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Actherm Infrared Ear Thermometers ACT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on pcople of all age, and is used with or without probe cover medACCU2010.

Actherm Infrared Ear Thermometers (Model ACT 8000R Series) are electronic thermometers using a thermopile as the temperature sensor. The sensor's electric signal is then calculated and displayed by a Micro-Controller. These thermometers display the temperature decimal. To compare with ACT 8000 Series, Model ACT 8000R Series has the same indication for use. ACT 8000R Series can be made with various functions, such as Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover, will be added following the model number. The infrared ear thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally. Actherm Infrared Ear Thermometers ACT 8000R Series can be combined with accessories, base, wall mount and power adapter. The base is a tray for holding probe cover box, power input, power/charge indicator, portable/ fixed probe-cover dispenser and the area for placing digital thermometer and its probe cover. For the wall mount, it can be fixed on the wall and the base can be put on this wall mount. The system uses two 1.5V DC alkaline rechargeable batteries for the power supply and the battery power is automatically the Micro-Controller and displayed in LCD if the battery is exhausted. The batteries can be recharged only when the ear thermometer ACT8000R put on the base. ACT 8000R cannot be used when recharging.

This document is a 510(k) summary for the Actherm Infrared Ear Thermometer ACT 8000R Series. It describes how the device meets acceptance criteria through conformance to various standards and provides limited information regarding specific study details.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "The clinical test results of Actherm Infrared Ear Thermometer ACT 8000 and Probe Cover medACCU 2010 conform to the requirements of ASTM E 1965-98 and EN 12470-5 that are the same performance for ACT 8000R Series." This implies that the testing was carried out on the predicate device (ACT 8000) and the results were deemed applicable to the ACT 8000R Series due to substantial equivalence.

• Sample size for the test set: Not explicitly stated. The text refers to "clinical test results" but does not provide details on the number of subjects or measurements.
• Data provenance: Not explicitly stated, but given that the submitter is Actherm Inc. in Taiwan, R.O.C., it is likely that the data originated from studies conducted in that region or through certified testing facilities. The study type (retrospective or prospective) is not mentioned.

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 standards mentioned define performance requirements for device accuracy, but the method for establishing "ground truth" (e.g., using a reference thermometer and standard clinical protocols) and the involvement of specific experts are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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 ear thermometer, a standalone measurement device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

Yes, a standalone performance evaluation was done. The entire summary describes the device's technical specifications and its performance against established medical device standards (ASTM, EN, ISO). The device operates independently to measure temperature, meaning its performance is evaluated in a standalone manner without human subjective input affecting the measurement itself. The clinical tests mentioned (conforming to ASTM E 1965-98 and EN 12470-5) are standalone performance evaluations of the thermometer.

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

For a thermometer, the "ground truth" typically involves reference temperature measurements from highly accurate and calibrated devices. The ASTM E 1965-98 standard, which the device conforms to, outlines methods for clinical accuracy studies, usually involving comparing the device's readings against a known, highly accurate reference thermometer in a controlled clinical setting. The document does not explicitly state the specific type of ground truth used beyond conformity to these standards.

8. The sample size for the training set

This device is a traditional electronic thermometer, not an AI/machine learning device that requires a "training set." Therefore, the concept of a training set sample size does not apply.

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

As mentioned above, this device does not utilize a training set in the context of machine learning.

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The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use when temperature taking.

The Digital Clinical Thermometer Probe Covers medACCU1010 and medACCU1010-1 are manufactured in the same shapes and sizes. The only difference between them is medACCU1010-1 coated with lubrication; therefore it is only used for rectal measurements for digital thermometers. The Digital Clinical Thermometer Probe Covers medACCU1020 are manufactured in different shapes and sizes from medACCU1010 and medACCU1010-1. The disposable digital thermometer probe covers medACCU1010 and medACCU1020 are used for either oral or rectal measurements for digital thermometers.

The provided text describes the 510(k) summary for Actherm Digital Clinical Thermometer Probe Covers. However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a specific study proving the device meets those criteria. The document states that the device "meet the ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98), as well as ISO 10993-1 biocompatibility testing," but does not explicitly provide the acceptance criteria or the specific performance results from a study.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

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

Note: The document states that the device "meets" these standards, implying compliance with their respective acceptance criteria. However, the specific quantitative acceptance criteria (e.g., "must have a barrier integrity greater than X") and the actual device performance values (e.g., "device achieved Y for barrier integrity") are not detailed in this 510(k) summary. It only confirms adherence to the standards.

Study Details

The provided document refers to compliance with standards (ASTM E 1104-98 and ISO 10993-1) as "Performance Data," which implies studies were conducted. However, it does not provide details about these studies.
Therefore, the following information is not available in the provided text:

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 provided in the 510(k) summary. The document only confirms compliance with standards, not the specifics of the testing methodology or data origin.

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 type of expert review or ground truth establishment is typically associated with studies involving diagnostic interpretation (e.g., medical imaging). For a device like a thermometer probe cover, the "ground truth" would be established by the physical testing methods defined within the ASTM and ISO standards (e.g., passing a leak test, material characterization). There would not be "experts establishing ground truth" in the diagnostic sense.

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

• This is not applicable to the type of device and testing described. Adjudication methods are used for resolving discrepancies in expert interpretations, which is not relevant for physical and biocompatibility testing of a probe cover.

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 is not applicable. MRMC studies and AI assistance relate to diagnostic software or tools, not physical medical devices like thermometer probe covers.

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

• This is not applicable, as the device is a physical accessory and does not involve an algorithm.

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

• For the performance data cited (ASTM E 1104-98 and ISO 10993-1), the "ground truth" would be the defined specifications and test methods within those standards. For example, for barrier integrity, the ground truth would be that the cover successfully prevents fluid penetration under specified conditions. For biocompatibility, the ground truth would be the absence of cytotoxic effects, irritation, or sensitization as defined by the ISO 10993 series of tests.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for a physical device like this, as it does not involve machine learning or AI.

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

• Not applicable, as there is no training set.

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Actherm Infrared Ear Thermometers ACT8000 Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover medACCU2010.

Infrared Ear Thermometers (Model ACT8000 Series) are electronic Actherm thermometers using a thermopile as the temperature sensor's electric signal is then calculated and displayed by a MicroController. These thermometers display the temperature decimal. Model ACT8000 Series has the same indication for use. However, appearance difference exists between ACT8000 Series. Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover.

The digital thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally.

The system uses two 1.5V DC batteries for the power supply and the battery power is automatically checked by the MicroController and displayed in LCD if the battery is exhausted.

Actherm Infrared Ear Thermometers ACT8000 Series can be combined with accessories, weighting base and wall mount. For the weighting base, the whole set of body temperature measurement devices, including infrared ear thermometer, digital thermometer, and probe cover, can be put on it, For the wall mount, it can be fixed on the wall and the cradle of infrared ear thermometer can be put on this wall mount. Also, the probe cover boxes can be hanged on the hook that under the wall mount or put inside the cradle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Actherm Infrared Ear Thermometer (K090031):

Device: Actherm Infrared Ear Thermometer ACT8000 Series and its Probe Cover medACCU2010

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that "Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling." However, the specific quantitative values for these criteria (e.g., ± 0.2°C) are not provided in this summary. It simply states they were met according to the labeling.

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

• Sample Size: Not explicitly stated for any of the studies (bench or clinical).
• Data Provenance: Not explicitly stated. The document mentions "bench testing contained in this submission and clinical testing supplied." It does not specify the country of origin or if these studies were retrospective or prospective.

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

• Experts: Not explicitly stated.
• Qualifications: Not explicitly stated.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported in this summary. This device is a thermometer, which typically does not involve human readers interpreting AI output in the same way imaging devices might.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• Standalone Performance: Yes, the performance criteria listed (accuracy, precision, repeatability) are inherently standalone performance measures for the device itself.
  • "Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling."
  • The thermometer operates autonomously to measure temperature.

7. Type of Ground Truth Used:

• Ground Truth: For the bench testing (accuracy, precision, repeatability), a "ground truth" would typically be established using a reference thermometer or a calibrated temperature source with known accuracy (e.g., a blackbody radiator for infrared thermometers).
• For "clinical testing," the ground truth for body temperature would likely be established by a highly accurate reference method, such as a rectal thermometer or an oral thermometer with known accuracy, under controlled clinical conditions. The document does not specify the exact method used for clinical testing ground truth.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is an infrared ear thermometer, a hardware medical device that measures temperature. It does not use "training sets" in the context of machine learning or AI algorithms. Its performance is based on its physical design, calibration, and adherence to established engineering and medical device standards.

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

• Ground Truth Establishment: Not applicable, as there is no "training set" in the context of this device.

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All Digital Clinical Thermometers are intended to precisely measure human body temperature. The Thermometers can be used in the measurement of oral, axillary and rectal temperature.

The Classic/Hypothermia Digital Clinical Thermometer consists of an electronically sensor which is located in a metal probe and is connected with a PCB and a Liquid Crystal Display all situated in a pen-like plastic housing. This structure is used for all kind of Thermometer mentioned in this description.

Hypothermia Thermometer have a greater measuring range so that they can be used as device for under cooled person temperature monitoring.

A flexible probe tip is provided by the Flexible Digital Clinical Thermometer that makes the measuring of the temperature more comfortable and safer.

With the patented 10-Second Digital Clinical Thermometer every user is able to receive the result of the measurement in a very quick time. The Express Models also operates with the vame efficient reliability and accuracy like the other Thermometer.

Due to a special integrated sensor in the Left-Right Handed Digital Clinical Thermometer display can easily be read whether the Thermometer is held in the right or the left hand. Especially for left-handed people it makes the measuring result read off more pleasant.

The Basal Digital Clinical Thermometer have a fourth digit on the display, because the measurement of this Thermometer is even more accurate compared with normal Thermometer. This precisely measuring method can be used to monitor and interpreting basal temperature changes.

The Lightweight-Probe Digital Clinical Thermometer consists of a flexible probe, connection cord and a display unit embedded in a round housing.

Variants Descriptions: "+" or Hypothermia, Express, Dual scale, Backlight, LR, following with the model numbers indicates different measuring range, different measuring time, scale switchable, with backlight with Left-Right Handed function.

For all Thermometers is essential, that they consist of a temperature sensor embedded in a special designed metal probe, which could be flexible or inelastic. This sensor is connected with the IC unit, which is connected with a Liquid Crystal Display (LCD) to display the measured temperature. All parts are situated in a pen-like plastic housing. During measuring, only the maximum measured value is displayed on LCD window and all devices are non-predictive.

All variant thermometers comply with referenced product standards of ATSM E1112-00, EN12470-3, IEC 60601-1, IEC 60601-1-2 and ISO 10993-1.

The provided text describes the submission for a 510(k) premarket notification for several models of digital clinical thermometers. It states that the new devices are substantially equivalent to previously cleared predicate devices and comply with relevant standards. However, the document does not contain a detailed study with specific acceptance criteria and performance results in the format requested.

The text focuses on demonstrating "substantial equivalence" to predicate devices rather than providing a standalone performance study with specific metrics like sensitivity, specificity, or accuracy derived from a new clinical trial.

Therefore, many of the requested items cannot be extracted directly from the provided text. I will provide the information that is available and indicate where the requested information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria (e.g., minimum accuracy levels in statistical terms) or detailed reported device performance (e.g., mean absolute deviation or confidence intervals from a clinical study). Instead, it states compliance with recognized standards.

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

This information is not provided in the document. The submission relies on compliance with standards and substantial equivalence, not a specific new test set with a reported sample size or data provenance from a prospective or retrospective study.

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. As no specific test set requiring expert ground truth is detailed, this does not apply.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided. As no specific test set requiring adjudication is detailed, this does not apply.

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 study is not mentioned and is not applicable to a digital clinical thermometer, which is a standalone measurement device and 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

The devices are standalone devices (thermometers); their performance is inherently "algorithm only" in the sense that they provide a direct temperature reading. However, a dedicated study proving this standalone performance with specific metrics as if it were a complex diagnostic algorithm is not detailed in the submission. The submission states compliance with relevant standards which implicitly covers standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For clinical thermometers, the "ground truth" typically refers to traceability to a recognized temperature standard (e.g., by calibration against a primary temperature standard or a calibrated reference thermometer) and comparison to core body temperature measurements in clinical validation. The document does not explicitly state the specific type of ground truth used but implicitly relies on the methods required by the cited standards (ASTM E1112-00, EN 12470-3), which dictate how accuracy is to be determined and validated, including calibration and clinical performance testing against reference methods.

8. The Sample Size for the Training Set

This information is not applicable as these are not AI/machine learning devices that require a "training set."

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

This information is not applicable as these are not AI/machine learning devices.

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The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Not Found

This document is a 510(k) clearance letter from the FDA for a digital clinical thermometer, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as typically described for software or AI-based medical devices.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined that the device is as safe and effective as a device already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence.

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

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

• Cannot be provided. This document does not specify acceptance criteria for performance (e.g., accuracy, precision) or report specific device performance data. It is a clearance letter, not a performance report.

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

• Cannot be provided. The document does not mention any sample sizes for test sets or data provenance.

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)

• Cannot be provided. This information is not relevant to a thermometer's performance evaluation and is not present in the document.

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

• Cannot be provided. This detail is not included in the document.

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

• Cannot be provided. This type of study is not applicable to a digital clinical thermometer, which is a standalone measurement device, and is not mentioned.

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

• Cannot be directly answered in the context of "algorithm" performance as understood for AI. The device itself is a standalone clinical thermometer. Its performance would be evaluated in a standalone manner (e.g., accuracy tests against a reference standard). However, the document does not detail these tests.

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

• Cannot be provided. While a thermometer's ground truth would typically be a highly accurate reference thermometer, the specific method used for this device's testing is not mentioned.

8. The sample size for the training set

• Cannot be provided. This device is a digital clinical thermometer, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Cannot be provided. As above, there is no training set for this type of device.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for a "Digital Clinical Thermometer." The FDA determined the device to be substantially equivalent to legally marketed predicate devices (K010238). This decision is based on an assessment that the device is as safe and effective as existing devices; however, the letter itself does not contain the detailed performance data, acceptance criteria, or study designs that would typically be provided in a clinical study report for an AI-enabled device. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, training sets, and how ground truth was established is not available in this document because it outlines a regulatory clearance, not a scientific study report for an AI/ML product.

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The Digital Clinical thermometers, Models ACT 2030 and ACT 2038's intended use are medical devices, supplied by internal power and intended to precisely measure temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Digital Clinical Thermometers, Models ACT 2030, ACT 2038

The provided text is a 510(k) clearance letter from the FDA for Digital Clinical Thermometers. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the input text. The request asks for details of a study that proves the device meets acceptance criteria, but no such study details are present in the provided document.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive 510(k) submission document that includes performance data.

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The Digital Clinical thermometers, Models ACT 3020's intended use are medical devices, supplied by internal power and intended to precisely measure human boduy temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Digital Clinical Thermometers, Models ACT 3020

The provided text is a 510(k) premarket notification letter from the FDA for a Digital Clinical Thermometer, Model ACT 3020. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way that would typically be found in a clinical study report for AI/machine learning devices.

Therefore, many of the requested sections regarding AI/ML device performance and study specifics cannot be answered from this document.

Here's an attempt to extract relevant information and note what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards, but it does not specify those standards or directly report the device's measured performance against them.

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

This information is not provided. This document is a regulatory approval letter, not a study report.

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.

4. Adjudication method for the test set

This information is not provided.

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 information is not provided. The device is a "Digital Clinical Thermometer," which is a measurement device and not typically an AI/machine learning diagnostic tool that assists human readers.

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

This information is not provided. Again, given the device type, this concept may not be applicable. The "standalone" performance here would refer to the thermometer's accuracy in measuring temperature.

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

For a clinical thermometer, the "ground truth" would typically be a reference standard for temperature measurement. This information is not explicitly stated in the document, but it would have been part of the underlying testing to demonstrate accuracy and substantial equivalence.

8. The sample size for the training set

This information is not provided. This device is not an AI/machine learning product that would have a "training set" in the conventional sense.

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

This information is not provided. As above, this concept is not applicable to this type of device.

Summary of what is available from the document:

• Device Name: Digital Clinical Thermometer, Model ACT 3020
• Manufacturer: Actherm, Incorporated
• Regulation Number: 880.2910
• Regulation Name: Clinical Electronic Thermometer
• Regulatory Class: II
• Product Code: FLL
• K Number: K021614
• Indications for Use: To precisely measure human body temperature. It can be used for oral, axillary, and rectal temperature measurement.
• Basis of Approval: Substantial equivalence to legally marketed predicate devices (specifically mentions K010238 for Actherm Digital Clinical Thermometers).

The document is a regulatory communication confirming that the device is substantially equivalent to existing devices and can be marketed. It does not delve into the specific technical details or study results that would demonstrate performance against detailed acceptance criteria.

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