(162 days)
Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.
Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
The provided text is a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor WSK-1011. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, a standalone study for the device's performance against those criteria, or an MRMC comparative effectiveness study.
The summary states:
- "No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance."
- "The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety."
Therefore, based solely on the provided text, I cannot directly answer most of your detailed questions regarding acceptance criteria, study specifics, ground truth, and sample sizes for a clinical performance study. The document explicitly states no clinical test report was submitted due to assumed equivalence in clinical performance.
However, I can extract information related to the non-clinical tests that were performed.
Here's what can be inferred or directly stated from the provided text, with limitations:
1. Table of acceptance criteria and the reported device performance:
Since no clinical study report is provided, specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure accuracy cannot be extracted from this document, nor can the device's performance against such criteria. The document states the device was evaluated according to IEC and SP-10 standards. These standards (such as ISO 81060-2 for non-invasive sphygmomanometers) would define the acceptance criteria for accuracy.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/Not provided. No clinical test set details are given.
- Data Provenance: Not applicable/Not provided for clinical data. The non-clinical tests follow IEC and SP-10 standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical test set details are given.
4. Adjudication method for the test set:
- Not applicable/Not provided. No clinical test set details are given.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a blood pressure monitor, not an AI-powered diagnostic imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies that the device's performance was evaluated through non-clinical bench testing against established standards (IEC and SP-10) for substantial equivalence in safety and effectiveness. A standalone clinical performance study was explicitly stated as not submitted.
7. The type of ground truth used:
- For non-clinical tests, the "ground truth" would be measurements obtained using reference standards and calibrated equipment as specified by IEC and SP-10 standards for blood pressure monitor testing.
- For clinical performance, if a study were done, the ground truth for blood pressure measurement would typically be established by validated invasive or non-invasive reference methods (e.g., auscultatory method by trained observers using a mercury sphygmomanometer). However, as stated, no clinical tests were submitted.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a hardware blood pressure monitor, not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided, for the same reason as above.
§ 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).