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The Sapiens* Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sapiens* TCS provides real-time PICC tip location information by using the patient's cardiac electrical activity. Sapiens* 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 PICC insertion, the use of an additional method is required to confirm catheter tip location.

The Sapiens* TCS consists of the following elements: PC netbook running Sapiens* TCS software, Sapiens* TCS ECG module, ECG leads connection, printer (optional), and remote control (optional). A stylet inserted into a central venous catheter can be connected to the Sapiens* TCS system via the Sapiens* TCS ECG leads connection, establishing a direct electrical connection to the catheter distal tip for ECG signal measurement. When the central venous catheter stylet is connected to Sapiens* TCS, the Sapiens* TCS PC netbook displays a cardiac electrical signal from the four ECG electrodes, including the catheter stylet (intravascular electrode) and three body electrodes, which provide ECG waveforms. The intravascular ECG waveforms provided by the Sapiens* TCS can be used for guiding and positioning of the central venous catheter. These ECG waveforms can be printed using an optional printer to document the procedural record for the patient's file.

The provided document, K112744, is a 510(k) Premarket Notification for the Sapiens* Tip Confirmation System (TCS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria or details of a study proving the device meets those criteria, as typically presented in clinical trial results or performance studies with defined endpoints.

The document states: "Verification and validation activities were designed and performed to demonstrate that the subject Sapiens* TCS met predetermined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device: IEC 60601-1:1988/1991/1995 Medical Electrical Equipment - Part 1: General Requirements for Safety IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests. The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."

This indicates that performance specifications were established and met, likely related to safety and electromagnetic compatibility based on the listed standards. However, the document does not provide a table of these acceptance criteria or specific performance values for the device. It also does not describe a clinical study focused on diagnostic accuracy or clinical effectiveness to demonstrate its ability to confirm PICC tip placement.

Therefore, many of the requested details about a study proving acceptance criteria cannot be extracted from this document because such a study, with the specific elements requested (e.g., sample size for test sets, expert ground truth, MRMC study, standalone performance), is not described.

Summary based on the provided document:

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

Note: The document states "Verification and validation activities were designed and performed to demonstrate that the subject Sapiens TCS met predetermined performance specifications" and "The subject device met all pre-determined acceptance criteria." However, it does not detail what those specific performance specifications or acceptance criteria were in terms of diagnostic accuracy or clinical outcomes, beyond general safety and EMC standards and substantial equivalence.*

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 document. The document refers to "Verification and validation activities" and "in-house protocols" but does not detail any specific clinical test set, its size, or provenance.

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 document. Since no specific clinical test set for diagnostic performance is described, there is no mention of experts establishing ground truth for such a test.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, 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 document. The Sapiens* TCS is described as a system for guiding and positioning PICCs using the patient's cardiac electrical activity, not a system involving "human readers" to interpret images or AI assistance in the way typically discussed for MRMC studies.

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

The document describes the device as providing "real-time PICC tip location information by using the patient's cardiac electrical activity" and displaying a cardiac electrical signal. It is an instrument that aids a clinician during a procedure. The concept of "standalone performance" for an algorithm in a diagnostic context is not directly applicable or described in this document. The device's performance is inherently tied to being used by an operator to guide placement.

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

This information is not explicitly stated in the document for the purpose of demonstrating diagnostic accuracy. The device "is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation." This implies that the standard ground truth for PICC tip confirmation would be chest X-ray or fluoroscopy. However, the document does not describe a study comparing the Sapiens* TCS results against such ground truth data in a formal performance study.

8. The sample size for the training set

This information is not provided in the document. The Sapiens* TCS works by measuring the patient's cardiac electrical activity and is not described as an AI/machine learning system that requires a "training set" in the conventional sense.

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

This information is not provided in the document for the reasons stated in point 8.

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