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The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition. The device is prescription only.

The subject device AVITA Pulse Oximeter with Bluetooth is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.

The provided text is a 510(k) Summary for the AViTA Pulse Oximeter (SP62B). It addresses medical device regulation, but it does not describe acceptance criteria and a study that proves the device meets specific acceptance criteria in the manner requested (e.g., in the context of an AI/ML algorithm's performance).

Instead, the document details the equivalence of the new device to a predicate device based on various non-clinical performance and safety tests, and a clinical validation of SpO2 performance.

Therefore, I cannot fully answer your request based on the provided text because the information specifically about "acceptance criteria and a study that proves the device meets the acceptance criteria" for an AI/ML device's performance, including details like sample size for test sets, data provenance, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, is not present.

The document mentions "acceptance criteria" generally for biocompatibility tests, electrical safety, and EMC testing, but not for an AI/ML performance study as implied by your detailed questions.

Here's what can be extracted and inferred from the text regarding the device's overall performance validation, with limitations noted:

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

The document states performance specifications rather than explicit acceptance criteria in a table format for each test, but the overall statement is that the device "met the acceptance criteria" for various tests. For SpO2 accuracy, the performance is explicitly stated.

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

• Test set sample size: For the clinical performance testing, it mentions "healthy, adult volunteers." The exact number (sample size) is not specified in the provided text.
• Data provenance: "healthy, adult volunteers." The country of origin is not specified. The study was prospective as it involved clinical validation testing.

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

• This information is not applicable in the context of a pulse oximeter's SpO2 accuracy against a reference measurement. Pulse oximeters are typically validated against arterial blood gas (ABG) measurements (co-oximetry) in a controlled desaturation study, where the ABG is the direct, objective ground truth. Expert readers are not usually involved in establishing ground truth for SpO2 values.
• The document implies the adherence to ISO 80601-2-61 for clinical performance, which outlines the methodology for such studies.

4. Adjudication method for the test set:

• Not applicable/Not specified. For SpO2 accuracy, the "ground truth" is typically the co-oximeter measurement from arterial blood, not a subjective interpretation requiring adjudication.

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:

• No. This is not an AI/ML device for diagnostic image interpretation. It is a pulse oximeter measuring physiological parameters.

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

• Not applicable in the AI/ML sense. The device itself is "standalone" in that it directly measures SpO2 and PR; it's not an AI algorithm assisting a human interpreter.

7. The type of ground truth used:

• For SpO2 accuracy, the ground truth is implied to be co-oximetry measurement from arterial blood gas (ABG), as is standard for pulse oximeter validation according to ISO 80601-2-61. The document states "Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.

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

• Not applicable. (See point 8)

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The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.

The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.

This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.

The provided text describes the performance testing and validation for the AViTA Nasal Aspirator (Model NS13). However, it does not contain the specific details required to fully address all parts of your request, particularly regarding acceptance criteria for a "device" in the context of an AI/ML medical device. This document describes a physical medical device (nasal aspirator), not an AI/ML algorithm. Therefore, many of your questions related to AI/ML specific criteria (such as "sample size for the training set," "number of experts used to establish ground truth," "MRMC comparative effectiveness study," etc.) are not applicable to the information provided.

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

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

The document lists performance specifications for the device and indicates that testing was conducted to demonstrate these specifications were met. While it doesn't provide a direct "acceptance criteria vs. reported performance" table for each specific parameter, it states that "The results of those testing show that the required limits for mean difference and standard deviation are fulfilled by the subject device."

• Irritation and skin sensitization (ISO 10993-10)
• Systemic toxicity (ISO 10993-11)
• Irritation (ISO 10993-23) | "The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance... [and passed]." |
  | Cleaning and Disinfecting | - 1000 times cleaning verification with mild non-abrasive soap and 70℃ water and soft dry cloth wiping | "This product has passed the cleaning verification... confirming that the product can be used continuously without any functional abnormalities." |
  | Safety (Electrical/Medical Device Standards) | - IEC 60601-1:2005+A1:2012 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-11:2010 (Medical electrical equipment - Requirements for medical electrical systems used in the home healthcare environment) | "the subject device has passed the relevant tests of IEC 60601-1" and "has passed the relevant tests in accordance with IEC 60601-1-11" |
  | Software Verification and Validation | - "Basic documentation" level of concern | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." |

In the comparison table on page 8, the subject device's performance specifications are listed, which can be interpreted as its target acceptance criteria for technical performance:

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

The document does not specify "sample size" in terms of patient data or clinical study cohorts, as this is a K510 submission for a physical device, not an AI/ML algorithm. The performance testing refers to engineering and laboratory tests on the device itself.

• Data Provenance: Not applicable in the sense of patient data. The tests are conducted on the device hardware and software.

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

Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the testing of this physical nasal aspirator. The "ground truth" here is the adherence to established technical standards and engineering specifications.

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

Not applicable. This is not a study involving human adjudication of results in the context of an AI/ML algorithm.

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. No MRMC study was performed as this is not an AI-assisted diagnostic device. The document explicitly states "Clinical Studies None."

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

Not applicable. This is a physical device, not an AI algorithm.

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

The "ground truth" for this device's performance is adherence to established international standards (e.g., ISO, IEC) for biocompatibility, electrical safety, and general performance, as well as the manufacturer's own internal specifications (e.g., vacuum pressure, sound level).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the AViTA Nasal Aspirator (Model NS13) meets its acceptance criteria through a series of non-clinical performance tests, biocompatibility tests, cleaning and disinfecting tests, and safety tests (electrical and general).

• Non-Clinical Performance Testing: Implied to include assessments of vacuum pressure, sound level, spray capacity, and operating/storage conditions. The document states these tests "show that the required limits for mean difference and standard deviation are fulfilled."
• Biocompatibility Testing: Conducted in accordance with recognized ISO 10993 standards (Parts 5, 10, 11, and 23) for cytotoxicity, irritation, skin sensitization, and systemic toxicity. The device "passed" these evaluations.
• Cleaning and Disinfecting Test: The device underwent "1000 times" of cleaning verification, confirming its ability for continuous use without functional abnormalities.
• Safety Testing: Compliance with IEC 60601-1 and IEC 60601-1-11 for basic safety and essential performance, particularly for home healthcare environments, was verified. The device "passed" these relevant tests.
• Software Verification and Validation: Performed according to FDA guidance for "Basic documentation" level of concern software in medical devices, demonstrating the software performs as intended.

The overall conclusion is that these non-clinical data support the device's safety and effectiveness, and its comparable performance to predicate devices already on the market.

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The product automatically measures human being's Systolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 150 mm to 520 mm (Approx.6 ~ 21 inches) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.

The AVITA Arm Type Blood Pressure Monitor (Model BPM82) consists of a main unit with an LCD display and four buttons, along with a cuff component. The device is designed for accurate and convenient monitoring of an individual's blood pressure and pulse rate through the application of oscillometric methodology. Specifically engineered for use on the upper arm, this over-the-counter device is tailored to adults with upper arm circumferences ranging from 150 mm to 520 mm (Approx. 6~ 21 inches) for in-home use.

Here's a breakdown of the acceptance criteria and study information for the AViTA Arm Type Blood Pressure Monitor (BPM82), based on the provided document:

Acceptance Criteria and Device Performance

Note: The document only explicitly states the fulfillment of the required limits for mean difference and standard deviation, rather than providing the exact numerical values for these metrics.

Study Information

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

• Test Set Sample Size: 90 adult subjects, resulting in 255 valid paired measurements.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical investigation," which is typically prospective.

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

• Number of Experts: Two observers.
• Qualifications: Not explicitly stated, but they used a "mercury sphygmomanometer," implying they were trained and qualified to expertly obtain blood pressure readings using this method, which serves as the ground truth.

4. Adjudication method for the test set:

• The document implies a direct comparison between the two observers using the mercury sphygmomanometer as the reference. It doesn't explicitly state an adjudication method like 2+1 or 3+1, but rather that "sequential measurements were taken... using a mercury sphygmomanometer (two observers) and the AVITA Blood Pressure Monitor." This suggests a direct comparison of the device's readings against these two expert readings.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. This device is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.

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

• Yes, a standalone performance study was done. The clinical study tested the AViTA Arm Type Blood Pressure Monitor (BPM82) itself against the ground truth reference measurements. It's an automated device, so its performance is inherently "algorithm only" in its measurement function.

7. The type of ground truth used:

• Expert Consensus / Reference Standard Measurement: The ground truth was established by two observers using a traditional mercury sphygmomanometer, which is the accepted gold standard for blood pressure measurement in clinical validation protocols like ISO 81060-2.

8. The sample size for the training set:

• The document does not specify a sample size for a training set. This is a medical device validation study for a physical device, not an AI/machine learning model that typically has distinct training and test sets. The "clinical investigation" referred to here is for validating the final device.

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

• As no distinct training set is mentioned for this type of device, the method for establishing ground truth for a training set is not applicable in this context.

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The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.

The AViTA Pulse Oximeter SPO2 is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for life-sustaining, not for implant and does not contain drug or biological products. The device is for prescription use only. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.

Here's a breakdown of the acceptance criteria and the study that proves the AViTA Pulse Oximeter meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The SpO2 accuracy of ±2% for the 70-100% range and the Pulse Rate accuracy are specifications, while the ARMS of 1.89% is the result of the clinical performance study. The 1.89% ARMS falls within the generally accepted range for pulse oximeters, which is often considered to be within ±2-3% for this range of SpO2.

Study Details

The primary study proving the device meets its acceptance criteria is a clinical performance study and various performance tests conducted in accordance with international standards.

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

• Clinical Performance Study: The study was conducted on healthy, adult volunteers. The specific number of volunteers (sample size) is not explicitly stated in the provided text.
• Data Provenance: The origin of the data is not specified beyond "healthy, adult volunteers." It is a prospective study as indicated by "clinical validation testing... under no motion."

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

The ground truth for pulse oximeters in clinical validation studies does not typically involve human expert consensus on the SpO2 values. Instead, it relies on a co-oximeter (or similar arterial blood gas analysis device), which provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2). The text states "oxygenated hemoglobin characterization testing" and "clinical validation testing of the SpO2 performance," which implies comparison against a reference method, likely a co-oximeter. Therefore, there is no mention of experts establishing ground truth in this context, nor their specific qualifications.

4. Adjudication method for the test set:

Not applicable for this type of medical device performance testing. Pulse oximeter accuracy is evaluated by comparing the device's readings against a precise, objective reference standard (like a co-oximeter), not by expert adjudication.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers interact with the output. The AViTA Pulse Oximeter is a direct measurement device; it does not involve human interpretation of complex data that would be enhanced by AI assistance.

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

Yes, a standalone performance evaluation was done. The results presented ("ARMS for SpO2 under no motion was found to be 1.89%") directly reflect the performance of the device's algorithms and hardware in measuring SpO2, without any human interpretation component for the measured value itself.

7. The type of ground truth used:

The type of ground truth used for the clinical performance study, though not explicitly named, would be a highly accurate, invasive arterial oxygen saturation measurement (SaO2) obtained via a co-oximeter. This is the standard reference method for validating non-invasive pulse oximeters. The text refers to "oxygenated hemoglobin characterization testing" which supports this assumption.

8. The sample size for the training set:

Not applicable. The AViTA Pulse Oximeter is a hardware-based device that employs principles of spectrophotometry to mechanically and optically measure SpO2 and PR. While it is "software-driven," it is not described as using machine learning or AI algorithms that would require a distinct "training set" in the conventional sense (e.g., for image classification or prediction). Its algorithms are based on established physiological models of light absorption by blood.

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

Not applicable. As noted above, there is no indication of a "training set" for AI/ML models in this context. The core operating principles rely on physics and established physiological relationships.

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BPM16B automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging 125 ~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use

Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate.

This document is a 510(k) Premarket Notification for a Wrist Type Blood Pressure Monitor (BPM16B). The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

The information provided does not describe an AI/ML device, nor does it detail a study proving the device meets acceptance criteria related to AI/ML or human augmentation. Instead, it focuses on the performance testing required for a non-invasive blood pressure measurement system.

Therefore, many of the requested criteria regarding AI/ML studies, expert adjudication, MRMC studies, and ground truth establishment for training sets are not applicable to this document. The document primarily focuses on compliance with established medical device standards for blood pressure accuracy and safety.

Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with ISO 81060-2 and IEC 80601-2-30 for performance. While it states that the device "meets the performance specifications for its intended use" and "the required limits for mean difference and standard deviation are fulfilled," it does not provide a specific table with numerical acceptance criteria and reported device performance values for blood pressure accuracy.

However, in the comparison table (Table 1 predicate device) in Section 6, "Technological Characteristics and Substantial Equivalence Comparison with Predicate," it lists the following for "Accuracy":

Note: This table only shows that the claimed accuracy of the new device is the same as the predicate and the general industry standard for non-invasive blood pressure monitors. It does not present the specific results from the clinical validation study proving these accuracies beyond stating "the required limits for mean difference and standard deviation are fulfilled."

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

• Sample Size: The document mentions "clinical investigation" but does not specify the sample size used for the performance testing (test set).
• Data Provenance: Not explicitly stated, but the submission is from Taiwan (Avita Corporation, New Taipei City, Taiwan). The testing would presumably be conducted in Taiwan. The study is a prospective clinical validation study, as it's testing the performance of the device against clinical standards.

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

• Not Applicable in the context of expert review for AI/ML ground truth. For a blood pressure monitor, the "ground truth" for blood pressure measurements is established by a reference method, typically auscultation by trained medical professionals, not by expert review of images or data in the way one might establish ground truth for an AI diagnostic algorithm. The ISO 81060-2 standard outlines the methodology for clinical validation, which involves direct comparison to a reference method. The document does not specify the number or qualifications of the individuals performing the reference measurements.

4. Adjudication Method for the Test Set:

• Not Applicable for a blood pressure monitor in the context of expert adjudication. The "adjudication" for a blood pressure monitor pertains to how the reference measurements are taken and compared to the device measurements according to the ISO standard. This does not involve an adjudication panel for discordant readings in the way an AI diagnostic study might.

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

• No, this was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images or data, and the AI assists or replaces them. This is a blood pressure monitor, not an AI diagnostic algorithm.

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

• Yes, in spirit. The performance testing (compliance to ISO 81060-2) is essentially a standalone performance assessment of the device's accuracy in measuring blood pressure compared to a reference method, without human intervention in the measurement process of the device itself. The device is "automated" and provides readings directly.

7. Type of Ground Truth Used:

• Comparator Measurement / Clinical Reference Standard: The ground truth for blood pressure accuracy is established by a reference method (e.g., auscultation with a sphygmomanometer by trained observers) as defined by the ISO 81060-2 clinical validation standard. It is not expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML study for diagnosis.

8. Sample Size for the Training Set:

• Not Applicable. This is a medical device, not an AI/ML algorithm that requires a "training set." The device's measurement algorithm is based on oscillometric principles and is likely deterministic or uses fixed, non-AI algorithms, not machine learning that would require a distinct training set for model development.

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

• Not Applicable. See point 8.

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BPM64R automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's Arm. The intended use of this over-the-counter device is for adults aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use.

Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate. The Blood Pressure Monitor, BPM64R uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AViTA Arm Type Blood Pressure Monitor BPM64R:

Based on the provided 510(k) summary, the device is a non-invasive blood pressure monitor, and its performance is evaluated against the ISO 81060-2 standard for clinical validation of automated measurement type.

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

Note: The document states that the "results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device." However, specific numerical values for the mean difference and standard deviation are not provided in this summary. To get these exact values, one would typically need to refer to the full study report or the detailed submission.

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

The document does not explicitly state the sample size used for the clinical validation. It mentions a "clinical investigation" and refers to "the subject device" fulfilling the required limits.

Regarding data provenance:

• Country of Origin: Not specified in the provided text for the clinical study.
• Retrospective or Prospective: Not specified. Clinical validations for devices like blood pressure monitors are typically prospective.

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)

The document does not provide details on the number of experts or their qualifications for establishing the ground truth. For blood pressure monitors, the "ground truth" (reference measurements) is usually established by highly trained technicians or physicians using a validated reference sphygmomanometer, often with protocols like auscultatory measurements by two independent observers.

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

The document does not specify the adjudication method. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers. For example, two observers taking sequential measurements, with a third if there's a significant discrepancy.

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 to this device. The AViTA Arm Type Blood Pressure Monitor BPM64R is a standalone automated measurement device; it is not an AI-powered diagnostic tool requiring human readers for interpretation, nor does it provide "assistance" to human readers in the way an AI algorithm might in imaging diagnostics.

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

Yes, a standalone performance study was done. The entire premise of this device is "automatically measures human's Systolic, Diastolic blood pressure and heart rate." The clinical investigation described is explicitly for the automated measurement type and demonstrates the device's ability to operate without human intervention for the measurement itself, though a human initiates the process and reads the display.

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

The ground truth for blood pressure monitor validation studies, as per ISO 81060-2, typically involves simultaneous or near-simultaneous auscultatory measurements performed by trained observers using a calibrated mercury or an equivalent reference sphygmomanometer. This would fall under a form of expert reference measurement rather than pathology or outcomes data.

8. The sample size for the training set

This device is an automated measurement system, likely based on traditional oscillometric principles. It does not appear to employ a machine learning or AI model that requires a distinct "training set" in the conventional sense of AI development. Therefore, a sample size for a training set is not applicable in the context of this device as described.

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

As there is no indication of a "training set" for a machine learning model, this question is not applicable. The device's underlying algorithms are likely based on established physiological models for oscillometric measurements, rather than being "trained" on a dataset in the AI sense.

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AViTA Radar Thermo NT16 Series IR Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature from the forehead in people of all ages.

AViTA Radar Thermo NT16 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AVITA Radar Thermo NT16 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from the forehead of human body.

1. Table of Acceptance Criteria and Reported Device Performance:

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The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

AViTA BPM6x Series Arm Type Blood Pressure Monitor

The provided text is a 510(k) summary from the FDA for the AViTA BPM6x Series Arm Type Blood Pressure Monitor. It outlines the device's indications for use and states that it has been found substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed acceptance criteria and study information requested.

The document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This sort of data is typically found in a clinical study report, which is not included.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging devices.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This is also more relevant for AI-driven diagnostic devices.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned. This would be relevant for machine learning-based algorithms, which is not explicitly stated to be part of this blood pressure monitor.
• How the ground truth for the training set was established: Not mentioned.

What the document does indicate about the device:

• Device Name: AViTA BPM6x Series Arm Type Blood Pressure Monitor
• Intended Use: Measures systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive oscillometric technique with an inflatable arm cuff.
• Cuff Circumference: Limited to 229 mm - 330 mm (approx. 9-13 inches).
• Intended Environment: Home use.
• Additional Feature: Detects irregular heartbeats during measurement and displays a symbol along with readings.
• Regulatory Classification: Class II (two) medical device.
• Product Code: DXN (Noninvasive blood pressure measurement system).
• Approval Type: 510(k) premarket notification (meaning it was found substantially equivalent to a predicate device).

To obtain the detailed acceptance criteria and study data, one would typically need access to the full 510(k) submission, which includes test reports and clinical data. This public summary only confirms the FDA's decision based on that submission.

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The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

AVITA Infrared Thermometer with Bluetooth Model no.: TS28B

This document is a 510(k) cleared device, meaning it is substantially equivalent to a predicate device. As such, it is not required to provide a study that proves the device meets the acceptance criteria but rather a study to demonstrate its equivalence.

Here's the breakdown of the information that can be extracted from the provided text regarding the AViTA Infrared Thermometer with Bluetooth Model no.: TS28B:

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

The provided text from the FDA 510(k) clearance letter does not include specific acceptance criteria or detailed reported device performance (e.g., accuracy, precision values). The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. For a 510(k) submission, the manufacturer would have submitted testing data demonstrating that their device performs as intended and is as safe and effective as the predicate device. However, these specific test results and acceptance criteria are not typically included in the public FDA clearance letter.

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 available in the provided document. A 510(k) clearance letter does not usually contain details about the sample size or data provenance for the underlying studies.

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 available in the provided document. Given that this is a medical device for measuring body temperature, the "ground truth" would likely be established using a highly accurate reference thermometer, not expert interpretation.

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

This information is not available in the provided document. Adjudication methods are more relevant for subjective evaluations, such as image interpretation. For a thermometer, the measurement is objective.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a thermometer for direct measurement, not an AI-assisted diagnostic tool.

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

The device is an infrared thermometer. Its performance is inherently "standalone" in that it directly measures temperature. It does not employ an algorithm that requires human-in-the-loop performance in the way AI-driven diagnostic tools do. The performance evaluation would focus on its accuracy and precision against a reference standard. Specific details of such a test are not provided in this document.

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

For a clinical electronic thermometer, the ground truth would typically be established by comparison to a highly accurate reference thermometer (e.g., a calibrated clinical mercury thermometer or a highly precise electronic thermometer that serves as a standard). This information is not explicitly stated in the provided document.

8. The sample size for the training set

This information is not applicable in the context of this device as described. Infrared thermometers are not typically "trained" using a dataset in the way a machine learning algorithm is. Their performance is based on their physical sensing capabilities and calibration.

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

This information is not applicable for the reasons stated in point 8.

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