(44 days)
The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.
The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (Model 90217A) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.
The Model 90217A allows the use of an automated or manual inflation system, and utilizes the oscillometric NIBP measurement method. The pressure sensor signal is amplified, digitized by an analog to digital converter (ADC), and supplied to a microprocessor which has control of the pump and vent valve. Measurements are made during the stepwise deflation of the cuff. The Model 90217A NIBP and HR algorithms are identical to that of the predicate. Additionally, the NIBP patient cuffs used with the Model 90217A are the same as those used with the predicate. A block diagram of the Model 90217A is presented in Figure 2.
The Model 90217A is powered by three (3) "AA" alkaline or rechargeable NiCad batteries; there is no capability to connect the Model 90217A to AC mains power. A lithium battery is used to provide backup power for the Model 90217A memory. Both battery types need to be periodically replaced.
The Model 90217A is carried in a pouch that is strapped and/or belted to the side of the patient. NIPB and HR measurements are taken using a blood pressure cuff attached to the patients arm. This information is recorded in the monitor, and can be transferred over a modem link, or by direct connection, between the Model 90217A and one of the ABP analysis systems.
The provided text describes the Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor and its 510(k) premarket notification. However, it does not contain the specific details required to fully address all components of your request, particularly regarding acceptance criteria, the study design (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies.
The document indicates that "Performance Testing" was conducted in accordance with applicable standards and that the device "complies with its predetermined specification." This implies that acceptance criteria were met, but the specific criteria and the detailed performance results are not provided in the summary.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Information Missing: The document states that performance testing was done and that the device "complies with its predetermined specification." However, it does not provide a table specifying the acceptance criteria (e.g., accuracy, precision targets) or the detailed reported device performance against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
Information Missing: The document states that "Performance Testing" was conducted, but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Information Missing: This device is a blood pressure monitor, and the ground truth for blood pressure measurements is typically established by another, often invasive or highly calibrated, measurement method, not usually by "experts" in the sense of image interpretation. The document does not specify how ground truth was established for performance testing, nor does it mention any experts involved in defining ground truth.
4. Adjudication Method for the Test Set
Information Missing: As there is no mention of "experts" or a consensus process for ground truth establishment for a blood pressure monitor, an adjudication method is not applicable and is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human interpretation is a primary component. The device is an automated blood pressure monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes (Implied): The device is an "Ambulatory Blood Pressure (ABP) Monitor" that "takes non-invasive blood pressure (NIBP) and heart rate (HR) measurements" and records them. It utilizes "oscillometric NIBP measurement method" and its "NIBP and HR algorithms are identical to that of the predicate." This description strongly suggests that the device operates in a standalone manner, with the algorithm performing the measurements without human intervention during the measurement process. The "Performance Testing" mentioned would assess this standalone performance.
7. Type of Ground Truth Used
Information Missing (Specifics): While not explicitly stated, for a non-invasive blood pressure measurement device, the implied ground truth for performance testing would typically be simultaneous measurements from a highly accurate reference standard, such as an intra-arterial blood pressure monitor or another highly validated non-invasive reference device. The document does not explicitly state the specific type of ground truth used.
8. Sample Size for the Training Set
Information Missing: The document states that the "NIBP and HR algorithms are identical to that of the predicate." This suggests that the algorithms themselves might not have undergone new "training" for this specific device, but rather are adopted from the predicate. If any new training was done, the sample size for the training set is not mentioned.
9. How the Ground Truth for the Training Set Was Established
Information Missing: Given the statement that the algorithms are identical to the predicate, detailed information on how ground truth was established for the original training of those algorithms (if applicable) is not provided. If new training was performed for this device, then the method for establishing ground truth for the training set is not mentioned.
§ 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).