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The Ivy Biomedical RT Carbon ECG Leads are intended for use in X-ray imaging environments. They connect between ECG electrodes that are placed on the patient by a trained healthcare professional and an ECC trunk cable that connects to the ECG monitoring device. The RT Carbon ECG Leads are reusable and nonsterile. The RT Carbon ECG Leads are intended for adult, pediatric and neonatal patient populations.

The RT Carbon ECG Leads are intended to connect electrodes placed on the patient to a physiological detection module or monitor (CTM-300, CTM-400, CTM-500, 7000 Series and 3000 Series). The design includes 3 and 4 lead designs with overall lengths of 24", 30" and 36".

The provided text describes a 510(k) premarket notification for the Ivy Biomedical RT Carbon ECG Leads. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than presenting novel clinical efficacy or diagnostic performance data. Therefore, many of the requested categories related to AI performance studies are not applicable.

Here's the information extracted and categorized as requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the format of specific thresholds and measured values for the RT Carbon ECG Leads. Instead, it states that the device was "thoroughly tested from design requirements through device verification and validation testing as required by 21 CFR 870.2900" and in accordance with EC53. The reported performance is summarized as:

"The performance data support the safety of the device and hardware verification and validation demonstrate that the RT Carbon ECG Leads should perform as intended in the specified use conditions and is substantially equivalent to the predicate."

This implies that the device met the acceptance criteria derived from the listed tests.

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

The document does not specify the sample size for individual tests conducted on the RT Carbon ECG Leads. The testing was described as "conducted at Ivy" (implying in-house lab testing) and does not involve human data, thus the provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical data.

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment for a test set. The tests are engineering and biological evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/diagnostic device that requires adjudication of interpretations.

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

Not applicable. This device is an ECG lead, not an AI system or diagnostic tool for interpretation.

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

Not applicable. This device is an ECG lead, not an algorithm.

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

The 'ground truth' for the performance testing is based on established engineering standards (EC53) and biocompatibility standards (ISO 10993-1). Compliance with these standards serves as the benchmark against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is a medical device (ECG lead), not an AI model that requires a training set.

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

Not applicable. This is a medical device (ECG lead), not an AI model.

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