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The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all been tested and evaluated for biocompatibility.

The provided text describes the acceptance criteria and the study that demonstrates the performance of the Disposable Temperature Probe.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test sets (e.g., for accuracy, biocompatibility, electrical safety, or EMC). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It generally states that "Non-clinical testings have been conducted" and refers to compliance with international standards.

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 in the document. The document refers to compliance with international standards for performance and safety tests, which typically involve laboratory testing rather than expert-established ground truth for a clinical dataset.

4. Adjudication method for the test set

This information is not provided in the document. As mentioned above, the tests described are primarily engineering and laboratory-based, not clinical studies requiring adjudications.

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 comparative effectiveness study was not conducted. This device is a disposable temperature probe, which is a physical measurement device, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.

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

This concept is not applicable to this device. The Disposable Temperature Probe is a sensor; it does not contain an algorithm in the sense of AI or image analysis. Its performance is evaluated through direct physical measurements against established standards.

7. The type of ground truth used

For accuracy, the ground truth would be precise temperature measurements from calibrated reference instruments or environments during laboratory testing. For biocompatibility, the ground truth is established by the accepted biological responses to materials as defined by ISO 10993 standards. For electrical safety and EMC, the ground truth is compliance with the limits and conditions specified in the respective IEC standards.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this information is not applicable.

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

As there is no training set for this device, this information is not applicable.

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The Vicks® VDT972 RapidRead™ Digital Thermometer is a handheld, battery-powered, predictive, digital stick thermometer intended for the intermittent determination of human body temperature orally, rectally, or under the arm, in a home-use environment for people of all ages (infants, children, and adults). It is intended to be used with a single-use, disposable probe cover for all measurements.

The Vicks® VDT972 RapidRead™ Digital Thermometer is a predictive, thermistor-based, stick thermometer capable of measuring oral, axillary, or rectal temperature in 2 to 8 seconds. It is equipped with a site selection button that requires the operator to select the desired measurement site before taking a temperature. For each measurement, it must be used with a commercially-available, single-use, disposable probe cover.

The Vicks® VDT972 RapidRead™ Digital Thermometer is a contact thermometer, using a negative temperature coefficient (NTC) thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes. This change in resistance is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user.

The Vicks® VDT972 RapidRead™ Digital Thermometer does not use a clinical offset algorithm. clinical offset algorithms are typically used to perform a measurement on one physiological site (i.e. the forehead. temple, or ear) and represent what the equivalent measurement would be at a different physiological site (i.e. oral), had the measurement been performed at that site instead. Typically, these formulas account for ambient temperature, at a minimum, in calculating the appropriate offset. Because the Vicks® VDT972 RapidRead™ Digital Thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via the use of a clinical offset.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Vicks® VDT972 RapidRead™ Digital Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vicks® VDT972 RapidRead™ Digital Thermometer are primarily based on demonstrating substantial equivalence to its predicate devices, especially regarding performance standards like accuracy, and compliance with relevant international standards. The study aimed to show non-inferiority in clinical performance compared to the predicate device and the "Gold Standard" reference device.

    *   > 12 months to 5 years: 30 (Axillary), 28 (Rectal), 0 (Oral) = 58 total
    *   > 5 to 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total
    *   > 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total

• Data Provenance: The document does not explicitly state the country of origin. It describes a "multicenter" clinical investigation, implying data collected from multiple locations, likely within the same country given the FDA submission.
• Retrospective or Prospective: The study was a prospective clinical investigation.

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

The ground truth was established by a "Gold Standard" reference device, the Welch Allyn SureTemp® Plus 690 Thermometer. The study methodology describes readings taken with this device. It does not mention human experts directly establishing ground truth for individual temperature readings. The accuracy of the reference device itself is presumed to be established through its own regulatory clearances and accepted metrological standards.

4. Adjudication Method for the Test Set

The document does not detail an adjudication method for disagreements between human readers, as the primary comparison was between devices. Instead, it describes:

• For afebrile subjects and febrile subjects ≥ 5 years of age: 1 reading with the reference thermometer, followed by 3 consecutive readings with the test thermometer, and 3 consecutive readings with the predicate thermometer, at one-minute intervals.
• For febrile subjects

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The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to detect body temperature. The FT-100A is intended for home use.

The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.

The provided text describes the 510(k) premarket notification for the Infrared Forehead Thermometer, FT-100A. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for the device's performance against specific statistical targets commonly seen in AI/ML medical devices.

However, I can extract information related to the device's accuracy and the clinical investigation performed.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for accuracy are implicitly derived from the comparison to the predicate device and the standards met. The table below combines the stated accuracy for the new device and the predicate, implying that the new device aims to meet or exceed the predicate's accuracy.

Clinical investigation demonstrated: "bias less than predicate device when compared to reference." This implies the FT-100A met or exceeded the accuracy of the predicate against the reference.
"clinical repeatability... statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Accuracy (Object Mode) | ± 1°C (±2°F) from 0°C (32°F) to 100°C (212°F) (From Predicate) | FOR OBJECT MODE:
± 4°C (±7.2°F) from 0°C (32°F) to 4.9°C (40.8°F)
± 1°C (±2°F) from 5.0°C (32°F) to 60.0°C (140.0°F)
± 4°C (±7.2°F) from 60.1°C (140.1°F) to 100°C (199.9°F) |
| Clinical Repeatability | Defined in ASTM E1965-98 (Reapproved 2009) as "clinical acceptability" (not explicitly quantified for predicate, but implied by standard compliance). | "statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Compliance with Standards | ISO 80601-2-56:2009, ASTM E1965-98(Reapproved 2009) (and others for biocompatibility, electrical safety, EMC) | Passed all listed standards (ISO 10993-5, ISO 10993-10, ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-56, ASTM E1965-98). |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The text states, "A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months-

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The VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.

The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.

Here's a breakdown of the acceptance criteria and study information for the VDT985US Vicks® SmartTemp™ Thermometer, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample Size and Data Provenance

The document states that a comparison study and clinical repeatability testing were performed on four age groups: 0-12 months, 12 months-

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The Braun Thermoscan® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.

The Braun Thermoscan® PRO 6000 Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. The Braun Thermoscan® PRO 6000 Ear Thermometer also includes a technique compensation feature to detect depth of insertion to compensate for common methods of misuse, this feature uses capacitive rings mounted in the speculum of the thermometer to detect insertion and depth and measurements of the outer ear temperature during insertion to detect misuse and correct accordingly. The Braun Thermoscan® PRO 6000 Ear Thermometer is meant for professional use in hospitals and healthcare or professional office settings.

The provided document describes the KAZ USA, Inc. Braun Thermoscan® PRO 6000 Ear Thermometer and its clinical study to demonstrate substantial equivalence to its predicate device, the Braun Thermoscan® PRO 4000 Ear Thermometer, in accordance with ASTM E1965-03.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office.

The MedStar Monitoring System II comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site. The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks. The Collection Server comprises a Personal Computer-type Processor Unit incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.

The provided text lacks the detailed study information required to complete the table and answer all questions comprehensively. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and specific statistical results.

Here's an attempt to extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but the "bench testing" mentioned suggests internal testing, not necessarily human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The device's function is data transfer, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation.

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. The MedStar System II is a data transfer device, not an AI-powered diagnostic tool used by human readers.

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

• Yes, implicitly. The "bench testing" mentioned would be a standalone evaluation of the device's technical performance (e.g., successful data transmission, accuracy of data transfer) without human intervention in its core function. However, specific results are not provided.

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

• For a data transfer device, the 'ground truth' would likely involve verifying the integrity and accuracy of the transmitted data against the original source data (e.g., verifying that a blood glucose reading of 'X' from the monitor is correctly received as 'X' by the server). The document does not specify the method used for this verification.

8. The sample size for the training set:

• Not applicable. This device is not described as using machine learning or AI that would require a training set.

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

• Not applicable, as there's no mention of a training set.

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The VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature. noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg, floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The model 53000 Series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpOz), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The provided text is a 510(k) summary for a medical device cleared through substantial equivalence, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information (such as specific performance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods) is not explicitly stated in this document.

However, based on the available text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the 510(k) summary. The document states that the device "will be tested in accordance with the Test Plan / Report, #831-0719-00, and Clinical Validation Report #831-0752-00 included with the submission," but the content of these reports, including specific acceptance criteria and performance data, is not summarized here. Instead, it relies on substantial equivalence to predicate devices, implying that its performance should be comparable.

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

This information is not explicitly provided. The document mentions a "Clinical Validation Report #831-0752-00," which would contain this data, but the summary does not detail it.

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

This information is not explicitly provided.

4. Adjudication Method for the Test Set

This information is not explicitly provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

This information is not explicitly provided. The document focuses on substantial equivalence based on technical specifications and performance compared to predicate devices, not on a comparative study with human readers for improved effectiveness.

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

This information is not explicitly provided. Given the device is a vital signs monitor, its core function is to produce readings directly, which implies a standalone performance would be inherent. However, specific details about such testing are not in this summary.

7. The Type of Ground Truth Used

This information is not explicitly provided. For vital signs monitors, ground truth would typically come from reference standards for each measurement (e.g., arterial line measurements for NIBP, co-oximetry for SpO2, calibrated thermometers for temperature), but this is not detailed in the summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a vital signs monitor that likely uses established algorithms and hardware for measurement, not a machine learning or AI-based device requiring a "training set" in the typical sense.

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

This information is not applicable/provided for the same reasons as point 8.

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