(20 days)
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
The 507EL monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 507EL can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), SpO3, Temperature, and Respiration. For all these vital parameters, the 507EL will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
The provided text is a 510(k) summary for the Criticare Systems, Inc. Model 507EL Vital Signs Monitor, submitted to the FDA in 2002. This document is a premarket notification asserting substantial equivalence to a predicate device, not a detailed study report on acceptance criteria and performance of a novel AI/ML device. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment for AI/ML, MRMC studies, standalone performance of an algorithm) is not applicable or available in this document.
However, based on the provided text, I can extract information related to the device's performance claims and how its equivalence was established.
Acceptance Criteria and Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance Summary (from text) |
|---|---|---|
| Safety | UL 544 Medical Electrical Safety | "The 507EL monitor complies with..." (Claimed compliance) |
| IEC 601-1-2 EMC Compliance | "The 507EL monitor complies with..." (Claimed compliance) | |
| ISO 10993-5,10-11 Biocompatibility | "The 507EL monitor complies with..." (Claimed compliance) | |
| Performance - NIBP | EN 60601-2-30 NIBP Safety | "The 507EL monitor complies with..." (Claimed compliance). "The 507EL monitor is substantially equivalent to the predicate devices." (Implies NIBP performance is equivalent to predicate, which has satisfactory field experience). |
| EN1060-1 NIBP Performance | "The 507EL monitor complies with..." (Claimed compliance) | |
| EN 1060-3 NIBP Performance (including EN 475 Alarm Performance) | "The 507EL monitor complies with..." (Claimed compliance) | |
| AAMI SP-10 NIBP Performance | "The 507EL monitor complies with..." (Claimed compliance) | |
| Performance - ECG | IEC 60601-2-27 ECG Safety | "The 507EL monitor complies with..." (Claimed compliance). "The 507EL monitor is substantially equivalent to the predicate devices." (Implies ECG performance is equivalent to predicate, which has satisfactory field experience). |
| AAMI EC-13 Basic ECG Performance | "The 507EL monitor complies with..." (Claimed compliance) | |
| Performance - Oximetry | EN 865 Oximetry Performance (Equivalent to ASTM F 1415) | "The 507EL monitor complies with..." (Claimed compliance). "The 507EL monitor is substantially equivalent to the predicate devices." (Implies SpO2 performance is equivalent to predicate, which has satisfactory field experience). |
| Overall Equivalence | Equivalence to predicate device (CSI Model 2200 Scholar Vital Signs Monitor K944860) | "The 507EL monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device." "This combination of equivalence testing, applicable objective standards compliance and field experience substantiates a high level of confidence in the safety and efficacy of the 507EL monitor." |
Study Information (Based on a 510(k) submission for a non-AI/ML device):
-
Sample size used for the test set and the data provenance:
- Test set size: Not specified. The document refers to "equivalence testing" and compliance with performance standards, which would involve testing the device against those standards and comparing its performance to the predicate. However, details on the patient numbers or specific data sets used for these tests are not provided in this summary.
- Data provenance: Not explicitly stated as "data provenance." The document mentions that the patient monitoring technologies have been in "clinical use for at least six years in the predicate device," and CSI's "field experience with these modalities in the predicate device has been satisfactory." This suggests that the predicate device's performance (and by extension, the new device's claim of equivalence) is supported by retrospective clinical use and field data, but for the 507EL's specific testing, the provenance of the test data (e.g., country, retrospective/prospective) is not detailed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a traditional medical device, not an AI/ML device requiring expert ground truth for interpretation. Ground truth for physiological measurements is typically established by reference instruments or established clinical methodologies.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device relying on human expert adjudication for its output.
-
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:
- Not applicable. This is not an AI/ML device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone vital signs monitor. Its "performance for each monitoring modality has been confirmed to be equivalent to the predicate device" through "equivalence testing" and "applicable objective standards compliance." This implies the device's output (ECG, NIBP, SpO2, Temp, Resp measurements) was evaluated directly against established methods and standards, without necessarily "human-in-the-loop performance" in the context of an AI/ML algorithm's output interpretation. The "user" is a "professional health care provider" responsible for interpreting the data, but this refers to the clinical use of the monitor's displayed data, not an evaluation of an AI algorithm's assistance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physiological measurements like NIBP, ECG, SpO2, and Temperature, ground truth is typically established by:
- Reference standard measurements: e.g., invasive blood pressure for NIBP, a gold-standard ECG recording device for ECG, co-oximetry for SpO2, or a calibrated thermometer for temperature.
- Clinical validation protocols: specific testing methodologies outlined in the referenced performance standards (e.g., AAMI SP-10 for NIBP, AAMI EC-13 for ECG, EN 865/ASTM F 1415 for Oximetry) dictate how ground truth is obtained and used for evaluating device accuracy. The document states compliance with these standards.
- For physiological measurements like NIBP, ECG, SpO2, and Temperature, ground truth is typically established by:
-
The sample size for the training set:
- Not applicable. This device does not employ machine learning that would require a "training set." Its core technologies are established and were already in "clinical use for at least six years in the predicate device."
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).