(14 days)
The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of intendou to ividual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.
The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly mentions adherence to the ANSI/AAMI - SP-10 Standard for "clinical tests." It doesn't detail specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure measurements as would typically be found in such a standard. However, the conclusion states the device is "as safe and effective as the predicate" based on these tests.
| Acceptance Criteria Category | Specific Criteria (from standard if named) | Reported Device Performance |
|---|---|---|
| Clinical Performance | Adherence to ANSI/AAMI - SP-10 Standard | Met standard; "as safe and effective as the predicate" |
| Electrical Safety | Adherence to FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" & IEC 60601-1 Safety Test | Met guidance and standard |
| Mechanical Performance | Adherence to FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (General Functions, Drop, Vibration Tests) | Met guidance and standards |
| Environmental Performance | Adherence to FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Storage Test) & EMC Test | Met guidance and standard |
| Reliability | General Functions Test, Drop Testing, Storage Reliability Test, Vibrating Testing | No reported failures; met requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "the clinical test" (singular) was performed.
- Data Provenance: Not explicitly stated. The submitter is from Taichung, Taiwan, R.O.C., but the location of the clinical test is not mentioned. It is a prospective clinical study, as it was "performed" for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not explicitly stated. The ANSI/AAMI SP-10 standard typically involves trained clinicians taking reference blood pressure measurements (often using a mercury sphygmomanometer) alongside the device under test. However, the document does not detail the number or specific qualifications of these clinicians.
4. Adjudication Method for the Test Set
Not explicitly stated. The ANSI/AAMI SP-10 standard outlines specific protocols for data collection and comparison, often involving multiple readings and statistical analysis, but it's not a jury-style adjudication in the sense of expert consensus described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not reported. The study focused on the performance of the device itself against a reference standard, not on how human readers' performance might improve with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical test described is a standalone performance evaluation of the device's ability to measure blood pressure independently. The device's algorithm determines the systolic and diastolic blood pressure and pulse rate. Human interaction is limited to operating the device, not interpreting its output for further diagnostic decisions.
7. The Type of Ground Truth Used
The ground truth for the clinical test was established by comparison with a reference method, as dictated by the ANSI/AAMI - SP-10 Standard. This standard typically mandates comparison to auscultatory measurements performed by trained observers using a mercury sphygmomanometer or another validated reference method.
8. Sample Size for the Training Set
No information is provided regarding a separate "training set" or its sample size. The device uses an "oscillometric method" algorithm, which is described as "well known" and "identical to the predicate device." This suggests the algorithm itself was developed and validated prior to this specific device's clinical testing, likely not requiring a new training set for this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no specific training set for this device's algorithm development is described in the context of this submission. The "oscillometric method" is a pre-existing, established technique.
§ 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).