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Arm Electronic Sphygmomanometer is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.

The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.

The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.

The provided document is a 510(k) Premarket Notification for an "Arm Electronic Sphygmomanometer" and demonstrates its substantial equivalence to a predicate device. This type of submission relies on showing equivalency to an already cleared device, rather than proving novel effectiveness through significant clinical studies.

Therefore, the document explicitly does not include the detailed clinical study information requested for an AI/ML powered medical device, such as:

• A complex table of acceptance criteria and reported device performance derived from a clinical trial.
• Sample sizes for test sets in a clinical trial context.
• Details about expert adjudication or multi-reader multi-case (MRMC) studies.
• Information on training set sizes or ground truth establishment relevant to AI/ML.

The device in question is a standard non-invasive blood pressure measurement system, not an AI-powered device. Its performance is evaluated against established electrical, electromagnetic, biocompatibility, and performance standards for such devices.

Here's an analysis of what is provided, framed in the context of device acceptance, while acknowledging that it's for a traditional medical device, not an AI one:

Acceptance Criteria and Device Performance (Based on Standards Compliance, not AI-specific metrics):

• Pressure: ±3mmHg
• Pulse: ±5% |
  | Biocompatibility (ISO 10993-5, ISO 10993-10) | Complies with ISO 10993-5 and ISO 10993-10 for biocompatibility. |
  | Usability (IEC 62366) | Complies with IEC 62366 for usability. |
  | Software Verification & Validation (FDA Guidance) | Complies with FDA guidance for software V&V. |
  | Lithium Battery Safety (IEC 62133) | Complies with IEC 62133 (if applicable model). |
  | Intended Use / Indications for Use | Substantially Equivalent to predicate device. Measures diastolic/systolic BP and pulse rate in adults via oscillometric technique. Cuff circumference 22-32cm. Use in hospital or home. |
  | Measuring Range (Pressure) | 0mmHg299 mmHg |
  | Measuring Range (Pulse) | 40 bpm199 bpm |
  | Pressure Resolution | 1 mmHg or 0.1kPa |
  | Cuff Circumference | 22~32cm |
  | Operation Condition | Temperature: +5 to +40 °C, Humidity: 15 to 90%, Atmospheric Pressure: 80-106 kPa |
  | Transport/Storage Environment | Temperature: -25°C to +70°C, Humidity: ≤93%R.H., Atmospheric Pressure: 70-106 kPa |

Study Details (as per the provided document):

1. Sample Size and Data Provenance:

   • The document mentions "lab bench testing" and compliance with international standards (e.g., ISO 81060-2 for blood pressure performance, IEC 60601 series for safety/EMC).
   • For blood pressure measurement devices, ISO 81060-2 typically requires a specific number of subjects for clinical validation (often at least 85 subjects with specific demographic and blood pressure range distributions). However, the document does not explicitly state the sample size or provenance (country/retrospective/prospective) of the data used for the ISO 81060-2 performance evaluation. It only states compliance.
   • This is a 510(k) submission, so the primary "study" is a comparison to a predicate device, not a de novo clinical trial. The performance data would have been generated to show compliance with the standards referenced in the submission.

2. Number of Experts and Qualifications for Ground Truth:

   • Not applicable in the context of this traditional medical device submission. Ground truth for blood pressure measurement performance is typically established by simultaneous readings from a calibrated mercury sphygmomanometer (or an equivalent reference device) by trained observers, as specified in standards like ISO 81060-2. There isn't an "expert consensus" process like for imaging AI.

3. Adjudication Method:

   • Not applicable as this is not an AI/ML device requiring human expert adjudication.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was done, as this is a standalone blood pressure measurement device, not an AI assistance tool for human readers.

5. Standalone Performance:

   • Yes, the performance tests (e.g., per AAMI / ANSI / ISO 81060-2) evaluate the standalone performance of the algorithm/device in measuring blood pressure and pulse rate. The accuracy criteria (±3mmHg for pressure, ±5% for pulse) are direct measurements of the device's capability.

6. Type of Ground Truth Used:

   • For blood pressure accuracy, the ground truth is typically established by simultaneous measurements from a reference standard method (e.g., auscultation with a calibrated mercury sphygmomanometer) conducted by trained observers, as described in blood pressure measurement standards like ISO 81060-2. This is direct physiological measurement, not expert consensus or pathology in the sense of diagnostic imaging.

7. Sample Size for Training Set:

   • Not applicable. This is not an AI/ML device that requires a "training set." The device is based on established oscillometric principles and hardware.

8. How Ground Truth for Training Set was Established:

   • Not applicable for the same reason as above.

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