(121 days)
The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is a hand held battery operated arm type blood pressure monitor which is intended for use by adults (age 18 or older) for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.
The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. SAA-102 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant and The pressure of the cuff is completely released automatically at the end w the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAA-102 turns off automatically. SAA-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
The provided text describes a 510(k) summary for the SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor. However, the document does NOT contain a detailed study with acceptance criteria and device performance results in the format requested.
The document states:
- "When compared to the predicate device, SAA-102 does not incorporate any significant changes in the intended use, method of operation, material or design that could affect safety and effectiveness." (Section 7)
- It refers to the device being "substantially equivalent" to a predicate device (A&D UA-779PC, FDA 510K, K993888).
This suggests that the SensaCare SAA-102 did not undergo an independent clinical study to establish its performance against specific acceptance criteria, but rather demonstrated substantial equivalence to a previously approved device. Therefore, I cannot fill out the requested table and answer the study-specific questions based on the provided text.
The information I can extract directly related to device characteristics (not performance data from a specific study) is:
1. Table of Acceptance Criteria and Reported Device Performance
- No specific acceptance criteria or reported device performance from a dedicated study are provided in this document. The submission relies on substantial equivalence to a predicate device.
- The document mentions the measuring ranges for the device:
- Systolic pressure: 30 to 280 mmHg
- Diastolic pressure: 20 to 255 mmHg
- Heart rate: 20 to 255 times/minutes
2. Sample size used for the test set and the data provenance
- Not applicable / not provided in the document. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / not provided in the document.
4. Adjudication method for the test set
- Not applicable / not provided in the document.
5. 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
- Not applicable / not provided in the document. This device is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / not provided in the document. The document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / not provided in the document.
8. The sample size for the training set
- Not applicable / not provided in the document.
9. How the ground truth for the training set was established
- Not applicable / not provided in the document.
In summary, the provided 510(k) summary does not contain the details of a performance study with acceptance criteria for the SensaCare SAA-102. It instead establishes substantial equivalence to a predicate device (A&D UA-779PC, K993888). To get the detailed performance data, one would need to refer to the substantial equivalence documentation for the predicate device, or a full submission document if it contained specific performance testing.
§ 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).