Search Results

The Microlife Digital Electronic Thermometer MT16K1 is used for the intermittent measurement and monitoring of human body temperature, oral, rectal and under the arm. The device is for the adult and pediatric population.

This Digital Electronic Thermometer enables easy and highly accurate readings over the body temperature range and has been designed to provide maximum user-friendliness. The body temperature is measured by the thermistor and displayed as numbers on the LCD (liquid crystal display) through microprocessor of IC.

The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.

For a given time period, by applying the R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

The provided document is a 510(k) summary for the Microlife Digital Electronic Thermometer, Model MT16K1. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a robust study report as might be seen for novel AI/software devices. Therefore, some of the requested information, particularly regarding AI-specific criteria like multi-reader multi-case studies, ground truth establishment for training data, and expert qualifications, is not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria is compliance with recognized voluntary standards for clinical electronic thermometers and a demonstration of substantial equivalence to a predicate device.

Note: The document does not provide specific numerical thresholds for "acceptance" for clinical bias, uncertainty, or repeatability, only that they were evaluated according to a standard.

Study Details

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

   • Test Set Sample Size: Not explicitly stated in the provided summary. The document mentions "Controlled human clinical studies were conducted in accordance with ASTM E1965-03," but does not give the number of subjects or measurements.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies as they are described as "controlled human clinical studies" using the device.

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

   • Not applicable/Not mentioned. For a digital electronic thermometer, the ground truth for temperature is typically established using a reference standard thermometer, not expert consensus as would be the case for image interpretation.

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

   • Not applicable/Not mentioned. Adjudication methods are typically used when subjective interpretations are involved, such as in image reading. For a medical device measuring a physical parameter, the "truth" is typically determined by a reference measurement instrument.

4. 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 electronic thermometer, not an AI-powered diagnostic imaging tool that would involve human readers and AI assistance.

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

   • Yes, in essence. The study evaluates the device's performance (temperature measurement algorithm) directly against a reference standard. The "algorithm only" performance is the core of the evaluation for this type of device.

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

   • The ground truth for temperature measurement would be established by a highly accurate and calibrated reference thermometer or established methods for taking body temperature, in accordance with standards like ASTM E1965-03. This is an objective measurement rather than expert consensus or pathology.

7. The sample size for the training set:

   • Not applicable/Not mentioned. For a simple electronic thermometer, there isn't typically a "training set" in the machine learning sense. The device's algorithm for converting thermistor resistance to temperature is based on physical principles and calibration, not learned from a dataset.

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

   • Not applicable. As there's no training set in the AI sense, there's no ground truth established for one. The device is calibrated and its algorithm is fixed.

Ask a specific question about this device

Microlife MT19S1R Instant Digital Electronic Thermometer is used for the intermittent measurement and monitoring of oral human body temperature. The intended use of this thermometer is for ages 18 months and above.

This Instant Digital Electronic Thermometer enables very fast and reliable measurements and with its predicative technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of user-friendliness.

The basic principle of this thermometer's that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of RC oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.

The provided document describes the Microlife Instant Digital Electronic Thermometer, Model MT19S1R, and its substantial equivalence to a predicate device. However, it does not contain the detailed clinical study results and acceptance criteria in the format requested. The document focuses on regulatory submission and comparisons to a predicate device, rather than a detailed performance study with specific metrics.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

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

This information is not explicitly provided in the document. The document states compliance with ASTM E1112, which is the standard for electronic thermometers and would define accuracy requirements. However, the specific acceptance criteria used for this submission and the numerical results are not listed.

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

• Sample Size: Not explicitly stated. The document mentions "Controlled human clinical studies were conducted," but the number of subjects is not provided.
• Data Provenance: Not explicitly stated. It mentions "clinical data was presented," which implies prospective collection for the study. Country of origin is not specified.

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 as the device measures temperature, and ground truth would likely be established against a reference thermometer, not by expert interpretation.

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

This information is not applicable/provided as the device measures temperature, which typically involves direct comparison to a reference standard, not expert adjudication of subjective findings.

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 applicable/provided. The device is a thermometer, not an AI-assisted diagnostic tool requiring human reader studies.

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

The entire device operates as a standalone algorithm for temperature measurement. The document states, "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline." This implies a standalone evaluation of the device's accuracy.

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

The ground truth for temperature measurement would typically be established using a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a laboratory-grade electronic thermometer). The document implies this by stating "clinical bias, clinical uncertainty and clinical repeatability" were evaluated, which requires a reference standard. However, the specific type of reference used is not explicitly detailed.

8. The sample size for the training set

The device is a traditional electronic thermometer, not an AI/ML model that requires a "training set" in the conventional sense. The "training set" concept is not applicable.

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

As above, the concept of a "training set" and its ground truth is not applicable to this type of device.

Ask a specific question about this device

The Microlife MT1751Q Digital Pacifier Thermometer is a non-sterile, reusable device intended for the determination of oral body temperature in infants to children five years of age.

The Microlife Digital Pacifier Thermometer, Model MT1751Q, is a batterypowered, liquid crystal display device using a thermistor inside the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable.

In addition, to speed up the measurement time, we have added the fixed offset into this thermometer, which is fulfilled by the hardware. With these characteristics, this thermometer can provide both a very high clinical accuracy and quick measurement time.

The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-Coscillator circuit, Therefore, temperature can be given by measuring the frequency of the oscillator.

The provided document does not contain all the requested information for acceptance criteria and study details as it primarily focuses on the 510(k) summary for a digital pacifier thermometer. However, based on the available text, here is a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states compliance with ASTM E1112 for clinical electronic thermometers. This standard typically defines accuracy requirements for such devices. While the specific numerical acceptance criteria (e.g., maximum allowable deviation from reference temperature) are not explicitly stated in this summary, the discussion section suggests improved performance.

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

• Sample Size: Not specified. The document only states "Controlled human clinical studies were conducted."
• Data Provenance: Not specified (e.g., country of origin). The studies were "human clinical studies," implying prospective data collection in a clinical setting.

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

This information is not provided in the document.

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 is not applicable as the device is a thermometer, not an AI-assisted diagnostic tool for human readers.

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

This is implicitly a standalone device. The "algorithm" in this context is the thermistor and associated circuitry. The measurement is taken directly by the device without human interpretation or intervention in the temperature reading process.

7. The Type of Ground Truth Used

For clinical accuracy, the ground truth would typically be a reference thermometer (e.g., a mercury-in-glass thermometer or a highly accurate electronic thermometer) against which the pacifier thermometer's readings are compared. The document mentions "clinical bias, clinical uncertainty and clinical repeatability," which are standard metrics for validating a thermometer's accuracy against a known reference.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a separate "training set" in the conventional sense.

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

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

Ask a specific question about this device

The Microlife MT 1811 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.

This predictive (instant) digital electronic thermometer enables very fast and reliable measurements. With its predictive technology, this thermometer offers very high clinical accuracy and, has been designed to provide maximum userfriendliness.

With Microlife patented fast probe, others being equal, temperature curve of sensor varies with sites ( oral, underarm, rectal ) , this thermometer can use of temperature detected in the first few seconds to predict body temp using a well established physical model.

The Microlife Instant Digital Electronic Thermometer, Model MT1811, was studied to demonstrate its substantial equivalence to a predicate device (Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958). The study focused on clinical accuracy, repeatability, and bias.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states compliance with standards and outlines clinical evaluations but does not explicitly list quantitative acceptance criteria tables or specific numerical performance metrics for clinical bias, uncertainty, or repeatability from the clinical study itself. It only states that these were "evaluated per the Microlife Clinical Test Protocol outline."

Note: The document references compliance with ASTM E1112, which specifies performance requirements for clinical electronic thermometers, including accuracy and precision. The detailed acceptance criteria would be defined within that standard and the "Microlife Clinical Test Protocol outline" which is not provided.

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

• Sample Size: The document states that "Controlled human clinical studies were conducted," but does not specify the sample size (number of subjects) used for these studies.
• Data Provenance: Not explicitly stated. The submission is from Microlife Intellectual Property GmbH, Switzerland, but the location of the clinical studies (e.g., country of origin for the data) is not mentioned. The studies were "clinical" and "human," indicating prospective data collection.

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

The document does not provide information regarding the number of experts or their qualifications used to establish ground truth. For thermometer validation, ground truth is typically established by highly accurate reference thermometers or invasive temperature monitoring (e.g., pulmonary artery catheter for core temperature).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given the nature of a thermometer study, "adjudication" in the traditional sense (e.g., for subjective image interpretation) is generally not applicable. Instead, the comparison is typically made against a physical reference standard measurement.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically relevant for diagnostic imaging interpretation where multiple human readers assess cases. This submission is for a digital electronic thermometer, which is a direct measurement device rather than an interpretive one.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was implicitly done. The device itself is an algorithm-driven electronic thermometer designed to provide a direct temperature reading. The clinical studies evaluated the performance of this device in "intermittent measurement and monitoring of human body temperature," which is its standalone function. There is no "human-in-the-loop" component for its primary function of temperature measurement.

7. The Type of Ground Truth Used

The document indicates that clinical bias, uncertainty, and repeatability were evaluated. For electronic thermometers, the ground truth is typically established using:

• Reference standard thermometers: Highly accurate and calibrated thermometers (e.g., mercury-in-glass or electronic readouts traceable to national standards).
• Invasive temperature measurements: For core body temperature, this might involve measurements from pulmonary artery catheters or esophageal probes, especially in hospital settings to validate different body sites (oral, rectal, axillary).

The specific nature of the reference standard used for ground truth is not explicitly detailed in the provided summary.

8. The Sample Size for the Training Set

The document does not specify a separate training set sample size. The "well established physical model" mentioned for predictive temperature calculation suggests that a model was developed, likely using clinical data, but the details of this development/training set are not provided in this 510(k) summary. For predictive algorithms, a training set is used to "learn" the relationship, and a separate test set (the "controlled human clinical studies") is used for validation.

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

The document states that the device uses "temperature detected in the first few seconds to predict body temp using a well established physical model." It does not explicitly describe how the ground truth for the training set (or the development of this physical model) was established. It can be inferred that earlier clinical data or physiological models would have been used to establish the "well-established physical model" and its ground truth, but the details are absent from this summary.

Ask a specific question about this device

The Microlife Digital Underarm Thermometer MT 18E1-1 (V932-1) is designed specifically for measuring underarm (axillary) temperatures.

Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the " hotspot" easily and comfortably every time.

The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.

The provided document is a 510(k) Summary for a medical device cleared by the FDA, the Microlife Digital Underarm Electronic Thermometer, Model MT18E1-1 (V932-1). This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new acceptance criteria.

Based on the provided text, the device did not undergo a study to prove it meets acceptance criteria in the way a novel AI or diagnostic device might. Instead, its acceptance was based on showing substantial equivalence to a previously cleared predicate device.

Here's an analysis of the information requested, based on the document's content:

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

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

• Not applicable. The document explicitly states "Discussion of Clinical Tests Performed: Not applicable." The acceptance was based on non-clinical tests (bench testing for standard compliance and comparison to predicate device). Therefore, there was no test set in the sense of clinical data.

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

• Not applicable. No clinical test set.

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

• Not applicable. No clinical 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

• Not applicable. This device is a digital 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. This device is a digital thermometer, not an algorithm. Bench testing verified the device's performance against standards and the predicate.

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

• For the non-clinical tests, the "ground truth" was established by voluntary standards (ASTM E1112, IEC60601-1, IEC60601-1-2, ISO 10993) and the performance characteristics of the predicate device. The fundamental principle of operation (thermistor resistance change correlated to temperature) is based on established physics, which serves as the underlying scientific ground truth for temperature measurement.

8. The sample size for the training set

• Not applicable. This device is a hardware product, not a machine learning algorithm that requires a training set.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

I'm sorry, but this document does not contain the information requested to describe the acceptance criteria and study proving device performance for a medical device. The document is a 510(k) summary for a dental implant system, primarily focusing on its substantial equivalence to predicate devices. It lists predicate devices, describes the device, and states its intended use, but it does not provide details on specific acceptance criteria for a study demonstrating performance, nor does it detail a study with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

Ask a specific question about this device

The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for dental implant abutments, intended to demonstrate substantial equivalence to predicate devices already on the market. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document discusses:

• Predicate Devices: Lists specific 510(k) numbers for previously cleared dental implant systems.
• Device Description: Describes the endosseous implant system, focusing on pre-machined angulated abutments (15 and 25-degree) and wide-body abutments (4, 5, and 6 mm platform diameters).
• Intended Use: To facilitate the prosthetic phase and installation of a prosthesis for the patient.
• Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and service are similar to predicate devices. Materials used are ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. It also mentions compliance with GMP guidelines.

Therefore, I cannot provide the requested information about acceptance criteria or a study demonstrating device performance because it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail performance studies against specific acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device