(121 days)
The SphygmoCor® XCEL System provides a derived ascending aortic blood pressure waveform and a r no ophygmood " Toller director in the measurements are provided non-invasively through the use of a Brachial cuff.
It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
Additionally, the SphygmoCor XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure.
The SphygmoCor XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.
The SphygmoCor XCEL System is indicated to perform non-invasive cardiovascular measurements as an adjunct to manage various cardiovascular conditions. The device can be used in any of 2 modes:
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- Pulse Wave Analysis Measurement (PWA or CP) A brachial cuff is used to measure the peripheral blood pressure and arterial pulses to derive the central blood pressure waveform and corresponding parameters. The brachial blood pressure measurement is calculated using the oscillometric technique. This feature is implemented essentially by a 30 party NIBP Module (SunTech Medical Advantage Mini OEM BP module).
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- Pulse Wave Velocity Measurement (PWV) Using a non-invasive Tonometer pressure sensor and Cuff, this mode measures the time difference between the Carotid and Femoral arterial pulses measured simultaneously. To determine the carotid to femoral pulse wave velocity, the distance measured between the two arterial sites is divided by measured time difference. This Pulse Wave Velocity (PWV) is an indicator of arterial stiffness. Higher PWV's are associated with increased arterial stiffness.
The main system components include an electronics hardware module, a tonometer pressure transducer and brachial & thigh cuffs. The basic device operation involves patient's physiological signals being gathered by the electronics hardware module via the patient-contacting cuff and/or tonometer pressure sensor. These signals are then transferred via USB communications to a PC running the Microsoft Windows-based SphygmoCor XCEL Software application. This software application provides the functionality to process the physiological signals and derive the central blood pressure waveform and various other central arterial indices (including Pulse Wave Velocity). The software application also provides a GUI-based interface to allow the operator to initiate measurements and to display the measured waveforms and parameters to the operator.
Here's a breakdown of the acceptance criteria and study information for the SphygmoCor XCEL, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly present a discrete table of acceptance criteria with specific performance thresholds and corresponding device performance values for the SphygmoCor XCEL in a direct comparison. However, it states that "Side-by-Side Equivalence testing was performed for both the PWA and PWV functions of the SphygmoCor XCEL System against the identified predicates. These comparison tests demonstrated equivalence between the measured and calculated parameters between the predicates and satisfactorily passed the acceptance criteria."
This implies the acceptance criteria were based on demonstrating equivalence to the predicate devices. The type of acceptance criteria would likely be related to statistical equivalence in derived parameters (e.g., central blood pressure waveform and associated indices for PWA, and pulse wave velocity for PWV).
General Acceptance: The device was deemed to have "satisfactorily passed the acceptance criteria," meaning it achieved equivalence to the predicate devices.
Study Details
The document describes several tests performed, broadly categorized as:
- Compliance to FDA Consensus Standards: This involved testing against AAMI/IEC 60601-1, AAMI/IEC 80601-2-30, ISO 81060-2, and IEC 60601-1-2. These are general safety, essential performance, and EMC standards, not direct clinical performance metrics.
- System Verification and Validation testing: This demonstrated that the integration of software and hardware met predefined Product System Requirements.
- Software Verification and Validation testing: Ensured compliance with predetermined specifications.
- Side-by-Side Equivalence testing: This is the most relevant for clinical performance and demonstrating substantial equivalence.
Given the nature of the submission (510(k) for substantial equivalence to predicate devices), the "study" primarily consists of the Side-by-Side Equivalence testing.
1. Acceptance Criteria and Reported Device Performance
| Parameter/Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| PWA Function | Equivalence to SphygmoCor CvMS System (K070795) in measured and calculated parameters. | "satisfactorily passed the acceptance criteria" and demonstrated "equivalence between the measured and calculated parameters." |
| PWV Function | Equivalence to SphygmoCor CvMS-PWV System (K080670) in measured and calculated parameters. | "satisfactorily passed the acceptance criteria" and demonstrated "equivalence between the measured and calculated parameters." |
| NIBP Function | Equivalence to Cheetah Reliant (K083093) | Implied equivalence as it uses the same 3rd party OEM module (SunTech Medical Advantage Mini OEM BP module). |
Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the SphygmoCor XCEL itself. The acceptance criteria are framed in terms of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of subjects or cases used for the "Side-by-Side Equivalence testing."
- Data Provenance: The submitter is AtCor Medical Pty Ltd, Australia. The document does not specify the country of origin of the data for the equivalence testing. It is a retrospective or concurrent comparison study against predicate devices, as it evaluates the new device side-by-side with existing, cleared devices.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The document does not mention the use of experts to establish ground truth for this specific equivalence testing.
- Qualifications of Experts: Not applicable, as experts are not mentioned in this context. The study compares the new device's readings to those of predicate devices, which are already accepted as providing valid measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: The document does not describe an adjudication method. This is likely because the "ground truth" for the equivalence study is the measurements obtained from the predicate devices, rather than a subjective expert assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, the document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a measurement system, not an AI-assisted diagnostic imaging interpretation tool.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
- Standalone Performance Study: The "Side-by-Side Equivalence testing" can be considered a form of standalone performance evaluation in the context of a measurement device. It assesses the device's output (measurements) directly against predicate devices. The system performs automatic measurements, and the comparison is of these automated outputs. The performance data section refers to "System Verification and Validation testing" and "Software verification and validation test results" which also fall under standalone testing.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Side-by-Side Equivalence testing," the ground truth is effectively the measurements obtained from the predicate devices (SphygmoCor CvMS System for PWA, SphygmoCor CvMS-PWV System for PWV, and Cheetah Reliant for NIBP). The assumption is that these predicate devices provide an accepted and validated measurement.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not specify a sample size for a training set. While the device uses software, the context is not of a machine learning or AI model that requires a distinct training set in the typical sense for a 510(k) submission of this nature. The "General Transfer Function (GTF) methodology" mentioned for deriving the central pressure waveform is a validated algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the context of this 510(k) submission as no distinct training set for a new machine learning algorithm is described. The GTF methodology for PWA is stated to be "validated," implying its performance has been established previously, likely using invasive catheter measurements as the ground truth in its initial development and validation.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).