(188 days)
The primary use of the CIM, as an intermittent themmeter, is to take a patient's temperature at a single point in time. However, the instrument's Monitor mode also allows continuous monitoring of the patient's temperature. The CIM is a clinical grade thermometer. It is intended for use by healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.
The Clinical Themometry Module is intended to be used for the intermittent determination of temperature in hypothermic normothermic of ebrildren or adults, In the Normal mode, oral use in compliant patients allowing maintenance of the sublingual picket for the temperature-taking cycle, enables the predictive algorithm to determine an accurate temperature in approximately 4 seconds. Rectal use results in a predictive temperature in approximately 10 seconds.
The CTM consists of an elongated metal heat-conductive probe connected to the multiparameter module (MPM) which may be used with the ESCORT® II Patient Monitor through a coiled cable. The probe contains a thermistor which conveys temperature information to the MPM for calculation of patient temperature which may be displayed on the ESCORT® II display panel.
Prior to use, the probe is inserted into a plastic probe cover. The cover offers no significant barrier to heat transfer from the patient to the probe body. The disposable nature of the probe cover prevents microbiological cross-contamination among patients such as might occur with a reusable probe.
Calculation of patient temperature may, in the normal mode, utilize algorithms which enable accurate temperature prediction within 3 to 10 seconds of probe placement.
Here's an analysis of the provided text regarding the K970011 Clinical Thermometry Module, focusing on acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance (CTM) | Predicate Device (SureTemp® & LifeSign®) |
|---|---|---|
| Display Temperature Range | 84.0°F to 108.8°F / 28.9°C to 42.2°C | 84.0°F to 108.8°F (SureTemp®), 84.0°F to 108.8°F (LifeSign®) |
| Laboratory Accuracy | ±0.2°F, in Monitor mode in a stirred water bath | ±0.2°F, in Monitor mode in a stirred water bath (SureTemp®), per ASTM E-1112-86 (LifeSign®) |
| Precision | 0.1°F / 0.1°C | 0.1°F / 0.1°C (SureTemp®), Not Specified (LifeSign®) |
| Operating Temperature Range | 60.8°F to 104°F / 16°C to 40°C | 60.8°F to 104°F (SureTemp®), 82°F to 104°F (LifeSign®) |
| Operating Humidity Range | 15% to 95%, non-condensing | 15% to 95%, non-condensing (SureTemp®), 15% to 90%, non-condensing (LifeSign®) |
| Storage Temperature Range | -4°F to 120°F / -20°C to 50°C | -4°F to 120°F (SureTemp®), -4°F to 122°F (LifeSign®) |
| Storage Humidity Range | 15% to 95%, non-condensing | 15% to 95%, non-condensing (SureTemp®), 15% to 90%, non-condensing (LifeSign®) |
| Bench Test - Environmental Data | Slope: 0.995, Y-Intercept: 0.0938, r: 0.999, SEE: 0.5246, Mean Error: 0.000, Std. Deviation: 0.0391 | (Not directly reported for predicate devices as comparative statistical analysis was against them) |
| Bench Test - Heat Well Data | Slope: 1.000, Y-Intercept: 0.000, r: 1.000, SEE: 0.000, Mean Error: 0.000, Std. Deviation: 0.000 | (Not directly reported for predicate devices as comparative statistical analysis was against them) |
2. Sample size used for the test set and the data provenance
The document describes "bench testing methods" used for device testing. It does not specify a sample size in terms of number of patients, readings, or specific data points for the test set. Instead, it relies on statistical analysis of temperature measurements.
- Data Provenance: The bench testing involved "making temperature measurements at operational environmental extremes of temperature and humidity" and "using a constant temperature source." This indicates the data was generated in a laboratory setting rather than from human subjects. The provenance is therefore considered retrospective/simulation based on laboratory conditions and not derived from clinical patient data or specific geographical regions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the bench testing appears to be established by the "constant temperature source" and the predicate devices themselves, as the CTM was validated "against the predicate devices incorporating Diatek technology."
4. Adjudication method for the test set
There is no mention of an adjudication method for the test set. Since the testing involved bench comparisons to known standards (constant temperature source) and predicate devices, a human adjudication method was not applicable or described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a direct measurement instrument (thermometer), not an AI-assisted diagnostic tool that would involve human interpretation or "readers." Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance evaluation was implicitly done. The "bench testing methods" evaluated the CTM's accuracy and repeatability in a lab setting, comparing its measurements to known standards and predicate devices without human intervention in the measurement process. The predictive algorithm's performance (determining accurate temperature in approximately 4 seconds orally, 10 seconds rectally) is described as an inherent function of the device itself.
7. The type of ground truth used
The ground truth used for the bench testing was:
- Known constant temperature sources: Implicit in "using a constant temperature source."
- Measurements from predicate devices: The CTM was validated "against the predicate devices incorporating Diatek technology." This means the predicate devices' measurements served as a reference for accuracy.
8. The sample size for the training set
The document describes a 510(k) submission for a medical device (thermometer), not an AI/machine learning model that typically requires a distinct "training set." Therefore, there is no mention of a training set sample size. The CTM's algorithms would have been developed and tested by the manufacturer during its design phase, but this is not referred to as a "training set" in the context of this submission.
9. How the ground truth for the training set was established
As there is no explicit mention of a "training set" in the context of this 510(k) submission, the method for establishing its ground truth is not provided. The device's underlying algorithms would have been designed based on established thermometry principles and validated through internal development testing, likely using similar methods to the bench tests described for the 510(k) submission.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.