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The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.

The Steelex Electrode Set comprises a stainless steel 316L braided wire (ASTM-F138), with a plastic isolating cover (Polyethylene). One end of the wire is armed with a stainless steel 420 (ASTM-F899) ½ circle or 3% circle round-bodied needle and the other end is armed with a stainless steel (ASTM-F899) straight needle (break-off). The straight break-off needle also serves as the connection to the generator. The needle sizes for Steelex Electrode Set are available in the USP sizes 302, 420 or 420F, 0, 1-0, 2-0 and 3-0.

The provided text is a 510(k) summary for the Steelex Electrode Set. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it explicitly states that "No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices." This means there are no formal acceptance criteria or a study proving the device meets them in the traditional sense of a clinical performance study with specific metrics.

Instead, the FDA's decision to clear this device via 510(k) is based on substantial equivalence to already approved predicate devices. This regulatory pathway means the new device is considered as safe and effective as a legally marketed device if it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics and the information submitted to FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.

Therefore, for this particular submission, the answers to your questions will reflect this regulatory approach rather than a traditional performance study.

Here's the information based on the provided text, while noting the absence of a specific performance study:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No specific "test set" was used for a performance study as described. The determination of substantial equivalence relies on comparing the device's design, materials, and intended use against already cleared predicate devices.

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

Not applicable. No specific ground truth was established by experts for a test set in the context of a performance study. The FDA's review panel (Cardiovascular) and Office of Device Evaluation (ODE) experts assess the submitted documentation for substantial equivalence to predicates.

4. Adjudication Method for the Test Set

Not applicable. No test set adjudication method is mentioned as there was no performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a temporary pacing electrode, not an AI-assisted diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance for human readers was performed.

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

Not applicable. This is a medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context is the safety and effectiveness profile of the predicate devices (Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503) and Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (K012459)) as established through their prior FDA clearances. The new device is deemed safe and effective because it is substantially equivalent to these already approved devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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