(126 days)
The temperature probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's instructions for use. The temperature probe is designed for use with a YSI tele-thermometer to monitor and display temperature.
The temperature probe devices are intended for use with the temperature monitoring adapter of compatible Medtronic devices and the YSI™ tele-thermometer 1. The probe has a thermistor sensor housed in a stainless steel sheath connected to a 3-m (10-ft) cable, terminating with a 6.35-mm (1/4-in) phono plug.
This refers to a 510(k) premarket notification for a Class II medical device, specifically a "Temperature Probe" (Product Code: FLL). The document details the device's characteristics and its comparison to predicate devices, along with performance testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical values. Instead, it lists performance tests and their "Pass" results, indicating the device met the requirements established for each test. The acceptance criteria for each test would be the specific requirements or standards defined prior to testing, which the device passed.
| Test Description | Reference Standard/Requirement (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| IEC 60601 | Ensures compliance with IEC 60601 electrical safety and Electromagnetic compatibility (EMC). | Pass |
| Temperature Range | Ensures performance at extreme temperature ranges. | Pass |
| Ambient Temperature Environment | Ensures performance at normal temperature ranges. | Pass |
| Accuracy | Accuracy over the entire specified temperature range. | Pass |
| Precision and Repeatability | Precision and repeatability of measurements over the specified temperature range with effects of air currents. | Pass |
| Time | Time required for the device to obtain a steady state reading. | Pass |
| Life Testing | Meets requirements for the expected life of the probe. | Pass |
| Liquid Ingress and Chemical Exposure Testing | Meets Ingress Protection and cleaning requirements. | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample size for each performance test. It states "Bench testing was used to demonstrate the performance characteristics," implying laboratory-based testing rather than clinical data from human subjects. There is no information regarding the country of origin of data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a temperature probe, and its performance (e.g., accuracy, precision) is typically established through objective measurements against traceable standards in a laboratory setting, not by human expert opinion or interpretation of data in the same way an AI diagnostic tool would be evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical image reading) where there might be disagreement among experts. For performance testing of a physical device like a temperature probe, objective measurements against established standards are used, not subjective adjudication.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is relevant for AI-assisted diagnostic tools involving human readers, which is not the case for this temperature probe.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable in the context of an AI algorithm. However, the performance tests listed in the table (e.g., accuracy, precision, life testing) assess the standalone performance of the device itself in a controlled environment, without human intervention beyond setting up the test conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests mentioned, the "ground truth" would be established by:
- Traceable standards: For accuracy and temperature range tests, the device's readings would be compared against highly accurate and calibrated reference thermometers.
- Defined specifications/requirements: For other tests like life testing, ingress protection, or time to steady state, the ground truth is whether the device meets pre-defined engineering and safety specifications.
- International standards: Compliance with IEC 60601 suggests adherence to internationally recognized electrical safety and EMC benchmarks.
8. The sample size for the training set
This information is not applicable. The temperature probe is a physical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical device.
§ 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.