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The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of intendou to ividual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.

The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions adherence to the ANSI/AAMI - SP-10 Standard for "clinical tests." It doesn't detail specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure measurements as would typically be found in such a standard. However, the conclusion states the device is "as safe and effective as the predicate" based on these tests.

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

• Sample Size: Not explicitly stated. The text mentions "the clinical test" (singular) was performed.
• Data Provenance: Not explicitly stated. The submitter is from Taichung, Taiwan, R.O.C., but the location of the clinical test is not mentioned. It is a prospective clinical study, as it was "performed" for this submission.

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

Not explicitly stated. The ANSI/AAMI SP-10 standard typically involves trained clinicians taking reference blood pressure measurements (often using a mercury sphygmomanometer) alongside the device under test. However, the document does not detail the number or specific qualifications of these clinicians.

4. Adjudication Method for the Test Set

Not explicitly stated. The ANSI/AAMI SP-10 standard outlines specific protocols for data collection and comparison, often involving multiple readings and statistical analysis, but it's not a jury-style adjudication in the sense of expert consensus described.

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

No, an MRMC comparative effectiveness study was not reported. The study focused on the performance of the device itself against a reference standard, not on how human readers' performance might improve with or without AI assistance.

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

Yes, the clinical test described is a standalone performance evaluation of the device's ability to measure blood pressure independently. The device's algorithm determines the systolic and diastolic blood pressure and pulse rate. Human interaction is limited to operating the device, not interpreting its output for further diagnostic decisions.

7. The Type of Ground Truth Used

The ground truth for the clinical test was established by comparison with a reference method, as dictated by the ANSI/AAMI - SP-10 Standard. This standard typically mandates comparison to auscultatory measurements performed by trained observers using a mercury sphygmomanometer or another validated reference method.

8. Sample Size for the Training Set

No information is provided regarding a separate "training set" or its sample size. The device uses an "oscillometric method" algorithm, which is described as "well known" and "identical to the predicate device." This suggests the algorithm itself was developed and validated prior to this specific device's clinical testing, likely not requiring a new training set for this submission.

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

Not applicable, as no specific training set for this device's algorithm development is described in the context of this submission. The "oscillometric method" is a pre-existing, established technique.

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The AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The AMPLIFE Upper Arm Automatic Blood Pressure Monitor, Model M100 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

This 510(k) summary provides limited information regarding the clinical study.

Here's a breakdown of the available information and areas where details are missing or unclear based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The document only states "We have performed the clinical test on AMPLIFE Upper Arm Blood Pressure".
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications: Not specified. For blood pressure monitors, ground truth is typically established by trained observers using a mercury sphygmomanometer or validated reference device. The qualifications of these observers (e.g., trained technicians, physicians) are not mentioned.

4. Adjudication Method for the Test Set

• Not specified.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is not typically relevant for a standalone blood pressure monitor, which measures a physiological parameter directly rather than requiring human interpretation of complex images or data.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was effectively done. The AMPLIFE Upper Arm Blood Pressure Monitor is a standalone device that measures blood pressure using an "oscillometric method" algorithm without human intervention in the measurement process itself. The clinical test described refers to the performance of this device in making those measurements.

7. Type of Ground Truth Used

• Ground Truth: The document states the clinical test was performed according to the "ANSI/AAMI -- SP-10 Standard, Section 4.4.2". This standard typically requires comparison of the device's measurements against a reference method, such as direct intra-arterial measurement or, more commonly for non-invasive devices, simultaneous auscultatory measurements performed by trained observers using a validated reference device (e.g., mercury sphygmomanometer). While not explicitly stated, it is implied that a reference method was used to establish the ground truth.

8. Sample Size for the Training Set

• Not applicable/Not specified. For a traditional blood pressure monitor using the oscillometric method, the "algorithm" is based on established physiological principles and signal processing, rather than a machine learning model that requires a separate "training set" in the common sense. The algorithm parameters might be refined or calibrated, but this isn't typically referred to as "training" in the same way as for AI/ML algorithms.

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

• Not applicable/Not specified for the reasons stated above.

In summary:

The provided 510(k) summary indicates that a clinical test was performed in accordance with the ANSI/AAMI SP-10 Standard, which is the relevant standard for validating the accuracy of automated sphygmomanometers. However, the summary lacks specific details regarding the clinical study's methodology, such as the exact acceptance criteria, the number of subjects (sample size), the ground truth measurement details, or the specific performance results (e.g., mean differences and standard deviations) that demonstrated compliance with the standard. It only provides a general statement that the device met the requirements of the standard.

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The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.

The device is used without a probe cover.

The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD.

Its operation is based on measuring the natural thermal radiation emanating from the eardrum.

The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts:

• a) IR Thermopile Sensor
• b) ASIC
  c) E2PROM IC
  d) LCD and Blacklight
• e) Kev2, Buzzer1

The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt. This document is a 510(k) summary for a medical device (AMPLIFE Digital Infrared Ear Thermometer, Model E100), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed acceptance criteria and performance metrics in the format you've requested for AI/machine learning models.

However, I can extract the information that is present and indicate what is missing:

Here's an attempt to answer your questions based only on the provided text, highlighting the limitations:

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

The document states compliance with ASTM E1965-98 for thermometry and IEC60601-1 and IEC60601-1-2 for medical electrical equipment safety. These standards contain specific performance criteria (e.g., accuracy, repeatability) for thermometers. However, the exact numerical acceptance criteria from these standards and the specific reported performance of the AMPLIFE device against those criteria are not explicitly detailed in the provided 510(k) summary. It only indicates that "bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness."

For example, ASTM E1965-98 specifies accuracy limits (e.g., ±0.2°C or ±0.3°C depending on the temperature range), but these are not directly presented in a table with the device's measured performance.

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

• Sample size: The document states "Controlled human clinical studies were conducted," but the exact sample size (number of subjects/measurements) is not provided.
• Data provenance: The studies were "Controlled human clinical studies" conducted by "AMPLIFE clinical test protocol for infrared Ear Thermometer." The country of origin is not specified. The studies are implied to be prospective clinical studies as they were "conducted" for this submission.

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. For a thermometer, "ground truth" often refers to a reference thermometer reading (e.g., rectal thermometer or highly accurate laboratory thermometer) rather than expert consensus on interpretation. The document refers to "clinical bias, clinical uncertainty and clinical repeatability," implying comparison to a reference.

4. Adjudication method for the test set

This information is not provided. Given it's a thermometer measuring a specific physical value, a formal adjudication method (like 2+1 for image reviews) is less likely to be directly applicable compared to a direct comparison against a gold standard reference.

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

• MRMC study: No, an MRMC study was not conducted or described. This device is a standalone thermometer, not an AI-powered diagnostic image interpretation tool.
• Effect size for human readers with/without AI: This is not applicable as the device is 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

• Standalone performance: Yes, the device's performance was evaluated in a standalone manner. The device "using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD." The "temperature measurements algorithm and its fundamental scientific technology are identical to the predicate device." The "discussion of clinical tests performed" refers to "Controlled human clinical studies were conducted using the AMPLIFE Infrared Ear Thermometer E100." This suggests the device's readings were directly evaluated.

7. The type of ground truth used

The ground truth used would be a reference temperature measurement from an established and highly accurate method (e.g., rectal temperature, or a calibrated standard thermometer) against which the ear thermometer's readings ("clinical bias, clinical uncertainty and clinical repeatability") are compared. The exact method is not explicitly stated, but it's implied by the nature of thermometer testing.

8. The sample size for the training set

This is not applicable in the context of this device. This device is a traditional infrared thermometer, not an AI/machine learning model that undergoes a training phase. Its algorithm is based on established physical principles for infrared thermometry and is stated to be "identical to the predicate device."

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

This is not applicable as there is no "training set" in the context of a traditional thermometer.

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