
• Tests Performed: Nonclinical tests including tensile, leakage, Luer, corrosion, force to activate, and force to override.
• Conclusion: The device is considered substantially equivalent to predicate devices based on "similar indications for use, intended use, fundamental scientific technology and similar design, materials, and manufacturing processes" and the results of the nonclinical testing, which demonstrated it "does not raise new issues of safety or effectiveness."

Conclusion based on the Request:

The provided document details a 510(k) submission for a physical medical device, not an AI or algorithm-driven device. As such, most of the requested information pertaining to acceptance criteria of an algorithm, studies involving human readers, ground truth establishment for AI, and training/test set sample sizes is not applicable or available in this type of regulatory document. The document focuses on demonstrating that the physical safety needle set is as safe and effective as pre-existing, legally marketed predicate devices through engineering and material performance tests, rather than clinical performance data with specific accuracy metrics.

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The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The Winged needle is designed with a safety shield, which can be activated to cover the noodle in houleve inmediately following venipuncture to aid in the protection against accreental in accordance with these instructions. The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set. The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths). The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.

The provided text describes a medical device, the VACUETTE® Safety Blood Collection Set, and its 510(k) summary for FDA approval. However, the document does not contain information regarding acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy), nor does it describe a study to prove the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sherwood Medical Angel Wing™ Safety Blood Collection Set, K912563) based on materials, biocompatibility, and overall performance characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance as it is not present in the provided text. The document primarily addresses regulatory aspects of device approval rather than detailed performance study results against specific metrics.

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