(29 days)
The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the atrial regions of the heart.
The Inquiry Optima PLUS Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop and on the shaft of the catheter also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
The provided text is a 510(k) summary for a medical device and does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth establishment in the context of device performance metrics like sensitivity, specificity, accuracy, etc. It primarily focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract what is stated regarding testing and comparison:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance values. Instead, it refers to a non-clinical test plan and its outcome.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated as quantifiable metrics for device performance) | "The test results indicated reliable performance when the device was used in accordance with the Instructions for Use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set, nor does it mention data provenance (country of origin, retrospective/prospective). The study described is "non-clinical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The non-clinical tests likely involved engineering or laboratory assessments rather than human expert evaluation for "ground truth" in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an electrophysiology catheter, and this type of study is typically associated with AI-driven diagnostic imaging devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical catheter, not an algorithm, and is used with a human in the loop (electrophysiologist).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly relevant to the described non-clinical performance testing of a physical medical device. The "test results" likely refer to engineering specifications and functional performance.
8. The sample size for the training set
No training set is mentioned as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
No training set is mentioned.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).