(152 days)
The Tesfacuard® Patient Monitor is capable of monitoring:
- SpO2 (Arterial Oxygen Saturation) .
- ECG (3-Lead) .
- IBP (Invasive Blood Pressure) .
- . NIBP (Non-invasive Blood Pressure)
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
The device is intended for use in the Adult, Pediatric and Neonatal populations.
MRI Compatibility Statement:
The Tesfa Guad® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
The Tesla Guard® design allows examination of intensive care patients while in an MRI-scanner. The Tesla Guard® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.
The provided 510(k) summary for the Tesla Guard® patient monitor primarily focuses on safety, EMC compliance, and biocompatibility, as well as a general statement about function and accuracy testing. It does not provide specific, quantifiable acceptance criteria or detailed results of a study designed to prove the device meets such criteria in the format or level of detail typically found for AI/ML device submissions.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantifiable acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity for SpO2, ECG, IBP, NIBP) in a summarized table. It generally states that "Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment," and "Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter fiberoptic sensors, and to demonstrate equivalency to the predicate device."
Without explicit criteria or detailed results in the provided text, a table cannot be constructed.
Regarding the study that proves the device meets acceptance criteria:
The summary refers to "Laboratory Testing" using human subjects for "functional and accuracy specifications of the pulse oximeter fiberoptic sensors" and to "demonstrate equivalency to the predicate device." However, no specific details about this study's design or quantitative results are provided.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document mentions "human subjects" for laboratory testing but doesn't quantify how many.
- Data Provenance: Not specified. It mentions "laboratory testing using human subjects," but details on country of origin, demographics, or whether the data was retrospective or prospective are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the device is a patient monitor taking physiological measurements rather than an AI/ML diagnostic tool that would typically rely on expert ground truth. The "ground truth" for a patient monitor would generally be a reference standard device or direct physiological measurement.
4. Adjudication method for the test set
- Not applicable/Not specified. Given the nature of a physiological monitor, adjudication in the sense of expert consensus for image or data interpretation is not relevant. The "ground truth" would be established by a reference standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The Tesla Guard® is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance is not relevant to its evaluation as described in this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied Standard Performance Assessment (Standalone): The document states, "Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment." This suggests a standalone performance evaluation of the device's ability to measure physiological parameters accurately. However, specific performance metrics (e.g., mean absolute error, bias, precision) for SpO2, ECG, IBP, or NIBP are not provided. The focus is on demonstrating its functionality and accuracy, and importantly, its equivalency to a predicate device, particularly in an MRI environment.
7. The type of ground truth used
- Reference Standard Comparison: For a physiological monitor, the ground truth would typically be established using a highly accurate reference standard device or method. For example, for pulse oximetry (SpO2), this could involve fractional arterial oxygen saturation measured from blood gas analysis. For ECG, IBP, and NIBP, it would be comparison to clinically accepted reference monitoring devices. The summary directly states, "demonstrate equivalency to the predicate device," implying the predicate device or its established performance characteristics served as a key reference for comparison.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physiological monitor, not an AI/ML algorithm that undergoes a distinct "training" phase with a dataset. Its development would involve engineering design, calibration, and validation, rather than machine learning training.
9. How the ground truth for the training set was established
- Not applicable. As a traditional medical device (non-AI/ML), the concept of a "training set ground truth" does not apply in the described context. The device's accuracy would be established through engineering specifications, calibration against known standards, and clinical validation studies using reference methods.
§ 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).