(266 days)
The SteadyTemp system is a wireless thermometer intended to provide precise body temperature for users of all ages. The SteadyTemp system comprises a single-use temperature measuring sensor, the SteadySense Patch, and the SteadyTemp application. SteadySense Patch measures and stores axillary skin temperature data up to 10 days. The typical application duration when using the system is 7 days.
SteadyTemp is a wireless thermometer designed to provide users of all ages with information about their body temperature. The device has two components, the SteadyTemp app, and the battery operated SteadySense patch. Both are required to measure temperature.
The SteadySense patch is a non-invasive, non-sterile, active temperature measurement device capable of detecting sub-degree (
The provided text is a 510(k) summary for the SteadyTemp device, a wireless thermometer. While it describes performance testing and comparisons to a predicate device, it does not contain the detailed acceptance criteria or a comprehensive study plan with the specific information requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (TempTraq) based on technological characteristics and general conformance to various IEC and ISO standards. It mentions "Performance testing was conducted to demonstrate..." for several aspects, but does not provide the specifics of these tests in terms of acceptance criteria, sample sizes, or ground truth establishment.
Therefore, I cannot extract the requested information from the provided text.
Here's a breakdown of why and what information is missing:
- 1. A table of acceptance criteria and the reported device performance: The document states that "Performance testing was conducted to demonstrate the subject device conforms with IEC 80601-2-56 for absolute temperature accuracy" and mentions an accuracy of "+/- 0.3°C. 30-42 °C". This is a performance metric and a potential acceptance criterion. However, a full table of all acceptance criteria for various aspects (e.g., memory function, run time, signal transmission, biocompatibility) and their corresponding reported performance is not presented in a systematic way. For example, for "Memory Function," it only says "Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness," but no specific numerical acceptance criterion or result is given.
- 2. Sample sized used for the test set and the data provenance: This information is completely absent.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a thermometer that measures a physical quantity directly (body temperature). The ground truth would typically be established by a reference thermometer with a known higher accuracy. The text mentions "Biocompatibility testing" and "Software documentation following enhanced documentation level of FDA guidance," which might involve expert review, but details are missing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a thermometer's direct measurement performance.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a direct measurement device, not an image interpretation or diagnostic aid involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone measurement device (with an app for display and interface). The performance metrics would inherently be standalone. However, the details of how the standalone performance was measured (e.g., against what reference, under what conditions) are not specified beyond compliance with IEC 80601-2-56.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For temperature accuracy, the ground truth would be a highly accurate reference thermometer. The document implies compliance with IEC 80601-2-56, which would dictate the method for establishing ground truth, but doesn't explicitly describe it here. For biocompatibility, the ground truth comes from standard biological tests.
- 8. The sample size for the training set: Not applicable. This is a medical device, not a machine learning model where a "training set" in that sense would be used for its core temperature measurement function. It has software, which undergoes "Software Verification and Validation," but this is different from an AI/ML training set.
- 9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above.
In summary, the provided FDA document is a regulatory submission summary that asserts compliance with various standards and provides comparisons to a predicate device. It does not provide the granular detail of the study design, acceptance criteria, sample sizes, and ground truth establishment that would be present in a full clinical study report or a more detailed technical file.
§ 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.