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HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s

HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s

HydroMID Single Lumen: Indicated for short term access(

The HydroMID catheters are a family of midline catheters 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. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The HydroPICC catheters are a family of peripherally inserted central catheter (PICC) comprised of a radiopaque hydrophilic catheter material 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. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The purpose of this 510(k) is to add an additional statement to the indications for use.

The provided FDA 510(k) clearance letter (K243458) details the HydroPICC and HydroMID catheters. The focus of this submission is to add a statement to the indications for use regarding the anti-thrombogenic properties of the MIMIX® Technology incorporated into these catheters. The acceptance criteria and supporting studies are described below:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate that the expanded Indications for Use statement, specifically concerning the anti-thrombogenic properties of the MIMIX® Technology, does not introduce new questions of safety or effectiveness and is supported by non-clinical data. The reported device performance is based on in vitro studies.

Note: The FDA letter explicitly states: "The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis." This indicates that the acceptance criteria are based solely on in vitro performance for the anti-thrombogenic claims, not on in vivo clinical outcomes.

Study Details for Acceptance Criteria

The provided document does not fully delineate separate "test sets" for the in vitro studies in the way one might for an AI/algorithm-based device. Instead, the "studies" themselves are the performance evaluations for the stated acceptance criteria.

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

   • The document lists several in vitro tests.
   • Sample Size: The specific number of devices or experimental replicates used in each in vitro test is not explicitly stated in the provided text.
   • Data Provenance: All studies are indicated as "in vitro" (meaning conducted in a test tube, culture dish, or other controlled environment outside of a living organism). The country of origin is not specified but is presumably where Access Vascular Inc. conducts its research and development or contracts with testing facilities.

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

   • For in vitro studies of this nature (evaluating properties like thrombus accumulation), the "ground truth" is typically established by the experimental setup, validated measurement techniques, and potentially statistical analysis.
   • No specific number of experts or their qualifications are mentioned as having established "ground truth" for these in vitro tests in the context of expert consensus, as might be the case for image-based diagnostic devices. The results are based on objective physical or biological measurements.

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

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective expert review (e.g., radiology image interpretation) to resolve discrepancies in independent assessments. As these are in vitro physical/biological tests, such adjudication methods are not relevant or mentioned.

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:

   • Not applicable. This device is a medical catheter, not an AI software/algorithm requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This device is a physical medical device (catheter) with a material technology, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

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

   • The ground truth for the in vitro studies described (e.g., "Assessment of PICC Catheter Thrombosis," "Thrombosis Accumulation Report") is based on objective measurements of physical and biological phenomena (e.g., quantification of thrombus accumulation, pressure required to remove occlusions) within controlled laboratory environments. This is a form of empirical scientific measurement, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI/machine learning model that requires training data.

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

   • Not applicable. As no training set is mentioned, the method for establishing ground truth for it is also not applicable.

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Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 4.0ml/s.

Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s.

The HydroPICC catheters are a family of peripherally inserted central catheters (PICC) made of radiopaque hydrophilic material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in catheter manufacturing. The catheters are provided in kit configurations with the necessary accessories for placement in clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. These reductions were evaluated using in vitro and in vivo models. Pre-clinical evaluations do not necessarily predict clinical performance with respect to thrombus formation. HydroPICC 5F Dual Lumen Catheter Components include: HydroPICC 5Fr Dual Lumen Catheter Assembly, Dispensing Tube, 2 Channel Clip, and Guidewire Introducer and Straightener.

The provided FDA 510(k) clearance letter pertains to a medical device (PICC catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, the content of the letter does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD, such as:

• A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, etc.)
• Sample sizes used for test sets and data provenance (for image/data-driven AI)
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for ground truth
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for training set
• How ground truth for the training set was established

The 510(k) summary for the HydroPICC Catheter focuses on physical device performance characteristics. It mentions:

• Acceptance Criteria/Performance (Implied through testing): The device was tested to demonstrate acceptable performance for the modified power injection ratings and device length.
• Study Type: Non-clinical tests were performed, specifically "Power injection Cyclical and Static Burst testing as well as dimensional verification testing."
• Conclusion: These tests demonstrated that "the modifications to the power injection rating and the length do not adversely impact product performance."

In summary, this document does not contain the specific information you requested relating to the acceptance criteria and study proving performance for an AI/SaMD device. The information provided is for a physical medical device clearance based on engineering and performance bench testing.

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The PM2+ System and SmartPICC Stylet is indicated for guidance and positioning of commercially available central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording for catheter guiding and positioning, and intravascular ionic dilution for supplemental catheter navigation. The SmartPICC Stylet, when used with the PM2+ System, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When relying on the patient's ECG signal, the PM2+ System and SmartPICC Stylet is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. The SmartPICC Stylet is indicated for use with PICC lines having a minimum lumen diameter of 0.021".

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion the use of an additional method is required to confirm catheter tip location.

The PM2+ System and SmartPICC Stylet is a device used by clinicians for bedside navigation and tip location confirmation of central venous catheters including PICCs. The PM2+ System and SmartPICC Stylet provide real-time catheter tip location information by using intravascular ECG (ivECG). The SmartPICC Stylet provides intravascular ECG for catheter tip location confirmation as well as an optional, ionic dilution navigation feature. The SmartPICC Stylet is used only during PICC installation, and removed once the PICC tip position is confirmed to be at the target location. The SmartPICC Stylet is electrically connected to the PM2+ system which processes, displays, and stores the ECG waveforms as well as the ionic dilution data. The PM2+ System is also compatible with the commercially available ECGuide Connector.

The provided FDA 510(k) clearance letter for the PM2+ System and SmartPICC Stylet does not include acceptance criteria or a detailed study that proves the device meets specific acceptance criteria related to its primary function (catheter tip placement confirmation using ECG).

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics derived from a clinical trial.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

This information is not provided in the document. The clearance letter states that "Performance testing performed on the PM2+ System and SmartPICC Stylet verified that device performance requirements including tensile strength, insertion force, corrosion resistance, catheter compatibility, leak testing, infusion rate testing, ionic dilution performance testing, algorithm verification, electrical hardware verification, sterile barrier packaging testing, biocompatibility, electrical safety, EMC, software verification and validation, design validation and human factors validation. All tests were successfully completed." However, the specific acceptance criteria (e.g., "tensile strength must be >X Newtons") and the measured performance values for these non-clinical tests are not disclosed.

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

This information is not provided for demonstrating the core performance of the device (catheter tip placement confirmation). The document explicitly states: "No human clinical data was provided to support substantial equivalence." This implies that there was no clinical test set for this specific submission to demonstrate the accuracy of the ECG-based tip localization. The performance testing mentioned in point 1 refers to non-clinical (engineering and benchtop) 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)

This information is not provided. As "No human clinical data was provided," there was no clinical ground truth established for a test set in this submission.

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

This information is not provided. As "No human clinical data was provided," there was no clinical test set requiring an adjudication method.

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

This information is not provided. The device is a "Tip Location System" and "Stylet," which assists in the placement of central venous catheters. It's not described as an AI system that improves human readers of medical images. The primary use case is direct guidance during placement, not interpretation of images post-placement. The clearance relies on substantial equivalence to predicate devices, where the ECG-based tip confirmation method is already established.

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

A standalone performance evaluation of the algorithm's accuracy in determining catheter tip location is not explicitly detailed with specific metrics. While "algorithm verification" is listed as a completed test, the specific methodology, dataset, and performance criteria for this verification are not disclosed. The device description explicitly states it provides "real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information," which implies it has an embedded algorithm, but its standalone performance against a ground truth is not specified in this document.

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

For the non-clinical tests (tensile strength, etc.), the ground truth would be established by objective physical measurements. However, for the crucial function of accurate catheter tip placement confirmation using ECG, the document does not specify the type of ground truth used for algorithm verification, nor does it provide a clinical study where a ground truth (e.g., fluoroscopy, chest X-ray interpreted by experts, or MRI) would be established for comparison. The clearance implies that the underlying technology (ivECG for tip location) is already validated from the predicate devices.

8. The sample size for the training set

This information is not provided. Given "No human clinical data was provided" for the current submission, and the reliance on substantial equivalence, details about a training set for a new algorithm performance claim are absent. If the "algorithm verification" refers to the core ECG-based localization, the training would have been part of the predicate device development.

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

This information is not provided. (See explanation for point 8).

In summary, the FDA 510(k) clearance for the PM2+ System and SmartPICC Stylet does not contain the detailed acceptance criteria and study data you requested for its primary function (ECG-based catheter tip localization). The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices (K200037 Piccolo Medical SmartPICC System and K240486 PM2 System and ECGuide Connector) which already use similar technology, and on successful completion of various non-clinical engineering and benchtop performance tests. The document explicitly states that "No human clinical data was provided to support substantial equivalence" for this specific submission.

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The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave:

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-Driven Rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Pilot TLS is designed to support quidance and tip positioning of Peripherally Inserted Central Catheters (PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory.

The device is only provided in one configuration, and non-sterile. The system is composed of:

• . A medical tablet with a kickstand attached on the back
• . The medical tablet's power supply
• . A Pilot TLS module attached to a USB-A cable
• A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector
• An ECG cable with 4 leads (red, white, green, black)
• 2 USB flash drives

Vygocard is an accessory provided sterile.

This document, a 510(k) Premarket Notification for the "Pilot TLS" device, primarily focuses on demonstrating substantial equivalence to a predicate device, the "C3 Wave," rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

However, based on the provided text, here's what can be extracted and inferred regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted to verify performance requirements. These tests are generally designed to ensure compliance with standards and safety, not necessarily to quantify specific performance metrics against a defined acceptance criterion for a clinical study.

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

The document does not provide details on a specific test set size for clinical performance evaluation. It explicitly states: "No human clinical data was provided to support substantial equivalence."

The "human factors study" mentioned could be considered a usability test set, but details about its size or provenance (country, retrospective/prospective) are not disclosed in this document.

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

As "No human clinical data was provided," there is no information about experts used to establish ground truth for a clinical test set. For the human factors study, the participants are referred to as "independent clinician participants," but their number or specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

Not applicable, as "No human clinical data was provided" for a clinical test set that would require ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, the document explicitly states: "No human clinical data was provided to support substantial equivalence." Therefore, no MRMC study or effect size for AI assistance is reported.

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

The document describes the "Pilot TLS" as a device providing "real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity." This implies human interaction as "displaying" information requires interpretation by a user. The software verification and validation would test the algorithm's functionality, but a formal "standalone" performance study in a clinical context (without human interaction) is not described. The device is intended as an "alternative method to chest X-ray or fluoroscopy confirmation," which inherently involves a human interpreting the device's output.

7. The Type of Ground Truth Used

Given the statement "No human clinical data was provided to support substantial equivalence," there is no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical performance. The comparison to chest X-ray or fluoroscopy implies these are the traditional "ground truth" methods for PICC tip placement confirmation, but no data is presented where the Pilot TLS's output is validated against these.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of a machine learning algorithm, and thus no training set sample size is mentioned. This device relies on "identification of a maximum P-wave in the patient's intravascular ECG signal," which is a known physiological principle, not a machine learning model requiring a training set in the typical sense.

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

Not applicable, as no training set for a machine learning model is mentioned.

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Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation.

In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.

Limiting but not contraindicated situations for use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.

The Neonav ECG Tip Location System (Neonav) is a non-invasive medical device that analyzes electrocardiographic signals (ECG) to track the location of central venous access devices (CVADs) in patients' blood vessels during placement in real time via a display.

Catheter position in the vasculature is analyzed based on the patient's intravascular ECG (I-ECG). An I-ECG is recorded via the catheter tip from within the blood vessels of a patient. For the conductive fluid method, the sterile Neonav ECG Adapter Cable are used whereas for guidewire/stylet method, the sterile Neonav ECG clip cable is used. These components allow the electrical impulses detected at the catheter tip to be recorded by a non-sterile Acquisition Unit and analyzed by the Neonav Console to assist in determining the catheter tip position. The Neonav Controlled via a touch screen interface or a Remote enclosed in a sterile cover. The Neonav Console displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, the patient's heart rate, and other device performance indicators. A surface electrode is placed on the subject to act as a reference electrode. A second surface electrode is placed on the subject for noise reduction.

Neonav components are designed to attach easily to standard catheter and IV therapy components via standard luer lock connections. The only patient contacting component of the ECG Adapter. It has indirect contact with the patient via fluids and is composed of biocompatible polycarbonate and stainless steel.

The Neonav ECG Tip Location System is intended for navigation and positioning of central venous access devices (CVADs). The acceptance criteria and supporting study details are outlined below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a specific sample size for a clinical test set used to prove the device meets acceptance criteria related to its primary function of tip location accuracy. The document primarily references non-clinical bench tests and compliance with various standards.

There is a mention of "most current literature and effectiveness of PICCs in infants and neonates" supporting expanded indications, but this is not described as a direct device performance study.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any performance study.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for a test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The Neonav system "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," suggesting it's an assistance tool rather than a fully automated AI interpretation.

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

The document does not explicitly describe a standalone performance study of the algorithm without human-in-the-loop. The description of Neonav states it "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," implying a human-in-the-loop operation. "Neonav does not provide computation of ECG signal for navigation. Neonav displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal."

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation. Given the device's function and the comparison to X-ray and fluoroscopy, it is highly probable that ground truth in any clinical validation would involve imaging modalities (e.g., chest X-ray or fluoroscopy confirmation) or direct physician assessment of catheter tip position, but this is not explicitly detailed in the provided text.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set.

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

The document does not provide any information on how ground truth was established for a training set.

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Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s

The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions 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.

The provided text is a 510(k) summary for the HydroPICC 4Fr Single Lumen Marked catheter, where the purpose of the submission is to modify the power injection ratings in the indications for use. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study against specific acceptance criteria for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document discusses "comprehensive data demonstrating the safety and efficacy" and "rigorous testing protocols" including "in vitro" data to support the modified power injection rating, and states that "the form, fit, and function of these devices have not changed from their previous clearances." However, it does not provide specific details of these tests or their results in a measurable, quantifiable way that would allow for the completion of the requested table and study breakdown.

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The Piccolo Medical PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated. for patients where cardiac rhythms may change presentation of the P-wave; including

-Atrial fibrillation

-Atrial flutter

-Severe tachycardia

-Pacemaker-driven rhythm

-Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The PM2™ System and ECGuide™ Connector is a device used by clinicians for bedside tip location confirmation of central venous catheters. The PM2™ System and ECGuide™ Connector provide real-time catherer tip location information by using intravascular ECG (ivECG). The ECGuide™ Connected to the distal lumen hub of a CVC and primed with saline to create an ivECG electrode at the distal tip of the catheter and allow for ECG catheter tip confirmation. The EGuide™ Connector is used only during CVC installation, and removed once the CVC tip position is confirmed to be at the target location. The ECGuide™ Connected to the PM2 system which processes, displays, and stores the ECG waveforms.

The provided FDA 510(k) summary (K240486) for the "PM2 System and ECGuide Connector" does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance for catheter tip placement confirmation.

The document states: "No human clinical data was provided to support substantial equivalence."

Instead, the summary focuses on non-clinical performance testing for aspects such as electrical safety, EMC, software verification and validation, tensile insertion force, corrosion resistance, catheter compatibility, leak testing, electrical hardware verification, sterile barrier packaging testing, biocompatibility, design validation, and human factors validation. It concludes that "All tests were successfully completed. The passing results supported the determination of substantial equivalence with the predicate device."

Therefore, I cannot provide the requested information as it is not present in the provided text.

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The CATHTONG III Tapered PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for the 4F single lumen catheters and the 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG III Tapered PICC Catheter may not exceed 325 psi. The CATHTONG III Tapered PICC Catheter is indicated for adult patients.

Not Found

The provided text is a 510(k) summary from the FDA for a medical device called the CATHTONG III Tapered PICC Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain information regarding a study that proves the device meets acceptance criteria, nor does it provide details on algorithm performance, expert consensus, ground truth establishment, or sample sizes related to AI/algorithm performance. These types of details are typically found in the clinical or non-clinical performance sections of a 510(k) submission, which are often redacted or not fully included in the publicly available summary letter.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details based on the provided text. The document primarily focuses on the regulatory clearance process and the intended use of the catheter.

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The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are indicated for short or long term peripheral access to the central venous system for the administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

The L-Cath™ Single and Dual Lumen and L-Cath™ Midline Catheters are sterile, single use devices, sold as standalone devices which includes the following accessories:
• Trim Tool
• Tape measure
• Stylet (include in the final catheter assembly as applicable)
• Polyurethane catheter
These catheters are also sold as a component in a Basic Kit (catheter and introducer packaged together) which includes the following:

• BD Introsyte Autoguard Introducer or Splittable Introducer ●
• Stylet (include in the final catheter assembly as applicable)
• Trim Tool
• Tourniquet
• Tape measure

The provided text describes a 510(k) premarket notification for Argon Medical Devices' L-Cath™ Single and Dual Lumen Catheters and L-Cath™ Midline Catheters. This document focuses on demonstrating substantial equivalence to an existing predicate device (BD L-Cath™ Midline Catheter, BD Cath™ Single Lumen, BD Cath™ Dual Lumen Peripherally Inserted Central Catheters PICC, K091670), rather than proving the device meets clinical acceptance criteria based on studies involving AI or human readers.

Therefore, many of the requested criteria in your prompt (e.g., acceptance criteria for device performance in terms of AI metrics, sample sizes for test/training sets in an AI study, number of experts, adjudication methods, MRMC studies, standalone AI performance, ground truth establishment) are not applicable to this type of regulatory submission. This document details the engineering and biocompatibility aspects of the device to show it functions safely and effectively similarly to devices already on the market.

However, I can extract the relevant information from the provided text regarding the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the requested information based on the provided text, highlighting what is applicable and what is not:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is a 510(k) for substantial equivalence, not a clinical study proving performance against AI-related metrics. The "acceptance criteria" here refer to engineering, biocompatibility, and sterilization performance standards, demonstrating the modified device is as safe and effective as its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject device met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device." While specific numerical acceptance criteria (e.g., "pressure burst must exceed X psi") are not explicitly detailed in a table, the document lists the types of performance tests conducted and confirms successful completion.

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

• Sample Size: Not explicitly stated in terms of number of units tested for each criterion, but implied to be sufficient for demonstrating compliance with ISO standards and internal protocols.
• Data Provenance: The tests were conducted internally by Argon Medical Devices, as indicated by the company providing the summary. The regulatory context implies these are laboratory tests, not clinical data from patients. They are likely prospective bench and lab tests.

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

• Not Applicable. This is a medical device 510(k) submission based on engineering and biocompatibility testing, not an AI performance study requiring human expert ground truth for image or diagnostic interpretation. The "ground truth" here is established by validated test methods and reference standards.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

• Not Applicable. This is not an AI-assisted diagnostic device. Clinical testing (human studies) was explicitly stated as "not required for the determination of substantial equivalence."

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

• Not Applicable. See point 5.

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

• Engineering and Biocompatibility Test Standards: The "ground truth" for the device's performance is established by recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for luer connectors, ISO 11135 for sterilization) and internal validated test protocols designed to assess the device's physical properties and safety characteristics.

8. The sample size for the training set

• Not Applicable. This document describes a medical device, not an AI algorithm. There is no "training set."

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

• Not Applicable. See point 8.

Summary of the Study Proving Acceptance:

The study presented in this 510(k) summary is a series of bench testing, laboratory analyses (biocompatibility), and sterilization validations designed to demonstrate that the modified L-Cath™ catheters are substantially equivalent to the previously cleared predicate devices. The primary change was the material used in the Luer Lock assembly.

The "study" involved:

• Performance Testing: Assessing mechanical characteristics like leak integrity, dimensions, pressure burst, durometer, radiopacity, retaining force, pull force, particulates, and material durability. These tests were stated to be the "SAME as K091670" (the predicate's testing) with additional supplemental testing specific to the Luer Lock material change (Luer Integrity, ISO 80369-7 Compliance).
• Biological Comparison (Biocompatibility Testing): Evaluation of potential biological risks including pyrogenicity, cytotoxicity, hemocompatibility, irritation/sensitization, systemic toxicity, ethylene oxide residuals, and local effects after implantation. Supplemental testing (Systemic Toxicity, Genotoxicity) was performed due to the Luer Lock material change.
• Sterilization Validation: Confirmation that the device can be consistently sterilized to meet a sterility assurance level (SAL) of 10-6, in accordance with ISO 11135:2014 and AAMI TIR28:2016.

The conclusion is that the modified device "met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device." This means the tests confirmed the new device performs within acceptable limits, similar to the predicate, and does not raise new questions of safety or effectiveness.

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The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, training set sizes, or how training set ground truth was established for a medical device.

The document is an FDA 510(k) clearance letter for the CATHTONG™ II PICC Catheter. It states that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use, including maximum flow rate and injection limit setting. However, it does not provide the detailed study information you're requesting.

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