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510(k) Data Aggregation
(28 days)
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
The Braun PrecisionSensor Pro (BP2590) wrist blood pressure monitor is indicated for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a professional environment. Use may be initiated as part of a hypertension screening, monitoring, and/or management program supervised by a healthcare provider.
The PrecisionSensor Pro is a non-invasive wrist blood pressure monitor that measures and displays systolic and diastolic blood pressure, and pulse rate. The values are ascertained by the oscillometric method.
Here's a breakdown of the acceptance criteria and study information for the Braun PrecisionSensor™ Pro (BP2590) wrist blood pressure monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for blood pressure and pulse rate accuracy. It primarily focuses on the device's substantial equivalence to a predicate device and its intended use. However, the implicit acceptance criterion is that the device performs at least as well as the predicate device and is suitable for its intended professional use.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Blood Pressure Accuracy | Comparable to Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor | The document states "The basic design, intended use, and indications for use... are similar. The fundamental scientific technology of the modified device has not changed from that of the predicate device." This implies that the accuracy performance is expected to be as good as the predicate. |
| Pulse Rate Accuracy | Comparable to Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor | Same as above. |
| Non-invasive Measurement | Device measures non-invasively using the oscillometric method | Explicitly stated in the "Device Description." |
| Professional Environment Suitability | Reconfigured display and memory, higher grade of Velcro for cuff closure | These modifications were made to "make it robust for use in a professional environment." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not include information about a specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary primarily asserts substantial equivalence based on modifications to an existing device rather than presenting new clinical study data for device accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As there's no detailed clinical study presented, there's no mention of ground truth establishment by experts for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe a standalone performance study for an algorithm. The device itself is a standalone blood pressure monitor; its performance is inherent to its design and oscillometric method.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any formal clinical validation study. Given the nature of a blood pressure monitor and the 510(k) summary's focus on substantial equivalence, it's highly probable that if a validation study were conducted, it would involve comparison to a gold standard like auscultatory measurements by trained professionals or a thoroughly validated sphygmomanometer. However, this is an inference and not explicitly stated.
8. The Sample Size for the Training Set
There is no mention of a training set sample size in the provided document. As a conventional medical device (blood pressure monitor) relying on established oscillometric principles, it's unlikely to have a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or machine learning components.
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