(181 days)
The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair. It may be used as an adjunctive tool in the detection of intraoperative endoleaks.
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 Interrogator
This 510(k) summary for the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System primarily focuses on its equivalence to a predicate device and does not contain detailed acceptance criteria or a dedicated study section with the specifics requested. The document emphasizes safety and general performance.
However, based on the provided text, here's an attempt to extract and infer the information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | "Testing has shown the EndoSure Wireless AAA Pressure Measurement System to be biocompatible..." |
| MRI Safety | "...MRI safe..." |
| Compatibility with ultrasound | "...compatible with ultrasound..." |
| Compatibility with pacemakers | "...compatible with... pacemakers..." |
| Compatibility with defibrillators | "...compatible with... defibrillators." |
| Functionality per specifications | "Bench and clinical testing confirm that the device functions per its specifications..." |
| Substantial Equivalence to Predicate Device | "...is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Bench and clinical testing" but does not quantify the number of cases or patients in these tests.
- Data Provenance: Not explicitly stated beyond "Bench and clinical testing." There is no mention of country of origin or whether studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable or not stated. The performance data section does not describe the establishment of a "ground truth" using expert consensus for the device's primary function of pressure measurement. The device directly measures pressure. For substantial equivalence, it's compared against a predicate, which implies its measurements are compared against an established method or device, not necessarily expert interpretation in the typical sense of diagnostic imaging.
- Qualifications of Experts: Not applicable or not stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not stated. The context of adjudication, typically seen in studies where multiple readers interpret data and discrepancies need resolution, is not present here. The device's primary function is direct pressure measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device directly measures pressure, rather than providing interpretative images or data that human readers would then analyze. The mention of its use as an "adjunctive tool in the detection of intraoperative endoleaks" could imply human interpretation, but no MRMC study details are provided.
- Effect Size of Human Readers with/without AI Assistance: Not applicable, as no MRMC study involving human readers and AI assistance is described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The device itself is described as measuring pressure and displaying data. The statement "Bench and clinical testing confirm that the device functions per its specifications" suggests standalone performance was evaluated. The device's "Technological Characteristics Summary" details how it remotely interrogates the sensor, records resonant frequency, and converts it to a pressure measurement, implying an automated, standalone process for acquiring the primary data.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the primary function of pressure measurement, the ground truth would inherently be established by direct comparison to a known, calibrated pressure standard (for bench testing) and/or comparison to other established clinical pressure measurement methods (for clinical testing). The text states it "functions per its specifications and is substantially equivalent to the predicate device," implying the predicate device's performance serves as a reference.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable or not stated. This device is a pressure sensor system, not a machine learning or AI algorithm that typically requires a discrete training set. Its functionality is based on physical principles (LC circuit, resonant frequency) rather than learned patterns from data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 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.