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The Polyshield Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

The Polyshield Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths, in both with and without wings on the catheter hub.

Polyshield: An over-the-needle, peripheral active safety IV catheter that incorporates a spring-activated needle shield to help prevent needle-stick injuries

Polyshield Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a spring-activated needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.

Polyshield BC: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made.

Polyshield BC Adva: An over-the-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle). Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.

Color-coding of the catheter hub (and wings, where fitted) is used to help identify the catheter gauge size, in accordance with ISO 10555-5.

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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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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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The RUBY Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The RUBY Intravascular Catheter is suitable for use with power injectors.

The RUBY Intravascular Catheter is intended to be inserted in the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.

The RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10kg) and adults.

The RUBY™ Intravascular Catheter consists of a radiopaque catheter having a usable length of 1.30 inches in 20-gauge size. The device is a single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor pressure, or administer fluids intravenously. The RUBY™ Intravascular Catheter's hub has a blood control valve mechanism that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter is restricted immediately after needle retraction until a secure luer connection has been made. The RUBY™ Intravascular Catheter is provided with a catheter guiding element with an atraumatic tip design positioned within the formed lumen between the catheter and the needle and connected to a slider used to deploy and retract the catheter guiding element; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries.

This document is an FDA Clearance Letter for a medical device (Ruby Intravascular Catheter), not a study report or clinical trial. Therefore, it does not contain the detailed information required to answer your prompt about acceptance criteria and study findings related to AI/algorithm performance.

The provided text focuses on:

• Regulatory Clearance: Explaining that the device is substantially equivalent to a predicate device, allowing it to be marketed.
• Device Description: What the Ruby Intravascular Catheter is and how it functions.
• Indications for Use: For what medical purposes the device can be used (e.g., blood sampling, fluid administration).
• Comparison to Predicate: Highlighting similarities and differences between the Ruby Catheter and a previously cleared device (AccuCath).
• Safety and Performance Tests (General): Listing the types of tests performed (e.g., performance, biocompatibility, sterilization, shelf-life and the standards they followed (e.g., ISO, ASTM).

Crucially, there is no mention of any AI, algorithm, or software component within the Ruby Intravascular Catheter. The device is a physical medical instrument (a catheter), and the testing described pertains to its physical and biological properties.

Therefore, I cannot provide a table of acceptance criteria for algorithm performance, sample sizes for an AI test set, expert qualifications for AI ground truth, or details about MRMC studies, as these concepts are not applicable to the information given in the FDA clearance letter for this specific device.

To answer your prompt with the requested details, the input would need to be a clinical study report or a 510(k) submission summary specifically for a software as a medical device (SaMD) or a device with a significant AI/algorithm component.

If you have a document related to an AI-powered medical device, please provide that, and I will do my best to extract the relevant information.

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OSPREY Midline Closed IV Catheter System (OspreyEDC) is an intravascular catheter intended to be inserted into the patient’s vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The OSPREY Midline Closed IV Catheter System (OspreyEDC) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.

The OSPREY Midline Closed IV Catheter System (OspreyEDC) has a usable (deployed) catheter length of 3.25 inches. The device is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (<30 days) use. The device is constructed with a clear housing having integrated wings and ribs to assist with its handling, a beveled needle that allows the catheter to be deployed through it and the needle fully and permanently passively retracts into the housing when the catheter hub with its integrated extension tube, including an incorporated pinch clamp, female luer with porous (vent) plug is fully advanced via the wire slider with integrated stainless steel guidewire. The device is placed in a thermal formed tray that goes into a Tyvek pouch providing the sterile barrier.

The provided FDA 510(k) clearance letter and summary discuss a medical device, the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20), and its substantial equivalence to a predicate device. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing detailed acceptance criteria and a study proving those criteria are met for an AI/software-as-a-medical-device (SaMD).

Here's an analysis based on the provided text, highlighting what information is available and what is not available regarding the specific questions about acceptance criteria and a study proving device performance in the context of AI/SaMD:

Summary of Acceptance Criteria and Device Performance (Based on provided document):

The document does not present explicit "acceptance criteria" in the format one might expect for a software or AI product's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence by comparing the new device's technological characteristics and performance outcomes against a predicate device and relevant industry standards. The implicit "acceptance criteria" are that the new device performs at least as well as the predicate and meets established safety and performance standards.

Since this is a filing for a physical medical device (an IV catheter system) and not an AI/SaMD, many of the requested items related to AI model validation, such as test sets, ground truth establishment, expert adjudication, and training set details, are not applicable and therefore not present in the document.

Here's a breakdown of the specific points from your request:

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

   • Available in document: Yes, a comparison table (Table VII - I) is provided on pages 7-11, outlining attributes of the subject device (OSPREY Midline Closed IV Catheter System) against the predicate device. This indirectly serves as acceptance criteria in the context of substantial equivalence for a physical medical device. The "Performance" section on page 12 also lists standards adhered to via bench testing.
   • Not explicitly stated as AI/SaMD performance metrics (e.g., sensitivity, specificity): This is a hardware device, so these metrics are not relevant or provided.

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

   • Not applicable/Not available in document: This information is typically for AI/SaMD. For a physical device, testing involves bench tests and biocompatibility, not data sets in the AI sense. No specific "sample sizes" for clinical data or data provenance are mentioned, as clinical studies in the AI context were not conducted or required for this type of device and submission. The document mentions "bench tests," but doesn't specify sample sizes for those tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable/Not available in document: "Ground truth" in this context refers to clinical data labeling for AI. For a physical device like a catheter, "ground truth" is established through engineering and biocompatibility standards, and performance against those standards is evaluated by engineers and lab personnel, not necessarily "experts" in the clinical decision-making sense with specific experience levels for data labeling.

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

   • Not applicable/Not available in document: This is relevant for clinical data labeling for AI performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable/Not available in document: This is entirely for AI-assisted diagnostic devices. This is a standalone physical medical device.

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

   • Not applicable/Not available in document: This pertains to AI algorithm performance.

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

   • Not applicable/Not available in document: As mentioned, for this physical device, "ground truth" is based on adherence to recognized industry standards (ISO, ASTM, USP) and established engineering principles and test methods (e.g., flow rate measurement, physical dimensions, material properties, biocompatibility assays).

8. The sample size for the training set

   • Not applicable/Not available in document: This applies to AI models.

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

   • Not applicable/Not available in document: This applies to AI models.

In conclusion, the provided document is a standard 510(k) submission for a physical medical device. It successfully demonstrates substantial equivalence to a predicate device by comparing design, materials, indications for use, and performance based on engineering bench tests and adherence to recognized international standards for medical devices. The specific questions you asked are geared towards the evaluation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), which is not the subject of this 510(k) clearance letter.

Ask a specific question about this device

The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products.

Rated for maximum power injection flow rate of 6ml/s.

The HydroMID catheter is a 5 French, dual lumen, midline catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

Catheter and accessories are supplied sterile. Product is sterilized by ethylene oxide (EO) except where labeled otherwise. Product should be stored in a cool, dry, dark place. The HydroMID Catheter is supplied in a dry state and must be hydrated before use.

The provided text describes a 510(k) summary for the HydroMID 5F Dual Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device through bench testing. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader study or clinical performance with ground truth established by experts/pathology/outcomes data.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and performance bench testing of a physical medical device (a catheter), not a medical device software or AI algorithm. Therefore, many of the requested categories in the prompt (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device submission.

However, I can extract the information relevant to the device's performance and the "acceptance criteria" as described in the 510(k) summary for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

The document states: "All tests passed the acceptance criteria specified for both the subject and predicate devices." It does not provide specific numerical acceptance criteria or numerical reported performance values for each test. Instead, it lists the types of tests conducted.

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

• Sample Size: The document states: "Testing was identical to the predicate in standard conformance, sample size, methods, and acceptance criteria." However, the specific numerical sample size for each test is not provided.
• Data Provenance: The tests are described as "Bench Data" conducted internally by the manufacturer, Access Vascular Inc. The country of origin for the data is not explicitly stated, but the company address is Billerica, MA, which implies the testing was conducted in the United States. The data is prospective in the sense that it was generated for this 510(k) submission to demonstrate the performance of the new device design.

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

• Not Applicable. This is a physical medical device. Ground truth for its performance is established by engineering and material science testing against predefined specifications, not by human expert review of images or clinical outcomes in the typical sense of AI/image analysis.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing results are objective measurements against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not Applicable. This is a physical medical device (catheter), not a software or AI device intended to assist human readers.

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

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

7. The Type of Ground Truth Used:

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance revolves around its physical and functional properties meeting predetermined engineering specifications and validated test methods (e.g., pressure resistance, flow rates, dimensional accuracy, material properties like tensile strength and kink resistance, sterility, and MRI compatibility). These are objective criteria, not based on expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and materials are based on established engineering principles and prior device iterations.

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

• Not Applicable. See point 8.

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