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510(k) Data Aggregation
(321 days)
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages.
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed device performance metrics beyond stating that the device is "substantially equivalent" to predicate devices. The document explicitly states: "The primary function of the ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are the same as the J & J Engineering, Inc. Thermistor Thermometer and the Exergen Corporation DermaTemp DT 1001 and raises no new questions of safety and effectiveness." This implies that the acceptance criteria for this device are met by demonstrating equivalence to the legally marketed predicate devices, which would have themselves met their respective performance standards.
Without specific performance data, it's impossible to create a table. However, if performance data were present, it would typically look something like this (hypothetical example):
| Performance Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Accuracy Range | ±0.2°C from 36°C-39°C | ±0.15°C from 36.5°C-38.5°C | Yes |
| Response Time | < 2 seconds | 1.5 seconds | Yes |
| Repeatability | Standard Deviation < 0.1°C | Standard Deviation 0.08°C | Yes |
| Temperature Range | 32°C - 42°C | 32°C - 42°C | Yes |
2. Sample size used for the test set and the data provenance:
The provided 510(k) summary does not contain any information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective). The submission relies on demonstrating substantial equivalence to predicate devices rather than reporting new clinical study data that would typically involve a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The provided 510(k) summary does not contain any information about experts used to establish ground truth. As mentioned, the submission relies on substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The provided 510(k) summary does not contain any information about an adjudication method.
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:
The device described is an infrared thermometer and not an AI-powered diagnostic tool requiring human interpretation. Therefore, no MRMC comparative effectiveness study was done or is applicable in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The provided 510(k) summary does not contain any information about standalone performance studies in the context of an algorithm. The device is a direct measurement tool. The "standalone performance" of the thermometer would be its inherent accuracy, reproducibility, etc., which is implied to be equivalent to the predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The provided 510(k) summary does not explicitly state the type of ground truth used, as it relies on substantial equivalence to existing devices. For a thermometer, "ground truth" for performance would typically be established by comparing its readings to a highly accurate reference thermometer or a known standard temperature source within a controlled laboratory environment. The submission assumes that the predicate devices had already established their accuracy characteristics through such ground truth methods.
8. The sample size for the training set:
The provided 510(k) summary does not contain any information about a "training set." This type of terminology is relevant for machine learning or AI-based devices. The ThermoTrace™ Infrared Thermometer is a direct measurement device; it does not "learn" from a training set.
9. How the ground truth for the training set was established:
As no training set is applicable to this type of device, the question of how its ground truth was established is not relevant to this 510(k) summary.
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