(29 days)
Pressure Wire™ is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.
The subject device, PressureWire™ Aeris™, is a new version of the predicate device (K131452), with the same name. The PressureWire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire is available in two different lengths.
The guidewire is uniquely paired with a specific connection cable for PressureWire Certus ( not subject device for this submission) or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.
The provided document describes a 510(k) summary for the PressureWire™ Aeris™ device, which is a new version of a previously cleared predicate device. This submission focuses on modifications to the transmitter part of the device. Therefore, the presented information does not contain a typical "study" proving performance against acceptance criteria in the sense of a clinical trial or a standalone algorithm evaluation. Instead, it details a design control activity demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/algorithm-based device. This is because the submission is for a medical device (a guidewire with a pressure sensor and its transmitter), not an AI algorithm.
Instead, the "acceptance criteria" are implied by successful completion of verification activities ensuring the modified components (transmitter hardware, software, enclosure, packaging, IFU, sterilization cycle) continue to meet required product specifications and do not negatively impact the operational principle or the fundamental scientific technology.
The "reported device performance" is summarized as:
- "The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications."
- "Based on passing verification criteria for mechanical and signal testing, PressureWire™ performs substantially equivalent to predicate devices."
- "The subject device, PressureWire™ Aeris™, meets the design inputs and raises no new safety or efficacy concerns."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The "tests" mentioned are verification and validation activities related to hardware and software changes, not a clinical study on a patient sample. Therefore, sample size and data provenance in the context of patient data are not relevant or discussed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided and is not applicable to this type of device submission. The "ground truth" for verification of hardware changes would be engineering specifications and design inputs, verified by engineers and quality assurance personnel rather than medical experts interpreting clinical data.
4. Adjudication Method
This information is not provided and is not applicable. Adjudication methods are typically used in clinical trials or studies where expert consensus is needed to establish ground truth for clinical endpoints.
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, an MRMC comparative effectiveness study was not done. This device is a guidewire for measuring physiological parameters, not an AI diagnostic or assistive tool for human readers. Therefore, there's no mention of AI assistance or its effect on human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an algorithm but a medical device (guidewire and transmitter).
7. The Type of Ground Truth Used
The "ground truth" for the verification activities described in this submission would be the design specifications, pre-established performance metrics for the previous version of the device, and engineering requirements. The intent was to show that the modified components function as intended and do not alter the established performance characteristics. It's essentially "engineering ground truth" rather than clinical or pathology ground truth.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is not a machine learning or AI algorithm development for which a "training set" would be used.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as above.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).