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Digital thermometers (Model: TP-100, TP-300, TP-300, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.

The Digital Thermometer is a general purpose thermometer is intended for oral or axillary temperature measurements of the human body. The thermometer should be used with a smart phone or other Bluetooth smart device on which the GuadiAngel app is installed. The thermometer communicates with the user's device through a Bluetooth connection.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: Digital Thermometer (Models: TP-100, TP-300, TP-400, TP-500, BT-A31A-BT)
Manufacturer: Fudakang Industrial Co., Ltd.
K Number: K172121

Based on the provided text, the device is a Digital Thermometer intended for measuring and monitoring oral or axillary temperature in adults, pediatric patients, and infants. It transmits measurements via Bluetooth to a smartphone or iPad with the GuardiAngel App installed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance specifications and the standards the device claims to meet. The reported device performance is directly stated or implied by the assertion of compliance with these standards and the comparison to predicate devices.

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

The document explicitly states "Clinical study: Not applicable." This indicates that no clinical study involving human subjects or a test set of data with specific sample sizes was conducted or reported for this 510(k) submission. The device's performance was evaluated through non-clinical studies and testing against established standards, as well as a comparison to predicate devices.

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

Given that no clinical study was performed, there was no test set with ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the relevant international standards (e.g., ISO 80601-2-56 for accuracy) and internal design specifications. The experts involved would be the engineers and quality assurance personnel responsible for conducting these tests and verifying compliance. Their qualifications are not specified in this document.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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 digital thermometer, not an AI-powered diagnostic imaging system requiring human readers or interpretation of complex cases. Therefore, an MRMC study is not relevant.

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

This refers to the performance of the device itself (the algorithm) independent of human intervention. The non-clinical studies described, such as verification of accuracy, electrical safety, EMC, and compliance with ISO 80601-2-56 for clinical thermometers, are essentially standalone performance evaluations of the device and its internal software (algorithm). The device measures temperature and transmits it; the "algorithm" here is the embedded software that processes the thermistor data into a temperature reading. The document indicates that "all software requirement specifications are met and all software hazards have been mitigated."

7. The Type of Ground Truth Used

The ground truth used for the device's technical performance and safety was primarily based on:

• Established Standards: International and national standards (e.g., IEC 60601-1, ISO 80601-2-56, FCC regulations) that define acceptable performance limits, safety requirements, and electromagnetic compatibility.
• Design Specifications: Internal specifications set by the manufacturer for parameters like measuring range and accuracy.
• Predicate Device Performance: The performance of legally marketed predicate devices (K160308 and K152739) served as a benchmark for substantial equivalence, implying that the proposed device should perform at least as well in relevant aspects.
• Biocompatibility Testing: Chemical and biological assays (ISO 10993-5, ISO 10993-10) directly testing the device's materials for adverse reactions.

8. The Sample Size for the Training Set

Not applicable. As this device is a "Digital Thermometer" and not an AI/ML-driven diagnostic tool that learns from data, there is no "training set" in the conventional machine learning sense. The device's performance is based on its hardware design, thermistor technology, and pre-programmed software.

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

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

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Fudakang Bluetooth Digital thermometer (Model: BT-A41CN-BT) is intended for the measurement and monitoring of oral, axillary, and rectal temperature of adults via a thermistor. The device is for use of a doctor or lay consumers in the hospital or home. The result of measurement can be transmitted to smart mobile device (cell phone, iPad) while displayed on the LCD.

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

The provided text from the FDA 510(k) clearance letter and Indications for Use document contains information about the Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT). However, it does not provide specific details about the acceptance criteria and the study conducted to prove the device meets these criteria.

This type of FDA document primarily focuses on documenting substantial equivalence to a predicate device and specifying the intended use, regulatory classification, and general compliance requirements. It typically does not include the detailed technical study information that would define acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics from validation studies. These details are usually found in the full 510(k) submission, which is not publicly available in this format.

Therefore, I cannot provide a table of acceptance criteria, reported performance, or details about the study design (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) based solely on the provided text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement is key – it indicates that the device was cleared because it was demonstrated to be equivalent to an already approved device, rather than necessarily undergoing a new comprehensive clinical trial with explicit acceptance criteria detailed in this public brief.

To obtain the information requested, one would typically need to refer to the full 510(k) submission's performance data section, which is proprietary to the manufacturer and not generally disclosed in the public clearance letter.

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Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments.

The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.

Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.

Fudakang Blood Pressure Monitor is battery driven automatic non-invasive Blood Pressure Monitor.

It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.

Fudakang Blood Pressure Monitor includes two types of automatic non-invasive Blood Pressure Monitor, Arm Automatic Blood Pressure Monitor and Wrist Fully Automatic Blood Pressure Monitor. The Arm Blood Pressure Monitor utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to 22cm-30cm (8.66 in - 11.8 in). The Wrist Blood Pressure Monitor utilizes an inflatable cuff wrapped around the wrist, the cuff circumference is limited to 13.5cm- 19.5cm (5.31in -7.67 in).

The BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and studies for the Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Accuracy within acceptable scope specified in ISO 81060-2	Clinical study results "showed the accuracy of the blood pressure monitor made by Fudakang Industrial Co., Ltd. is within acceptable scope specified in ISO 81060-2."

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

   • Sample Size: 123 patients (65 males and 58 females).
   • Data Provenance: Not explicitly stated, but the study was a clinical study conducted (likely for regulatory approval), suggesting it was prospective. The location of the study (country of origin) is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable in this context. The study uses a manual Mercury Sphygmomanometer as the reference device for ground truth, which is a widely accepted standard measurement. No "experts" are establishing a subjective ground truth.

4. Adjudication Method for the Test Set:

   • Not applicable. The ground truth is established by a reference device (manual Mercury Sphygmomanometer) rather than expert consensus requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not done. The study described is a comparison of the device against a reference standard (manual Mercury Sphygmomanometer), not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study:

   • Yes, a standalone study was performed. The clinical test involved comparing the Fudakang device's measurements directly against those obtained from a manual Mercury Sphygmomanometer. This evaluates the algorithm's (device's) performance independently.

7. Type of Ground Truth Used:

   • Reference Device Measurement: The ground truth was established by readings from a manual Mercury Sphygmomanometer. This is considered a gold standard for blood pressure measurement.

8. Sample Size for the Training Set:

   • Not specified. The document only describes a clinical study, which generally serves as the validation (test) set for demonstrating performance against a standard, not the training set for developing the algorithm. Medical device approval documents often don't detail the training phases of algorithms unless they are a central part of the device's novelty or specific AI claims.

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

   • Not specified, as the training set details are not provided.

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Infrared Thermometer (FT-F11) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.

This infrared Ear Thermometer measure the temperature. It's from the ear canal which can be got more quickly and accurate the human body temperature.

This product has the following advantages:

1). Easy to Clean& Probe cover Free.
2). High speed & Accuracy scan the reading of temperature.
3). Conveniency, Only one key operation.
4). Automatic display last memorized measuring temperature. When do you turn on the power.

The provided text describes the substantial equivalence of the "Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)". The acceptance criteria, study details, and related information are extracted below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance metrics like accuracy, but rather uses a comparison table to predicate devices. The implied acceptance criteria are that the new device's specifications are comparable to or within acceptable ranges of the predicate devices, and that testing confirms its safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size for the test set used in the clinical or bench tests. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

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):

This information is not provided in the document. For a clinical thermometer, ground truth typically comes from highly accurate reference thermometers or other established temperature measurement methods, rather than expert interpretation of images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method for establishing ground truth for the test set.

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:

This device is an infrared thermometer, not an AI-assisted diagnostic tool for which MRMC studies involving human readers would typically be conducted. Therefore, no MRMC study or effect size related to human reader improvement with AI is mentioned or relevant in this context.

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

The device itself is a standalone electronic clinical thermometer. The clinical and bench tests assess the performance of the device on its own. The document states, "The clinical and bench tests demonstrated its accuracy and effectiveness." This implies standalone performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For a clinical thermometer, the ground truth for temperature measurement would typically be established using a highly accurate reference thermometer or other validated temperature measurement standard. This would be part of the "clinical and bench tests" conducted, specifically adhering to standards like ASTM E 1965. The document does not explicitly state the specific method used to establish ground truth beyond referencing standards.

8. The sample size for the training set:

This information is not applicable and not provided. As an infrared thermometer, this device is likely a hardware-based measurement system and does not typically involve "training sets" in the context of machine learning or AI algorithms. Its functionality is based on established physical principles of infrared detection.

9. How the ground truth for the training set was established:

This information is not applicable and not provided, as there is no mention of a "training set" for this type of device.

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