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A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

The Platinum Series EP Diagnostic Catheter is an electrophysiology catheter with a range of two to ten platinum recording/stimulating electrodes arranged on its distal end. The distal band electrode is approximately .050" from the spherically molded Pebax tip. The distal band electrode serves as the tip electrode. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each platinum electrode to the electrical connector in the proximal end. The outside diameter of the catheter is 5 to 6 French and the usable length ranges from 60 to 125 cm.

This 510(k) summary for the K953185 Platinum™ Series of Diagnostic Electrophysiology Catheters does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study design. The document is from 1995, and regulatory submission requirements regarding clinical study specifics were different then.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. It mentions "in-vivo testing," implying biological testing, but details on human subjects or animals, their origin, or the study design (retrospective/prospective) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. This device is an electrophysiology catheter for recording and stimulating, not an imaging device requiring expert interpretation for ground truth. The "ground truth" would relate to the accuracy of its electrical and mechanical measurements, which would be assessed by engineers/biomedical scientists through non-clinical and in-vivo testing, not expert consensus on diagnostic images.

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

• Not applicable for this type of device and study. Adjudication methods like 2+1 are relevant for interpreting diagnostic images where human variability exists. For direct measurement devices, performance is typically assessed against engineering specifications or known electrical/mechanical properties.

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. This is not an AI-assisted diagnostic imaging device. An MRMC study is not relevant for an electrophysiology catheter.

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. Its performance is inherent in its electrical and mechanical properties, not an algorithm that operates independently.

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

• Type of Ground Truth: The "ground truth" for this device's performance would be established through:
  • Engineering specifications and standards: For electrical parameters (impedance, signal integrity) and mechanical properties (flexibility, durability, steerability).
  • Biocompatibility testing results: Assessed against ISO standards or similar.
  • In-vivo measurements: Actual recorded electrical signals and stimulation effects within a living system (animal or human), compared against expected physiological responses.
  • Comparison to predicate device performance: Showing equivalence in various test parameters.

8. The sample size for the training set

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

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

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

Summary of what is known:

• Study Type: Non-clinical (benchtop) and in-vivo testing.
• Purpose: To quantitate and confirm the adequacy of electrical and mechanical performance and reliability, and to support equivalence with predicate devices.
• Predicate Devices: Medtronic CardioRhythm Torqr catheter and Bard Intracardiac Electrode catheter.
• Biocompatibility: Fulfilled because patient-contacting materials are identical to those in the predicate Medtronic CardioRhythm Torqr catheter.

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