(297 days)
The CARTO XP EP Navigation System with QWIKMAP software is intended to acquire real time catheter based cardiac electrophysiolgical maps in patients who are eligible for a conventional electrophysiological study. There are no special contraindications when using the CARTO XP with OWIKMAP software.
The intended use of the CARTO XP EP Navigation System is catheter-based atrial and ventricular mapping.
The CARTO XP EP Navigation System allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
The CARTO XP EP Navigation system with QWIKMAP software is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, chamber geometry maps, and impedance maps. In the CARTO XP with OWKMAP mapping system the location information needed to create the cardiac maps is acquired using catheters equipped with magnetic proximal and distal location sensors. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Cardiac EP mapping procedures are generally performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the tip of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure. The CARTO XP with QWIKMAP mapping system enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.
The provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving device performance against those criteria.
The document is a 510(k) summary for the CARTO™ XP EP Navigation System with QWIKMAP™ software. It provides information about the device's indications for use, general description, and compliance with safety standards. It also mentions non-clinical bench and animal testing that showed the device to be as safe and effective as a predicate device.
However, it lacks specific details about:
- Quantitative acceptance criteria: There are no numerical targets for performance metrics like sensitivity, specificity, accuracy, or any other relevant measures.
- A specific study design to prove these criteria: While it mentions "non-clinical bench and animal testing," it does not describe the methodology, sample sizes, or results of any study that directly addresses predefined acceptance criteria.
- Ground truth establishment for a test set: No information regarding expert involvement, adjudication methods, or the type of ground truth used (e.g., pathology, follow-up outcomes) for a test set is provided.
- MRMC comparative effectiveness study: There is no mention of a study involving human readers with and without AI assistance.
- Standalone algorithm performance: No data on the algorithm's performance without human intervention is presented.
- Training set details: No information about the size or ground truth establishment for a training set.
Therefore, most of the requested fields cannot be populated from the provided text.
Here's an attempt to fill out what little can be inferred, with many fields explicitly marked as "Not provided in text":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative Measures) | Reported Device Performance |
|---|---|
| Not provided in text | Not provided in text |
2. Sample size used for the test set and data provenance
- Sample size (test set): Not provided in text
- Data provenance: "Non-clinical bench and animal testing" are mentioned, implying controlled experimental conditions, but specific countries of origin or whether the data was retrospective/prospective are not stated.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of experts: Not provided in text (no ground truth establishment described for a test set)
- Qualifications of experts: Not provided in text
4. Adjudication method for the test set
- Not provided in text (no ground truth establishment described for a test set)
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
- No, an MRMC comparative effectiveness study is not mentioned in the provided text.
6. If a standalone (algorithm only) performance study was done
- No, details about a standalone algorithm performance study are not provided in the text. The document refers to the "CARTO™ XP EP Navigation System with QWIKMAP™ software," which suggests an integrated system, but no data on the algorithm's isolated performance is given.
7. The type of ground truth used
- Not provided in text (no ground truth establishment described for a test set). The "non-clinical bench and animal testing" implies experimental validation against known physical or physiological conditions, but specific types of ground truth (e.g., pathology) are not defined.
8. The sample size for the training set
- Not provided in text (no mention of a training set).
9. How the ground truth for the training set was established
- Not provided in text (no mention of a training set).
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).