(317 days)
The Vital Signs Monitor is intended for the monitoring of parameters such as ECG, non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, blood glucose and oxygen saturation of arterial hemoglobin (SpO2) of adult patient. The monitor is intended to be used by clinicians and medically qualified personnel and trained users.
The Vital Signs Monitor is intended for the monitoring of parameters such as ECG, non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, body temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2) of adult patient. The monitor is intended to be used by clinicians and medically qualified personnel and trained users.
The body temperature and blood glucose measurements are cleared by FDA under K101259 and K120042 respectively.
VTRUST Vital Signs Monitor and FORA Vital Signs Monitor are exactly identical in design technical and physical appearance. The only difference is the brand name and model name.
This document is primarily a 510(k) summary for a vital signs monitor, focusing on demonstrating substantial equivalence to predicate devices, rather than an in-depth study report with acceptance criteria and detailed performance data like those for AI/ML devices. Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present.
However, I can extract the available information and indicate where the requested details are missing.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in the format of specific numerical thresholds for performance metrics. Instead, it refers to the device meeting the "specification cleared under" previous 510(k)s for the predicate devices. The "Test Objective" is to ensure performance meets these prior specifications.
| Parameter | Test Objective | Reported Device Performance (as stated in the document) |
|---|---|---|
| ECG performance | To ensure the ECG performance meets the specification cleared under K101569. | The "Performance Bench Testing" section states: "The laboratory and clinical evaluations for the performance of Vital Signs Monitor demonstrate that the modifications do not impact on the effectiveness. The performance of this system meets its intended use and is equivalent to the predicated devices." |
| SpO2 performance | To ensure the SpO2 performance meets the specification cleared under K101259. | (Same as above) |
| NIBP (Non-Invasive Blood Pressure) performance | To ensure the NIBP performance meets the specification cleared under K101259. | (Same as above) |
| Blood Glucose performance | To ensure the blood glucose performance meets the specification cleared under K120042. | (Same as above) |
| Thermometer performance | To ensure the thermometer performance meets the specification cleared under K101259. | (Same as above) |
| Clinical Evaluation | To ensure the device performance complies with the designed specification. | (Same as above) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not provided in the document. The document mentions "laboratory and clinical evaluations" but does not give specific numbers of subjects or data points for these evaluations.
- Data Provenance: This information is not provided in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable/not provided. For a vital signs monitor, ground truth is typically established by reference devices or calibrated standards, not expert readers as would be the case for image-based diagnostic AI. The document refers to meeting specifications cleared under previous 510(k)s.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in cases where interpretation is subjective (e.g., radiology reads). For a vital signs monitor, performance is assessed against objective measurements.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is a key metric. This document describes a vital signs monitor for measuring objective physiological parameters.
6. Standalone Performance Study (Algorithm Only)
- Yes, a form of standalone performance was assessed. The document states that "laboratory and clinical evaluations for the performance of Vital Signs Monitor demonstrate that the modifications do not impact on the effectiveness." This implies that the device's measurements (ECG, SpO2, NIBP, Blood Glucose, Thermometer) were directly evaluated against established performance specifications, independently of a human-in-the-loop scenario. The term "algorithm only" is less fitting here as it's a hardware device measuring physiological signals.
7. Type of Ground Truth Used
- The ground truth for this type of device would typically be established through calibrated reference standards or predicate devices known to be accurate. The document repeatedly states that the device's performance is intended "To ensure ... meets the specification cleared under [previous 510(k) numbers]." This implies the prior 510(k) submissions established what constitutes acceptable performance against a gold standard for each physiological parameter.
8. Sample Size for the Training Set
- This information is not applicable/not provided. This device is a vital signs monitor, not an AI/ML device that requires a training set in the conventional sense. Its function is based on established signal processing and measurement principles, not learned from a training dataset.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reasons above (not an AI/ML device with a training set).
§ 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).