(161 days)
Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.
The proposed device Vital Signs Monitor MD2000C is a device powered by internal electrical power source and external electrical power source. The MD2000C is used in hospital,community hospitals and medical facilities. It can measure and record functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult and pediatric patients. Its accessories include SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter. It has data storage,display,alarm.
Here's a breakdown of the acceptance criteria and study information for the Vital Signs Monitor MD2000C based on the provided text:
Acceptance Criteria and Device Performance
The direct acceptance criteria for the Vital Signs Monitor MD2000C are not explicitly stated as a separate table within the document in terms of specific performance targets for NIBP, SpO2, and PR beyond accuracy ranges. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MD2000B and MD300M for SpO2, and Multi-parameters health Examination System for NIBP).
The performance data available relates to the MD300M (for SpO2) and Multi-parameters health Examination System (for NIBP), which the new device MD2000C claims to be identical to in those modules.
Table of Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:
| Parameter | Implied Acceptance Criteria (from predicate) | Reported Device Performance (from predicate studies) |
|---|---|---|
| SpO2 Accuracy | ARMS of ≤ 2-3% (common for pulse oximeters) | MD300M: ARMS of 1.75% (over 70-100% range) |
| NIBP Accuracy | Mean error within ±5mmHg, Standard deviation within 8mmHg (per ISO 81060-2:2018 or similar) | Multi-parameters health Examination System: Mean error within ±5mmHg, Standard deviation within 8mmHg |
| SpO2 Measuring Range | 70%-100% | 70%-100% |
| SpO2 Resolution | 1% | 1% |
| PR Measuring Range | 30-235 bpm (predicate) | 30-250 bpm (proposed) |
| PR Resolution | 1 bpm | 1 bpm |
| PR Accuracy | 30-100 bpm: ±2bpm; 101-235 bpm: ±2% (predicate) | ±2bpm or ±2% (choose larger) (proposed) |
| NIBP Measurement Method | Oscillometric method | Oscillometric method |
| Static pressure measurement range | 0~270mmHg (predicate) | 20~280mmHg (proposed) |
| Maximum static pressure error | ±3mmHg | ±3mmHg |
Note: The "Implied Acceptance Criteria" are based on the performance of the predicate devices which the new device is seeking equivalence to. The direct acceptance criteria for the specific device are not explicitly listed in a regulatory numerical format but are demonstrated through equivalence to these predicate performances.
Study Information:
2. Sample sizes used for the test set and the data provenance:
- SpO2 Accuracy Study (MD300M):
- Sample Size: 12 healthy adult volunteer subjects (6 females, 6 males)
- Demographics: Ages 21-43 years, 47-82 kg, 155-185 cm, with a representative range of pigmentation.
- Data Provenance: Conducted in Yue Bei People's Hospital. Prospective study. Country of origin not explicitly stated but implied to be China (as the manufacturer is Beijing Choice Electronic Technology Co., Ltd.)
- NIBP Accuracy Study (Multi-parameters health Examination System):
- Sample Size: 85 subjects (35 child subjects aged 3-12 years, 50 adult subjects)
- Data Provenance: Conducted in PLA Rocket Force Characteristic Medical Center. Prospective study. Country of origin not explicitly stated but implied to be China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth for either the SpO2 or NIBP studies.
- For SpO2, ground truth is typically established using a co-oximeter in controlled desaturation studies (e.g., fractional oxyhemoglobin measurement compared to pulse oximeter readings).
- For NIBP, ground truth is typically established simultaneously with a reference auscultatory or invasive blood pressure measurement taken by qualified personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not provide details on any adjudication methods used for the test sets. The studies appear to be direct performance comparisons against a reference standard rather than assessments requiring multiple human interpretations.
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:
- No MRMC study was performed. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides physiological parameters directly.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, standalone performance was evaluated. The studies described for SpO2 and NIBP accuracy directly measure the device's performance against a reference standard, without human interpretation of the device's output influencing the accuracy metrics. The device itself is designed to provide direct physiological measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- SpO2: The ground truth for SpO2 accuracy studies is typically established by fractional oxyhemoglobin measurement using a co-oximeter during controlled hypoxia conditions. This is considered the reference standard for pulse oximetry.
- NIBP: The ground truth for NIBP accuracy studies is established by simultaneous measurements using a reference auscultatory method (e.g., mercury sphygmomanometer with stethoscope by trained observer) or an invasive arterial line, compared to the device's oscillometric readings.
8. The sample size for the training set:
- The document does not specify sample sizes for training sets. It describes the device's performance through validation studies (test sets) for specific modules that were adopted from previously cleared devices. It's implied that the algorithms within these modules were developed and potentially trained using proprietary datasets not detailed in this 510(k) summary.
9. How the ground truth for the training set was established:
- The document does not specify how ground truth was established for any potential training sets. This information would typically be part of the internal development process for the SpO2 and NIBP algorithms, which predates this 510(k) application (as the modules are reused from previously cleared devices).
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).