(104 days)
The NGT Temperature Sensor is indicated for continuous measurement of patient core (esophageal) temperature in patients using Bard® or Argyle® 16 Fr or 18 Fr nasogastric sump tubes or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen.
The Medivance Nasogastric Tube (NGT) Temperature Sensor is a sterile, single use, disposable YSI400 series thermistor temperature probe that is designed for placement in the vent lumen of a 16 or 18 Fr Bard Nasogastric Sump or Argyle Salem Sump® nasogastric tube (or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen) for measurement of esophageal temperature.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medivance Nasogastric Tube Temperature Sensor:
Acceptance Criteria and Device Performance
The provided text only explicitly states one accuracy specification. The other "acceptance criteria" are implied through compliance with standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Physiologic Temp Range) | ± 0.2°C |
| Compliance with BS EN 12470-4 | Meets applicable requirements |
| Compliance with ISO 80601-2-56 | Meets applicable requirements |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing (per ISO 10993-1) |
Study Details
Based on the provided text, the study focused on technical and performance testing against recognized standards rather than a clinical trial with human subjects.
- Sample size used for the test set and the data provenance: Not specified. The document states "Testing demonstrated that the Medivance NGT Temperature Sensor performance meets the applicable requirements...", implying lab-based performance testing rather than human patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for performance standards is defined by the standards themselves, not by expert consensus on specific cases.
- Adjudication method for the test set: Not applicable. The testing seems to be objective measurement against predefined technical specifications within the standards.
- 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 device is a sensor, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the testing described appears to be standalone performance testing of the device itself against technical specifications and safety standards.
- The type of ground truth used: Technical specifications and safety requirements outlined in the international standards BS EN 12470-4 and ISO 80601-2-56, and biocompatibility standards in ISO 10993-1.
- The sample size for the training set: Not applicable. This technical testing does not involve a "training set" in the context of machine learning or AI.
- How the ground truth for the training set was established: Not applicable.
§ 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.