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The Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old. The device is for home healthcare used by the layperson.

The Temp Pal is designed for the following: A comprehensive Android and iOS App are provided to access Temp Pal from a smart device. It is used for measuring and monitoring armpit temperature and transmitting measured results to authorized caregivers via a real-time cloud service.

Here's an analysis of the acceptance criteria and study information for the Temp Pal device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states compliance with various standards rather than presenting a direct side-by-side comparison of specific numerical acceptance criteria and performance for all aspects. However, based on the "Differences and Equivalences" table and the "Non-clinical Testing Summary," we can infer the primary performance acceptance criterion:

2. Sample Size Used for the Test Set and Data Provenance

The document states: "A series of verification and validation activities were conducted on the subject device as below, and no clinical testing is performed to support the decision of substantial equivalence." This indicates that the performance evaluation relied on non-clinical (bench) testing and comparison against established standards and a predicate device.

Therefore:

• Sample size for the test set: Not explicitly stated as this was non-clinical testing. The "sample" would refer to the physical devices and components tested.
• Data provenance: Non-clinical (bench) testing, likely conducted in a lab environment. Origin, if outside the manufacturer's own facilities, is not specified. It is inherently retrospective in the sense that the device's performance was evaluated against pre-defined criteria and standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical testing was performed and the evaluation was based on non-clinical performance and compliance with standards, the concept of "experts" establishing ground truth for a clinical test set doesn't directly apply in this context. The "ground truth" for non-clinical performance is defined by the technical specifications of the standards (e.g., ASTM E1112 for thermometer accuracy) and the design requirements. Expert roles would be in the interpretation and application of these standards, typically by qualified engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable as there was no expert-adjudicated clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states "no clinical testing is performed." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is not applicable here as the device is a thermometer, and its performance is assessed via direct measurement accuracy and adherence to technical standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a physical electronic thermometer, not an AI or algorithm-only device in the diagnostic sense. Its standalone performance refers to its ability to accurately measure temperature according to specified standards. All the non-clinical testing described (accuracy, electrical safety, EMC, biocompatibility, etc.) can be considered standalone (device-only) performance evaluations as they assess the device's inherent characteristics without direct human intervention as part of the measurement process itself, beyond operating the device.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is primarily:

• Standard Specifications: Requirements outlined in international and national standards such as EN 12470-4, ASTM E1112, ISO 80601-2-56 for performance, and EN ISO 10993 series for biocompatibility, IEC/EN 60601 series for electrical safety and EMC.
• Predicate Device Specifications: The performance characteristics of the legally marketed predicate device (Wireless Thermometer, Model WT701, K132761) served as a benchmark for comparison to establish substantial equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning or AI models. Since the Temp Pal is an electronic thermometer and not an AI device in this context, there is no training set in the machine learning sense. The device's design and calibration would be based on engineering principles and validated through the non-clinical testing mentioned.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device.

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The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Fever Scout Continuous Monitoring thermometer is an ambulatory continuous body temperature monitor designed for armpit location, and uses Bluetooth Low Energy (BLE) for wireless communication with the Smartphone app for temperature display, trending and alert. This product is composed of The Fever Scout VV-200 patch, The Smartphone app (supporting iOS), AAA charging system with BLE relay function, and Eight adhesives. The patch hardware primarily includes the following function modules: 1) temperature sensor, 2) control module, 3) Bluetooth Low Energy (BLE) communication module and 4) battery. All are integrated onto a flexible electronic printed circuit board. A MS Lithium rechargeable battery is attached to the board to supply 3.0V DC internal power. The app includes 1) User account, profile and alert temperature setup and 2) GUI for temperature display, trending and alerts. The charging system provides a cordless charging method to the patch, a storage to the replaceable double-sided adhesives, as well as an alternative BLE communication channel from the patch to the charger and then to the iPhone, in order to extend communication range. This product contains Type B applied part (per IEC 60601-1: 2012). All components, the patch, charger and adhesives are all user accessible parts. However, the user is only expected to change the charger AAA batteries, but not to open or modify any other parts of the product.

Here's a breakdown of the acceptance criteria and the study information for the "Fever Scout™ Continuous Monitoring thermometer," based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria and Performance: The document mainly uses the phrase "Equivalent" or "Identical" when comparing to predicates, and then states that the device "meets" or "conforms" to specific standards. The specific numerical acceptance criteria for the predicates (where available) are inferred here to represent the bar the Fever Scout had to meet for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• The document mentions "product verification, software verification, user/usability validation, biocompatibility test, mechanical hazards test, EMC test and IEC 60601-1 safety compliance test" as the performance data.
• Specific sample sizes for a clinical test set are not explicitly mentioned in this 510(k) summary. It refers to compliance with standards like ASTM E1112, which typically involve specific test methodologies and potentially human subjects for accuracy testing, but the number of subjects or samples is not provided here.
• Data Provenance: Not explicitly stated as retrospective or prospective for a specific clinical study related to accuracy with human subjects. The tests mentioned are performance and safety engineering tests. No country of origin for specific human subject data is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document. For a thermometer, "ground truth" for accuracy is typically established by comparing the device's readings to a highly accurate reference thermometer in a controlled environment or in vivo with a controlled reference method. Experts would likely be involved in designing and executing such tests, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set:

• This information is not provided as there is no mention of a traditional expert-adjudicated test set in the context of diagnostic performance (e.g., medical image interpretation). For a thermometer, accuracy is typically determined through direct comparison with a traceable reference, not through adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases with and without AI assistance. This device is a thermometer, and the evaluation focuses on its direct measurement accuracy and safety, rather than its impact on human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Yes, a standalone performance was done for the thermometer's core function. The accuracy, measurement range, and operating conditions are assessed directly for the device itself, conforming to standards like ASTM E1112. The "algorithm" here is the temperature sensing and processing, and its output (temperature reading) is evaluated against reference standards. The device is intended for continuous monitoring and displays information via a smartphone app. Its performance is inherent to the device's measurement capabilities.

7. Type of Ground Truth Used:

• The ground truth for thermometer performance (e.g., accuracy) is typically established by comparing the device's measurements to that of a traceable reference thermometer or a recognized standard temperature source in a controlled laboratory setting, as defined by standards like ASTM E1112. For biocompatibility and electrical safety, the ground truth is adherence to the specified international standards (e.g., ISO 10993, IEC 60601-1).

8. Sample Size for the Training Set:

• This information is not applicable and not provided. The "Fever Scout™ Continuous Monitoring thermometer" is a sensor-based medical device, not an AI/ML diagnostic algorithm that requires a separate "training set" of data in the conventional sense. Its temperature sensing and processing are based on established physics and sensor technology, verified through engineering tests and adherence to standards.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable and not provided for the same reason as point 8.

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The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.

The CliniCloud Non-Contact Thermometer Model SPL1024 (abbreviated 'CliniCloud Non-Contact Thermometer') is a battery powered Bluetooth Low Energy (BLE) enabled portable infrared thermometer intended for the measurement of human body temperature for persons of all ages. It features no physical buttons or a display and must be used in conjunction with the CliniCloud App on a compatible BLE enabled smartphone. The CliniCloud App is free to download.

When power is applied to the device via 2 AAA batteries, the CliniCloud Non-Contact Thermometer starts to advertise via BLE, and can establish a BLE connection with BLE enabled smart phones with the CliniCloud app. The user could then request the CliniCloud non-contact thermometer to take temperature readings from within the CliniCloud app. The measured temperatures are sent back to the smart phone via the established Bluetooth link and displayed on the smartphone's display in the CliniCloud app. The CliniCloud Non-Contact Thermometer uses a medical grade MLX90614ESF-DCC thermopile sensor supplied by Melexis to passively measure object surface temperature using infrared radiation emitted by patients. The sensor also measures the ambient temperature with a built-in thermistor. The sensor is factory calibrated to meet consensus standard ASTM E1965-98. Upon receiving a request from the CliniCloud APP over the established BLE connection the onboard Nordic Semiconductor NRF51822 BLE SOC microcontroller communicates with the thermopile (MLX90614ESF-DCC) over the 12C bus and sends the received temperature readings including the object surface temperature and the ambient temperature to the CliniCloud app via the established BLE connection. On the smartphone app, the well-known heat loss equation is used to perform conversion of forehead surface temperature to oral equivalent temperature.

Here's a breakdown of the acceptance criteria and study information for the CliniCloud Non-Contact Thermometer, Model SPL1024, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ASTM E1965-98 standard for infrared thermometers.

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The Wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is single-use and intended for armpit temperature measurement for persons of all age.

The TempTraq™, Model TT-100 patch consists of a temperature sensor integrated circuit mounted to a flexible electronic printed circuit board that also contains a microprocessor and a Bluetooth Low Energy (BLE) radio transmitter. Two 1.5V flexible batteries are attached to the circuit board to supply 3.0V DC internal power. The temperature sensor integrated circuit utilizes diode technology where voltage varies with temperature. The sensor circuit is factory calibrated and converts the voltage to an output temperature. The algorithm for conversion is a proprietary algorithm which compensates for the nearly linear behavior of the diode voltage, providing an extremely accurate temperature measurement.

The Blue Spark Technologies TempTraq™, Model TT-100 is a battery-operated electronic device intended for measuring human body temperature precisely, specifically for armpit temperature measurement for persons of all ages. This device is single-use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Clinical testing was not required to establish equivalency of the device." Therefore, there is no test set of clinical data from human subjects reported in this summary. The performance was demonstrated through "bench tests," "System Verification," "Software Verification and Validation," and compliance with voluntary standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was performed on human subjects for the test set, no experts were used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set
Not applicable, as no clinical test set on human subjects was used.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical testing was not required to establish equivalency of the device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes "bench tests" and "System Verification" which would inherently be standalone performance evaluations of the device itself and its integrated software/firmware. However, it does not explicitly use the term "standalone performance" in the context of an algorithm or AI. The device's primary function is a temperature sensor and transmitter, not an AI-driven diagnostic algorithm. The accuracy specified (±0.1 °C between 30 °C ~ 42.4 °C) likely comes from these standalone bench tests comparing the device's readings against a known accurate temperature source.

7. The Type of Ground Truth Used
For the bench tests and system verification, the ground truth would have been established by known, calibrated reference temperatures generated by laboratory equipment. This is implied by the nature of "bench tests" for thermometer accuracy.

8. The Sample Size for the Training Set
Not applicable. This device is a thermometer, and its core function relies on direct physical measurement via a diode's voltage proportionality to temperature, combined with a proprietary calibration algorithm. This kind of device does not typically involve "training" in the machine learning sense to establish its fundamental measurement accuracy for in-vitro/in-silico testing. The "proprietary algorithm" for temperature conversion is likely a fixed mathematical model based on physical principles and factory calibration, not a trained machine learning model requiring a training dataset.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of a machine learning "training set" for this device. The "factory calibrated" nature of the sensor circuit suggests a one-time calibration process against precise reference temperatures during manufacturing.

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