(25 days)
The ACIST RXi Mini is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus Catheter is intended for use with the ACIST RXi Mini.
ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit, which converts the optical sensor pressure signal into an analog pressure signal that can be read by a third party hemodynamic system in real-time. These two hardware components are intended to be located on or around a patient bed, and multiple mounting options are available to accommodate different workflows. Both components contain software.
The two modules are connected using the Navvus Interface cable, which contains both a fiber optic cable and an electrical signal (communication) cable. A hemodynamic cable is connected to the Processing Unit and is plugged into the appropriate channel programmed to accept the distal pressure in the hemodynamic system. The power cord is plugged into the Processing Unit and is then connected to the mains power source.
The provided text describes a 510(k) submission for the ACIST RXi Mini System, a medical device for measuring intravascular pressure. However, the document focuses on non-clinical tests (bench testing, electrical, software verification) to demonstrate substantial equivalence to a predicate device. It does not present clinical study data or specific acceptance criteria for device performance.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be populated from the provided information.
Here's a summary based on the available text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly met by testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Electrical Safety (IEC 60601-1) | Successfully performed |
| - Electromagnetic Compatibility (IEC 60601-1-2) | Successfully performed | |
| - Bed Mount compatibility | Successfully performed | |
| - Operating Environment compatibility | Successfully performed | |
| - Packaging Integrity | Successfully performed | |
| Software Performance | - Software Verification | Successfully performed |
| Overall Performance | - Design Validation | Successfully performed |
| Safety and Performance | - No new safety or performance issues raised | Achieved |
| Substantial Equivalence | - Same intended operating environments | Confirmed |
| - Same FISO signal conditioner | Confirmed | |
| - Same fundamental technology | Confirmed | |
| - Similar components and accessories | Confirmed | |
| - Performance appropriate for intended use | Confirmed |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing," "electrical testing," "software verification," and "design validation" which are non-clinical and do not typically involve human patient "test sets" in the context of diagnostic accuracy.
- Data Provenance: The tests were non-clinical, likely conducted at the manufacturer's facilities or accredited labs. Country of origin for data is not applicable as it's not patient data. Retrospective/Prospective: Not applicable as it's non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this was non-clinical engineering and software testing, there was no "ground truth" established by medical experts in the context of patient diagnosis. Performance was assessed against engineering specifications and regulatory standards.
4. Adjudication method for the test set
- Not applicable. There was no clinical imagery or patient data requiring expert adjudication.
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 device is a transducer system for measuring intravascular pressure, not a diagnostic imaging AI system. Therefore, an MRMC study or AI assistance evaluation is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The "standalone" performance refers to the device's ability to accurately convert the optical sensor pressure signal into an analog pressure signal. This performance was validated through non-clinical testing (bench testing, electrical testing, software verification, design validation) to show it functions as intended by itself, without human interpretation of its output beyond ensuring it meets specifications.
7. The type of ground truth used
- The "ground truth" for the non-clinical tests would have been engineering specifications, established standards (e.g., IEC 60601-1, IEC 60601-1-2), and design requirements. The device’s output was measured against these predefined technical benchmarks rather than against a medical outcome or expert consensus on clinical data.
8. The sample size for the training set
- Not applicable. This device is a hardware and software system for signal processing, not a machine learning or AI model that requires a "training set" of data in the typical sense.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set in the context of machine learning.
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).