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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 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 Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen of 0.021". The SmartPICC system provides real-time catheter tip location information by using the patient's cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.

Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.

The Piccolo Medical SmartPICC System is a device used by clinicians for guidance and positioning of commercially available central venous catheters. The reusable SmartPICC System consists of a computer tablet with data processing and display capabilities, a SmartPICC Controller data acquisition module, and a Kit that includes a single use sterile SmartPICC Stylet to enable the use of ivECG confirmation of final PICC tip location by the clinician who is placing the catheter. The SmartPICC System has a supplemental ionic dilution navigation feature to provide qualitative blood flow direction information which requires 5% Dextrose infusion utilizing a mechanical syringe driver, a sterile 20 ml disposable syringe, and tubing with extension set to provide constant flow rate infusion to the SmartPICC Stylet distal tip.

Additional components associated with the reusable system include a USB cable to connect the tablet to the controller and an external ECG (xECG) Trunk Cable to connect the xECG leads to the controller.

Additional accessories in the Stylet Kit include:

• Sterile Drape Clip to secure Stylet hub to sterile patient drape
• Sterile cover for the tablet
• Sterile scissors for opening sterile tubing pouch
• xECG Electrodes and Leads
• Instructions for Use

The Piccolo Medical SmartPICC System is intended to help position Peripherally Inserted Central Catheters (PICC) in adult patients by providing real-time catheter tip location information using intravascular ECG (ivECG) signals. It also includes a supplemental ionic dilution feature for qualitative blood flow information to assist catheter navigation.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage accuracy or precision target) for the performance of the SmartPICC system. Instead, the "Summary of Human Factors Testing" states that the simulated use testing "adequately reviewed" the device's application to ensure "safe, effective use" and demonstrated "suitability for its intended purpose." This suggests that the acceptance criteria for this study were likely qualitative and focused on the device's ability to facilitate correct PICC tip placement and user comprehension of the device's output.

While no precise performance metrics are given, the overall conclusion is that the device should "perform as intended" and is "substantially equivalent" to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample size for the "Simulated Use / Human Factors Testing." It only mentions "Human Factors Testing."
• Data Provenance: The document does not specify the country of origin of the data nor if it was retrospective or prospective. Given it was "Simulated Use," it was likely prospective, but the location is not mentioned.

3. Number of Experts and Qualifications for Ground Truth in Test Set

The document does not specify the number of experts used to establish ground truth for the human factors/simulated use testing, nor does it detail their qualifications. It only states that the testing was conducted to evaluate the application of the system.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the "Simulated Use / Human Factors Testing."

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance versus without. The study described is a "Simulated Use / Human Factors Testing," which focuses on the device's application and user interaction, not a reader study of clinical images.

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop) performance study evaluating the accuracy of the ivECG signal interpretation or ionic dilution feature in isolation. The human factors testing involved the device being used by humans.

7. Type of Ground Truth Used (Test Set)

For the "Simulated Use / Human Factors Testing," the type of ground truth used is not explicitly stated. However, since the test aimed to confirm "PICC tip position," it can be inferred that the ground truth would have been the actual, verified PICC tip position established by a gold standard method during the simulation, although the specific method is not detailed. The comparison to chest x-ray or fluoroscopy confirmation suggests these are the accepted gold standards the device aims to emulate or provide an alternative to.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The text indicates that "Clinical testing was determined to be not applicable for this 510(k) submission. Bench testing was sufficient to demonstrate substantial equivalence of the Smart PICC System to the predicate device." This suggests the device's performance was not primarily established through a machine learning model requiring a large training set, but rather through engineering and human factors validation demonstrating equivalence to a predicate device.

9. How Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing ground truth for a training set is not applicable or provided in this document.

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