(58 days)
The Ostar A2, and K7 are indicated for trained medical professionals to operate on the patient at clinical settings to collect and measure blood pressure, pulse rate noise index and pressure waveform diagram (including heartbeat waveform and noise waveform). In addition, the Ostar P2 and X2 are indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider. P2 and X2 do not display the measuring waveform.
The devices do not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Basically the measuring system were composite of blood pressure measuring circuit via Dacillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.
The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero measuring our at unfine inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :
- Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
- Heart beat rate.
- Heart beat noise calculated via FFT ( Fast Fourier Transformation).
For the display of measuring results and operation interface, the following difference were provided for the following different models :
- For model A2, RS 232 is provided for the connection with PC for the measurement operation and display of the whole measuring pressure waveform, noise waveform, systolic and diastolic pressure, heat beat rate, and noise index.
- For model K7, the operation and display details are completely identical to that of model A2.
- For model X2 and P2, all the measurement components are mounted within a compact housing with operation key and display LCD. These two models do not display the measurement waveform and noise waveform, but they could display the measurement results of systolic and diastolic pressure, heat beat rate, and noise index.
The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device's intended use, comparison to a predicate device, and non-clinical tests performed. However, it does not contain detailed information about specific acceptance criteria for performance metrics (like accuracy, precision, sensitivity, specificity, etc.) nor does it report the results of a specific study proving the device meets said criteria in the format requested.
The document states that the substantial equivalence determination is based on the device having the "same intended use and technological characteristics" as the predicate device (DynaPulse 500G) and that "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
It mentions compliance with voluntary standards:
- ANSI/AAMI SP 10-1992: "American National Standard, Manual, electronic, or automated sphygmomanometers" - This standard sets accuracy requirements for blood pressure monitors.
- EN 60601-1: "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance"
- EN 60601-1-2: "Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests"
It also mentions that "software verification has been carried out according to the FDA software guidance."
Since the document does not provide the specific "acceptance criteria" and "reported device performance" in a quantitative manner, nor does it detail a specific study with sample sizes, expert qualifications, and ground truth methodologies, I cannot fill in the table or the other requested points directly from the provided text.
Therefore, many of the requested fields will be marked as "Not provided in the text."
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Metric) | Value (If provided) | Reported Device Performance (Value) |
|---|---|---|
| Compliance with ANSI/AAMI SP 10-1992 (Accuracy, etc.) | Met | Not explicitly detailed |
| Compliance with EN 60601-1 (Basic safety & essential performance) | Met | Not explicitly detailed |
| Compliance with EN 60601-1-2 (Electromagnetic compatibility) | Met | Not explicitly detailed |
| Software verification according to FDA software guidance | Performed | Not explicitly detailed |
| Same safety and effectiveness as predicate device (DynaPulse 500G) | Verified by "verification and validation tests contained in this submission" | Not explicitly detailed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the text.
- Data provenance: Not provided in the text. The manufacturer is from Taiwan, R.O.C., but the location of the clinical data (if any) is not mentioned.
- Retrospective or prospective: Not provided in the text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in the text. The document refers to "verification and validation tests" but does not detail the methodology for establishing ground truth or the involvement of experts for a test set. Blood pressure monitors are typically validated against a reference standard (like a mercury sphygmomanometer) during device testing, observing agreement within specified limits rather than relying on expert consensus for "ground truth" in the same way an imaging algorithm might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the text.
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. This is a blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device itself is a standalone blood pressure monitor. The document implies its performance was evaluated against standards and compared to a predicate device, which would inherently be a "standalone" evaluation of the device's measurement capabilities. However, specific performance metrics are not given.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- While not explicitly stated, for blood pressure monitors, the "ground truth" for accuracy testing is typically established by simultaneously measuring blood pressure using a validated reference method (e.g., a trained observer using a mercury sphygmomanometer following a standardized protocol) on the same subjects, and comparing the device's readings to these reference measurements. The document mentions compliance with ANSI/AAMI SP 10-1992, which specifies such comparison methods.
8. The sample size for the training set
- Not applicable/Not provided. This device is a traditional medical device (oscillometric blood pressure monitor), not explicitly an AI/ML algorithm that requires a "training set" in the common sense. Its "algorithm" is fixed and based on oscillometric principles.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no mention of a "training set" for an AI/ML algorithm.
§ 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).