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BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient's subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient's peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

BD Saf-T-Intima™ Subcutaneous Catheter System is an over-the-needle subcutaneous and intravenous (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle attached to a wire stylet, wings for insertion assistance and catheter securement, integrated extension tubing, a clamp, a single or dual port, a BD ® PRN Adapter, vent plug (dual port only), and a needle shield. The needle and catheter are protected by a needle cover.

BD Saf-T-Intima™ Subcutaneous Catheter System is designed to keep blood contained within the device throughout the insertion process. The needle is passively protected when it is removed, reducing the risk of accidental needlestick injury. Both the wings and single port or dual port are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue).

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BD Nexiva™ Closed IV Catheter System - Single Port

BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva™ Closed IV Catheter System - Dual Port

BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva™ Closed IV Catheter Systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and pre-attached needle-free connector (BD Q-Syte™ or BD MaxZero™) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte™ Needle-free Connector, BD MaxZero™ Needle-free Connector, or end cap with protective cover is provided in the unit package (not available with all configurations).

The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices have BD Instaflash™ needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).

The provided 510(k) clearance letter and summary discuss the BD Nexiva™ Closed IV Catheter System, not an AI/ML medical device. Therefore, information regarding acceptance criteria, study details, and ground truth establishment pertinent to AI/ML device performance (sample sizes, expert consensus, MRMC studies, etc.) is not available in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K183399) through performance testing of the physical catheter system, rather than validating an algorithm's diagnostic or predictive capabilities.

The performance tests mentioned are:

• Frequency Response Testing
• Kink Resistance Testing
• Blood Fill Time Testing
• ISO 80369-7 Testing
• ISO 11607-1 Testing

However, the specific acceptance criteria and detailed reported performance results for these tests are not explicitly listed in a tabular format, nor are sample sizes, ground truth methodologies, or expert involvement for these physical device performance tests detailed as one might expect for an AI/ML device. The document only states that the device "met all predetermined acceptance criteria for the above-listed performance tests."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device as the input document describes a physical medical device.

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BD Cathena™ Safety IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ catheter, a needle, a grip, a passive safety needle shield, and a flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. BD Cathena™ Safety IV Catheter has BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

BD Cathena™ Safety IV Catheter is available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.

BD Cathena™ Safety IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).

The FDA 510(k) clearance letter for the BD Cathena™ Safety IV Catheter (K251155) indicates that the submission is for manufacturing changes (new colorant supplier, new needle lubricant supplier) and the creation of new performance specifications for existing indications for use (blood sampling and blood pressure monitoring) rather than a novel AI/ML device. Therefore, a traditional acceptance criteria and study proving device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or standalone algorithm performance, as typically understood in AI/ML medical devices, is not applicable here.

However, based on the provided document, the acceptance criteria and supporting studies are related to demonstrating that the modified device maintains substantial equivalence to its predicate for its stated indications for use, including the new performance specifications.

Here's an interpretation of the relevant information provided:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood as the "predetermined design requirements" that the device must meet. The document states that the subject device met all predetermined acceptance criteria for the listed performance tests, demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance criteria are not explicitly detailed in this summary for each test, but the successful completion of these tests serves as evidence of meeting those criteria.

II. Sample Size and Data Provenance for Test Set

The document does not specify exact sample sizes for each performance test (e.g., number of catheters tested for Blood Fill Time, Kink Resistance, or Frequency Response). However, it implies that sufficient samples were tested to "ensure that the subject device meets pre-determined design requirements."

The "test set" in this context refers to the samples of the subject device used for physical and functional testing. The provenance of these samples would be prospective, as they are newly manufactured devices undergoing verification for the submission. No information is provided regarding the country of origin of this test data, but it would typically be generated at the manufacturer's testing facilities or authorized contract labs.

III. Number of Experts and Qualifications for Ground Truth

This question is not applicable in the context of this 510(k) submission. This is not a study assessing diagnostic or predictive performance requiring expert interpretation for ground truth. The "ground truth" for the performance tests (e.g., Blood Fill Time, Kink Resistance) is established through standardized laboratory measurement methods and engineering specifications, not expert consensus on medical images or clinical outcomes.

IV. Adjudication Method for Test Set

Not applicable. As described above, the tests are objective physical and functional performance assessments, not subjective interpretations requiring adjudication.

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

No. An MRMC study is typically conducted for diagnostic imaging devices or AI tools where human readers are interpreting cases. This submission is for an intravascular catheter, a physical medical device. The "new performance specifications" are related to the physical and functional characteristics of the catheter (e.g., how quickly blood fills, how well it resists kinking for pressure monitoring), not to aiding human interpretation of medical data. Therefore, a study comparing human readers with and without AI assistance is not relevant or reported here.

VI. Standalone (Algorithm Only) Performance

Not applicable. The BD Cathena™ Safety IV Catheter is a physical medical device and is not an AI algorithm. Its performance is assessed through physical and functional bench testing.

VII. Type of Ground Truth Used

The "ground truth" here is based on engineering specifications and standardized test methods. For example:

• Blood Fill Time: Measured against a specific time objective.
• Frequency Response: Measured against a defined physiological frequency range for accurate blood pressure monitoring.
• Kink Resistance: Measured against criteria for maintaining lumen patency under stress.
• Biocompatibility: Assessed against ISO 10993 standards.
• Sterilization: Assessed against ISO 11135 standards.
• Luer Connections: Assessed against ISO 80369-7 standards.

These are objective, quantitative measurements derived from established industry standards and internal design requirements, not from clinical outcomes, pathology, or expert consensus in a diagnostic sense.

VIII. Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this type of device submission.

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The BD Vacutainer® Eclipse™ Blood Collection Needle is a sterile, single-use, medical device specifically intended to be used by healthcare professionals experienced with venipuncture on adults and children in accordance with the instructions for use for the collection of multiple venous blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needlesticks.

The BD Vacutainer® Eclipse™ Blood Collection Needle includes a one-piece double-ended needle/cannula fixed to a plastic hub. One end of the cannula is the intravenous (IV) end, and the other is the non-patient (NP) end covered with a sleeve. The whole device is encased in two plastic covers; one at each end of the cannula to protect the device, with a tamper-evident seal placed around the plastic covers. The protective cover/cap is provided to prevent damage and maintain the needle sterility before the point of use. A safety shield is connected to a hinge on a collar attached to the hub. The safety shield is manually activated by locking over the needle after removal from the vein, providing protection from accidental needlestick injuries.

The BD Vacutainer® Eclipse™ BCN consists of:

• Double-ended hollow stainless-steel cannula
• Threaded polystyrene hub
• Polystyrene collar
• Protective needle sleeve that interrupts blood flow between filling multiple tubes
• Safety shield that can be activated to cover the needle immediately after venipuncture to protect against accidental needle sticks during normal handling and disposal
• Pre-attached holder (for user convenience in some models)

The BD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder (PAH) consists of a BD Vacutainer® Eclipse™ Blood Collection Needle threaded and bonded to a BD Vacutainer® One Use Holder. The Eclipse™ BCN with PAH allows for the immediate use of the product without the need for assembling the two components. This provides increased convenience to the user and is designed to help minimize the exposure of the user to the non-patient (NP) end of the needle.

The provided FDA 510(k) clearance letter and summary for the BD Vacutainer® Eclipse™ Blood Collection Needle confirm its clearance based on substantial equivalence to a predicate device. However, this document does not contain specific acceptance criteria, reported device performance data, detailed study designs, or ground truth information typical of a clinical performance study for an AI/ML medical device.

The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and biocompatibility testing, rather than clinical trials comparing diagnostic accuracy or AI performance.

Therefore, many of the requested details for an AI/ML device study, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and training set details, are not applicable or not provided in this type of submission.

Here's a breakdown based on the information available in the document, acknowledging the limitations for an AI/ML device context:

Device: BD Vacutainer® Eclipse™ Blood Collection Needle

The submission is for a medical device (blood collection needle) and not an AI/ML driven diagnostic device. Therefore, the detailed breakdowns requested for AI/ML performance studies are largely not applicable. The provided document details non-clinical performance and biocompatibility studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document performs non-clinical (engineering and material) tests to demonstrate that the device meets design specifications and relevant standards. The "acceptance criteria" are implied by compliance with these standards and successful completion of the tests.

Specific AI/ML Study Details (Not Applicable for this Device)

As this is a traditional medical device (blood collection needle) and not an AI/ML driven diagnostic device, the following points are not applicable and therefore, no information is provided in the document:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance was evaluated through non-clinical bench testing and material compatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is based on engineering specifications, material standards, and validated testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is for an AI/ML comparative study, which this device is not.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is established by engineering specifications, international standards (e.g., ISO, AAMI), material properties, and validated test methods.
8. The sample size for the training set: Not applicable. There is no AI/ML model for this device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates the BD Vacutainer® Eclipse™ Blood Collection Needle meets its acceptance criteria through a comprehensive set of non-clinical performance tests and biocompatibility evaluations, ensuring it is safe and effective and substantially equivalent to a predicate device. The information requested regarding AI/ML specific study details is not part of this type of traditional device approval process.

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BD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.

BD Insyte™ Autoguard™ Shielded IV Catheter incorporates BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey, 14 GA (2.1 mm) = Orange).

BD Insyte™ Autoguard™ Shielded IV Catheter facilitates the introduction of guidewires and other vascular access devices. The following labeled gauge sizes correspond to the following inside diameter (ID): 24 GA (0.40 mm ID), 22 GA (0.55 mm ID), 20 GA (0.7 mm ID), 18 GA (0.8 mm ID), 16 GA (1.2 mm ID), and 14 GA (1.6 mm ID).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.

The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.

BD Insyte™ Autoguard™ BC Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ BC Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.

The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

This document is a 510(k) clearance letter for three IV catheter devices, indicating that they are substantially equivalent to a previously cleared predicate device (K201075). It describes the changes made (new performance specifications and revised IFU) and provides a summary of performance tests conducted.

However, it does not contain the detailed acceptance criteria and reported device performance information that you specifically asked for in a table, nor does it describe a study that "proves the device meets the acceptance criteria" in the format of a clinical trial or algorithm validation study. The document primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on bench testing and comparisons of technological characteristics, rather than extensive clinical studies or AI algorithm performance validation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it is not present. Similarly, information regarding sample sizes for test/training sets, data provenance, expert ground truth adjudication for AI, MRMC studies, standalone algorithm performance, or training set ground truth establishment is not applicable or not provided within this 510(k) clearance document, as it pertains to a physical medical device (IV catheter) and not an AI/ML-driven device.

The study described to demonstrate substantial equivalence consists of bench testing to verify new performance specifications and ensuring compliance with relevant ISO and ASTM standards.

Here's an overview of the information that is available in relation to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in this document. The document states that "the subject device met all predetermined acceptance criteria for the above-listed performance tests," but it does not specify what those acceptance criteria were (e.g., specific thresholds or ranges for frequency response, kink resistance, or blood fill time). It also does not present the numerical results ("reported device performance") of these tests.

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

• Not applicable / Not provided. The document describes bench testing of physical devices, not an AI/ML system or a clinical study with a "test set" of patients or data in the context of AI validation.

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

• Not applicable / Not provided. This information is relevant for AI/ML device validation and is not present for this physical medical device.

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

• Not applicable / Not provided. This information is relevant for AI/ML device validation and is not present 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:

• No. This is not an AI/ML device, so an MRMC study is not relevant.

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

• No. This is not an AI/ML device.

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

• Not applicable / Not provided. For the performance tests listed (Frequency Response, Kink Resistance, Blood Fill Time, Catheter Separation Force), the "ground truth" would be the direct measurements obtained from the physical properties of the devices themselves, compared against pre-defined engineering specifications.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device.

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

• Not applicable / Not provided. This is not an AI/ML device.

Summary of Performance Tests and Compliance (as described in the document):

The document states that a risk analysis was conducted to assess the impact of modifications. When technological characteristics were identical to the predicate, results from the predicate were applied. For other aspects, the following tests were conducted:

BD Internal Requirements:

• Frequency Response Testing: To support blood pressure monitoring indications.
• Kink Resistance Testing: To support blood pressure monitoring indications.
• Blood Fill Time Testing: To support blood sampling indications.
• Catheter Separation Force: (No specific indication mentioned, but likely related to structural integrity during withdrawal)

Compliance with Standards Testing:

• Luer Testing: According to ISO 80369-7 (Small-bore connectors for liquids and gases in healthcare applications).
• Packaging Testing: According to ISO 11607-1, ASTM F2096-11 (for gross leaks), and ASTM F88/F88M-15 (for seal strength).
• Biocompatibility: According to ISO 10993-1 (general biological evaluation) and ISO 10993-5 (for in vitro cytotoxicity).

Conclusion: The document explicitly states: "Per the design control requirements specified in 21 CFR §820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices." This indicates that the tests were performed and the results aligned with the internal and regulatory specifications, affirming the device's substantial equivalence.

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BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva™ Diffusics™ Closed IV Catheter Systems (Nexiva Diffusics) and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Nexiva Diffusics with Max Zero) are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ Catheter Material with three side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package.

A BD MaxZero™ device with protective cover is provided in the unit package for BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector kit. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needle stick injury.

These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).

The provided FDA 510(k) clearance letter and summary for the BD Nexiva™ Diffusics™ Closed IV Catheter System does not contain information related to software, artificial intelligence, or diagnostic imaging. Therefore, it is impossible to describe acceptance criteria and study details related to a device using AI, ground truth, expert readers, or sample sizes for training/test sets as requested in the prompt.

The document pertains to a physical medical device (an IV catheter system) and its substantial equivalence to predicate devices, focusing on:

• Indications for Use: Changes to include "blood pressure monitoring indication" for one of the devices.
• Physical Characteristics: Materials, dimensions, sterilization, and packaging components.
• Performance Testing: Mechanical and functional tests relevant to IV catheters (frequency response, kink resistance, blood fill time, luer lock performance, packaging integrity).

There is no mention of:

• A device that uses AI.
• Any form of image analysis, signal processing, or diagnostic output that would require a "test set," "ground truth," "expert consensus," "human-in-the-loop performance," or "MRMC comparative effectiveness study."
• Specific acceptance criteria percentages for sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device performance.
• Training or test data sets, data provenance, or the number/qualifications of experts for labeling or adjudication.

The questions in the prompt are designed for a different type of medical device submission, specifically those involving software as a medical device (SaMD) or AI/machine learning components for diagnostic or prognostic purposes.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information.

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CentroVena Central Venous Catheter (CVC)

Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

• 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

CentroVena One Insertion System

The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters. Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

• 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
• 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

Vena Central Venous Catheters are power-injectable, constructed of medical grade polyurethane and designed for insertion into the central venous system. The central venous catheters are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with other applicable insertion kit accessories.

The CentroVena One Insertion System integrates the essential components for placing central venous catheters. It combines an introducer needle with a passive needle tip safety mechanism, syringe, guidewire, and self-dilating catheter into one unit. The device is preassembled and also has an integrated drape clip permanently attached to the guidewire designed to keep the system organized in the sterile field and prevent guidewire embolism.

The provided document is a 510(k) clearance letter for a medical device: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System.

Important Note: The document is primarily a regulatory approval and comparison to a predicate device. It lists numerous "acceptance criteria" through reference standards and tests, but it does not provide the specific numerical results or performance metrics that demonstrate the device quantitatively meets these criteria. It also doesn't detail specific study designs for these tests beyond listing the reference standards.

Therefore, the following information will be extracted where explicitly stated or inferable from the document. Many aspects of a detailed study design (like sample sizes for performance tests, expert qualifications, adjudication methods, or specific effect sizes for human performance improvement with AI) are not typically included in a 510(k) summary for a physical medical device like a catheter and related insertion system as they are more relevant to AI/software as a medical device studies.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System underwent various performance and safety tests to demonstrate substantial equivalence to its predicate device, the BD Acute Central Line (K190855). The acceptance criteria for the device are primarily derived from compliance with recognized industry consensus standards and FDA guidance documents. The studies involved functional performance testing, biocompatibility testing, and evaluation of the insertion system.

1. Table of Acceptance Criteria (as indicated by reference standards) and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each of the numerous tests conducted. The testing described is typical for physical medical devices and usually involves a statistically relevant number of units/components for each specific test to ensure robust results.

The data provenance is not explicitly stated beyond the fact that these are tests conducted by Becton Dickinson Inc. (BD) to support their 510(k) submission. These would generally be pre-market, prospective tests conducted in a controlled laboratory environment. The country of origin of the data is not mentioned but would presumably be where BD's testing facilities are located.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable and not provided in the document. The device is a physical catheter and insertion system, not an AI/software device that requires expert labeled ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the established scientific and engineering principles outlined in the reference standards themselves.

4. Adjudication Method

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies where human readers are interpreting images or data and their decisions need to be reconciled to establish a ground truth, often for AI performance evaluation. This is not relevant for the type of bench and performance testing documented here.

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

No MRMC study was done or is mentioned. This type of study is specifically designed for evaluating the performance of diagnostic devices, especially those involving human interpretation (e.g., radiology AI aids), and comparing human performance with and without AI assistance. This device is a physical medical instrument, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical instrument, not an algorithm or software requiring standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is established by:

• Established Industry Consensus Standards: Such as ISO 10993, ISO 10555, ASTM F640, etc. These standards outline methodologies and acceptable performance limits for specific characteristics of medical devices.
• FDA Guidance Documents: Which also provide testing recommendations and performance expectations for device types.
• Engineering Specifications and Design Requirements: The device must meet its own design specifications, which are based on the intended use and safety considerations, often derived from the above standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set. The tests performed are for verification and validation of the manufactured device.

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

Not applicable. As there is no training set for this type of device, no ground truth needs to be established for it.

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The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.

The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood.

The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles.

Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised.

The device consists of the following components:

• Non-patient (NP) Cannula
• Sleeve
• Luer Hub
• NP Shield
• IV Shield
• Epoxy

Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.

This document is a 510(k) premarket notification for a medical device, the BD Vacutainer® Multiple Sample Luer Adapter (K243649). It details the device's characteristics, intended use, and a comparison to a predicate device (K991088) to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (a luer adapter) used for blood collection, not an AI/software-based medical device that would typically involve acceptance criteria related to algorithmic performance metrics like sensitivity, specificity, or image analysis. Therefore, much of the requested information (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of device submission.

Instead, the "acceptance criteria" for a physical device like this are met through a series of non-clinical performance tests, biocompatibility testing, and sterilization validation. The "study that proves the device meets the acceptance criteria" refers to the entire battery of these tests.

Here's a breakdown of the applicable information:

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

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values for each test. Instead, it states that the tests were conducted to "verify that the subject device met all design specifications and performance standards" and "demonstrates acceptable performance." The acceptance criteria are implicitly defined by the relevant standards and internal design specifications, and the "reported device performance" is summarized as having met these.

However, we can list the types of tests performed, which serve as the basis for the performance evaluation:

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

The document does not explicitly state the sample sizes used for each of the non-clinical performance tests. These types of tests often follow specific ISO or ASTM standards that prescribe minimum sample sizes for statistical confidence, but the exact numbers are not detailed in this summary.

• Data Provenance: The tests were conducted internally by Becton Dickinson and Company. The provenance would be the manufacturer's own testing facilities. No information regarding country of origin of data or retrospective/prospective status is relevant, as this concerns bench testing of physical prototypes/production samples, not patient data.

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

This question is not applicable as the device is a physical, mechanical medical device. "Ground truth" in this context is established through engineering and scientific measurements and adherence to recognized performance standards (e.g., ISO, EN standards), not through expert consensus on interpretation of data like medical images.

4. Adjudication method for the test set

This question is not applicable for the same reasons as point 3. No adjudication of expert opinions or subjective interpretations is involved.

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 question is not applicable. The device is a physical blood collection adapter, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical blood collection adapter, not an algorithm.

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

For a physical device, the "ground truth" is based on:

• Engineering specifications and tolerances: The physical dimensions, material properties, and functional capabilities must meet predefined engineering standards.
• Regulatory standards: Adherence to international standards (e.g., ISO, EN) for medical devices, manufacturing quality, biocompatibility, and sterilization.
• Predicate device performance: The new device must perform comparably to the predicate device in relevant tests.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a physical device, not an AI algorithm that undergoes machine learning training.

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

This question is not applicable for the same reasons as point 8.

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The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.

The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "PIVO™ Pro Needle-free Blood Collection Device." This document details the device's indications for use, technological characteristics, and comparison to a predicate device, along with a summary of performance tests. However, it does not describe an AI/ML powered device or a study involving human experts for ground truth establishment, MRMC studies, or training/test set sample sizes in the context of AI/ML.

The document primarily focuses on establishing substantial equivalence for the device itself (a needle-free blood collection device), specifically for the addition of blood culture collection and an extended shelf life. The performance tests mentioned (e.g., Insertion Test, Blood Leak Test, Package Integrity) are related to the physical and functional aspects of the hardware device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML powered device, the study proving its performance (in terms of AI metrics), sample sizes for AI test/training sets, expert involvement in ground truth, or MRMC studies, as this information is not present in the provided text.

The text does state:

• "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
• "Summary of Performance tests completed on the subject devices were limited to those tests required Performance to support a determination of substantial equivalence to the predicate device."
• "Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance test, demonstrating substantial equivalence to the predicate device."

This indicates that internal performance tests were conducted against pre-determined acceptance criteria, but these are for the physical device's functionality and safety, not for an AI/ML algorithm's diagnostic or predictive performance.

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The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.

The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.

The provided document is a 510(k) Summary for the BD Vacutainer® One Use Holder, a blood specimen collection device. It describes the device, its intended use, and compares it to a predicate device (Greiner Vacuette® Blood Culture Holder).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

This document does not contain information about acceptance criteria and studies that prove a device meets those criteria in the context of an AI/ML medical device. This is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically a blood specimen collection holder.

Here's why the requested information cannot be extracted from the provided text:

• Type of Device: The BD Vacutainer® One Use Holder is a physical, non-sterile, single-use plastic device. It is not an AI/ML-powered software device.
• Study Focus: The "Non-clinical Performance Summary" states that tests were conducted to "verify that the proposed devices met all design specifications and performance standards." This typically refers to mechanical, material, and functional testing for a physical device, not the evaluation of an AI algorithm's performance on a dataset.
• "Clinical Data - Not Applicable": This explicitly indicates that no clinical studies (which would be the source of test sets, ground truth establishment, expert adjudication, etc., for AI/ML devices) were required or performed for this device.
• Absence of AI/ML Specific Terminology: There is no mention of algorithms, machine learning, deep learning, models, training sets, test sets, inference, sensitivity, specificity, AUC, or any other terminology associated with AI/ML device evaluation.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on indications for use, design, materials, and non-clinical performance characteristics relevant to a conventional medical device.

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