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The Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) is indicated as follows:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The device includes the Atrial Fibrillation Detection Feature analyzes pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of atrial fibrillation (AFib) and provides a notification on the display screen to the user. This feature is intended to be used for home screening for the possibility of AFib.

The Atrial Fibrillation Detection Feature is not intended to provide a notification on every episode of AFib and the absence of detection is not intended to indicate the absence of atrial fibrillation. The feature is not intended to replace traditional methods of diagnosis or treatment or to be used in the management of patients with known AFib.

The device is intended for over-the-counter (OTC) use in the home environment. The device is intended for use in adults (22 years or older); it has not been tested for and is not intended for use in pregnant women or people with implanted pacemakers or defibrillators.

The Omron Blood Pressure Monitor with AFib Detection Feature is an OTC, at home use, upper arm blood pressure monitor. The device consists of a monitor and an arm cuff designed to be used on the upper arm. It is battery powered and can optionally be connected to an AC adapter. The proposed device measures blood pressure (systolic [SYS] and diastolic [DIA]) and pulse rate (PR), detects the presence of irregular heartbeats, and can also detect the possible presence of AFib by analyzing pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of AFib and provides a notification on the display screen to the user.

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

Acceptance Criteria and Device Performance

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The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population.

The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use.

The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use.

The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEM-RML31-B which are adjustable to ranges of 17-22cm and 22-42cm, respectively. Other than the difference in circumference, the two cuffs function in the same manner.

The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron Connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared software of the AliveCor, Inc. KardiaMobile System (K191406) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user.

In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared Kardia App (part of the KardiaMobile System, K191406) or Omron Connect App (Omron functional equivalent). The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others.

The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archive and review by the user.

The Omron Model BP7900 Blood Pressure Monitor + EKG received 510(k) clearance based on its substantial equivalence to two predicate devices: the Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) and the AliveCor, Inc. KardiaMobile System (K191406). The primary change in the proposed device is a software update to the onboarding procedure for accessing ECG functionalities, aligning it with the secondary predicate.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent, meaning its performance for key functionalities (blood pressure measurement, ECG recording, and ECG analysis) is expected to be as safe and effective as the predicate devices. The document explicitly states: "With respect to technological characteristics, there are no differences between the proposed and primary predicate devices with respect to the key functionalities blood pressure measurement, ECG recording, or ECG analysis."

The acceptance criteria are implicitly tied to the performance specifications of the predicate devices, particularly the primary predicate (K182579) which the proposed device largely mirrors in hardware and core functionality.

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

The document explicitly states: "No clinical testing was conducted in support of this 510(k) Premarket Notification."

Therefore, there is no information regarding a test set sample size or data provenance (country of origin, retrospective/prospective). The clearance relies on substantial equivalence to predicate devices, supported by nonclinical testing.

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

Since no clinical testing was conducted for this specific 510(k) submission, there were no experts used to establish ground truth for a new test set. The ECG analysis relies on the cleared AliveCor KardiaAI platform (K181823), which would have had its own validation studies involving experts. However, details of those studies are not part of this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set was created or evaluated for this submission.

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

No MRMC study was conducted or reported in this 510(k) submission for the proposed device. The device's clearance is based on its substantial equivalence to existing devices and the fact that the changes made (primarily software for onboarding) do not raise new questions of safety or effectiveness. The ECG analysis is performed by the previously cleared KardiaAI platform, which likely had its own validation studies, but those are not detailed here for the proposed device itself.

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

The document does not detail any new standalone studies for the algorithms within the proposed device. The ECG analysis functionalities are provided by the "KardiaAI platform (K181823)," which was previously cleared. The blood pressure measurement is hardware-based (oscillometric method) with software analysis, and its performance is considered unchanged from the primary predicate. The nonclinical testing performed focused on verifying the software update related to onboarding procedures.

7. The Type of Ground Truth Used

For the current submission, no new ground truth was established as no new clinical studies were conducted. The device's performance is assumed to be equivalent to the predicate devices, which would have been validated against their respective ground truths (e.g., reference blood pressure measurements for the BP monitor, and expert-adjudicated ECGs for the KardiaMobile component).

8. The Sample Size for the Training Set

No information is provided regarding a training set for the proposed device, as no new clinical studies were conducted for this submission. The ECG analysis algorithms ("KardiaAI platform") had their own training sets, but details are not included here.

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

Not applicable to this submission, as no new training set or ground truth establishment relevant to the device's clearance were detailed. The KardiaAI platform's previous clearance (K181823) would contain this information.

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The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.

Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.

However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 7.1 inches to 8.5 inches (18.0cm to 21.5cm).

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Omron HEM-6410T-ZL Wrist Blood Pressure Monitor ("HEM-6410T-ZL") is a battery-powered, automatic, non-invasive blood pressure system intended for home use. HEM-6410T-ZL is intended for use in adult patient population with wrist circumference ranging from 7.1 inches to 8.5 inches (18.0cm to 21.50cm). The device is powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 40 to 180 beats/min.

The blood pressure reading is displayed in "red" color if the blood pressure recorded is equal to or greater than 130/80 based on the American Heart Association (AHA)/ American College of Cardiology (ACC) High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The device also detects the appearance of irregular heartbeats during the blood pressurement process. An irregular rhythm is defined as the appearance of two (2) or more heartbeat intervals which differ by greater than 25% from the average heartbeat rhythm. Detection of such irregular rhythms would result in an "irregular heartbeat symbol" displayed along with the blood pressure and pulse rate readings.

In addition, the device includes an Advanced Positioning Sensor (APS), known as the Heart Zone Indicator, which aids the user to determine if the wrist cuff is at the correct height in relation to the heart. This determination is based on the reading of an accelerometer (integral to the device) to measure the angle of the arm. The APS feature is identical to that of the predicate device. The operation of the device is intended for home use. Additional functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and charging the battery as needed. As an optional feature, the user can also pair the HEM-6410T-ZL to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6410T-ZL does not connect with other collateral devices.

The provided text describes the OMRON HEM-6410T-ZL Wrist Blood Pressure Monitor and its clearance through a 510(k) premarket notification (K190693). The document primarily focuses on demonstrating substantial equivalence to a predicate device, the OMRON HEM-6410T-ZM (K182481). While it mentions clinical testing, it does not provide detailed acceptance criteria or extensive specifics about the study that proves the device meets these criteria in the way typically expected for an AI/ML medical device.

Therefore, many of the requested details, particularly regarding AI/ML-specific validation (e.g., sample sizes for training/test sets, data provenance, expert ground truth, MRMC studies, standalone performance), are not present in this document because this is a traditional medical device, not an AI/ML device.

The device in question is a non-invasive blood pressure measurement system that uses the oscillometric method. Its "software" analyzes pulse waveform data to determine blood pressure and pulse rate, and it detects irregular heartbeats. While it contains software, it is not described as an AI/ML-powered device in the sense of needing large, annotated datasets for training and sophisticated validation of AI model performance.

Below is an attempt to address the request based only on the information provided, with an acknowledgment of what is missing due to the nature of the device:

Acceptance Criteria and Device Performance for OMRON HEM-6410T-ZL Wrist Blood Pressure Monitor (K190693)

Based on the provided 510(k) submission, the device's performance is primarily assessed against the accuracy standards for blood pressure monitors and compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "Clinical validation of the HEM-6410T-ZL was conducted," but it does not specify the sample size (number of patients/subjects) used for this clinical testing.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the study was conducted in accordance with ANSI/AAMI/ISO 81060-2:2013. This standard typically requires prospective clinical studies.

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

• The ground truth for blood pressure measurement was established by "trained medical staff" using an "auscultation method" with a "calibrated sphygmomanometer."
• The number of experts/medical staff is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience" is not applicable here as it's a blood pressure device, not an imaging device).

4. Adjudication Method for the Test Set

• The document implies a direct comparison of the device's readings against the auscultation method. It does not describe an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as is common in diagnostic AI/ML studies. The auscultation method itself serves as the reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. This device is not described as an AI-assisted diagnostic tool where human readers interpret outputs. It is a standalone measurement device.

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

• The clinical validation directly assessed the device's performance (which includes its embedded algorithm) against the auscultation method. In essence, this is a form of "standalone" performance assessment of the device's measurement capabilities, as it's measuring blood pressure directly without human interpretive input beyond starting the measurement. However, it's not a standalone algorithm assessment in the way one would evaluate an AI model's output for an imaging device.

7. The Type of Ground Truth Used

• The ground truth used was auscultation method measurements taken by trained medical staff using a calibrated sphygmomanometer. This is a recognized clinical reference standard for blood pressure measurement.

8. The Sample Size for the Training Set

• This information is not applicable/not provided in the context of this device. The document describes "algorithm parameters" being changed and validated, implying a modification to a traditional blood pressure measurement algorithm rather than a machine learning model that requires a "training set."

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

• This information is not applicable/not provided as there is no mention of a "training set" in the context of machine learning model development. The "ground truth" for validation was established via auscultation method.

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The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use.

The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use.

The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEM-RML31-B which are adjustable to ranges of 17-22cm and 22-42cm. respectively. Other than the difference in circumference, the two cuffs function in the same manner.

The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared AliveCor Heart Monitor algorithm (K142743) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user.

In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared AliveCor Heart Monitor or OMRON Connect App. These two applications are effectively the same, with the only difference being branding. The cleared app allows the user to view their ECG and the results of analysis using the AliveCor algorithm (cleared under K142743) which detects the presence of atrial fibrillation, and normal sinus rhythm.

The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. All software V&V testing performed and submitted in this 510(k) utilized this algorithm.

The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archiving and review by the user.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the ECG analysis for atrial fibrillation, bradycardia, and tachycardia detection.

Part 1: Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Omron Model BP7900 Blood Pressure Monitor + EKG primarily relate to its substantial equivalence to predicate devices for blood pressure measurement and ECG recording and analysis. For the ECG analysis specifically distinguishing atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm, the device leverages the algorithm from the AliveCor KardiaAI (K181823) and AliveCor Heart Monitor (K142743). Therefore, the device's performance for these ECG detections is implicitly expected to meet the established performance of these cleared devices.

Since specific numerical acceptance criteria or reported device performance for the ECG detection capabilities (sensitivity, specificity, accuracy) of the BP7900 itself are not explicitly provided in this document, we must infer that the substantial equivalence claim relies on the prior clearance of the AliveCor algorithms. The document states:

• "The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823." (Page 5)
• "The BP7900 employs the algorithm used for the AliveCor Heart Monitor. The BP7900 does not have an "Irregular Heartbeat Detection" feature which Omron BPMs normally have (estimated from measured BP pulse). Instead, it has an irregular pulse detection feature to identify possible AF, tachycardia which are estimated from ECG waveforms, not from blood pressure pulse." (Page 6)
• "Yes, includes ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician). Same as Heart Monitor. Bradycardia and Tachycardia detection same as reference device." (Page 10, "Irregular Heart Beat Detection" row)

Given this, the table below reflects an interpretation based on the provided text, implying that the acceptance for device performance is met by using a previously cleared and validated algorithm.

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

The provided document does not specify a sample size for an independent test set for the ECG detection performance of the BP7900 itself. The justification for the ECG detection capabilities (AF, bradycardia, tachycardia, normal sinus rhythm) relies entirely on the fact that the BP7900 utilizes the same algorithm as the previously cleared AliveCor Heart Monitor (K142743) and AliveCor KardiaAI (K181823) devices.

Therefore, any test set and data provenance information would refer to the studies originally conducted for the AliveCor devices, not a new, independent study for the BP7900's ECG detection performance. This document does not provide details of those original AliveCor studies.

Part 3: Number of Experts and Qualifications for Ground Truth

Similar to Part 2, the document does not provide details about the number and qualifications of experts specifically for the BP7900's ECG detection capabilities. This information would have been part of the original AliveCor submissions (K142743 and K181823). The BP7900's clearance for ECG detection is predicated on the re-use of these already cleared algorithms.

Part 4: Adjudication Method for the Test Set

As no specific new test set for the BP7900's ECG detection performance is detailed in this document, no adjudication method is described. This information would refer to the original AliveCor studies.

Part 5: Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

The document does not mention an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance specifically for the Omron BP7900. The device's ECG capabilities are based on a standalone AI algorithm (from AliveCor) that performs the detection. Whether the original AliveCor clearances involved such MRMC studies is not detailed here.

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

Yes, a standalone (algorithm only) performance was done, not for the BP7900 as a new, independent study, but through the pre-existing clearance of the AliveCor Heart Monitor (K142743) and AliveCor KardiaAI (K181823) algorithms. The BP7900 integrates these already validated algorithms. The document explicitly states: "The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823." (Page 5, and Page 18 under "Summary" and "Substantial Equivalence"). This phrasing indicates reliance on the standalone performance of those previously cleared algorithms.

Part 7: Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the original AliveCor algorithms. However, for ECG rhythm analysis, ground truth is typically established by:

• Expert Consensus: Multiple board-certified cardiologists or electrophysiologists independently reviewing ECG tracings and reaching a consensus diagnosis.
• Adjudicated Clinical Data: ECGs from patients with confirmed diagnoses based on a combination of clinical information, reference standard tests, and expert review.

Given the nature of ECG interpretation, expert consensus and/or adjudicated clinical data would be the most probable ground truth methods for the AliveCor algorithms.

Part 8: Sample Size for the Training Set

The document does not provide the sample size for the training set used to develop the AliveCor algorithms. This information would be specific to the original AliveCor submissions (K142743 and K181823).

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

The document does not provide details on how the ground truth for the training set of the AliveCor algorithms was established. As mentioned in Part 7, it would typically involve expert review and/or adjudicated clinical data from cardiologists or electrophysiologists.

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This device is intended for the relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11. The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics. The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.

The provided text describes the 510(k) summary for the Omron Healthcare Maxpower Relief Model PM3032B. This is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief. The submission aims to demonstrate substantial equivalence to predicate devices, K141978 (Omron MaxPower Relief) and K172079 (Omron Avail), to expand its indications for use.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for device performance. Instead, it demonstrates substantial equivalence by comparing various features of the new device to two predicate devices. The "performance" is generally described as "identical" or "equivalent" to the predicates, and compliance with recognized standards.

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The Omron Heat Pain Pro Model PM311B is intended for:
The relief of pain associated with sore or aching, muscles of the lower back, arm, legs, shoulder, or foot due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.

The Heat Pain Pro (PM311B) is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion batterv. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
Stimulation from PM311B is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls and indicators. Software controls waveform characteristics.
The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the PM311B. These are the identical accessories cleared under K160115 for the Model PM311.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The PM311B is identical to the PM311 cleared under 510(k) K160115, this submission is for expanded indications under product code NYN.
The PM311 and PM311B are considered - OTC devices.

The provided text is a 510(k) summary for the Omron Heat Pain Pro Model PM311B. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the context of AI/ML devices. Therefore, much of the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable or available in this document.

However, I can extract information related to the device's technical specifications and how its performance is compared to predicate devices to establish substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of statistical metrics (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, the "acceptance criteria" appear to be based on demonstrating that the proposed device, PM311B, is substantially equivalent to its predicate devices (PM311 and Avail) in terms of:

• Indications for Use: The PM311B's expanded indication for chronic, intractable pain and arthritis pain relief is identical to the Avail (K172079) predicate. Otherwise, its indications are identical to the PM311 (K160115).
• Design and Technology: Identical to the PM311, and equivalent to the Omron Avail.
• Performance and Specifications: Identical to the PM311, and equivalent to the Omron Avail. This is primarily demonstrated through the detailed "Output Specification Comparison" tables (pages 10-12) which show the technical parameters of the electrical stimulation.
• Patient Population: Adult (identical to predicates).
• Environment of Use: Clinics, hospital, and home environments (identical to predicates).
• Compliance with Voluntary Standards: Adherence to AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11 (identical to predicates).

Reported Device Performance (from "Output Specification Comparison" tables):
The PM311B is shown to have identical output specifications to its primary predicate, the Omron PM311 (K160115), across all tested parameters for its various modes (Tap, Knead, Rub, Arm, Lback, Leg, Foot, Joint, Shldr). These parameters include:

• Waveform (Biphasic, Rectangular shape)
• Maximum Output Voltage (@500Ω, @2kΩ, @10kΩ)
• Maximum Output Current (@500Ω, @2kΩ, @10kΩ)
• Duration of primary phase [usec]
• Pulse Duration [usec]
• Frequency [Hz]
• Net Charge (µC per pulse) (@500Ω) [µC]
• Maximum Phase Charge (@500Ω) [µC]
• Maximum Current Density (@500Ω) [mA/cm2] r.m.s.
• Maximum Average Current (average absolute value), mA
• Maximum Average Power Density (@500Ω) [W/cm²]
• Burst Mode parameters (N/A for this device)
• ON Time, OFF Time (N/A for this device)

The tables on pages 10 and 11 are identical, effectively stating that the PM311B's output is the PM311's output. The table on page 12 shows the specifications for the secondary predicate, Omron Avail (K172079), which has similar but not identical numerical values for some parameters, and also includes a "Microcurrent" mode not present in the proposed device. The "Discussion of Differences" column confirms that the proposed device, PM311B, is "Identical to predicate PM311 K160115" for almost all detailed features and electrical characteristics, except for the expanded indications for use, which are identical to the Avail.

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

Not applicable. This device is an electrical nerve stimulator, not an AI/ML device relying on a "test set" in the context of diagnostic or prognostic model performance. The "testing" referred to is non-clinical engineering testing.

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

Not applicable. No "ground truth" establishment by experts is described as this is not an AI/ML diagnostic or prognostic system.

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

Not applicable. This is not an AI/ML device where adjudication of outputs would be relevant.

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 conducted as this is not an AI/ML device that assists human readers.

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

Not applicable. This is not an AI/ML device with an algorithm for standalone performance. The device's "standalone" performance is its electrical output, which was tested against engineering standards and compared to predicates.

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

Not applicable. No "ground truth" of this nature is relevant for this device type within the context of the provided document. The "truth" lies in its adherence to electrical safety and performance standards and its equivalence to legally marketed devices.

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. This is not an AI/ML device that requires a training set or ground truth establishment in that context.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 6.3 inches (16.0cm to 19.0cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Omron HEM-6410T-ZM Wrist Blood Pressure Monitor ("HEM-6410T-ZM") is a battery-powered automatic non-invasive blood pressure system intended for home use. HEM-6410T-ZM is intended for use in adult patient population with wrist circumference ranging from 6.3 inches to 7.5 inches (16.0cm to 19.0cm). The device is powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device. but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 299mmHz, and the pulse rate range from 40 to 180 beats/min.

The blood pressure reading is displayed in "red" color if the blood pressure recorded is equal to or greater than 130/80 based on the American Heart Association (AHA)/ American College of Cardiology (ACC) High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The device also detects the appearance of irregular heartbeats during the blood pressure measurement process. An irregular rhythm is defined as the appearance of two (2) or more heartbeat intervals which differ by greater than 25% from the average heartbeat rhythm. Detection of such irregular rhythms would result in an "irregular heartbeat symbol" displayed along with the blood pressure and pulse rate readings.

In addition, the device includes an Advanced Positioning Sensor (APS), known as the Heart Zone Indicator, which aids the user to determine if the wrist cuff is at the correct height in relation to the heart. This determination is based on the reading of an accelerometer (integral to the device) to measure the angle of the arm. The APS feature is similar to that of the predicate device. The operation of the device is intended for home use. Additional functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and charging the battery as needed. As an optional feature, the user can also pair the HEM-6410T-ZM to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6410T-ZM does not connect with other collateral devices.

The provided text describes the OMRON HEM-6410T-ZM Wrist Blood Pressure Monitor and outlines its acceptance criteria and the study conducted to prove it meets them for FDA

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5.3 inches (13.5cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Wrist Blood Pressure Monitor Model BP4350 ("BP4350") is a battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) home use. BP4350 is designed for wrist circumference ranging from 5.3 inches to 8.5 inches (13.5cm to 21.5cm). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an integral controllable Piezoelectric pump and deflates via an electric automatic rapid deflation valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 40 to 180 beats/min.

The device also detects the appearance of irregular heartbeats during the blood pressure measurement process, which is defined as the appearance of two (2) or more heartbeat intervals which differ by greater than 25% from the average heartbeat rhythm. Detection of such irregular rhythms would result in an "irregular heartbeat symbol" displayed along with the blood pressure and pulse rate readings. In addition, a "HIGH" indication appears if the blood pressure recorded is greater than 130/80 based on the AHA/ACC High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017.

In addition, the device includes an Advanced Positioning Sensor (APS) feature known as the Heart Zone Indicator, which aids the user in determining if the Wrist Cuff is at the correct height in relation to the heart. It makes this determination based on the reading of an accelerometer (integral to the device) to measure the angle of the arm in relation to the table. The APS feature is similar to the predicate device.

The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The operation of the device is intended for home use. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the blood pressure and pulse measurement cycle, and installing and changing the batteries as needed. As an optional feature, the user can also pair the BP4350 to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, BP4350 does not connect with other collateral devices.

The provided text describes the 510(k) summary for the Omron Healthcare, Inc. Wrist Blood Pressure Monitor Model BP4350. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven device.

Therefore, much of the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details cannot be extracted from this document as it is not an AI/ML device and the study described is a traditional clinical validation for a blood pressure monitor.

However, I can extract the information relevant to a traditional medical device clinical validation study as presented in the document:

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

The document refers to the acceptance criteria implicitly by stating adherence to the ANSI/AAMI/ISO 81060-2:2013 standard for non-invasive sphygmomanometers. This standard dictates the accuracy requirements for blood pressure monitors.

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

• Sample Size: The document does not explicitly state the exact sample size (number of subjects) used for the clinical investigation. ANSI/AAMI/ISO 81060-2:2013 typically requires a minimum of 85 subjects for full validation.
• Data Provenance: Not specified in the provided text (e.g., country of origin). The study was a "clinical investigation" which implies it was prospective.

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

• The ground truth was established by "trained medical staff" using an "auscultation method" with a "calibrated sphygmomanometer."
• The exact number of experts and their specific qualifications (e.g., medical doctors, nurses, with how much experience) are not detailed in this summary. The ANSI/AAMI/ISO 81060-2:2013 standard often requires multiple observers to mitigate bias.

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

• The document does not specify any adjudication method for the clinical investigation results. For blood pressure validation, direct comparison to reference measurements from trained observers is the primary method, and the standard outlines protocols for this.

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, an MRMC study was not done. This study is for a blood pressure monitor, not an AI/ML-driven diagnostic device that relies on human readers interpreting images with or without AI assistance. The device directly measures blood pressure.

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

• This is a standalone device that provides direct blood pressure readings. Its performance is measured independently against a reference standard (auscultation). So, in a sense, its "standalone" performance is what was evaluated. There is no "human-in-the-loop" interaction in the measurement process itself that would alter the device's reading.

7. The type of ground truth used

• The ground truth was established by expert auscultation (manual blood pressure measurement by trained medical staff) using a calibrated sphygmomanometer. This is the gold standard for clinical validation of automated blood pressure devices.

8. The sample size for the training set

• Not applicable. This device is a traditional blood pressure monitor, not an AI/ML device that requires a "training set" in the machine learning sense. Its design and algorithm are based on established oscillometric principles and engineering, not on learning from a large dataset.

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

• Not applicable. See point 8.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5.3 inches to 8.5 inches (13.5 cm to 21.5 cm).

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Wrist Blood Pressure Monitor (BPM) Model BP6100 ("BP6100") is an automatic, non-invasive, wrist-worn blood pressure measurement system for over-the-counter (OTC) home use. During measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The systolic and diastolic pressures are determined via the oscillometric cuff method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/min.

The BP6100 is intended for use in the adult patient population, in wrist circumferences ranging between 5.3 - 8.5 inches (13.5 - 21.5 cm). During measurement, the device also detects the appearance of irregular heartbeat rhythms. BP6100 further includes administrative functions for automatic storage of the 60 most recent readings taken by the device. The device also provides an "average" function, which can calculate an average reading based on the latest two (2) or three (3) readings, when taken within a 10-minute span.

The operations of BP6100 are primarily through use of buttons. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping measurements, and installing and changing batteries as needed. It has no potential connection to external power. There are no additional parts or accessories to the BP6100. The BP6100 does not connect to any other devices.

The provided document is a 510(k) summary for the Omron Healthcare, Inc. Wrist Blood Pressure Monitor Model BP6100. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device (Omron Healthcare, Inc. HEM-6131).

Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria for the Omron BP6100 are primarily aligned with the standards used for the predicate device, K131742 (HEM-6131), and the ANSI/AAMI/ISO 81060-2:2013 standard.

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: The document does not explicitly state the numerical sample size for the clinical investigation. It mentions that the study was conducted "in accordance with guideline per ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type." This standard typically specifies minimum sample sizes (e.g., 85 subjects for validation in the general population). While the exact number isn't present, compliance with this standard implies a sufficient sample size was used.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical investigations for device validation like this are almost universally prospective 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)

• The ground truth for blood pressure measurement in the clinical investigation was established using an "auscultation method using a calibrated sphygmomanometer by trained medical staff."
• The document does not specify the exact number of experts (medical staff) or their specific qualifications (e.g., years of experience, specific medical degree beyond "trained medical staff"). However, for such studies, it implies that the personnel performing the auscultation measurements are qualified and trained according to standard medical practices for blood pressure measurement.

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

• The document does not describe a specific adjudication method like "2+1" or "3+1." The ground truth was established by "trained medical staff" using the auscultation method. In the context of a clinical investigation for a blood pressure monitor validating against an auscultatory reference, the comparison is typically direct, and an adjudication process beyond the core measurement methodology itself is not usually required or described in a 510(k) summary for this type of device.

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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. The study was a clinical investigation validating the accuracy of the device against a reference method (auscultation), not evaluating human performance.

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

• Yes, a standalone performance evaluation was indeed done. The clinical investigation directly validated the accuracy of the BP6100 device's oscillometric measurements ("algorithm only") against the auscultation method. This represents the device's performance without "human-in-the-loop" assistance in the measurement itself, although a human operates the device. The non-clinical bench testing also evaluated the device's standalone performance.

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

• The primary ground truth for the clinical investigation was expert-performed auscultation using a calibrated sphygmomanometer. This is considered the reference standard for non-invasive blood pressure measurement.

8. The sample size for the training set

• The document describes a clinical investigation and bench testing for device validation. It does not mention a "training set" or "test set" in the context of machine learning (AI/ML models). This is a traditional medical device, not an AI device. Therefore, there is no AI model training set.

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

• As this is not an AI/ML device, there was no "training set" in the AI sense, and therefore no ground truth established for such a set. The studies described are for validation of the device's inherent accuracy and performance.

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