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510(k) Data Aggregation
(81 days)
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(275 days)
For intermittent measurement of body temperature in patients of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
The Cecilia® Thermometer consists of an IR sensor, an electronic signal processing detector, a digital LCD display, and disposable probe covers.
The provided text is a 510(k) summary for the Cecilia® Penguin Multi-Use Thermometer. It details the device's substantial equivalence to a predicate device and mentions general testing, but does not contain the specific information required to complete the table and answer all questions related to acceptance criteria, detailed study design, ground truth establishment, or sample sizes for specific tests.
The document states: "The Cecilia® Thermometer was subjected to safety and performance tests for compliance against applicable recognized standards. Additional testing activities were conducted to establish the performance and reliability characteristics of the device, including testing to establish laboratory and clinical accuracy." However, the results of these tests and the methodologies are not described in this summary.
Therefore, I cannot provide a complete answer with the requested details from the given text.
Here's what I can extract or infer based on the provided text, and what is missing:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specific metrics and thresholds are missing from the text) | Reported Device Performance (Specific results are missing from the text) |
|---|---|
| Accuracy: (Likely defined by a specific deviation from a reference temperature within a clinical range) | The document states "testing to establish laboratory and clinical accuracy" was performed, but does not provide the specific performance values (e.g., mean bias, standard deviation of differences, clinical acceptance based on limits of agreement). |
| Safety: (Likely compliance with electrical safety, biocompatibility, etc.) | The document states "safety...tests for compliance against applicable recognized standards" were performed, but does not detail the specific safety criteria or the device's performance against them. |
| Reliability/Durability: (Likely stability of measurements over time, resistance to environmental factors) | The document states "testing activities were conducted to establish the performance and reliability characteristics," but specific criteria and results are absent. |
| Functionality: (e.g., proper display, ease of use) | Implied by "performance characteristics," but specific criteria and results are absent. |
Missing Information Details:
- 2. Sample sizes used for the test set and the data provenance: Not specified in the provided text.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/specified. For a thermometer, ground truth is usually established by a calibrated reference device, not human expert consensus.
- 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 device is a thermometer, not an AI diagnostic tool involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement tool. Its performance would be evaluated in a standalone manner against a reference, but "algorithm only" implies a more complex AI system which this is not.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a thermometer, the ground truth would typically be established using a calibrated reference thermometer in a controlled environment (laboratory testing) and potentially a clinical reference method (e.g., rectal thermometry for core body temperature, or another established tympanic thermometer as a clinical reference) for clinical accuracy. The document mentions "laboratory and clinical accuracy" testing.
- 8. The sample size for the training set: Not applicable. This device is not an AI/machine learning model that typically requires a "training set." It's a medical device with an IR sensor and electronic signal processing.
- 9. How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of this device.
Summary of what is present:
- Device Name: Cecilia® Penguin Multi-Use Thermometer
- Intended Use: Intermittent measurement of body temperature in individuals of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
- Predicate Device: Braun Thermoscan® IRT 3020/3520 (K983295)
- Technology: IR measurement technology, electronic signal processing, digital LCD display.
- Testing conducted: Safety and performance tests against recognized standards, including laboratory and clinical accuracy.
Summary of what is NOT present in the provided text:
- Specific acceptance criteria (numerical thresholds for accuracy, reliability, etc.).
- Detailed performance results against those criteria.
- Sample sizes for clinical or laboratory accuracy studies.
- Details about the "ground truth" methods (e.g., type of reference thermometer used, environmental controls).
- Any information related to AI/ML specific concepts like training sets, test sets, expert adjudication methods, or MRMC studies, as the device is not an AI diagnostic system in the sense implied by these questions.
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