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INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers.

The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter.

The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting.

The provided document is a 510(k) summary for a medical device called the INTERIM™ AV Shaped Temporary Pacing Catheter, Model INT-AV610. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding test sets, ground truth establishment, or comparative effectiveness studies that would typically be performed for an AI/ML powered device.

Based on the content, here's what can be extracted and what is explicitly stated as not performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria in a table format for performance metrics. Instead, it relies on substantial equivalence to a predicate device already on the market. The general "performance" indicated is related to the physical design, materials, and a "feasibility study" for optimal electrode placement for atrial sensing.

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

• Sample Size for Test Set: Not applicable. The document mentions "feasibility studies" but does not specify a sample size for a "test set" in the context of performance evaluation, especially one related to an AI/ML algorithm.
• Data Provenance: Not applicable in the context of AI/ML testing. The "feasibility studies" are mentioned in general terms. No country of origin is specified for these studies, nor whether they were retrospective or prospective.

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

• Not applicable. The document does not describe the establishment of ground truth for a test set, as no clinical study or AI/ML algorithm performance evaluation is detailed.

4. Adjudication method for the test set:

• Not applicable. There is no mention of a test set or an adjudication method.

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:

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies using the actual design of the subject device were not performed." This device is a physical medical instrument, not an AI/ML powered tool that would involve human readers interacting with AI.

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

• No, a standalone algorithm performance study was NOT done. This device is a physical medical instrument, not an AI/ML algorithm.

7. The type of ground truth used:

• Not applicable in the AI/ML context. The closest concept might be that the "feasibility studies" determined "optimal location for the atrial electrodes with regard to atrial sensing potential," which implies some form of established physiological understanding or experimental outcome as a "ground truth" for design decisions. This is not the typical "ground truth" used for evaluating AI/ML models (e.g., pathology, outcomes data).

8. The sample size for the training set:

• Not applicable. This document is for a physical medical device, not an AI/ML algorithm that would have a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is mentioned.

In summary: This 510(k) submission pertains to a physical temporary cardiac pacing catheter and does not involve AI/ML technology. Therefore, many of the requested details related to AI/ML evaluation (such as test sets, ground truth, MRMC studies, training data) are not present in the document. The device passed regulatory review based on substantial equivalence to an existing predicate device and general feasibility studies for its physical design and function.

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