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510(k) Data Aggregation
(36 days)
All Digital Clinical Thermometers are intended to precisely measure human body temperature. The Thermometers can be used in the measurement of oral, axillary and rectal temperature.
The Classic/Hypothermia Digital Clinical Thermometer consists of an electronically sensor which is located in a metal probe and is connected with a PCB and a Liquid Crystal Display all situated in a pen-like plastic housing. This structure is used for all kind of Thermometer mentioned in this description.
Hypothermia Thermometer have a greater measuring range so that they can be used as device for under cooled person temperature monitoring.
A flexible probe tip is provided by the Flexible Digital Clinical Thermometer that makes the measuring of the temperature more comfortable and safer.
With the patented 10-Second Digital Clinical Thermometer every user is able to receive the result of the measurement in a very quick time. The Express Models also operates with the vame efficient reliability and accuracy like the other Thermometer.
Due to a special integrated sensor in the Left-Right Handed Digital Clinical Thermometer display can easily be read whether the Thermometer is held in the right or the left hand. Especially for left-handed people it makes the measuring result read off more pleasant.
The Basal Digital Clinical Thermometer have a fourth digit on the display, because the measurement of this Thermometer is even more accurate compared with normal Thermometer. This precisely measuring method can be used to monitor and interpreting basal temperature changes.
The Lightweight-Probe Digital Clinical Thermometer consists of a flexible probe, connection cord and a display unit embedded in a round housing.
Variants Descriptions: "+" or Hypothermia, Express, Dual scale, Backlight, LR, following with the model numbers indicates different measuring range, different measuring time, scale switchable, with backlight with Left-Right Handed function.
For all Thermometers is essential, that they consist of a temperature sensor embedded in a special designed metal probe, which could be flexible or inelastic. This sensor is connected with the IC unit, which is connected with a Liquid Crystal Display (LCD) to display the measured temperature. All parts are situated in a pen-like plastic housing. During measuring, only the maximum measured value is displayed on LCD window and all devices are non-predictive.
All variant thermometers comply with referenced product standards of ATSM E1112-00, EN12470-3, IEC 60601-1, IEC 60601-1-2 and ISO 10993-1.
The provided text describes the submission for a 510(k) premarket notification for several models of digital clinical thermometers. It states that the new devices are substantially equivalent to previously cleared predicate devices and comply with relevant standards. However, the document does not contain a detailed study with specific acceptance criteria and performance results in the format requested.
The text focuses on demonstrating "substantial equivalence" to predicate devices rather than providing a standalone performance study with specific metrics like sensitivity, specificity, or accuracy derived from a new clinical trial.
Therefore, many of the requested items cannot be extracted directly from the provided text. I will provide the information that is available and indicate where the requested information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria (e.g., minimum accuracy levels in statistical terms) or detailed reported device performance (e.g., mean absolute deviation or confidence intervals from a clinical study). Instead, it states compliance with recognized standards.
| Acceptance Criteria (Not Explicitly Stated as Criteria for a New Test) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Compliance with ASTM E1112-00 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | The devices comply with ATSM E1112-00. This standard specifies requirements for accuracy, repeatability, and other performance characteristics for electronic clinical thermometers. For example, ASTM E1112-00 typically specifies accuracy within ±0.1°C or ±0.2°F for oral/rectal use in a specified temperature range. |
| Compliance with EN 12470-3 (Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device) | The devices comply with EN12470-3. This standard also sets requirements for accuracy, safety, and performance for compact electrical thermometers. |
| Compliance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The devices comply with IEC 60601-1, ensuring basic safety and essential performance. |
| Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The devices comply with IEC 60601-1-2, ensuring electromagnetic compatibility. |
| Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | The devices comply with ISO 10993-1, indicating biological compatibility. |
| Substantial Equivalence to Predicate Devices | The devices are declared substantially equivalent in intended use, technology, and performance to the identified predicate devices (K010238, K021612, K021614, K031905, K954792). Their performance is presumed to be similar to these already cleared devices, which would have met regulatory requirements. |
| Enhanced accuracy for Basal Digital Clinical Thermometer | The Basal Digital Thermometer has "poligher accuracy" (likely a typo, meaning higher accuracy) and a fourth digit on the display for more precise measurement, suitable for monitoring and interpreting basal temperature changes. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The submission relies on compliance with standards and substantial equivalence, not a specific new test set with a reported sample size or data provenance from a prospective or retrospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. As no specific test set requiring expert ground truth is detailed, this does not apply.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided. As no specific test set requiring adjudication is detailed, this does not apply.
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
An MRMC study is not mentioned and is not applicable to a digital clinical thermometer, which is a standalone measurement device and not an AI-assisted diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The devices are standalone devices (thermometers); their performance is inherently "algorithm only" in the sense that they provide a direct temperature reading. However, a dedicated study proving this standalone performance with specific metrics as if it were a complex diagnostic algorithm is not detailed in the submission. The submission states compliance with relevant standards which implicitly covers standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For clinical thermometers, the "ground truth" typically refers to traceability to a recognized temperature standard (e.g., by calibration against a primary temperature standard or a calibrated reference thermometer) and comparison to core body temperature measurements in clinical validation. The document does not explicitly state the specific type of ground truth used but implicitly relies on the methods required by the cited standards (ASTM E1112-00, EN 12470-3), which dictate how accuracy is to be determined and validated, including calibration and clinical performance testing against reference methods.
8. The Sample Size for the Training Set
This information is not applicable as these are not AI/machine learning devices that require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as these are not AI/machine learning devices.
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