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The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The Vascular Positioning System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The Vascular Positioning System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. NOTE: If a steady blue bull's eye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. 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 VPS System consists of a VPS Console with tablet display and a VPS Stylet. The VPS G4 Console consists of two key integrated software-driven components: a data acquisition module and an embedded computer with processing capabilities. The data acquisition module within the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VPS Stylet. Using signals gathered by the data acquisition module, the graphical user interface provides the user with guidance for tip positioning of central venous access devices. The separately provided VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end of the stylet connects to an extension cable that connects to the VPS Console.

The provided text describes the 510(k) summary for the Vascular Positioning System™ (VPS™) G4 Console. It does not contain a comprehensive study proving the device meets specific acceptance criteria in the way a clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K103260 VasoNova Vascular Positioning System™ (VPSTM) Console) by showing that the technological characteristics are similar and that the device complies with relevant electrical safety, electromagnetic compatibility, and software verification/validation standards.

Therefore, many of the requested details about acceptance criteria and study methodology are not explicit in this summary. However, I can extract the information that is present and highlight what is not available from the provided text.

Here's the breakdown:

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

The document does not present specific clinical or performance acceptance criteria in the typical sense of metrics like sensitivity, specificity, accuracy, or positive/negative predictive values for tip placement. Instead, the "acceptance criteria" are implied by compliance with regulatory standards and verification/validation testing.

The primary "performance" stated is that the device is compliant with safety and functionality standards and is "substantially equivalent" to its predicate in terms of safety, efficacy, and performance. The intended use also specifies that: "When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location." However, performance data demonstrating the accuracy of this "Blue Bullseye" indication against a gold standard (like X-ray) is not provided in this 510(k) summary.

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

This information is not provided in the given text. The filing focuses on technological equivalence and compliance with engineering standards rather than clinical performance data from a specific test set.

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 in the given text. As no specific clinical test set data is presented, there is no mention of experts establishing ground truth.

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

This information is not provided in the given text.

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 in the given text. The device is a "Vascular Positioning System" that guides catheter placement, not an AI-assisted diagnostic tool for human readers.

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

The device is designed for "guidance and tip positioning" of central venous catheters, meaning it provides real-time information to a human operator. The system "provides the user with guidance for tip positioning" and "When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location." This implies it's a human-in-the-loop system. A standalone performance assessment without human interaction is not described.

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

The 510(k) summary does not describe specific ground truth data for a clinical test set. The intended use mentions that the VPS System is indicated for use "as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients." It also states: "If a steady blue bull's eye is not obtained, standard hospital practice should be followed to confirm catheter tip location." This implies that standard imaging (fluoroscopy or chest x-ray) would be the clinical gold standard (ground truth) if such a performance study were done, but no such study is detailed here.

8. The sample size for the training set

This information is not provided in the given text. Given that this is a 510(k) summary for a substantial equivalence determination based on technological characteristics and compliance with standards, details about machine learning training sets are typically not included unless the device's core functionality relies on a novel AI/ML algorithm that requires specific training data for its performance claims. The device relies on "physiological (cardiac electrical activity and blood flow) information" and "software algorithm to determine the symbols used to indicate catheter migration," but the details of any "training" are not specified.

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

This information is not provided in the given text, for the reasons mentioned in point 8.

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The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. 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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. 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 VPS System consists of a VPS Console and VPS Stylet. The VPS Console consists of two key integrated software-driven components: a data acquisition module; and a PC with processing and display capabilities. The VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet can be inserted and removed from any catheter with a luminal diameter of at least 0.021 inches. The data acquisition module of the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VSP Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.

Here's a breakdown of the acceptance criteria and study information for the VasoNova™ Vascular Positioning System™ (VPS™ System) Stylet, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures". While not framed as a 'pre-defined' acceptance criterion with a specific numerical threshold like ">= 95%", the achievement of 98.4% is presented as the performance demonstrating effectiveness for its intended use as an alternative to imaging.

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

• Sample Size for Test Set: 77 patients
• Data Provenance: The study was a "prospective, single-armed, open design study clinical study." The country of origin of the data is not explicitly stated, but the submission is to the US FDA, implying it could be US-based or an international study accepted by the FDA. Given the company's address is in Menlo Park, CA, a US origin is likely.

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

This information is not provided in the given text. The document does not detail how the ground truth for "proper PICC tip placement" was established for the 77 patients in the clinical study. It is implied that post-procedure confirmation (likely via chest x-ray or fluoroscopy, which the device aims to replace) would serve as ground truth, but the specifics of who performed this assessment are absent.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the method for establishing ground truth isn't detailed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The clinical study described is a "single-armed" study, focusing on the performance of the VPS System itself, not a comparison involving multiple human readers with and without AI assistance.

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

Yes, the clinical study performed appears to be a standalone performance study of the device. The text states, "The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures," implying the system's output (the "blue bullseye" guidance indicator) was assessed against the actual tip placement. While a human uses the device, the 98.4% figure reflects the system's ability to accurately guide/indicate.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated but is strongly implied to be the actual physical location of the catheter tip as determined by a "gold standard" method after the procedure. The device is intended as "an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation." Therefore, the ground truth for assessing the device's accuracy would logically be derived from these post-placement imaging modalities.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for a training set. This is typical for a device like this, which likely relies on physiological signal processing and established anatomical/physiological principles rather than machine learning models trained on vast datasets in the same way an AI imaging algorithm would.

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

This information is not provided. As no training set is discussed, the method for establishing its ground truth is also not mentioned.

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The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bull's-eye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients.
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, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. 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 VPS System consists of a VPS Console and VPS Stylet.
The VPS Console consists of two key integrated software-driven components: a data acquisition module; and a PC with processing and display capabilities. The data acquisition module of the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VPS Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.
The VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet can be inserted and removed from any catheter with a luminal diameter of at least 0.021 inches.

Here's an analysis of the acceptance criteria and study details from the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 77 patients
   • Data Provenance: Not explicitly stated, but the study was prospective and single-armed, indicating it was conducted during the device's development/evaluation phase, likely in a clinical setting. Country of origin is not specified but given the submitter's address (Menlo Park, CA), it's reasonable to infer a US-based study, although not guaranteed. The study was prospective.

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

   • This information is not provided in the given text. The text only states that the VPS System "correctly indicated proper PICC tip placement" but doesn't detail how this "correctness" (ground truth) was established or who adjudicated it.

3. Adjudication method for the test set:

   • This information is not provided in the given text.

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

   • No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this document. The study described focuses on the standalone performance of the device in indicating proper PICC tip placement. The VPS System is itself providing the "guidance indicator" for the user.

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

   • Yes, a standalone performance study was done. The reported 98.4% accuracy reflects the device's ability to "correctly indicate proper PICC tip placement." While a human operator uses the device, the 98.4% figure represents the accuracy of the device's output compared to the ground truth of tip placement, not the performance of human readers using or not using the device. The device's "guidance indicator shows a blue bull's-eye" when the tip is in the desired location, implying an algorithmic determination.

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

   • The specific method for establishing ground truth is not explicitly stated. However, the intended use clearly states the system is an "alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation." This strongly suggests that the ground truth for the study was established using one or both of these traditional imaging methods (fluoroscopy or chest x-ray) to independently verify the actual PICC tip location.

7. The sample size for the training set:

   • The text does not provide any information about a training set or its sample size. The clinical study described refers to the test set used to evaluate the device's performance.

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

   • As no information about a training set is provided, this question cannot be answered from the given text.

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VPS Catheters are indicated for short or long-term central access to the central venous system for intravenous therapy, central venous pressure monitoring and contrast studies. For blood or hyperalimentation delivery, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. Each VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console).

The VPS Catheter is designed for use with or without the VPS Console. When sold together, the VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter is sterile, single use, non-pyrogenic and non-toxic.

VPS Catheters are single lumen (3F and 4F) or dual lumen (5F) open-ended central venous access catheters fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 or 55 cm and catheter markings at 1 cm intervals and 5 cm increments. VPS Catheters are packaged sterile with the VPS Stylet in a tray with accessories necessary for a percutaneous micro-introducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper design.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Previously provided in vivo and in vivo testing demonstrated that the subject device meets all acceptance criteria." However, the specific quantitative acceptance criteria for each test are not detailed in the provided text.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "in vivo and in vitro testing."

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

This information is not provided in the document. The performance data section refers to "in vivo and in vitro testing" results, but there is no mention of expert-established ground truth for these tests.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text. The performance data focuses on device and material characteristics.

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

This question is not applicable as the device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth for the performance tests described (e.g., static pressure, flow rate, tensile strength) would be the objective measurements obtained during the actual physical and mechanical testing of the catheter. This is not explicitly detailed but implied by the nature of the tests. There is no mention of expert consensus, pathology, or outcomes data as a form of ground truth for these specific performance criteria.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical catheter and not an AI/ML algorithm that would require a training set.

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

This question is not applicable as the device is a physical catheter and not an AI/ML algorithm.

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VPS Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. The VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console) sold separately.

The VPS Catheter and VPS Stylet are designed for use together and with the VPS Console. The VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter/Stylet is sterile, single use, non-pyrogenic and non-toxic.

The VPS Catheters are single lumen (3 and 4 Fr) or dual lumen (5 Fr) central venous access catheters made from soft, radiopaque medical grade polyurethane and packaged with the VPS Stylet in a tray with the accessories necessary for a percutaneous microintroducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper open ended design with a working length of 50 or 55 cm. VPS Catheters are marked at 1 cm intervals and labeled every 5 cm for the entire length.

The VPS Stylet is a 6 foot long polymeric tube which contains a Doppler sensor at the distal tip and an intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the ivECG signal sensing wire, when connected to the VPS Stylet are used to detect and transmit physiological information to the VPS Console (available separately). The VPS Stylet has an outer diameter of 0.019 inches and is designed to be used with the compatible VPS Catheter with an inner lumen of 0.021 inches.

The provided text describes the VasoNova VPS Catheter and its 510(k) submission (K083920). However, the document focuses on regulatory approval based on in vitro performance data for substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance with human readers, or a standalone AI algorithm. It does not mention any AI components in the context typically found in AI/ML medical device submissions.

Therefore, many of the requested sections about AI-specific studies (e.g., MRMC studies, standalone AI performance, training set details, expert ground truthing for AI) cannot be answered from the provided text. The device is a central venous catheter with a stylet containing a Doppler sensor and an ivECG sensing wire, implying it facilitates sensing, but there is no mention of an AI algorithm interpreting these signals for diagnostic or predictive purposes.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where gaps exist for AI-specific questions:

Acceptance Criteria and Device Performance (based on in-vitro testing)

Note: The document states that "In vitro testing demonstrates that the subject device meets all acceptance criteria." However, it does not provide specific numerical values or detailed acceptance limits for each criterion. It only lists the categories of tests performed.

Study Details (based on what's available in the text)

Given that this is a 510(k) summary for a physical medical device (catheter) and not an AI/ML device, the following details are either not applicable or not provided:

1. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: Not applicable. The performance data is based on "in vitro testing," which generally involves laboratory measurements on device prototypes or production samples, not a clinical "test set" of patient data. The specific number of samples tested for each in vitro criterion is not provided.
* Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as it's in-vitro testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth, in the context of expert consensus, is typically for clinical or imaging data interpretation, which is not the subject of this 510(k) summary. The acceptance criteria for the in-vitro tests would be defined by engineering standards and internal specifications.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable for in-vitro physical performance testing.

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 catheter, not an AI-powered diagnostic tool requiring human reader studies.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. There is no mention of an "algorithm only" component for this device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For the in-vitro tests, the "ground truth" would be established by validated measurement techniques and adherence to predefined engineering specifications and standards (e.g., ASTM, ISO standards for catheters). It is not expert consensus, pathology, or outcomes data.

7. The sample size for the training set:
* Not applicable. This document does not describe an AI/ML algorithm or a training set.

8. How the ground truth for the training set was established:
* Not applicable. This document does not describe an AI/ML algorithm or a training set.

Summary of AI Relevance:
The provided 510(k) summary describes a central venous catheter and its approval based on in-vitro performance testing demonstrating substantial equivalence to predicate devices. It does not contain any information regarding Artificial Intelligence (AI) components, algorithms, or associated studies (such as MRMC, standalone AI performance, or details on training/test sets for AI models). The questions regarding AI performance criteria are not applicable to the content of this specific regulatory document.

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The FlowPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec.

The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.

The FlowPICC Catheter is a double lumen open-ended PICC designed for power injection through one designated lumen. The FlowPICC Catheter is fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 cm with markings in 5 cm increments. The catheter is packaged with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. A stylet and adaptor sidenort are provided to assist in catheter insertion.

The provided text describes a medical device, the VasoNova FlowPICC Catheter, and its 510(k) submission. However, it does not contain detailed information about acceptance criteria for device performance or a specific study proving it meets those criteria in a quantitative manner.

The "Performance Data" section merely states: "In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria." It does not provide the acceptance criteria themselves, nor does it present the results of those tests.

Therefore, I cannot fulfill your request for the specific table, sample sizes, expert qualifications, or details about standalone or MRMC studies as these are not present in the provided document.

To answer your request, here's what can be extracted from the text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified.
• Data provenance: "In vitro and in vivo testing." No country of origin or whether the data was retrospective or prospective is mentioned.

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

• Not specified. The document indicates performance data was generated through "in vitro and in vivo testing," but no mention of expert-established ground truth for a test set is made in the context of human evaluation.

4. Adjudication method for the test set

• Not applicable as no human-reviewed test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study is not mentioned.

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

• Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used

• The document refers to "in vitro and in vivo testing." For a physical medical device like a catheter, "ground truth" would likely refer to established engineering standards, physiological measurements, or clinical outcomes from the in vivo studies. Specifics are not provided.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Summary of available information:

The document is a 510(k) summary and an FDA clearance letter for a medical device (a catheter). It states that performance data exists from "in vitro and in vivo testing" and that this data meets "all acceptance criteria." However, it does not disclose the specifics of these criteria, the test results, sample sizes for studies, or any details related to human evaluation, ground truth establishment by experts, or AI-related performance metrics. The focus is on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation.

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The FlowPICC System is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with a minimum luminal diameter of 0.021" for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological information.

The FlowPICC™ System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal.diameter of 0.021 inches. The FlowPICC Console integrates a data acquisition system, two DAQ cards, an isolation transformer and a PC pre-loaded with proprietary software. The Console, when used as intended, uses a blood velocity profile and heart electrical activity to provide user feedback and guiding indicators for proper PICC catheter tip placement in the caval-atrial junction. The Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify when the catheter is moving towards the heard, moving away from the heart, in the proper location or should be adjusted because there isn't enough information.

The provided text does not contain specific acceptance criteria or the details of a study that proves the device meets them. It is a 510(k) summary, which states that "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices," but it does not elaborate on these tests, their criteria, or the results.

Therefore, I cannot populate the requested table or answer most of the questions.

Here's a breakdown of what can be inferred from the provided text, and what is missing:

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

  • Acceptance Criteria: Not specified in the provided text.
  • Reported Device Performance: Not specified with quantitative metrics in the provided text. The statement "Performance test results support the performance characteristics of the device" is qualitative and lacks detail.

• 2. Sample size used for the test set and the data provenance: Not provided.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.

• 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 provided. The device is a "Console" that provides "user feedback and guiding indicators," suggesting human interaction, but no MRMC study details are given.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but the nature of the device ("Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify...") implies it's an assisted device, not a standalone diagnostic.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.

• 8. The sample size for the training set: Not provided.

• 9. How the ground truth for the training set was established: Not provided.

In summary, the provided document is a high-level regulatory submission summary and does not contain the detailed performance study information, acceptance criteria, or experimental setup details that would be found in a full scientific study report.

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The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021'' for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording, and intravascular ultrasound for catheter guiding and positioning.

The FlowPICCTM System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal diameter of 0.021 inches. The FlowPICC Stylet is a polymeric tube which contains a Doppler sensor and in intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the exposed portion of the ivECG signal sensing wire are located at the flowPICC Stylet. The FlowPICC Stylet is 6 feet long and has an outer diameter of 0.019". The tip of the FlowPICC Stylet is positioned within a compatible catheter (luminal diameter 0.021") and maintained there throughout the PICC placement procedure. The proximal end has two connectors provide the connectivity to the FlowPICC Console.

This FDA 510(k) summary for the FlowPICC™ Stylet (K081625) does not provide details of specific acceptance criteria or a dedicated study demonstrating the device meets those criteria.

The document states: "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices." This is a general statement and does not include the detailed information requested in your prompt regarding acceptance criteria and a specific study plan.

Based on the provided text, here's what can be inferred and what is not present:

1. Table of acceptance criteria and reported device performance:

   • Not provided. The document does not list any specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) or acceptance thresholds for them.

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

   • Not provided. The document states "Performance test results" but does not specify the sample size, type of data (e.g., in-vitro, ex-vivo, in-vivo), patients included, or their country of origin. It also doesn't mention if the data was retrospective or prospective.

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

   • Not provided. There is no mention of a ground truth establishment process, experts, or their qualifications.

4. Adjudication method for the test set:

   • Not provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Not done/reported. The document does not mention any MRMC study or evaluation of human readers with or without AI assistance. The FlowPICC System is described as providing "real-time catheter tip location information" to assist in placement, implying it's a tool for a clinician, but no study is described to quantify this assistance.

6. Standalone (algorithm only without human-in-the-loop performance) study:

   • Not explicitly reported as a separate study with specific metrics. The device's function is to provide real-time information. While this implies a standalone measurement capability, the document doesn't detail a separate "standalone" performance study. The statement about "performance characteristics" is general.

7. Type of ground truth used:

   • Not provided. Since no specific study is detailed, the method for establishing ground truth (e.g., pathology, surgical confirmation, independent imaging) is not mentioned.

8. Sample size for the training set:

   • Not applicable / Not provided. The device is described as using "physiological (cardiac electrical activity and blood flow) information" and "intravascular ultrasound." This suggests a sensor-based system and signal processing, rather than a machine learning model that would typically have a "training set" in the common sense of AI/ML. There's no indication of a training set as would be relevant for an AI model.

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

   • Not applicable / Not provided. (See point 8).

Summary of what is present:

• Device Description: The FlowPICC System uses a Stylet with a Doppler sensor and an intravascular ECG (ivECG) signal sensing wire connected to a Console to provide real-time catheter tip location information using cardiac electrical activity and blood flow information.
• Intended Use: Supplemental aid in PICC placement to assist in tip placement of the PICC catheter.
• Performance Data Statement: "Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices." This is a generalized statement of sufficiency for 510(k) clearance, not a detailed study report.
• Predicate Devices: ComboMap (Volcano K041134) and Sherlock (Bard K063240) are cited, implying that the "performance test results" likely demonstrated equivalence to these devices based on their established performance.

In conclusion, the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a specific study with defined acceptance criteria and its outcomes. It does not contain the specific information requested in your prompt regarding detailed performance studies, ground truth, expert involvement, or sample sizes.

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