(28 days)
The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.
The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System includes:
- The CardioMEMS EndoSure™ Sensor with radio-opaque markings (implant)
- A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ Sensor)
- CardioMEMS EndoSure™ Electronics System
The provided text details the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, information about adjudicated ground truth, or details about training and test sets as requested in the prompt.
The document is a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to a predicate device, rather than a clinical study report with detailed performance data against pre-defined acceptance criteria.
Therefore, the majority of the requested information cannot be extracted from the provided text.
Here's a summary of what can be extracted and a clear indication of what is missing:
Acceptance Criteria and Study for CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Bench testing confirms that the device functions per its specifications." |
| "Testing has shown the EndoSure Sensor with Delivery System to be biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators." |
Missing Information: The document states that bench testing confirms the device functions per its specifications, but it does not detail what those specifications (i.e., acceptance criteria) are, nor does it provide quantitative performance data (e.g., accuracy, precision, error margins) from these tests.
2. Sample size used for the test set and the data provenance
Missing Information: There is no mention of a "test set" in the context of a clinical or performance study with a specific sample size. The document refers to "bench testing," which typically involves simulated conditions rather than patient data or a test set. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: There is no mention of a "test set" or experts establishing ground truth for performance evaluation in the provided text.
4. Adjudication method for the test set
Missing Information: 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
Missing Information: This device is a pressure measurement system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be applicable and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: The document states the device "may be used as an adjunctive tool," implying a human-in-the-loop scenario. No standalone algorithm performance is described.
7. The type of ground truth used
Missing Information: Since specific performance studies with detailed data are not provided, the type of ground truth used (e.g., pathology, outcomes data) for evaluation is not described. The "bench testing" likely compared the device's pressure readings to known reference pressures.
8. The sample size for the training set
Missing Information: As this document describes a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not applicable and is not mentioned.
9. How the ground truth for the training set was established
Missing Information: Not applicable as there is no training set described.
Conclusion from Provided Text:
The document primarily serves as a regulatory submission (510(k)) to demonstrate substantial equivalence to a predicate device for market clearance. It broadly states that "Bench testing confirms that the device functions per its specifications" and is "biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators." However, it does not provide the detailed performance data, acceptance criteria, sample sizes, or ground truth methodologies that would be typically found in a comprehensive study report evaluating a device's performance against specific metrics.
§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
(a)
Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.