(35 days)
The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.
The VivaTherm™ Temperature Measurement System consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-ProbeTM).
The provided document, K031556 for the VivaTherm™ Temperature Measurement System, mentions "Bench testing of the VivaTherm™ Temperature Measurement System confirmed similar performance as compared to a predicate device." However, it does not provide specific acceptance criteria, reported device performance metrics in a table, or detailed information about a study to prove these criteria were met.
Therefore, many of the requested sections cannot be filled from the given text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated in the document. The document only mentions "confirmed similar performance as compared to a predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
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)
- Number of Experts: Not applicable, as no expert-based ground truth establishment is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no expert-based adjudication is described.
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
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device is a direct temperature measurement system, not an AI-assisted diagnostic tool for human readers.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The document states "Bench testing... confirmed similar performance as compared to a predicate device." This implies a standalone (device only) test, but no specific metrics or study details are provided beyond this general statement. No "algorithm only" study is discussed as this is a hardware device for direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For a temperature measurement device, the "ground truth" would likely be a highly accurate reference thermometer or controlled temperature environment. The document only refers to comparison with a predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a temperature measurement device, not an AI/ML model that requires a training set in that context.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
Summary of Available Information:
- Acceptance Criteria: Not explicitly stated. Implied to be "similar performance" to a predicate device.
- Study Description: "Bench testing...confirmed similar performance as compared to a predicate device." No details provided.
- Device Type: VivaTherm™ Temperature Measurement System, consisting of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-Probe™).
- Intended Use: To monitor tissue temperatures during clinical procedures requiring temperature feedback.
- Predicate Devices: Luxtron Multichannel 2000 Fluoroptic Thermometer (K841105), Endocare Electronic Thermometer System (K961365), URI Therm-X Model TX-100 Multichannel Thermocouple Thermometry System (K843381).
The provided text focuses on the substantial equivalence argument based on general performance similarity and device characteristics (indications for use, basic function, materials, manufacturing), rather than detailed performance study results against specific acceptance criteria.
§ 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.