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The Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.

The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a hydrophilic coating. Pacing is achieved through a bipolar electrode configuration integrated in the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. Unshrouded adaptor pins are provided to ensure compatibility with all connecter cable terminals. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

This document is a 510(k) Summary for the Wattson Temporary Pacing Guidewire (Model 2250). It details the device's indications for use, its characteristics, and a comparison to a predicate device (K192454, also a Wattson temporary pacing guidewire). The summary also outlines the performance data gathered to support the claim of substantial equivalence.

Based on the provided text, the device is a medical guidewire used in cardiac procedures, specifically Transcatheter Aortic Valve Replacement (TAVR) and Balloon Aortic Valvuloplasty (BAV), which also has the capability to transmit an electrical signal for temporary cardiac pacing.

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

Important Note: The provided document is a 510(k) Summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. It typically summarizes testing, but does not provide the full detailed study reports. Therefore, some information requested in your prompt (e.g., number of experts, specific effect sizes for MRMC studies, sample sizes for training sets for AI models) may not be present because this device is a traditional guidewire, not an AI/ML-driven diagnostic device. The questions you've asked are largely applicable to AI/ML device submissions, which is not what this document describes.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a physical medical device (guidewire) and not an AI/ML diagnostic tool, "acceptance criteria" are typically defined by engineering specifications, material biocompatibility, and functional performance benchmarks rather than diagnostic metrics like sensitivity/specificity. The document doesn't present a formal table of quantitative acceptance criteria and performance results in the way one would for an AI model.

However, the "Performance Data" section outlines the types of testing performed, which implicitly demonstrates "acceptance" based on successful completion of these tests.

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

• Animal Study (GLP Safety): The study was performed in a porcine model. The document states "No animals experienced sustained arrhythmia...", implying a cohort of animals, but the exact number of animals (sample size) is not specified.
• Data Provenance: The animal study was a prospective GLP Safety study. The country of origin for the data is not specified but given the US FDA submission, it's likely a US-based study or conducted to US regulatory standards. Biocompatibility and Bench tests are laboratory-based and generally don't have "data provenance" in the same regional sense.

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

This question is not applicable to this device submission. The Wattson Temporary Pacing Guidewire is a physical medical device, not an AI-based diagnostic tool that relies on expert interpretation for "ground truth" to validate an algorithm's performance on image data. For an AI/ML device, ground truth would typically be established by expert radiologists or pathologists.

For this device, "ground truth" (or verification) is established through technical performance specifications, material science, and observed biological/physiological responses in animal models and bench testing.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device is not an AI/ML diagnostic. Adjudication methods (like 2+1 or 3+1) are used in studies where multiple human readers interpret data to create a consensus "ground truth" for evaluating an AI algorithm. For a physical device, performance is measured against engineering specifications, biological responses, and comparative performance to a predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images with or without AI assistance). This submission is for a guidewire, which does not involve human readers interpreting images in a way that would necessitate an MRMC study for its primary function.

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

Not applicable. This is not an AI algorithm; it is a physical medical device. Therefore, the concept of "standalone performance" for an algorithm does not apply. The device's performance is inherently "standalone" in its primary function as a guidewire and pacing tool.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is based on:

• Physiological/Biological Outcomes: Observed responses in the porcine model (e.g., return to normal sinus rhythm, absence of sustained arrhythmia, lack of adverse events, histological findings).
• Bench Test Specifications: Performance against internal engineering parameters, safety margins, structural integrity, and material properties.
• Biocompatibility Standards: Conformance to recognized ISO standards (ISO 10993-1).
• Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that the study device performs "similarly" and raises "no new questions of safety or effectiveness" compared to the predicate device.

8. The Sample Size for the Training Set

Not applicable. As this device is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

Not applicable. Since there is no AI/ML algorithm and therefore no training set, the concept of establishing ground truth for a training set does not apply.

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The Wattson™ temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.

The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary rapid pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a silicone lubricant applied to the outer surface. Rapid pacing is achieved through a bipolar electrode configuration integrated in the shaft of the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

The provided document describes the Wattson™ temporary pacing guidewire and its substantial equivalence to predicate devices, but it does not explicitly state specific quantifiable acceptance criteria for the device performance or present a table comparing such criteria with reported performance values.

Instead, the document focuses on demonstrating substantial equivalence through various types of testing. I will extract information related to the closest aspects of 'acceptance criteria' and 'reported device performance' based on the safety and effectiveness testing conducted.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantifiable acceptance criteria are not provided in the document, this table will summarize the types of tests and the outcomes as described for demonstrating substantial equivalence.

2. Sample Size and Data Provenance

• Test Set (Clinical): 20 subjects.
• Data Provenance (Clinical): Single-center, prospective study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting a U.S. study or a study compliant with U.S. regulatory standards.

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

This information is not provided in the document. The clinical study describes the outcomes observed in patients undergoing TAVR procedures but does not detail the process of establishing a "ground truth" through expert consensus for a test set, as might be typical for diagnostic AI devices. The assessment of performance appears to be based on the observed clinical outcomes and utility during the procedures.

4. Adjudication Method (Test Set)

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not conducted or reported. The document describes performance for the device itself, not an AI-assisted human reading scenario.

6. Standalone Performance Study

Yes, the studies described (bench, animal, and clinical) represent the standalone performance of the Wattson temporary pacing guidewire. There is no mention of human-in-the-loop performance; the device's efficacy is assessed directly.

7. Type of Ground Truth Used

• Biocompatibility & Bench Testing: Established by adherence to recognized international standards (ISO 10993-1) and internal design specifications/engineering measurements.
• Animal Studies: Established through direct observation of physiological responses, adverse events, histological findings, and procedural success in a porcine model, conducted under GLP. Comparison was made against predicate (control) devices.
• Clinical Study: Established by observed clinical outcomes during TAVR procedures, including aspects like guidewire support, pacing efficacy (reliable bipolar pacing at low thresholds), and safe transcatheter heart valve delivery.

8. Sample Size for the Training Set

This information is not applicable / not provided. The Wattson temporary pacing guidewire is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" of the device is through its design and manufacturing process, and its "performance" is evaluated through the validation studies described.

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

This information is not applicable / not provided for the same reasons as (8).

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