(261 days)
This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults, using wrist cuff and oscillometric method of measurement.
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement.
There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.
The user interface panel of FP-0217 has power button, mode button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate and date. FP-0217 has memory capacity to store the 58 most recent measurement results.
The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.
Acceptance Criteria and Study for FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217
The provided document, K092061, is a 510(k) summary for a blood pressure monitor, not a detailed clinical study report. Therefore, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full independent study with explicit acceptance criteria and corresponding performance data.
Based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are generally derived from the established performance standards for blood pressure monitors and the performance of the predicate device. The document does not explicitly state numerical acceptance criteria but implies adherence to recognized standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Measurement of Systolic Blood Pressure accuracy (compared to a reference method) | Equivalent to predicate device (K012054) |
| Measurement of Diastolic Blood Pressure accuracy (compared to a reference method) | Equivalent to predicate device (K012054) |
| Measurement of Pulse Rate accuracy | Equivalent to predicate device (K012054) |
| Safety of device operation | Equivalent to predicate device (K012054) |
| Effectiveness for intended use (adults, home care, wrist cuff, oscillometric method) | Equivalent to predicate device (K012054) |
Note: The document does not provide specific numerical performance data (e.g., mean difference, standard deviation) for the device itself. The core argument is substantial equivalence to the predicate device, K012054, meaning its performance characteristics are considered similar enough not to raise new questions of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state a sample size for an independent test set used to evaluate the FP-0217 directly against clinical standards. The entire premise of the submission is demonstrating substantial equivalence to a predicate device (K012054).
For blood pressure monitors, clinical validation typically involves studies adhering to standards like ANSI/AAMI/ISO 81060-2 (or its predecessors at the time of submission). While such studies would have a defined sample size, this document does not present such a study for the FP-0217. It's highly probable that the predicate device (K012054) would have undergone such validation with a specified sample size.
- Data Provenance: Not explicitly stated for specific validation data for FP-0217. The submission is from a South Korean manufacturer (Genexel Medical Instrument Inc.) and indicates the device is intended for "home care environment."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this 510(k) submission relies on substantial equivalence rather than presenting a new, full clinical validation study for the FP-0217, this information is not provided.
If a clinical validation study had been performed for the FP-0217, the ground truth for blood pressure measurements would typically be established by trained observers (often medical professionals) using a auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device), following a standardized protocol (e.g., as per ANSI/AAMI/ISO 81060-2). The number and qualifications of these observers would be detailed in such a study.
4. Adjudication Method for the Test Set
This information is not provided as no explicit test set data for the FP-0217 is presented for clinical performance evaluation. For a proper clinical validation study of a blood pressure monitor, when multiple observers establish ground truth, adjudication methods (e.g., averaging readings, resolving discrepancies) are crucial.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it typically relevant for a standalone blood pressure monitor of this type. MRMC studies are primarily used for diagnostic imaging devices where human readers interpret medical images, and the AI's role is to assist or augment that interpretation. This device is an automated measurement device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The device is a "Digital Blood Pressure Monitor" intended for home use, meaning it operates in a standalone fashion, providing measurements without human interpretation or intervention in the measurement process itself. The user initiates the measurement, but the device's "oscillometric method of measurement" is an automated algorithmic process to determine blood pressure and pulse rate. The safety and effectiveness claim is for this automated measurement.
7. The Type of Ground Truth Used
For blood pressure monitors, the "ground truth" for clinical accuracy studies is typically established by:
- Expert Consensus / Reference Method: Simultaneously measuring blood pressure using a standardized auscultatory method (e.g., using a mercury sphygmomanometer) performed by trained observers, against which the automated device's readings are compared. This involves specific protocols for simultaneous readings, observer blinding, and statistical analysis of differences.
While not explicitly stated for this particular device's validation due to the nature of the 510(k) submission, this is the standard ground truth method for blood pressure monitors.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 is described as using an "oscillometric method of measurement." While oscillometric algorithms are developed and refined, they are typically based on established physiological principles and extensive prior research, rather than "training" an AI model in the sense of modern deep learning. Therefore, there isn't a "training set" in the context of recent machine learning-based medical devices. The algorithm's parameters might be calibrated or optimized, but this is different from a large-scale supervised learning training set.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" and associated ground truth establishment for this type of device (traditional oscillometric BP monitor) is not applicable in the same way it would be for an AI/ML-driven diagnostic device. The oscillometric algorithm's development would rely on engineering principles, signal processing, and prior physiological data, rather than a specific "training set" with established ground truth labels for an AI model.
§ 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).