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It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.

The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.

It's important to clarify that the provided document does not describe a study that proves the device meets acceptance criteria in the way a clinical trial or a performance study for an AI-powered diagnostic device would.

This document is a 510(k) Summary for a Rapid Digital Thermometer, which is a Class II medical device. For such devices, regulatory clearance often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical studies proving novel diagnostic performance.

Therefore, many of the typical questions regarding AI device studies (like expert consensus, MRMC studies, training set details) are not applicable to this type of device and submission.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance for Rapid Digital Thermometer (Model RDT-18-XY)

The "acceptance criteria" for this device are largely defined by compliance with established performance standards for clinical electronic thermometers and by demonstrating substantial equivalence to a predicate device. The "study" referenced is primarily a series of non-clinical tests performed according to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. For performance tests like temperature range, accuracy, and resolution conducted according to ASTM E1112, there would be specific sample sizes (e.g., number of readings, number of devices tested). However, this detail is not included in the summary.
• Data Provenance: The tests were "conducted according to ASTM E1112 standards," "IEC 60601-1, IEC 60601-1-2 requirements," and "ISO 10993-1:2003 biocompatibility testing." The location where these tests were performed is not explicitly stated but is likely within a lab setting. The data is non-clinical/bench testing, not data collected from patients. It's retrospective in the sense that these are lab tests designed to demonstrate performance characteristics.

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

• Not Applicable. For a basic electronic thermometer, "ground truth" is typically established by reference standards or calibrated equipment (e.g., a highly accurate reference thermometer in a temperature-controlled bath) for the performance tests, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or between an algorithm and human readers, as this is a non-AI, non-diagnostic device. The tests involve comparing device readings against a known reference or standard.

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 is not an AI-powered diagnostic device, and no MRMC study was conducted.

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

• Not Applicable. This is an electronic thermometer, not an algorithm. Its performance is inherent in its design and manufacturing. The "standalone" performance refers to the device's ability to measure temperature accurately on its own.

7. The Type of Ground Truth Used

• Reference Standards/Calibrated Equipment: For performance tests like accuracy, the ground truth would be established by highly accurate, calibrated reference instruments (e.g., a standard thermometer or a temperature bath maintained at precise temperatures) as prescribed by standards like ASTM E1112. For electrical safety and biocompatibility, the "ground truth" is compliance with documented international standards.

8. The Sample Size for the Training Set

• Not Applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not Applicable. As there is no training set, this question is irrelevant.

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The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.

Fluid Filled Teether

This document is a 510(k) submission for a fluid-filled teether, which is a medical device. However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The provided text is a summary of the 510(k) submission, primarily focusing on the administrative details, intended use, and substantial equivalence determination by the FDA. It states that the Global Fluid Filled Teether is substantially equivalent to a previously cleared device (K031094). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require extensive clinical trials or performance studies if the technological characteristics are similar and the intended use is the same.

Therefore, I cannot provide the requested information based on the input text. The information typically requested (such as sample sizes, ground truth, expert qualifications, efficacy studies, etc.) is more relevant for novel or high-risk devices that require more rigorous performance testing and clinical data. For a device like a teether seeking substantial equivalence, such detailed performance studies as those outlined in your request are generally not required for the 510(k) pathway.

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The Flexible Tip Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).

The Teddy Bear Flexible Tip Thermometer is intended for professional and over-the-counter use. A pediatric model will be available.

The Flexible Tip Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.

Electronic Thermometer

The provided 510(k) submission for the Flexible Tip Thermometer is a premarket notification and does not contain the detailed study results or acceptance criteria that would typically be found in a clinical trial report or a performance testing document. The submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (GT010706 Digital Thermometer K021052).

Therefore, based only on the provided text, I cannot complete most of the requested sections. The document states "Performance Characteristics: The Flexible Tip Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity)." However, this describes the device's functional characteristics, not specific acceptance criteria or performance metrics from a validation study.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. Acceptance criteria for a thermometer would typically involve accuracy (e.g., ±0.2°F), response time, and stability over its operating range. These are not present.
• Reported Device Performance: Only general functional characteristics are mentioned.

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

• Not specified. The document mentions the device is "substantially equivalent" to a predicate device but does not detail any specific test set for the Flexible Tip Thermometer itself to prove performance against specified criteria.

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)

• Not applicable/Not specified. The provided document does not describe a study involving expert-established ground truth for the device's performance.

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

• Not applicable/Not specified. No such study or adjudication is described.

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 is a medical device (thermometer), not an AI-assisted diagnostic tool.

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

• Not applicable/Not specified. This refers to an algorithm's performance, which is not relevant for a thermometer in this context. The document implies performance testing was done to ensure the device functions as intended and is equivalent to the predicate, but specific "standalone" algorithmic performance data is not provided.

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

• Not specified. For a thermometer, ground truth would typically be established by a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a high-precision electrical thermometer) in a controlled environment. The document does not describe how any "ground truth" was established for testing within this submission. Its primary argument is substantial equivalence.

8. The sample size for the training set

• Not applicable/Not specified. This device is a thermometer, not an AI-based system that requires a "training set."

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

• Not applicable/Not specified. Not an AI-based system.

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The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm). The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.

Electronic Thermometer

The provided document is a 510(k) summary for the "Standard Thermometer" by Global Treasures Industrial, Inc. It details the product, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study results, acceptance criteria, or the specific information required to answer all the questions comprehensively.

Based on the available information, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the provided 510(k) summary. A 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria as would be found in a full performance report. It states: "The Standard Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity)." This describes characteristics but not acceptance criteria for a performance study.

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

This information is not present in the provided 510(k) summary.

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 present in the provided 510(k) summary. This type of information is typically relevant for studies involving subjective interpretations (like medical imaging), which is not directly applicable to a digital thermometer's performance testing where ground truth would be established by highly accurate reference measurements.

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

This information is not present in the provided 510(k) summary.

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 question is not applicable to a thermometer. MRMC studies are used for evaluating diagnostic devices that rely on human interpretation, often with AI assistance, which is not the function of a standard electronic thermometer.

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

This information is not present in the provided 510(k) summary. For a thermometer, "standalone performance" generally refers to the device's accuracy and precision as measured against a known standard, which would typically be part of a performance study, but the details of such a study are not included here. The summary focuses on comparing it to another thermometer.

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

This information is not present in the provided 510(k) summary. For a thermometer, the "ground truth" would typically be established by a highly accurate, calibrated reference thermometer.

8. The sample size for the training set:

This information is not present in the provided 510(k) summary. This question is typically relevant for machine learning or AI-based devices, which a standard digital thermometer is not.

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

This information is not present in the provided 510(k) summary. As above, this question is typically relevant for machine learning or AI-based devices.

In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence. It lacks the detailed technical performance study information, acceptance criteria, and ground truth establishment methods that would be found in a comprehensive device performance report.

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Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0 degrees - 109.9 degrees F (32.0 degrees - 43 degrees C)
Accuracy- +/-0.2 degrees F
Targeted population- Individuals requiring temperature measurements
Environment of use- Hospital and home
Disposable / reusable- Reusable, clean with alcohol

The intended product is an electronic digital thermometer for measuring patient temperature.

{
  "acceptance_criteria_and_study": {
    "acceptance_criteria_table": {
      "headers": [
        "Parameter",
        "Acceptance Criteria",
        "Reported Device Performance"
      ],
      "rows": [
        [
          "Temperature range",
          "Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 89.6-109.4° F",
          "90.0-109.9° F"
        ],
        [
          "Ambient temperature",
          "Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 60.8-104° F",
          "60.8-104° F"
        ],
        [
          "Response time",
          "Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's ~1 minute",
          "About 20 seconds"
        ],
        [
          "Accuracy and Performance",
          "Meets ASTM E1112",
          "Meets ASTM E1112"
        ],
        [
          "Accuracy (for indications for use)",
          "+/- 0.2° F",
          "+/- 0.2° F (stated in Indications for Use, implies conformance)"
        ],
        [
          "Material safety",
          "Non-toxic and in compliance with EN ISO 10993",
          "All materials used are non-toxic and in compliance with EN ISO 10993"
        ]
      ]
    },
    "study_details": {
      "sample_size_test_set": "Not specified. The document states \"Performance testing,\" and notes that the device \"meets ASTM E1112,\" but does not detail the sample size for this testing.",
      "data_provenance": "Not specified. The testing was conducted to meet ASTM E1112 standards.",
      "number_of_experts_ground_truth": "Not applicable. The ground truth for performance and accuracy is based on compliance with a recognized standard (ASTM E1112) rather than expert interpretation of data.",
      "qualifications_experts": "Not applicable.",
      "adjudication_method": "Not applicable.",
      "mrmc_comparative_effectiveness_study": "No. This is a digital thermometer, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.",
      "standalone_performance_study": "Yes, a standalone performance study was conducted to demonstrate compliance with ASTM E1112. The data provenance and sample size are not explicitly detailed beyond the standard reference.",
      "type_of_ground_truth": "Standard compliance (ASTM E1112) for accuracy and performance, and safety standard compliance (EN ISO 10993) for materials.",
      "sample_size_training_set": "Not applicable. This is a physical device, not an AI algorithm requiring a training set.",
      "ground_truth_training_set_established": "Not applicable."
    }
  }
}

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