(259 days)
The A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse.
Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
The HealthSTATS A-PULSE CASPal® and MC3100™ are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.
The CASPal®+ Monitor is comprised of four main elements:
- System embedded processing unit.
- Integrated oscillometric blood pressure module for calibration (identical to the BPCalibrator [listed device K041546], also cleared iin CASPal device K101002).
- Wrist sensor module for acquistion of central aortic systolic pressure (CASP) via radial arterial tonometry at the wrist [cleared accessory and method K101002].
- Bluetooth® wireless communications module.
The MC3100™* is a reduced feature set of the CASPal®* which only offers the oscillometric blood pressure measurement and not the CASP measurement, but is otherwise identical. my-BP™ PC software may be used with either device to store and display blood pressure and pulse rate measurements on a suitably equipped computer.
The provided 510(k) summary does not contain the information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria, particularly as it relates to AI/machine learning performance studies.
This document describes a blood pressure monitor (HealthSTATS A-PULSE CASPal®+ and MC3100™+ Monitors) and associated software. The "Clinical Tests Submitted" section explicitly states that no new clinical data was submitted for this specific 510(k) submission (K131788). Instead, it relies on clinical testing performed on a cleared predicate device (A-PULSE CASPal) because the current devices are considered "functionally and physically identical" except for the addition of Bluetooth wireless data transmission.
Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment are not present in this document, as they would have been part of the predicate device's clearance.
However, I can extract what is stated:
Summary of Acceptance Criteria and Device Performance (based on provided text):
The document frames "acceptance criteria" through the lens of substantial equivalence to predicate devices, focusing on safety and effectiveness.
| Acceptance Criteria Category | Stated Performance / Conclusion |
|---|---|
| I. Functional Performance | Blood Pressure Measurement Accuracy: Implied to meet standards of predicate devices (A-PULSE CASPal, A&D Medical UA767BT Blood pressure monitor, Omron Health Management Software). The device measures conventional oscillometric blood pressure and (for CASPal+) Central Aortic Systolic Pressure (CASP) via radial arterial tonometry. Specific accuracy thresholds (e.g., mean difference, standard deviation) are not provided in this summary, but would have been part of the predicate device's clearance. |
| II. Safety | Electrical Safety: Tested to meet applicable standards. |
| Electromagnetic Compatibility (EMC): Tested to meet applicable standards. | |
| Environmental (Temp & Humidity): Tested to meet applicable standards. | |
| Mechanical Strength (Shock & Vibration): Tested to meet applicable standards. | |
| Biocompatibility: Materials in skin contact surfaces (accessories) met biocompatibility requirements. | |
| Risk Management: System level risk, hazard, and failure mode analysis performed on hardware and software; residual risks determined to be acceptable. | |
| III. Software Performance | Embedded Software (Monitors): Verified to requirements and validated to meet intended use. |
| my-BP™ PC Software: Verified to meet specified requirements for storage and display of retrospective vital blood pressure and pulse rate data. | |
| IV. Intended Use and Applicability | Patient Population: Intended for use on patients eighteen (18) years and older. For CASPal+, patients must have a palpable radial pulse. |
| User: Readings intended for use by qualified healthcare personnel as an aid to diagnosis and treatment. | |
| V. Equivalence | Overall Conclusion: "The testing demonstrates that the A-PULSE CASPal® /MC3100 ** Monitors and my-BP™ PC Software are as safe and effective as, and function in a manner equivalent to the referenced predicate devices." No new clinical data was submitted for this 510(k), relying on data from the predicate A-PULSE CASPal device (K101002). |
Study Details (based on provided text):
Since this submission relies on a predicate device's clearance for clinical data, the details of the original clinical study are not provided in this document. The following points represent what can be inferred or are explicitly absent:
- A table of acceptance criteria and the reported device performance: See table above. Specific numerical clinical performance metrics (e.g., mean difference and standard deviation of BP readings compared to a reference) are not provided in this summary, as clinical data was not submitted anew for this device.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in this document. This information would have been part of the predicate device's submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/provided. For a blood pressure monitor, the "ground truth" is typically established by concomitant measurements using a validated reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer, intra-arterial catheterization for CASP, or another FDA-cleared device with established accuracy), not by human experts adjudicating images or reports. The document does not describe the specifics of the clinical study method for the predicate.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided. As per point 3, this is not a study type where human adjudication of results would typically occur.
- 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 is not an AI/machine learning device that assists human readers. It's a medical device for measuring blood pressure.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device measures blood pressure automatically, so its performance is inherently "standalone" in that sense. It does not involve a human in a decision-making loop that an AI would typically augment. The performance of the measurement algorithms themselves would have been evaluated in the predicate device’s clinical study against reference methods.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure measurement, the ground truth is typically a reference measurement from a validated standard method (e.g., intra-arterial catheter, or manual auscultatory measurement by trained personnel according to a standard protocol). The specific method used for the predicate device's clinical study is not detailed in this 510(k) summary.
- The sample size for the training set: Not applicable. This device is not described as utilizing a machine learning algorithm that has a "training set." Its function is based on established physiological principles and signal processing, not a trained AI model.
- How the ground truth for the training set was established: Not applicable. (See point 8).
§ 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).