(16 days)
The BPCard is a Non-Invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, adult subjects. The BPCard also measures heart rate.
- Patient Population: Male/Female, Adults .
- Environment of Use: Hospital, Clinic and Home Use .
- Prescription Device by a Physician .
Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the ausculatory method. The BPCard also measures heart rate.
- . Patient Population: Male/Female Adults
- . Environment of Use: Hospital, Clinic and Home Use
- . Prescription Device by a Physician
The provided text focuses on the 510(k) summary for the QRS Diagnostic BPCard, a blood pressure monitor. It compares the modified device to a previously cleared predicate device and lists compliance with various standards. However, it does not contain the detailed study information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically found when describing acceptance criteria and a study that proves a device meets those criteria.
The document primarily states that the device complies with the ANSI/AAMI SP10:2002 standard. This standard itself defines acceptance criteria for automated sphygmomanometers.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states that the device "Meets AAMI SP10:2002". Therefore, the acceptance criteria are implicitly those defined by the AAMI SP10:2002 standard for manual, electronic, or automated sphygmomanometers. The reported performance is that the device meets this standard.
| Acceptance Criteria (Implicit from AAMI SP10:2002) | Reported Device Performance |
|---|---|
| Device meets the requirements of AAMI SP10:2002 | Meets AAMI SP10:2002 |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not mentioned or implied. This device is a measurement system (blood pressure monitor), not an AI-assisted diagnostic tool for image interpretation, so an MRMC study is not applicable in this context.
- Effect Size of AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: The document implies standalone performance testing by stating compliance with "ANSI/AAMI SP10:2002, Manual, Electronic or Automated Sphygmomanometers". Such standards define requirements for the automated device's accuracy. However, specific details of such a study are not provided. The device measures blood pressure using an "auscultatory method," which traditionally involves listening, but in an automated context, it refers to the device detecting Korotkoff sounds.
7. The type of ground truth used:
- Type of Ground Truth: The AAMI SP10 standard typically requires comparison against a reference method, often auscultation by trained observers using a mercury sphygmomanometer as the gold standard for blood pressure measurement. The document doesn't explicitly state this but implies it through compliance with the standard.
8. The sample size for the training set:
- Sample Size: Not applicable/Not specified. This device is a blood pressure monitor, not a machine learning model that requires a training set in the conventional sense. Its algorithms are based on established physiological principles and signal processing, not statistical learning from a labeled dataset.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable/Not specified. (See point 8).
§ 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).