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510(k) Data Aggregation
(245 days)
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).
The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
The provided text describes the 510(k) summary for the AVICHE Automatic Digital Blood Pressure Monitor (K210152). Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Standard or Predicate) | Reported Device Performance (K210152) |
|---|---|
| BP Accuracy: ± 3 mmHg (ISO 81060-2:2018) | ± 3 mmHg |
| BP Range: Comparable to predicate (0-300 mmHg) | 0-280 mmHg |
| PR Range: Comparable to predicate (40-200 beats/min) | 40-199 beats/min |
| Pulse Accuracy: ± 5% of reading value | ± 5% of reading value |
| Electrical Safety: Complies with IEC 60601-1 | Complies with IEC 60601-1 |
| Home Use Compliance: Complies with IEC 60601-1-11 | Complies with IEC 60601-1-11 |
| EMC Compliance: Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Biocompatibility: Complies with ISO 10993-1, FDA Guidance | Complies with ISO 10993-1, FDA Guidance |
| Software Level of Concern: Moderate | Moderate |
| Labels & Labeling: Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements |
| Memory Size: Comparable to predicate (Up to 60x2 sets of data or Up to 99x2 sets) | 2x60 set of data |
| Operation Condition: Comparable to predicate (Temp +5~+40°C, Humidity 15%-90%RH, Air pressure 80.0kPa-105.0kPa) | Temperature +5~+40°C, Humidity $\leq$ 80%RH, Air pressure 80.0kPa-105.0kPa |
| Storage Condition: Comparable to predicate (Temp -20-+55 °C, Humidity 15%-90%RH, Air pressure Not publicly available) | Temperature -20-55 °C, Humidity 10%~90% RH, Air pressure 80.0kPa-105.0kPa |
| Power Supply: Comparable to predicate (4 AA batteries or 6V/600mA AC adapter) | 4 AA batteries or 5V/1.0A AC adapter |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects.
- Data Provenance: The text states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." This indicates a prospective study. The country of origin is not explicitly stated, but the submission is from a Chinese company, so it is likely derived from China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. It only mentions that "Auscultation was applied as gold standard" and "qualified calibrated mercurial sphygmomanometer used as control group." This implies a clinical setting where trained professionals would perform the auscultatory measurements, but specifics are missing.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that auscultation was used as the "gold standard."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance
This is an automated blood pressure monitor, not an AI-assisted diagnostic device that involves human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance study was done. The device itself (the "Automatic Digital Blood Pressure Monitor") is the algorithm-only component in terms of its measurement capability. The clinical trial directly assessed the accuracy of the device's measurements against a gold standard (auscultation), without intervention or interpretation by "human readers" in the typical sense of AI-assisted image analysis.
7. The Type of Ground Truth Used
The ground truth used was auscultation with a qualified calibrated mercurial sphygmomanometer. This is considered a direct physiological measurement by a trained operator, serving as the clinical gold standard for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The clinical trial described (150 subjects) is presented as the performance validation for the device's accuracy. For non-adaptive devices like this, there isn't typically a "training set" in the machine learning sense. The device's underlying measurement algorithm would have been developed and refined through engineering and calibration, not necessarily "trained" on a specific dataset in the way an AI model is.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, information on a specific "training set" and its ground truth establishment is not provided, as it's not directly applicable to the type of device described. The device's measurement principle (oscillometric method) and its calibration would be based on established physiological principles and engineering standards.
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(410 days)
Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.520 cm and the intended arm circumference has several models: 2333 cm, 2535 cm, 2242 cm, 33~43 cm.
Automatic Digital Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home. The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled. Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.
This document is a 510(k) summary for an Automatic Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the blood pressure monitor's accuracy are based on ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|
| Accuracy within acceptable scope specified in ISO 81060-2:2013 | "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2." |
| Pressure accuracy: ±3 mmHg | Pressure: ±3 mmHg |
| Pulse accuracy: ±5% | Pulse: ±5% |
Note: The document explicitly states the device meets the ISO 81060-2 standard but doesn't provide granular numerical data beyond the +/- tolerance levels. It confirms the device's accuracy specifications align with the standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Arm Sphygmomanometer: 90 patients (divided by cuff size: 23-33cm: 49 males and 41 females; 25-35cm: 38 males and 52 females; 22-42cm: 48 males and 42 females; 33-43cm: 38 males and 52 females).
- Wrist Sphygmomanometer: 90 patients (43 males and 47 females).
- Total Patients: 180 (90 arm + 90 wrist).
- Data Provenance: The document does not explicitly state the country of origin. It indicates the clinical study was conducted, and "All the subjects were volunteer to take part in the clinical study." The study is described as a clinical investigation, implying a prospective study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts or their qualifications. However, for blood pressure measurements, the "ground truth" is typically established by trained medical professionals (e.g., physicians, nurses) using a reference device.
4. Adjudication Method for the Test Set
The document states: "The manual Mercury Sphygmomanometer was used as a reference device." This implies a comparison method where the device's readings are compared against the gold standard (manual mercury sphygmomanometer readings). It does not describe an adjudication method with multiple readers deciding on a "ground truth" where there might be inter-reader variability, as would be common in diagnostic imaging studies. The reference device is the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic devices to assess how AI impacts human reader performance. This device is a direct measurement device (automatic blood pressure monitor), not an AI-enabled diagnostic tool in the sense that an algorithm assists human interpretation of images. The study focused on the device's accuracy compared to a reference standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, the primary test conducted was a "standalone" performance test of the device. The clinical study evaluated the direct output of the Automatic Digital Blood Pressure Monitor against a manual mercury sphygmomanometer, without human interpretation of the device's output being a variable. The device itself performs the measurement and provides readings.
7. The Type of Ground Truth Used
The ground truth used was measurements from a manual Mercury Sphygmomanometer. This is considered a highly reliable and commonly accepted gold standard for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. This is typical for medical devices that perform a direct physical measurement (like a blood pressure monitor) and are validated against a known standard. The "training" for such a device is typically part of its engineering and algorithm development, not a discrete data set for a machine learning model submitted for regulatory review in the same way as AI software.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the regulatory document (likely because the device's function is a direct measurement and not an AI/ML model requiring a separate training data ground truth for submission), this information is not provided. The device's underlying algorithm is likely developed and refined through engineering and calibration processes based on known physiological principles of oscillometric measurement, rather than learning from a 'labeled training dataset' in the context of AI.
Ask a specific question about this device
(62 days)
The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
Fully Automatic Blood Pressure Monitor Model: LD-535 & LD-539
The provided text is an FDA 510(k) clearance letter for an automatic digital blood pressure monitor. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested table and information based on the given input.
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