(128 days)
The Endocare Electronic Thermometer System are designed for use in General Surgery, Urology, and Gynecology to monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback.
The Endocare Electronic Thermometer System incorporates a flexible user interface for easy of use. The Temperature Monitoring System can be used with a variety of thermocouple probes. The probes can be used for intra-operative temperature monitoring to avoid unintended tissue damage.
The provided text describes a medical device, the Endocare Electronic Thermometer System, and its purpose. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects like sample sizes, ground truth methodologies, expert qualifications, or MRMC studies that are typically found in modern medical device submissions.
This document is from 1996 (K961365). Medical device regulatory requirements and the level of detail expected for performance studies have significantly evolved since then. The provided text is primarily a "Summary of Safety and Effectiveness" from a 510(k) submission, which at that time focused heavily on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
Therefore, I cannot fulfill the request using only the provided input, as the necessary information is not present.
Here's a breakdown of why I cannot answer your specific questions based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: The document states "The Endocare Electronic Thermometer System has the same temperature measuring characteristics as current electronic thermometer systems." and claims substantial equivalence to predicate devices, but it does not specify what those characteristics are (e.g., accuracy ± X degrees, precision, response time) nor does it provide a table of measured performance data for the Endocare system against specific, quantitative acceptance criteria.
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth... and qualifications: Not mentioned, as no such study is detailed.
- 4. Adjudication method: Not mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study would be highly unlikely for a thermometer in 1996, as it's typically for image-based diagnostic systems where human interpretation is key.
- 6. If a standalone performance study was done: The closest it gets is stating "The Endocare Electronic Thermometer System has the same temperature measuring characteristics...", implying some testing might have been done internally to verify this, but no details of such a study are provided.
- 7. The type of ground truth used: Not mentioned.
- 8. The sample size for the training set: Not applicable, as this is a thermometer, not an AI/ML device requiring a "training set."
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a high-level summary for a 1996 510(k) submission focusing on substantial equivalence, and it does not contain the detailed performance study information you are asking for, which is more typical of modern device submissions, especially for AI/ML-driven devices or newer, more complex diagnostic tools.
§ 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.