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The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary transvenous intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip.

The provided text is a 510(k) summary for the BioTrace Medical Tempo Temporary Pacing Lead. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a formal "table of acceptance criteria" with specific pass/fail thresholds for most tests. Instead, it describes various types of testing performed and then broadly states the outcomes. For the clinical study, it outlines specific endpoints and their achievement.

2. Sample Sizes and Data Provenance for the Clinical Study (Test Set):

• Sample Size: Twenty-five (25) patients.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was "multicenter." The manufacturer BioTrace Medical, Inc. is based in San Carlos, California, USA, suggesting the study was likely conducted in the US.
  • Study Design: Prospective, multi-center, non-randomized, single-arm study.

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

• The document describes a clinical study involving patients and clinical outcomes. The "ground truth" for safety and effectiveness endpoints would be established by the treating physicians and clinical staff involved in the study, and confirmed by documented patient data (e.g., echocardiogram reports, medical records, vital signs, adverse event reporting).
• The document does not specify the number of individual "experts" formally adjudicating the clinical trial data in the way one might for an imaging AI study (e.g., a panel of radiologists). The ground truth is the direct clinical observation and measurements from the patient study.

4. Adjudication Method for the Test Set:

• For the clinical study, the "adjudication method" is inherent to clinical trial conduct. Data collection would follow a pre-specified protocol, and endpoints like "freedom from pericardial effusion" or "pace capture" would be determined by physicians based on clinical assessment and diagnostic findings.
• The document does not mention a specific "x+y" or "3+1" expert adjudication method. This type of adjudication is typically for image-based diagnostic ground truth and is not directly applicable to a study evaluating a physical medical device's functional performance and safety in patients. Clinical trial data collection and review processes serve this purpose.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This study evaluates a physical medical device (temporary pacing lead) in patients, not an AI algorithm assisting human readers in interpreting medical images. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. Standalone Performance (Algorithm Only):

• This is not an AI algorithm. It is a physical medical device (a temporary pacing lead). Therefore, the concept of "standalone (i.e. algorithm only without human-in-the loop performance)" is not applicable. The device's performance is intrinsically linked to its use by a clinician.

7. Type of Ground Truth Used for the Clinical Study:

• The ground truth for the clinical study was based on clinical outcomes and direct physiological measurements in patients.
  • Safety Ground Truth: Absence of pericardial effusion requiring intervention, absence of echocardiographic evidence of tamponade, absence of device-related adverse events.
  • Effectiveness/Feasibility Ground Truth: Successful intracardiac delivery, successful pace capture, measured pace capture thresholds (PCT), visual confirmation of no lead dislodgement, and assessment of sustained ventricular arrhythmias.

8. Sample Size for the Training Set:

• This document describes a regulatory filing for a physical medical device. It does not mention any "training set" in the context of an AI/machine learning model. The device design and verification would have relied on engineering principles, predicate device comparisons, and pre-clinical testing, not a data training set for an algorithm.

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

• As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The equivalent for a physical device would be the design specifications, pre-clinical testing, and manufacturing quality controls, where "ground truth" is defined by engineering standards and functional requirements.

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