(26 days)
The reusable temperature probes are intended to be used for monitoring temperature. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.
These devices are indicated for use by qualified medical personnel only.
Reusable temperature probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are used during patient temperature measurement. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only.
Temperature probes measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.
These temperature probes are typically used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175).
Products are packed individually into a plastic bag in non-sterile condition. Package label describes product REF codes, manufacturing date, CE-mark, legal entity information and a caution "Rx Only (USA), U.S. Federal law restricts this device to sale by or on the order of a physician."
This is an interesting case where the provided document is a 510(k) summary for a medical device that isn't AI-powered. Therefore, much of the requested information about AI model performance, ground truth, and expert evaluation is not applicable.
However, I can extract the relevant information regarding the acceptance criteria and the study proving the non-AI device meets those criteria from the provided text.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study or AI performance metrics. Instead, it refers to compliance with established international and national standards for medical devices, particularly regarding safety and performance.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance Claim) |
|---|---|
| EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996 Part 1: General requirements for safety | Assessed against, thoroughly tested through validation and verification of specifications. |
| IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient monitoring equipment) | Assessed against, thoroughly tested through validation and verification of specifications. |
| 21 CFR Part 898 (FDA Radiation Control Regulations for electronic products) | Assessed against, thoroughly tested through validation and verification of specifications. |
| EN 1041:1998 Information supplied by the manufacturer with medical devices | Assessed against, thoroughly tested through validation and verification of specifications. |
| EN 980:2003 Graphical symbols for use in the labeling of medical devices | Assessed against, thoroughly tested through validation and verification of specifications. |
| ISO 10993-5:1995, ISO 10993-10:1996 Biological evaluation of medical devices | Assessed against, thoroughly tested through validation and verification of specifications. |
| ISO 14971:2000 Medical devices Application of risk management to medical devices | Assessed against, thoroughly tested through validation and verification of specifications. |
| EN12470-4:2000 Performance of electrical thermometers for continuous measurement | Assessed against, thoroughly tested through validation and verification of specifications. |
| Accuracy in 32 to 42° C range (Claim of similarity to predicate device) | The proposed reusable temperature probes have "accuracy in 32 to 42° C range" similar to the predicate device, implying this range is met. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is referred to as "validation and verification of specifications" against the listed standards. This is not a clinical study with human subjects, but rather a series of engineering and quality assurance tests. The document states: "The reusable temperature probes... have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications."
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a physical temperature probe and not an AI algorithm processing data. The "test set" refers to the specific probes manufactured and subjected to testing to ensure compliance with the standards. There is no mention of a fixed "sample size" for a data test set in the context of AI.
The data provenance, again, is not applicable in the AI sense. The "data" here would be the measurements and test results from the physical probes themselves during their validation and verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth, in the context of AI, refers to annotated data. For a physical device like a temperature probe, the "ground truth" for accuracy is typically established by comparing the probe's readings to highly accurate reference thermometers traceable to national standards, carried out by laboratory technicians or engineers, not medical experts establishing a diagnosis.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1 or 3+1 for resolving disagreements among human annotators) are relevant for establishing ground truth in AI training or evaluation data. For physical device testing, the methods involve standardized test procedures and measurement comparison.
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
This is not applicable as the device is a physical temperature probe, not an AI algorithm assisting human readers. Therefore, no MRMC study looking at human reader improvement with AI assistance would have been conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable for the same reason as above. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these temperature probes (specifically accuracy) would be established by comparison to reference standards (e.g., highly accurate, calibrated thermometers in a controlled environment), not expert consensus, pathology, or outcomes data. The document explicitly mentions "accuracy in 32 to 42° C range" among its similarities to the predicate device, suggesting this was a key performance metric evaluated against an objective standard.
8. The Sample Size for the Training Set
This is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this is a physical medical device, not an AI model.
§ 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.