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The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™ TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC 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. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm PICC tip location.

The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CGTM TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CGTM TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.

The Sherlock 3CG Tip Confirmation System (TCS) is indicated for guiding and positioning Peripherally Inserted Central Catheters (PICCs) by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the ECG signal, it provides an alternative to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

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

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., a specific accuracy percentage for tip placement). Instead, it states that the device "met all pre-determined acceptance criteria" and "demonstrated substantial equivalence as compared to the predicate device." The overall conclusion from the testing is that the subject device "is as safe, as effective, and performs as well as or better than the predicate device."

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size 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 or prospective). It refers to "verification and validation activities" and "in-house protocols" for determining the appropriate methods for evaluating performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on the device itself and its equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

The information suggests that a standalone performance evaluation of the algorithm and device without a human-in-the-loop was conducted. The "verification and validation activities" and the statement that the device "met all pre-determined acceptance criteria" imply testing of the device's functionality and accuracy on its own. The primary claim is about the device's ability to locate the PICC tip, rather than its enhancement of human interpretation.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the provided text. However, given the device's function of confirming PICC tip location as an alternative to chest X-ray and fluoroscopy, it is highly probable that the ground truth for tip location was established using imaging methods like X-ray or fluoroscopy, which are considered the conventional and definitive methods for confirming PICC tip placement at the time of the submission. It could also potentially involve direct visualization or measurement during a medical procedure.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The submission focuses on verification and validation testing for market clearance, not on the development or training of an AI model in detail.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not detail the development or training phases of the device.

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The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC 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. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm PICC tip location.

The Sherlock 3CG* TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CG* TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CG* TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CG* TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.

The provided text does not contain information on specific acceptance criteria and detailed study results with quantitative performance metrics for the Sherlock 3CG* Tip Confirmation System. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full clinical trial report with detailed performance data against predefined acceptance criteria.

However, based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states:

• "Verification and validation activities were designed and performed to demonstrate that the subject Sherlock 3CG* TCS met predetermined performance specifications."
• "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."

While these statements confirm that acceptance criteria existed and were met, the actual criteria (e.g., accuracy percentages, specificity, sensitivity, failure rates for specific outcomes) and the corresponding reported performance values are not detailed.

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

This information is not provided in the document. The 510(k) summary does not include details about the clinical study design, patient numbers, or data collection methodology (retrospective/prospective, country of origin) that would typically be found in a full study report.

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

This information is not provided in the document. Details on how ground truth was established, including the number and qualifications of experts, are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document. The adjudication method (e.g., 2+1, 3+1, none) for the test set is not described.

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

This information is not provided in the document. The Sherlock 3CG* TCS is a device that provides real-time tip location using magnetic tracking and ECG, functioning as an alternative to chest X-ray/fluoroscopy for PICC tip confirmation; it is not presented as an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable in this context based on the device description.

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

The device itself is a "Tip Confirmation System" that "provides real-time PICC tip location information" and "displays the location... using a magnetic stylet and magnetic sensors" and "displays ECG waveforms." The phrasing suggests that the device provides direct information, and its performance would inherently be "standalone" in generating tip location guidance. However, the document does not present a specific "standalone study" with detailed results. The device's "without human-in-the-loop performance" could be inferred from its function as a direct measurement and display system, but no data is presented to quantify this.

7. The Type of Ground Truth Used

While not explicitly stated for the "test set," the device's indications for use state that "When relying on the patient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients." This strongly implies that chest X-ray and/or fluoroscopy would be the ground truth comparators for confirming PICC tip placement in any validation studies. However, the specific method used for establishing ground truth in the actual performance studies is not detailed.

8. The Sample Size for the Training Set

This information is not provided in the document. The 510(k) summary does not mention a "training set" or "validation set" in the context of device development or performance testing, as it is primarily focused on demonstrating substantial equivalence rather than detailing an AI/machine learning model's development.

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

This information is not applicable/not provided as there is no mention of a "training set" in the context of device development in the provided document.

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