(288 days)
WX non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model. The device is applicable to all patients at least 2 years of age.
WX non-Automated Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL WX02, WX0201, WX0202, WX0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model WX0201, WX0202, WX0203 include additional stethoscope (Single head, Dual head, and Sprague Rappaport). It is conjunction with Stethoscope when use.
The provided text describes WX non-Automated Blood Pressure Meters. Here's an analysis of the acceptance criteria and supporting studies based on the document:
1. Table of acceptance criteria and the reported device performance:
| Criteria | Device Performance (New Device) Total Result |
| :--------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :----------- |
| Accuracy (Pressure) | +/- 3 mmHg of reading | SAME |
| Biocompatibility | Biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10 | SAME |
| Performance | Compatible as requirement of ISO 81060-1 | SAME |
| Display | Aneroid Manometer | SAME |
| Monitor Scale | From 0 to 300 mmHg with a minimum interval of 2 mmHg | SAME |
| Compatibility with environment | It can be used from 50°F to 104°F (10°C to 40°C) and 15%~85%RH humidity. | SAME |
The document states that the new device meets these criteria by being "compatible as requirement of ISO 81060-1" for performance and "biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10" for biocompatibility. The accuracy is explicitly stated as "+/- 3 mmHg of reading". For all these criteria, the "Result of Comparison" field in the table is marked as "SAME" when compared to the predicate device.
2. Sample sized used for the test set and the data provenance:
The document mentions "Non-clinical testing included biocompatibility and bench testing." It does not specify the sample size used for these tests. There's no information about data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical testing.
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. The document refers to "bench testing" and compliance with standards (ISO10993 and ISO81060-1), which implies objective measurements rather than expert-established ground truth in the context of clinical interpretation.
4. Adjudication method for the test set:
Not applicable, as no external expert review or adjudication process for a test set is mentioned. The testing mentioned is non-clinical bench testing.
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. The device is a "non-Automated Blood Pressure Meter" and does not involve AI or human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical, non-automated blood pressure meter. It does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the accuracy and performance criteria, the "ground truth" would be established by reference measurement instruments or standardized methods as defined by the ISO 81060-1 standard for non-invasive sphygmomanometers. For biocompatibility, the ground truth is established by adherence to the testing protocols outlined in the ISO 10993 series. These are objective standards, not subject to expert consensus in the diagnostic sense.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI, and therefore does not have a training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as point 8.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).