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The PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

The PICC Tip Positioning Aid includes a standalone Monitor containing software, battery and power cord accompanied by an ECG Patient Cable, a Remote Control Cable, probe cover and ECG Clip Cable.

The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is communication from the FDA regarding a 510(k) premarket notification for a device named "PICC Tip Positioning Aid". The document concludes that the device is substantially equivalent to a previously cleared predicate device, the "Celerity System."

The basis for this substantial equivalence is explicitly stated as: "As the only differences between the device and its predicate are names, logos, and addresses in the labeling". Therefore, the "Performance Data" section primarily refers to the existing satisfaction of recognized standards (IEC 60601 series) by the predicate device and a "Simulated Use / Human Factors Testing" that was likely conducted for the predicate device.

To directly address your request, here's what can be extracted and what is missing based on the provided text:

1. Table of acceptance criteria and the reported device performance

No specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics are provided for the "PICC Tip Positioning Aid" device itself. The document asserts substantial equivalence based on the device being identical to its predicate, except for labeling details.

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

The document mentions "Simulated Use / Human Factors Testing" but does not provide details on the sample size for this test, its data provenance, or whether it was retrospective or prospective.

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.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study for the "PICC Tip Positioning Aid" is not mentioned in the document. The device is described as an "alternative method to chest x-ray or fluoroscopy confirmation" and uses ECG to observe P-wave changes, suggesting it's an automated positioning aid rather than an AI-assisted interpretation tool for human readers in the traditional MRMC sense.

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

The device is a "PICC Tip Positioning Aid" that "provides real-time catheter tip location by using the patient's cardiac electrical activity." This implies a standalone function of the device to guide placement. However, whether a formal "standalone performance study" was conducted for this specific device (separate from its predicate) is not detailed. The "Simulated Use / Human Factors Testing" mentioned seems to evaluate the application of the entire system as an alternative to X-ray, which would implicitly include the algorithm's performance within the simulated use context. No explicit details of an algorithm-only standalone study are given.

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

The document primarily focuses on the device being "substantially equivalent" to its predicate. For the "Simulated Use / Human Factors Testing" mentioned, the ground truth would likely be established using established methods for confirming PICC tip placement (e.g., actual X-ray or fluoroscopy confirmation as the standard of care it aims to replace), but this is not explicitly stated in the provided text.

8. The sample size for the training set

Since the document indicates the subject device is identical to its predicate in design, production, and technology, there is no mention of a training set for the "PICC Tip Positioning Aid" in this submission. Any training would have occurred for the predicate device, but those details are not included here.

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

As there's no mention of a training set for this specific device in the submission, this information is not applicable/provided.

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