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Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories:

1. The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene.
2. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle.
3. The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave).
4. The extracorporeal end of wire has a straight needle with breakaway tip attached.
5. The wire length is 60 cm.
6. Wires range in multiple diameters from 0 to 2-0, depending on the product code.

The provided text is a 510(k) Premarket Notification summary for a medical device called "Temporary Cardiac Pacing Wire." It describes the device, its intended use, and compares it to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed device rather than proving the device meets a set of acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically for an AI/algorithm-based device. The device in this document is a physical medical device (cardiac pacing wire), and the "performance modification" mentioned refers to testing its compatibility with an MRI environment, not a software algorithm's performance.

To answer your request, if this were an AI/algorithm-based device, the document would need to outline the specific performance metrics (e.g., sensitivity, specificity, accuracy), the thresholds for those metrics (acceptance criteria), and details of a clinical or performance study (e.g., test set size, expert ground truth establishment, MRMC studies) to demonstrate that the algorithm met those criteria.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI/algorithm. The document focuses on showing substantial equivalence of a physical device with a predicate through design and material comparisons, and non-clinical performance testing related to MRI compatibility.

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The Temporary Cardiac Pacing Wire with wave is intended for use in temporary cardiac pacing or monitoring.

The Temporary Cardiac Pacing Wire with wave has the same intended use as predicate device Temporary Cardiac Pacing Wire (TPW).

The Temporary Cardiac Pacing Wire is intended for use in temporary cardiac pacing or monitoring.

The Temporary Cardiac Pacing Wire with wave is a lead that consists of an uninsulated multifilament stainless steel wire electrode and an insulated multifilament conductor coated with blue polyethylene attached to a straight Keith needle. There is no exposed wire at the point of the swage to the straight Keith needle. The Keith needle is scored eliminating the need to cut the needle. The Keith needle is connected to an external temporary cardiac pacing or monitoring device. A 'wave' is preformed into the uninsulated distal end, then attached to a curved needle.

The provided document K980503 is a 510(k) summary for a Temporary Cardiac Pacing Wire with wave. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria in the way a new, novel device might. Therefore, the information requested regarding a study proving acceptance criteria is largely not applicable in the typical sense for this submission type.

However, I can extract the information that is present and explain why some of the requested points are not explicitly detailed in a 510(k) for a substantially equivalent device.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Explanation: For a 510(k) submission, the primary "acceptance criterion" is often substantial equivalence to a predicate device. This means the new device shares the same intended use and technological characteristics as the predicate, or if there are differences, they do not raise new questions of safety or effectiveness and can be demonstrated to be as safe and effective as the legally marketed predicate. Specific numerical acceptance criteria are typically not provided as they would be for a de novo or PMA submission.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "Nonclinical laboratory testing was performed to determine pullout force after implantation." It does not specify the number of wires tested.
• Data Provenance: The testing appears to be nonclinical laboratory testing, likely performed by the manufacturer, ETHICON, Inc. The document does not specify country of origin for the data or whether it was retrospective or prospective. Given it's nonclinical lab testing, it's typically prospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For nonclinical laboratory testing like pullout force, "ground truth" is established by direct physical measurement using validated testing protocols, not through expert consensus or interpretation of clinical data. Therefore, no experts were involved in establishing ground truth for this specific lab test.

4. Adjudication method for the test set

• Not Applicable. As the "ground truth" for the pullout force test is a direct physical measurement, there is no need for adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

• No. This is not a diagnostic device that involves human interpretation of results, but rather a medical device for temporary cardiac pacing. Therefore, an MRMC study is not relevant or required for this type of device.

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

• Not Applicable. This is a physical medical device, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used

• For the reported performance data (pullout force), the ground truth was established by direct physical measurement during nonclinical laboratory testing.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. See point 8.

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