(114 days)
The 740 SELECT series of monitors is indicated for use as a portable, multi-parameter, variable aculty device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring and recording of:
- Blood pressure and pulse rate of adult, pediatric and neonatal patients; .
- Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and . neonatal patients;
- Additionally the Masimo Rainbow SET technology provides noninvasive monitoring of . carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed on the 740 SELECT with the Masimo Rainbow SET option includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (PI), and/or Pleth Variability Index (PVI) indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused;
- Carbon Dioxide concentration of the expired and inspired breath and respiration rate of adult, . pediatric, infant or neonatal patient and included, with the Oridion option, an Integrated Pulmonary Index (IPI):
- Intermittent predictive body temperature (oral, axillary, rectal) of adult, pediatric and neonatal ● patients;
- Infrared (over the temporal artery) measurement of body temperature of people of all ages. .
The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature and CO2 in various modes of operation.
The CASMED 740 SELECT is a multi-parameter physiological monitor. The provided document does not contain an "acceptance criteria" table with specific performance metrics and acceptance thresholds for the device as a whole. Instead, it states that the device has undergone clinical and non-clinical testing to demonstrate substantial equivalence to predicate devices, and that the OEM's clinical work for the pulse oximeters, CO2, and temperature functions is cited.
Therefore, the acceptance criteria are implicitly tied to demonstrating substantial equivalence, meaning the 740 SELECT performs comparably to the identified predicate devices for each parameter (NIBP, SpO2, Temperature, CO2).
Here's an analysis of the provided information based on your request, with limitations due to the nature of the available document (a 510(k) summary, not a detailed study report):
1. Table of Acceptance Criteria and Reported Device Performance
As noted, a formal table of acceptance criteria and specific reported device performance values is not provided in this 510(k) summary. The summary focuses on demonstrating substantial equivalence. The document indicates that for the NIBP, SpO2, CO2, and Temperature functions, the 740 SELECT incorporates technologies from other manufacturers (OEMs) that have already undergone validation.
The implicit acceptance criteria for each parameter would be that its performance is equivalent to, or within the accepted ranges of, its respective predicate device or the OEM component's validated performance.
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- NIBP: The document states that CAS has "conducted a full program of individual hardware, software and systems verification and validation studies." It also mentions "clinical validation reports for the NIBP." However, specific sample sizes for the NIBP clinical validation are not provided.
- Pulse Oximeters, CO2, Temperature: The document explicitly states that the 740 SELECT incorporates OEM components (Masimo, Nellcor, Exergen, Phasein, Oridion). For these parameters, the "OEM's clinical work" is cited. This implies that the validation data for these components predates the 740 SELECT and was done by the original equipment manufacturers. No specific sample sizes for these OEM components' clinical work are provided in this document pertaining to the 740 SELECT's submission.
- Data Provenance: The document does not specify the country of origin for any clinical data. Given the submission is to the FDA, it is likely some data would involve studies conducted or accepted in the US, but this is not explicitly stated. It refers to "clinical validation reports for the NIBP" (presumably conducted by CAS Medical Systems) and "the OEM's clinical work" for other parameters. It is retrospective in the sense that the OEM data was already established.
3. Number of Experts and Qualifications for Ground Truth - Test Set
- NIBP: Not specified. "Clinical validation reports" are mentioned, which would typically involve qualified medical professionals, but their number and specific qualifications are not detailed.
- Pulse Oximeters, CO2, Temperature: Not specified. For the OEM components, the ground truth establishment would have been part of their original validation studies, which are not detailed here.
4. Adjudication Method - Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the clinical validation studies, either for the NIBP component or for the OEM components.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done as described (human readers improving with AI vs. without AI assistance).
- The device being submitted (740 SELECT) is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting data with and without AI assistance for comparative effectiveness. The focus is on the accuracy and reliability of the physiological measurements themselves.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, in essence, standalone performance was assessed for the measurement algorithms.
- The document implies that the measurement algorithms for NIBP, SpO2, CO2, and Temperature are intended to operate independently to provide accurate physiological readings. The "clinical validation reports for the NIBP" and the "OEM's clinical work for the pulse oximeters, CO2 and the temperature functions" refer to studies evaluating the accuracy of these measurement technologies.
- The 740 SELECT itself is a "device" with algorithms embedded to perform these measurements. The "clinical validation" and "OEM's clinical work" would have primarily focused on the accuracy of these algorithms and sensors in determining physiological parameters against a reference standard.
7. Type of Ground Truth Used
- NIBP: While not explicitly stated, NIBP validation typically uses invasive arterial line measurements as the gold standard ground truth for comparing non-invasive readings.
- Functional Oxygen Saturation (SpO2): For pulse oximeters, the ground truth is often established by co-oximetry of arterial blood samples.
- CO2: For CO2 monitors (Capnography), the ground truth is typically derived from direct measurement of CO2 concentration in exhaled gas using a laboratory reference method.
- Temperature: For thermometry, the ground truth is usually established by highly accurate reference thermometers measuring core body temperature (e.g., rectal, esophageal, or arterial temperature probes).
8. Sample Size for the Training Set
- Not specified. The document does not provide details on training sets for any of the algorithms. Since the device integrates established technologies, the initial development and "training" (if applicable to the algorithm type) would have occurred during the development of these OEM components, not explicitly for the 740 SELECT submission.
9. How the Ground Truth for the Training Set Was Established
- Not specified. As mentioned above, details about training sets and their ground truth establishment are not present in this 510(k) summary. This information would typically be found in detailed design and validation documentation for the individual components by their respective OEM manufacturers.
§ 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).