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The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD Plastipak™ Syringe is a three-piece, single use, sterile, hypodermic syringe with a 6% (Luer) male connector in 20 mL and 50 mL eccentric luer slip tip configurations. The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Plastipak™ Syringe is provided sterile by Ethylene Oxide Gas (ETO) sterilization method.

The provided text is a 510(k) Clearance Letter for a medical device (BD Plastipak™ Syringe). It details the device's characteristics, intended use, and comparison to a predicate device. However, it does not describe an AI/ML-driven medical device or a study involving human readers or expert consensus for ground truth establishment.

The document discusses bench performance testing and biocompatibility tests for a physical device (syringe), not a software or AI-based diagnostic tool. Therefore, many of the requested criteria (like sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this specific submission.

Despite the irrelevance of some questions to the provided document, I will structure the answer based on the questions asked, indicating "Not Applicable" or providing the information that is present in the document.

Here's an analysis of the provided 510(k) clearance letter in the context of the requested information about acceptance criteria and study data:

This 510(k) clearance letter pertains to a physical medical device, the BD Plastipak™ Syringe, not an AI/ML-driven diagnostic or image analysis tool. As such, many of the typical acceptance criteria and study methodologies applicable to AI models (e.g., ground truth established by experts, MRMC studies, training/test set sizes for algorithms, human reader improvement with AI assistance) are not relevant or described in this document.

The "study" referenced in the document primarily consists of non-clinical performance and biocompatibility testing to demonstrate the substantial equivalence of the new syringe (with a changed barrel resin) to a previously cleared predicate syringe.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The subject device met all the predetermined acceptance criteria for the above listed performance and biocompatibility tests." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for each test. It only lists the tests performed and the standards they adhere to.

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

• Sample Size for Test Set: Not specified in the provided document. The tests are "bench performance testing" on various syringe units.
• Data Provenance: Not specified, but generally, bench testing for physical devices is conducted in a controlled lab environment by the manufacturer. It is non-clinical.
• Retrospective or Prospective: Not applicable for this type of physical device testing.

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

• Not Applicable. Ground truth for this physical device testing is established through standardized laboratory test methods and measurements against international or internal specifications, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. (See point 3)

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. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is 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. Therefore, no standalone algorithm performance was assessed. The performance tests are for the physical syringe itself.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on measurements against established engineering specifications and international standards (e.g., ISO, ASTM, USP) for physical and material properties (e.g., force, leakage, volume accuracy, biocompatibility reactions). It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of the reported non-clinical bench testing for a physical syringe.

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

• Not Applicable. (See point 8)

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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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The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.

The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.

The BD Intelliport™ System is intended for patients with body weights >20 kg.

Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.

BD Intelliport™ System integrates into an intravenous line and automatically captures information about the anesthesia medications administered to the patient. It wirelessly transmits anesthesia medication administration information to the patient's Electronic Medical Record (EMR) via hospital server applications (Gateway software). The BD Intelliport™ System provides core technologies that enable key functions of the system:
• Medication Identification: Informs clinician of medication and concentration along with any informational notifications such as patient allergy and expired medication reminders. This occurs when syringes with the correct type of RFID encoded label are attached.
• Dose Measurement: Measures volume of drug administered to the patient through the system, then calculates dose weight.
• Automatic Charting: Wirelessly transmits measured doses to the EMR.

The following are the main system components:
• BD Intelliport™ Injection Site which is comprised of the following two components:

• BD Intelliport™ Sensor
• BD Intelliport™ Reader
  • BD Intelliport™ Mount (optional accessory)
  • BD Intelliport™ 2-Bay Charger (accessory)
  • BD Intelliport™ Gateway

The provided FDA 510(k) clearance letter and summary for the BD Intelliport™ System (K243062) describes the performance testing conducted to demonstrate substantial equivalence to its predicate device (K182092). However, it does not provide specific acceptance criteria or reported device performance values in a quantifiable table format, nor does it detail a standalone study with quantitative results, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and a list of performance tests completed.

Here's an attempt to structure the answer based on the available information, with caveats where data is missing:

Acceptance Criteria and Device Performance

The 510(k) summary states that "The subject device, the BD Intelliport™ System, has met all predetermined acceptance criteria for the non-clinical and human factors testing conducted in accordance with relevant FDA guidance, recognized consensus standards, and internal requirements." However, the specific numerical acceptance criteria and the quantitative reported device performance values for most tests are not explicitly stated in the provided document.

The only quantitative performance criteria and reported values mentioned are for "Volume measurement accuracy" and "Volume Measurement Resolution."

Note: The document states these are "Identical" to the predicate device, implying the reported performance matches the specified criteria.

Study Information

Due to the nature of a 510(k) summary, detailed study reports with specific quantitative results (beyond volume measurement accuracy) are not included. The document generally refers to "performance testing" and "human factors evaluation."

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

   • Test Set Sample Size: Not explicitly stated for each test. For "Volume Measurement Performance Window," the volume range tested was 0.5ml to 30ml, and average push speed 10ml/min to 400 ml/min. This implies tests were conducted across this range, but the number of injections or trials is not provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be non-clinical (laboratory-based) and human factors studies. The human factors testing likely involved simulated clinical environments.

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

   • Not applicable/Not provided within the scope of this 510(k) summary. These types of details are usually found in full study reports, not the summary itself, especially for a device that primarily automates record-keeping and measurement, rather than making diagnostic assessments that require expert ground truth. The human factors testing involved "intended device users," but their specific qualifications or roles in establishing "ground truth" (in a diagnostic sense) are not outlined.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is disagreement in expert interpretation of diagnostic data. This device automates measurements and record-keeping, so such a method is not relevant.

4. 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, an MRMC comparative effectiveness study was not explicitly reported or appears not to have been the primary method for demonstrating substantial equivalence. The device's primary function is "automated record keeping" and facilitating "documentation of the medications." It improves efficiency and accuracy of recording medication administration, rather than assisting human readers in interpreting medical images or data. The human factors evaluation assessed "critical tasks completed by intended device users," implying usability and user performance with the system, not a comparison of expert diagnostic accuracy with and without AI.

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

   • The document implies that standalone (algorithm-only) performance testing was conducted for various technical attributes. For example, "Bolus volume measurement accuracy," "Sensor flow rate," "Decoding response time," "Wifi functionality," and "Dose transmission time" are intrinsic functions of the system and its algorithms, which would have been tested independently of a human operator to verify their technical specifications. The "Flow Algorithm" itself was updated and "qualified through verification testing." However, explicit, detailed results from a standalone study with acceptance criteria are not presented in a formal table like format for all algorithm-driven functions.

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

   • For the technical performance tests (e.g., volume measurement), the "ground truth" would have been established using calibrated instruments and reference standards (e.g., known volumes, known flow rates) in a laboratory setting.
   • For the human factors evaluation, the "ground truth" would be defined optimal task performance and safety outcomes as determined by medical device standards and clinical best practices.

7. The sample size for the training set:

   • The document does not provide information on a training set size. The BD Intelliport System involves embedded software and algorithms (e.g., flow algorithm, RFID reading, EMR communication). While such systems often involve development and testing cycles, the summary does not detail a specific "training set" like one would find for a machine learning or AI algorithm that learns from data in a traditional sense. The "Flow Algorithm" was updated and "qualified through verification testing," which implies validation against known physical models or experimental data, rather than a statistical "training set" in the context of deep learning.

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

   • As no "training set" is explicitly mentioned for a machine learning model, this question is not applicable in the context of the provided information. The "ground truth" for verifying the updated flow algorithm would have been established through physical experiments and engineering measurements with known parameters (e.g., precise drug volumes, flow rates) to ensure the algorithm accurately processes the sensor data.

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The BD Veritor™ System for SARS-CoV-2 is a chromatographic digital immunoassay for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BD Veritor™ System for SARS-CoV-2 and followed up with a molecular test.

A negative test result is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established between April 2024 and August 2024 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The BD Veritor™ System for SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in anterior nasal swab specimens taken from patients with signs and symptoms of upper respiratory infection (i.e., symptomatic) who are suspected of COVID-19 by their healthcare provider. The test is intended for use with an opto-electronic interpretation instrument, the BD Veritor™ Plus Analyzer Instrument and is not interpreted visually.

• When specimens are processed and added to the test device, SARS‑CoV‑2 antigens present in the specimen bind to biotinylated antibodies and antibodies conjugated to detector particles in the test strip.
• The biotinylated antibody‑antigen‑conjugate complexes migrate across the test strip to the reaction area and are captured by a line of streptavidin bound on the membrane.
• A positive result is determined by the BD Veritor™ Plus Analyzer when antigen‑conjugate is deposited at the Test "T" position and a control conjugate is deposited at the Control "C" position on the assay device.
• The instrument analyzes and corrects for non‑specific binding and detects positives not recognized by the unaided eye to provide an objective result.

Procedures to evaluate test devices depend on the BD Veritor™ Plus Analyzer workflow configuration chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of a BD Veritor™ Plus Analyzer to a printer or IT system is possible if desired. Additional result documentation capabilities are possible with the integration of a BD Veritor™ barcode scanning enabled module.

The Analyzer uses a proprietary algorithm that subtracts the nonspecific signal at the negative control line from the signal present at the test line. If the resultant test line signal is above a preselected cutoff, the specimen is scored as positive. If the resultant test line signal is below or equal to the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The Analyzer measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during the test interpretation as the reflectance value is compared to that of the control and test zones.

The provided FDA 510(k) clearance letter and summary describe the BD Veritor System for SARS-CoV-2. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. However, based on the clinical study results and FDA clearance, the implicit acceptance criteria for clinical performance are related to the confidence intervals for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). The reported device performance is presented below:

Note: The document does not explicitly state numerical acceptance thresholds for PPA and NPA (e.g., "PPA must be > 80%"). Therefore, the "Implicit Acceptance Criteria" are inferred from the demonstrated performance and the fact that the device received clearance. The FDA typically evaluates these metrics within acceptable ranges for diagnostic tests.

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

• Sample Size for Test Set: 1,032 direct anterior nasal swabs.
• Data Provenance: The samples were prospectively collected from individual symptomatic patients across 15 geographically diverse areas across the United States between April and August 2024.

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

The document does not specify the number of experts used to establish the ground truth. The ground truth was established by an FDA-cleared SARS-CoV-2 RT-PCR test. For the false positive/negative re-testing, it broadly states "a second RT-PCR method," implying multiple tests might have been performed to confirm results without specifying expert involvement in interpreting these specific results beyond the RT-PCR outcome itself.

4. Adjudication Method for the Test Set

The primary ground truth for the clinical study was established by an FDA-cleared SARS-CoV-2 RT-PCR test without explicit mention of expert adjudication for every case. However, there was a form of adjudication for discordant results:

• False Positive Adjudication: The three BD Veritor System for SARS-CoV-2 false positive results were retested with a second RT-PCR method and were confirmed negative. This suggests a method where initial discrepancies against the reference method were independently verified.
• False Negative Adjudication: The 23 BD Veritor System for SARS-CoV-2 false negative results were retested with a second RT-PCR method in which 14 were confirmed positive and 9 were negative.

This indicates a process of re-testing or confirmation for discordant results, which serves as a form of adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance (or similar comparative effectiveness of human readers with vs. without the device) was not explicitly mentioned or described in the provided document. The BD Veritor System for SARS-CoV-2 uses an instrument (BD Veritor™ Plus Analyzer) for interpretation, replacing visual interpretation with an automated read. The comparison is between the device's performance and a reference RT-PCR, not between human readers with and without assistance from the device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The entire clinical performance study (Table 9 and 11) is a standalone study, as it evaluates the performance of the BD Veritor System for SARS-CoV-2 (algorithm/device only) compared to a reference RT-PCR without human interpretation of the lateral flow assay itself. The BD Veritor™ Plus Analyzer instrument is explicitly stated to read and interpret the results, and the device "is not interpreted visually."

7. Type of Ground Truth Used

The ground truth used for the clinical study was an FDA-cleared SARS-CoV-2 RT-PCR test (molecular test results).

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This submission is for a device, and the analytical and clinical studies described are for validation of the device's performance, not for developing or training an AI/ML algorithm in the context of a typical AI/ML development pipeline. The device uses a "proprietary algorithm" for signal subtraction and interpretation, but it's not presented as a machine learning model that requires a distinct training set in the typical sense.

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

Since no specific training set and its ground truth establishment are discussed in the context of AI/ML model training, this information is not applicable/provided based on the document. The "proprietary algorithm" for the instrument is described in terms of processing reflectance data and applying a preselected cutoff, and its development process (including any data used for internal calibration or parameter setting) is not detailed here.

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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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