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The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518 and Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.

The applicant device of Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1 are the electronic thermometers by using a the temperature sensor. tor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC), JA31106, the CMOS digital clinical thermometer IC for measuring body temperature from 32.0℃~42.0℃(90°F ~ 109.0°F)

All variants follow same design, same application with same performance and safety. The only difference is appearance. Therefore, all variants have same specifications parameters, same PCB Design, and same components with exception of shell.

No antimicrobial or antithrombotic ingredient is applied on the applicant device.

No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.

No specific drug or biologic is applied with the applicant device.

The provided 510(k) summary for the Clinical Electronic Thermometers (Models MT901, MT518, ECT-1) does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a definitive study proving the device meets those criteria.

This 510(k) submission is for a Class II device and relies on demonstrating substantial equivalence to a predicate device (Rapid Digital Thermometer, Model RDT-18-XY, K062016). The summary explicitly states: "The applicant device has same classification informations and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device."

Therefore, concrete acceptance criteria and a detailed study proving performance against those specific criteria for the new device are generally not provided in such a submission when substantial equivalence is asserted. Instead, the assumption is that if the new device is substantially equivalent to a legally marketed predicate, it shares the predicate's established performance and safety.

However, I can extract the relevant information and infer some details based on typical thermometer requirements and the general nature of 510(k) submissions for substantially equivalent devices.

1. Table of Acceptance Criteria and Reported Device Performance

As the submission relies on substantial equivalence and does not present a new specific performance study against defined acceptance criteria, I will infer typical performance expectations for clinical electronic thermometers and note that the device is stated to meet the "same performance effectiveness" as the predicate.

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

• Sample Size for Test Set: Not specified. It's highly unlikely a new clinical test set was used if the claim is substantial equivalence based on design and specifications rather than a de novo performance study. It's more likely that bench testing was performed to confirm the specifications of the new device match the predicate.
• Data Provenance: Not specified. For substantial equivalence, the "data" primarily refers to the characteristics and specifications of the new device matching the predicate, and possibly engineering/bench testing data. Not a typical clinical study in this context.

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

• Number of Experts/Qualifications: Not applicable for this type of 510(k) submission. Ground truth, in the sense of clinical expert consensus for diagnosis, is not relevant here as it's a device for direct physiological measurement, not an interpretative AI/diagnostic tool.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.

• MRMC Study: No. This device is a standalone electronic thermometer, 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.

• Standalone Performance: Yes, in the sense that the device itself is standalone. Bench testing would have been implicit to verify that the thermometer accurately measures temperature within its specified range. However, no specific details of such "standalone" testing are provided in this 510(k) summary beyond asserting it has the "same performance effectiveness" as the predicate.

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

• Type of Ground Truth: For a thermometer, the "ground truth" would be calibrated reference temperature standards used during manufacturing and quality control testing, and implicitly, during any verification testing to confirm the device's accuracy against its specifications.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. See point 8.

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The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.

AIV's Clinical Electronic Thermometers (also referred to as Temperature Probes) are replacement thermometers for temperature monitoring/measuring systems. The device is reusable. The devices are electronic thermometers using a thermistor temperature sensor. The devices are placed inside a protective sheath (not manufactured or supplied by AIV). Then the thermometer is used on the patient by trained medical personnel. The sensor is displayed on a monitor/measuring system (not manufactured or supplied by AIV). The probe consists of a thermistor located in a metal tipped plastic shaft is attached to a plastic body that allows the protective sheath (not supplied component that actually touches the patient) to be gripped and ejected off the probe. A shielded multi-conductor cable is used to conduct thermistor signals to the connector for the monitor/measuring system. Some a heating resistor that allows a more rapid temperature measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AIV Clinical Electronic Thermometer:

Acceptance Criteria and Device Performance Study for AIV Clinical Electronic Thermometer

The provided document describes a 510(k) Premarket Notification for a replacement clinical electronic thermometer. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide extensive clinical performance data against specific acceptance criteria.

Based on the document, the "acceptance criteria" are primarily implicit in the demonstration of substantial equivalence to existing predicate devices. The study proving this substantial equivalence is limited to bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a replacement device, the "acceptance criteria" are largely derived from the characteristics and performance of the predicate devices. The document explicitly states that the AIV device uses "the same type of construction and have the same technological characteristics" as the predicate devices.

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

The document does not specify a sample size for a test set in the traditional sense of a clinical trial or a structured validation study with a defined dataset. The "study" referenced is bench testing.

• Data Provenance: The data provenance is not specified beyond "bench testing." It is not clinical data (patient data), so concepts like "country of origin" are not applicable in this context. It's an in-house prospective test by the manufacturer.

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

Not applicable. This submission is for a medical device (thermometer) and relies on bench testing and comparison to predicate devices, not on expert clinical interpretation or ground truth establishment in the way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" described as the testing is not based on expert review of ambiguous cases.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The AIV Clinical Electronic Thermometer is a direct measurement device, not an AI diagnostic tool that assists human readers.

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

Yes, in spirit, a standalone performance was done, in that the device's performance was evaluated independently through bench testing. However, it's not an "algorithm only" performance as the device is a physical electronic thermometer. The "standalone" evaluation here refers to the device itself performing its intended function (temperature measurement) without a human's interpretative cognitive task being assisted by AI. The human is involved in placing and operating the device, but the temperature reading itself is generated by the device.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be established by reference temperature standards and calibrated measurement equipment. While not explicitly detailed, standard engineering and metrology practices dictate that the thermometer's readings would be compared against highly accurate and traceable temperature sources to verify its performance specifications (e.g., accuracy, precision). This is essentially physics/engineering-based ground truth, not clinical or pathology-based.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electronic thermometer; it does not involve machine learning or AI algorithms that require a "training set" of data.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.

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The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.

The Clinical Electronic Thermometer is a thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans.

The provided text describes a 510(k) premarket notification for a Clinical Electronic Thermometer. Here's a breakdown of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these standards were met "In terms of physical requirements and operating parameters."

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

No information is provided regarding the sample size used for any test set or the provenance of any data. The document explicitly states: "Controlled human clinical studies were not conducted using the Clinical Electronic Thermometer and predicate devices." This indicates that the device's performance was not evaluated through human clinical trials.

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

Not applicable. As no human clinical studies were conducted, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. No human clinical studies were conducted.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and 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-assisted diagnostic tool for image interpretation, and no MRMC studies are mentioned.

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

No, an algorithm-only standalone performance study was not done in the context of an AI device. The device is a thermometer, and its performance was assessed against established engineering and safety standards (ASTM E1112, IEC 60601-1, IEC 60601-1-2).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for demonstrating the device's performance was conformance to established industry standards for electronic thermometers (ASTM E1112, IEC 60601-1, IEC 60601-1-2). These standards define acceptable performance characteristics for such devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (thermometer) and not an AI/machine learning model that typically involves training sets.

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

Not applicable. As this is not an AI/machine learning model, there was no training set or corresponding ground truth to establish.

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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Clinical Electronic Thermometer

The provided text concerns an FDA 510(k) clearance for a "Clinical Electronic Thermometer" (K982140). The documents focus on the regulatory approval process and indications for use, rather than a detailed study description of acceptance criteria and device performance. Therefore, I cannot extract the specific information requested in your prompt based on the provided text.

The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set.
5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study.
6. Details about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document is a letter from the FDA to Valeo Corporation granting 510(k) clearance for their Clinical Electronic Thermometer, indicating it is "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" document specifies the purpose of the device (measures body temperature via a sensor, amplification, and digital display, reusable, intended for oral, axillary, or rectal measurements).

To provide the requested information, you would need a clinical study report or a detailed 510(k) summary that includes performance data and validation methodology for the device.

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