(260 days)
PlusCare Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for use by qualified medical personnel only.
The Skin Temperature Probe and Rectum Temperature Probe are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with compatible temperature measurement systems only. Temperature probes measure temperature through a resistor that is sensitive to temperature changes. The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.
This document is a 510(k) Premarket Notification from the FDA regarding a temperature probe. It is not a document describing the acceptance criteria and study proving an AI/Machine Learning device meets acceptance criteria.
The information provided describes a traditional medical device (a temperature probe) and demonstrates its substantial equivalence to a predicate device. This process primarily relies on comparing design, materials, technological characteristics, and performance specifications, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.
Therefore, many of the specific questions you've asked, which are highly relevant to AI/ML device evaluations, are not applicable to the content of this document. For instance:
- No AI/ML device: There is no AI component, so there are no "acceptance criteria" related to AI performance, no "test set" for AI, no "ground truth" to establish for AI, no "MRMC studies," no "standalone algorithm performance," and no "training set."
- Traditional device equivalence: The study instead focuses on demonstrating that the new temperature probe is "exactly the same" as a previously cleared predicate device in terms of its intended use, design, operating principle, materials, measurement range, accuracy, and compliance with relevant safety and biocompatibility standards (e.g., IEC 60601-1, ISO 80601-2-56, ISO 10993 series).
To answer your prompt based solely on the provided text, the response would be:
This document describes the 510(k) clearance for a traditional medical device, the PlusCare Temperature Probe, not an AI/Machine Learning enabled device. Therefore, the information requested regarding acceptance criteria and studies demonstrating performance for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable to this submission.
The "acceptance criteria" for this device relate to its ability to meet established performance standards for clinical thermometers and demonstrate substantial equivalence to a legally marketed predicate device (Unimed Temperature Probe, K121427). The study conducted was a non-clinical test data assessment to ensure compliance with recognized standards for safety, biocompatibility, and performance, demonstrating that the subject device's specifications (e.g., accuracy, measurement range) are identical to those of the predicate device.
Here's what can be extracted from the document relating to its clearance, even though it's not an AI device:
1. A table of acceptance criteria and the reported device performance
For a traditional device like a temperature probe, acceptance criteria are typically specified in recognized standards and internal company specifications. The document highlights the key performance characteristics that were compared and found to be "Same" as the predicate device, implying these represent the performance thresholds met.
| Characteristic | Acceptance Criteria (Predicate Device K121427) | Reported Device Performance (Subject Device K203636) | Meets Acceptance Criteria? |
|---|---|---|---|
| Measurement range | 25-45°C | 25-45°C/77-113°F | Yes (expanded range, but includes predicate's) |
| Thermistor resistance | NTC resistance $2.25 K\Omega @25°C$ | NTC resistance $2.25 K\Omega @25°C$ | Yes |
| Accuracy | $\pm 0.1°C$ | $\pm 0.1°C/\pm 0.18°F$ | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for "test set" in the context of AI evaluation. This document does not describe patient-based clinical "test sets" for performance evaluation in the way an AI device would.
- The "testing" involved non-clinical lab tests to ensure the device itself met physical, electrical, and biocompatibility standards. The document doesn't specify sample sizes for these internal engineering or bench tests for components, but rather focuses on the device's adherence to established standards.
- Data Provenance: The testing was presumably conducted by the manufacturer (JKH USA, LLC). No country of origin for specific test data is provided, but the submission is to the US FDA. The tests are "non-clinical" which implies laboratory or bench testing, not patient data trials.
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)
- Not applicable. There is no "ground truth" established by experts in the context of interpreting medical images or data, as this is a measurement device, not an interpretative AI device. The ground truth for temperature measurement is established by calibrated reference thermometers and physical principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for medical expert interpretations is relevant here. Performance is based on direct measurement and compliance with engineering/biocompatibility standards.
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
- Not applicable. This relates to AI-assisted human performance, which is not relevant to a simple temperature probe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This describes an algorithm's performance without human interaction. This device is a sensor, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for a temperature probe's accuracy is its ability to measure temperature precisely against traceable reference standards (e.g., highly accurate thermometers, known temperature baths).
- For safety and biocompatibility, the ground truth is compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above.
§ 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.