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Intended Use:
The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are only for use on one patient at a time.

The monitors are not therapeutic devices.

The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT is intended to be used as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments.

The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

The Edwards FloTrac solution offers continuous assessment of hemodynamic parameters. It is indicated to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is indicated for use in adult critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. The Edwards FloTrac solution is indicated to be used in the operating room, intensive care unit, and emergency room.

The monitors are intended for use by trained healthcare professionals in a hospital environment.
They are not intended for home use.
The monitors are additionally intended for use in transport situations within hospital environments.

The IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals. The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display. The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

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The intended use of TigerConnect Alarm Management is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).

For medical alarms, TigerConnect Alarm Management is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events TigerConnect Alarm Management does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert.

TigerConnect Alarm Management is intended for use as a secondary alert. It does not replace the alarm function on the primary device.

TigerConnect (TC) Alarm Management is a software as a medical device (SaMD) installed on the Amazon Web Services (AWS) TigerConnect cloud capable of acquiring alarms, events, and parameters from healthcare systems, and intelligently forwarding this information as secondary notifications to designated commercial endpoint devices. The endpoint devices act as non-regulated medical device data system (MDDS) devices that display the information from TC Alarm Management.

TC Alarm Management is intended for use as a secondary alarm; it does not replace the alarm function on the primary device.

Users receive interactive, time-critical information from clinical systems directly via their endpoint devices as text (visual) or alarms (audible) or data. Received attributes related to the presentation of alerts include color and quantity of tones (beeps) in addition to, and in coordination with, event priorities. TC Alarm Management allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.

A portion of the software, the Health Services Agent, is deployed to the customers' premises using ECS Anywhere, an extension of Amazon ECS that allows customers to run native ECS tasks on customer-managed infrastructure without compromising on the simplicity and control of the cloud. ECS Anywhere must be deployed in a customer provided virtual machine prior to implementing the Health Systems Agent. This allows TC Alarm Management to securely send, receive, process, and appropriately encrypt data from systems that are typically unencrypted.

TC Alarm Management connects to the information sources through wired ethernet connections which are part of the customer's infrastructure and acquires patient data from primary medical device sources and clinical systems. TigerConnect implementation engineers configure TC Alarm Management, in collaboration with the customer, to determine which information, including alarm notifications, is delivered to which users. TC Alarm Management then formats the data for wireless delivery to the endpoint devices through TigerConnect's proprietary Clinical Collaboration Platform (CCP) non-regulated MDDS messaging service.

TC Alarm Management is designed to accept inputs from a variety of healthcare systems utilizing the HL7 Minimum Lower Layer Protocol (MLLP) communication protocol. These clinical systems include the following:

• Medical device gateways providing HL7 MLLP communications, which includes, but is not limited to, the following parameters and events surrounding them, e.g. alarms:
  • Patient monitors such as electrocardiograms (ECGs), respiratory rate, pulse oximetry (SpO2 and heart rate), end-tidal carbon dioxide (EtCO2), non-invasive blood pressure, cardiac output, temperature and associated derived outputs.
  • Lung ventilators.
  • Respiratory gas monitors.
  • IV infusion (including patient-controlled analgesia) pumps.
• Nurse call systems.
• Electronic health record (EHRs) systems.

TC Alarm Management provides a wireless communications system platform for delivery of secondary notifications to endpoint devices with Android or iOS operating systems (OSs) through the CCP messaging service.

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The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.

The Assert-IQ™ ICM is designed to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review. The Assert-IQ ICM system, cleared under K230286 on May 17, 2023, includes implantable and remote care components. The implantable components include the Assert-IQ™ ICM device models DM5000, DM5300, or DM5500. The remote care portion consists of the Merlin.net™ Software model MN7000 and myMerlin™ mobile apps (Android (APP1000) and iOS (APP1001)).

The subject of this premarket notification is the integration of two new artificial intelligence (AI) algorithms utilizing machine learning (ML) techniques for the evaluation of atrial fibrillation (AF) and Pause episodes within the Assert-IQ™ ICM remote care component, Merlin.net MN7000. The goal of the AI-enabled function in Merlin.net is to reduce non-actionable clinical review burden due to false Pause and false AF episodes presented for clinician review. Specifically, this premarket submission pertains to the addition of the proposed deep neural network AI models as integrated sub-components of the Merlin.net software, MN7000, resulting in MN7000 version v2.0. There are no other proposed changes to the Assert-IQ device hardware, device firmware, device detection algorithms or other components of the system cleared in K230286.

The two new AI algorithms (CARE: Classification using AI for Rhythm Evaluation) classify AF and pause EGM episodes detected by Assert-IQ ICM devices as either true or false detection. Episodes classified as "true" will be retained in the transmission data and displayed to clinicians for review in Merlin.net web application, whereas episodes classified as "false" will be removed and not displayed to the user. These two AI algorithms, CARE-AF and CARE-Pause, are designed to significantly reduce false episodes, while maintaining true arrhythmic episodes detected by the Assert-IQ devices.

Here's a summary of the acceptance criteria and study details for the Assert-IQ ICM System with AI, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The core purpose of the AI algorithms (CARE-AF and CARE-Pause) is to reduce non-actionable clinical review burden due to false pause and false AF episodes while maintaining true arrhythmic episodes. The acceptance criteria are therefore focused on "relative sensitivity" and "false positive reduction."

Study Details

The document describes two primary studies for assessing the performance of the AI algorithms:

1. Retrospective Observational Cohort Study (for independent AI algorithm performance)

• Sample Size (Test Set):
  • CARE-Pause: 1498 Assert-IQ ICM patients
  • CARE-AF: 911 Assert-IQ ICM patients
• Data Provenance: Retrospective, observational cohort study. Patients were from 504 clinics across the United States (for CARE-Pause) and 360 clinics across the United States (for CARE-AF). Data was from Assert-IQ ICM patients who had AF or Pause detection over 30 days of remote monitoring post device implant.
• Number of Experts & Qualifications: Not explicitly stated. The document refers to "the overall system performance of Assert IQ with CARE-AF is assessed using data collected from the Assert-IQ post-market study (NCT06172699) comparing device detection against a Holter monitor." For the retrospective study, the ground truth establishment method implies expert review, but the number and qualifications of these experts are not provided.
• Adjudication Method: Not explicitly stated. The description mentions "AF and Pause EGM episodes detected by Assert-IQ ICM devices as either true or false detection," implying expert review to establish ground truth for these episodes. The method of achieving consensus among experts for this ground truth is not detailed (e.g., 2+1, 3+1).
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This study focuses on standalone AI algorithm performance relative to the predicate device's detections, and then overall system performance without explicit human-in-the-loop comparison.
• Standalone Performance: Yes. The "relative sensitivity" and "false positive reduction" metrics directly assess the independent performance of the AI algorithms (CARE-AF and CARE-Pause) in classifying episodes as true or false, relative to the existing device detection. The "overall system performance" metrics also reflect the algorithm's influence on the final output presented to clinicians.
• Type of Ground Truth: The ground truth for individual episodes was established by classifying EGM episodes as "true" or "false." This likely refers to expert consensus interpretation of the EGM data, but this is not explicitly detailed.
• Sample Size (Training Set): Not provided in the text. The document only states that "Patients whose ICM data have been utilized in algorithm training and preliminary performance evaluation were completely excluded from this study" (referring to the test set).
• Ground Truth for Training Set: Not provided in the text. It can be inferred that ground truth was established for training data in a similar manner to the test set, likely through expert review of EGM episodes.

2. Assert-IQ Prospective, Multicenter Post-Market Study (NCT06172699) - for Overall System Performance of CARE-AF

• Sample Size (Test Set): 151 patients enrolled, with 135 patients having analyzable data.
• Data Provenance: Prospective, multicenter post-market study (NCT06172699). Patients had symptomatic, drug-refractory paroxysmal or persistent AF.
• Number of Experts & Qualifications: Not explicitly stated.
• Adjudication Method: Not explicitly stated. The study compared Assert-IQ ICM AF detection against Holter assessment (up to 7 days per patient). This indicates that the Holter assessment served as a primary reference for ground truth for AF detection, likely interpreted by experts.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, not explicitly described as such. The study compares the Assert-IQ system with CARE-AF against Holter assessment, not human readers with and without AI.
• Standalone Performance: The "overall system performance" metrics for Assert-IQ with CARE-AF from this study represents the performance of the algorithm-enhanced system.
• Type of Ground Truth: Holter assessment (likely interpreted by experts) served as the ground truth comparator for AF detection.
• Sample Size (Training Set): Not provided.
• Ground Truth for Training Set: Not provided.

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The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia, such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath. The LUX-Dx ICM is indicated for atrial fibrillation monitoring in patients that have been previously diagnosed or treated for atrial fibrillation.

The LUX-Dx II and LUX-Dx II+ ICM devices evaluate S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation and evaluation when the algorithm criteria are met. The ICM device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The ICM device is powered by an integrated battery. The LUX-Dx system includes the following main components:

• ICM device - a subcutaneously-implanted cardiac monitor device for cardiac arrhythmia event data collection and transmission. In addition, symptom events are collected and transmitted from the device.
• Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the ICM device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
• LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
• System Accessories - for insertion of the ICM device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate ICM/MM app communication.

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Intended Use:
The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are only for use on one patient at a time.
The monitors are not therapeutic devices.
Caution: The monitors are for prescription use only.

The ECG measurement is indicated to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).
ST segment monitoring is indicated for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is indicated for use with adult patients only.
The derived measurement Pulse Pressure Variation (PPV) is indicated for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Predictive Temperature Module is indicated to provide an accurate prediction of patient temperature using the oral, axillary, or rectal body sites, or to provide an actual temperature reading in the continuous monitor mode to adult and pediatric patients.
The NanoPod capnography module is indicated to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is indicated for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport.
The NanoPod capnography module provides the clinician with an integrated pulmonary index (IPI). The IPI is based on end tidal carbon dioxide, respiration rate, oxygen saturation and heart rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The Integrated Pulmonary Index (IPI) is indicated for use with adult and pediatric (1 to 12 years) patients only.

Warning: The IPI is an adjunct to and not intended to replace vital sign monitoring.

The new IntelliVue Patient Monitors 6100 (867311), 6300 (867313) and 6500 (867315) are display units with built-in CPUs. They integrate a TFT LCD flat panel display with dimensions of 10' for model 6100 and 6300 and 15' for the 6500 model). All Monitors are outfitted with a touchscreen interface as a primary input for the device. They also support data input devices such as a dedicated remote control, keyboard and pointing devices such as a mouse.

The new patient monitors have integrated measurements such as ECG/Resp, SpO2, NIBP, IBP and Temperature. In addition to their integrated measurements, these devices can also connect to other external measurement modules through their FlexLink connector. The FlexLink connector serves as an interface between the 6100, 6300 and 6500 Patient Monitors and Medtronic's Microstream™ CO2 NanoPod as well as the Predictive Temperature Module.

The new Patient Monitors run on mains power or on the internal battery. They serve as stationary patient monitors and can also be used as portable patient monitors in hospital transport only.

The new Patient Monitors can communicate with the Philips Central Station (aka Patient Information Center iX, last cleared with K211900) as well as with Philips XDS Software, which is intended for use as an independent display replicating the Patient Monitors screen. They are outfitted with an ECG-Out connector, which may be used to synchronize (via an analog ECG signal output) a connected external device such as a defibrillator, CT scan or Intra-aortic Balloon Pump.

The provided FDA 510(k) clearance letter and summary for the Philips IntelliVue Patient Monitors (6100, 6300, 6500) primarily focus on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical bench testing. However, it explicitly states that no clinical trials were generally required, except for specific Philips initiated laboratory tests for the Philips FAST PicoSAT X SpO2 technology.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, expert involvement, and ground truth for a general "study that proves the device meets the acceptance criteria" in a typical clinical evaluation sense is not present for the overall device clearance. The clearance is based on meeting harmonized standards and non-clinical bench tests for safety and effectiveness, and demonstrating the subject device introduces no new safety or effectiveness issues compared to the predicate.

Here's an attempt to extract and infer the information based on the provided document:

Acceptance Criteria and Device Performance (Primary Device Clearance)

For the overall device, the acceptance criteria are largely implied by compliance with the listed harmonized standards for safety and essential performance. The "reported device performance" is the statement of compliance with these standards and the assertion of substantial equivalence to the predicate, meaning it performs similarly and safely for its intended use.

Specifics regarding the Philips FAST PicoSAT X SpO2 Technology Clinical Data:

The document mentions: "The 510(k) included clinical data from Philips initiated laboratory tests with the intent to demonstrate the accuracy performance of the Philips FAST PicoSAT X SpO2 technology." This is the only explicit mention of "clinical data" related to a performance study. Given the limited information, assumptions are made where details are not provided.

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The Zio monitor is a prescription-only, single-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients, 18 years and older, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, or anxiety.

The Zio monitor is a non-sterile, single-use, continuously recording, long-term ambulatory ECG monitor that is adhered to a patient's left pectoral region in a modified Lead II orientation. The goal of the Zio monitor is to help physicians initiate long-term, patient-compliant ECG monitoring utilizing proprietary technology. The Zio monitor is applied and activated by the patient at home or at a clinic. Once activated, the device provides continuous, uninterrupted ECG recording into memory with minimal patient interaction. There is a button on the surface of the Zio monitor, which serves to activate the device and may be pressed by the patient during wear to indicate when he or she is experiencing a symptom. Additionally, there is a surface LED light that blinks green to confirm proper activation or that the device is working, and orange to indicate loss of connection with the skin or the presence of error conditions.

The Zio monitor utilizes firmware that captures single-channel ECG data into memory, there is no wireless transmission of data during the wear period of the device. After the prescribed monitoring period is complete, the Zio monitor is returned to iRhythm where the ECG data is then analyzed and annotated by the ZEUS System (K222389). ECG data is then presented to the Qualified Cardiac Technicians (QCT) at the Independent Diagnostic Testing Facility (IDTF) for review and subsequent creation and posting of the end-of-wear report with preliminary findings. Zio monitor device is not intended for real-time patient monitoring.

The provided text is an FDA 510(k) clearance letter and summary for the Zio® monitor. It details the device, its indications for use, comparison to a predicate device, and nonclinical testing performed to establish substantial equivalence. However, it explicitly states:

"No clinical testing was performed in support of this premarket notification."

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on a clinical study, nor specific details about sample size, data provenance, ground truth establishment, expert qualifications, or MRMC studies, as these aspects relate to clinical testing which was not conducted for this submission.

Here's what I can extract and state based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the acceptance criteria and device performance are established through nonclinical testing, demonstrating conformance to recognized standards and performance specifications, rather than through a clinical study with specific performance metrics like sensitivity or specificity for detecting arrhythmias.

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

• Sample Size for Test Set: Not applicable as no clinical testing was performed. The nonclinical testing would have used various test samples, components, or simulated data as appropriate for each specific engineering and performance test (e.g., system testing, electrical testing).
• Data Provenance: Not applicable for clinical data. For nonclinical testing, the data is generated in-house or by accredited testing laboratories as part of the device's design verification and validation.

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

• Not applicable as no clinical testing with human-established ground truth was reported. Ground truth in nonclinical testing refers to established engineering specifications or reference standards.

4. Adjudication method for the test set:

• Not applicable as no clinical testing requiring expert adjudication was performed.

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 MRMC comparative effectiveness study was done as no clinical testing was performed. The device, Zio monitor, is described as recording ECG data which is then "analyzed and annotated by the ZEUS System (K222389)" and "presented to the Qualified Cardiac Technicians (QCT) at the Independent Diagnostic Testing Facility (IDTF) for review." This implies an existing workflow with a human-in-the-loop, but this submission specifically states no clinical testing was performed to evaluate its effectiveness in combination with human readers.

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

• The document implies that the "ZEUS System (K222389)" performs initial analysis and annotation of the ECG data, but this specific 510(k) is for the Zio® monitor hardware device. Performance data for the ZEUS System itself would be found in its own 510(k) clearance (K222389). This submission does not provide standalone algorithm performance metrics.

7. The type of ground truth used:

• For the nonclinical testing, the ground truth would be based on:
  • Engineering Specifications: Device design requirements and intended performance.
  • Recognized Consensus Standards: Compliance with international standards (e.g., IEC 60601 series, ISO 10993 series).
  • Internal Product Specifications: How the device is designed to function and its measurable outputs.

8. The sample size for the training set:

• Not applicable. This submission is for a hardware device and relies on nonclinical testing for substantial equivalence, not a machine learning model's training set. While the ZEUS System (K222389) likely uses a training set, details for that system are outside the scope of this document.

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

• Not applicable as no training set for an algorithm is discussed in this submission for the Zio® monitor hardware.

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The LuMon™ System is a noninvasive, non-radiation device that provides information on regional impedance variation within a cross-section of a patient's thorax. Graphical and numerical information is presented to the user as an adjunctive tool to other clinical information to support the user to assess a patient's respiratory condition.

The LuMon™ System is indicated for neonatal and infant patients with chest circumferences between 16.5 - 50 cm and adolescent through adult patients with chest circumferences between 76 - 128 cm who are breathing spontaneously or require mechanical ventilation in professional healthcare facilities.

Impedance-based respiratory rate monitoring is indicated for adults 22 years and older whose chest circumference is above 76 cm only.

The LuMon™ System also displays selected physiological and respiratory parameters from supported bedside devices.

The LuMon™ System does not measure regional ventilation of the lungs.

The LuMon™ System is a compact and lightweight Electrical Impedance Tomography (EIT) system that provides noninvasive monitoring of variations of regional air content/volume within a cross-section of the patient's thorax and patient respiration. It displays the results as real-time EIT images, waveforms, and derived parameters.

The system consists of a controller display unit, signal acquisition connector cable, and patient-applied conductive textile electrode belts. The system can connect to external bedside devices such as ventilators and monitoring devices to display contextual information for interpretation of EIT measurements.

The provided FDA 510(k) clearance letter and summary for the LuMon™ System contains information regarding its acceptance criteria and the studies conducted to demonstrate its performance. However, some specific details commonly found in a comprehensive study report (e.g., exact sample size for each clinical study, number of experts for ground truth, adjudication methods beyond "clinician-scored") are not explicitly stated in this high-level summary.

Based on the provided text, here's a structured response addressing your request:

Acceptance Criteria and Device Performance for LuMon™ System

The LuMon™ System underwent extensive non-clinical (bench and pre-clinical) and clinical testing to demonstrate its safety and effectiveness. The acceptance criteria are implicitly defined by the performance characteristics presented in the comparison tables and the successful attainment of stated accuracies and correlations.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established as equivalent to or better than the predicate/reference devices, or as meeting pre-defined tolerances for specific parameters.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Pre-clinical: "Rabbit and piglet models" (specific number not given).
  • Clinical (Global Volume Changes): "Healthy Adult Volunteers" and "Adult ICU patients on mechanical ventilation" (specific numbers not given).
  • Clinical (Regional Impedance Distribution): "Healthy Adult Volunteers" (specific numbers not given).
  • Clinical (Respiration Rate): "Healthy Adult Volunteers" and "Adult spontaneously breathing and mechanically ventilated ICU patients" (specific numbers not given).
  • Chest Circumference for EIT Measurements: Validated across 19 cm to 47 cm (pre-clinical) and 16.5 - 50 cm (neonatal/infant) and 76 - 128 cm (adolescent/adult) (indications for use).
  • Chest Circumference for RR Monitoring: Adults 22 years and older with chest circumference > 76 cm.
• Data Provenance: Not explicitly stated regarding country of origin for clinical data. The studies are described as "pre-clinical" and "clinical," with no indication of being retrospective. "Clinical testing was performed to support safety and effectiveness" generally implies prospective data collection for regulatory purposes.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: For the Respiration Rate study, the reference standard was "Clinician-scored EtCO2 capnogram." This implies medical professionals were involved in establishing the ground truth, but their specific qualifications (e.g., types of physicians, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• For Respiration Rate Ground Truth: "Clinician-scored EtCO2 capnogram" implies expert review. However, the exact adjudication method (e.g., 2+1, 3+1, majority vote, independent reads with reconciliation) is not specified.

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

• It is not explicitly stated that a specific MRMC study was conducted to compare human readers with and without AI assistance.
• The device is presented as an "adjunctive tool to other clinical information to support the user," meaning it assists clinicians rather than replacing them. Its effectiveness is shown through its ability to provide accurate EIT data and respiratory rate, which clinicians would then integrate into their assessment. The summary focuses on the device's accuracy relative to reference standards or predicate devices, not on direct human-AI performance comparison studies.

6. Standalone (Algorithm Only) Performance

• Yes, the performance characteristics listed in the tables (e.g., R-squared correlations for EIT-CT, accuracy for RRi against reference standards, SNR, voltage accuracy) represent the standalone performance of the algorithm and the device. The clinical studies compare the device's output itself to established medical standards or other modalities, distinct from how a human user might interpret or use that output.

7. Type of Ground Truth Used

• Pre-clinical (Regional Impedance Distribution): Differential CT changes in aeration (healthy and injured lungs, one- and two-sided intubation) and "established physiological changes" were used as ground truth.
• Clinical (Global Volume Changes): Body plethysmograph traces and Ventilator flow-sensed volumes were used as ground truth.
• Clinical (Regional Impedance Distribution): The Timpel Enlight 2100 predicate comparison was used for ground truth.
• Clinical (Respiration Rate): Clinician-scored EtCO2 capnogram was used as ground truth.

8. Sample Size for the Training Set

• The information provided is a 510(k) summary, which typically focuses on validation. The sample size for the training set is not provided in this document. Training data details are usually proprietary and not disclosed in 510(k) summaries unless directly relevant to the regulatory pathway or substantial equivalence claim.

9. How Ground Truth for the Training Set Was Established

• The document does not specify how ground truth was established for the training set. Similar to the training set size, details about the training data and its ground truth establishment are generally considered proprietary and are not typically included in a public 510(k) summary. The summary focuses on the independent test data performance.

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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).

• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.

• Printing patient data from compatible physiological monitor, and anesthesia devices.

• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.

• Transfer of patient clinical data and settings between several CentralStations.

• Provides a Resting 12 Lead interpretation of previously stored data.

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.

• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

• The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.

The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.

It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:

• Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
• Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
• Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document confirms the following regarding the study:

• Study Type: Software verification and validation testing, along with specific bench testing.
• Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
• Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.

What is present in the document that somewhat relates to your request:

• "Bench Testing" section (Page 19): This lists specific tests performed:
  • AlarmGUARD IEC 60601-2-27
  • AlarmGUARD IEC 60601-1-8
  • AlarmGUARD Human Factors
  • Waveform Display Accuracy from compatible Anesthesia Machine

To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.

Here's a structured response based on the provided document, indicating what information is present and what is absent:

Device Acceptance Criteria and Performance Study Summary (K242728)

Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.

The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.

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

• No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.

6. Standalone Performance (Algorithm Only)

• The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."

7. Type of Ground Truth Used

• The ground truth for the device's performance appears to be:
  • Design Specifications: For general software verification and validation.
  • External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
  • International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.

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

• Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.

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The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

The CX&UX series Patient Monitor including CX10/CX12/CX15/UX10/UX12/UX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

Minor differences from the predicate device are limited to some modifications of monitoring parameter specifications. These updates do not change the fundamental scientific technology of the cleared predicate device and thus do not raise any questions about the safety and effectiveness of the subject device.

The provided FDA 510(k) clearance letter details the device's technical specifications and comparisons to predicate devices, along with the non-clinical performance data and adherence to various IEC and ISO standards. However, it explicitly states: "Clinical data: The subject device did not require new clinical studies to support substantial equivalence."

This means that the submission for this Patient Monitor device (CX10, CX12, CX15, UX10, UX12, UX15) relies on demonstrating substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962) through non-clinical performance testing and software verification/validation, rather than new clinical trials or studies involving human patients.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria through clinical performance (e.g., sample size for test set, expert involvement, MRMC studies, ground truth establishment for test/training sets, effect size of human reader improvement with AI) cannot be extracted from this document, as such clinical studies were explicitly not required for this 510(k) submission.

The document focuses on demonstrating that the new device's technical specifications and performance are similar to the predicate device, and that it complies with relevant safety and performance standards through bench testing.

Here's what can be extracted from the provided text regarding acceptance criteria and the type of study performed, specifically focusing on the non-clinical aspects:

Device: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The acceptance criteria for this device are implicitly tied to its performance meeting the standards and accuracy specifications of the predicate device and relevant international standards. Since no new clinical studies were conducted, the "proof" comes from non-clinical bench testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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

• Sample Size: Not applicable in terms of human subjects or patient data test sets, as "new clinical studies" were not required. The "test set" refers to bench testing and functional system-level validation. The specific number of test cycles or a detailed breakdown of test cases for bench testing is not provided in this summary.
• Data Provenance: The data primarily originates from Edan Instruments Inc. (Shenzhen, Guangdong, China) through internal engineering and quality assurance processes for non-clinical bench testing and software validation. It is not patient data, so concepts like "retrospective or prospective" do not apply.

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

• Not applicable for clinical ground truth: Since no clinical studies were performed requiring human interpretation or diagnosis for a test set, no medical experts (e.g., radiologists) were used to establish ground truth in this context.
• Internal experts: Bench testing and software validation would have involved engineers and quality assurance professionals, whose qualifications are implicit in the quality system (21 CFR Part 820) but not specified in detail here.

4. Adjudication Method for the Test Set:

• Not applicable: Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving multiple readers. This was not a clinical study. Bench testing relies on established technical specifications and standard compliance.

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

• No: No MRMC study was performed as no new clinical studies were required or conducted. Therefore, there's no effect size of human readers improving with AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

• Yes (for the technical components): The "performance testing-Bench" effectively represents a standalone evaluation of the device's functional components (ECG, NIBP, SpO2, etc.) and software against defined technical specifications and standards. The "software verification and validation testing" also represents a standalone evaluation of the algorithm and software functions. The specific algorithms (e.g., iCUFS, iFAST for NIBP, arrhythmia analysis logic) are tested independently for their accuracy against known inputs or reference standards as part of bench testing.

7. The Type of Ground Truth Used:

• Technical/Reference Standards: For the bench testing, the "ground truth" would be derived from:
  • Reference standards/simulators: Calibrated medical equipment, physiological simulators, and test signals (e.g., known ECG waveforms, simulated blood pressure readings, temperature standards) are used to provide the "true" values against which the device's measurements are compared.
  • Defined specifications: The device's internal design specifications and the requirements of the referenced IEC/ISO standards serve as the "ground truth" for compliance testing.
• Not clinical ground truth: No expert consensus, pathology, or outcomes data from real patients were used for establishing ground truth for this submission.

8. The Sample Size for the Training Set:

• Not applicable: The device is a patient monitor, not a machine learning/AI algorithm that typically undergoes a distinct "training" phase with a large dataset. Its functionality is based on established physiological measurement principles and programmed algorithms. Any internal calibration or algorithm refinement would be part of the product development process, not a dedicated "training set" in the AI/ML sense.

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

• Not applicable: As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this 510(k) submission.

In summary, this 510(k) clearance relies on demonstrating that the new Patient Monitor is substantially equivalent to a previously cleared predicate device, primarily through robust non-clinical bench testing and software validation, proving compliance with established medical device standards and functional specifications. No new clinical studies with patient data were required or conducted for this specific submission.

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MoMe ARC® is indicated for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe ARC® is contraindicated for:

1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients.
3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs.

Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle with accessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram (ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLE wireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® Gateway Mobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwards the ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link.

The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe Device Communications Protocol. The MoMe Software System (K152491) analyzes the data via the embedded algorithm and, when indicated, data identified by the algorithm is flagged for physician review.

Once activated and operating normally, the system requires no patient intervention to capture or analyze data. However, the MoMe ARC® has an optional patient triggered event feature that allows for manual selection and recording of patient symptoms, if and when desired.

The device is intended for use under prescription only (Rx only) for monitoring patients with suspected cardiac arrhythmias.

The MoMe ARC®:

• Is non-invasive and poses no significant safety issues;
• Uses existing electrode and patch ECG technology; and
• Is used in an adjunctive fashion, where physicians also use patient symptoms and other tests, in the diagnosis or monitoring of patients with suspected cardiac arrhythmias.

MoMe ARC® is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device's performance met "predefined acceptance criteria" for sensitivity and positive predictivity, and provided a "mean absolute error" for heart-rate accuracy. However, the precise numerical values for the acceptance criteria thresholds themselves for sensitivity and positive predictivity are not explicitly stated in the provided text. We only have the reported performance.

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

• Sample Size: 87 adult subjects.
  • Inpatient cohort: 75 subjects
  • Outpatient cohort: 12 subjects
• Data Provenance:
  • Country of origin: United States ("single U.S. clinic").
  • Retrospective or Prospective: Prospectively collected.

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

• Number of Experts: Not explicitly stated as a number of individual experts. However, the ground truth was established by "Certified Cardiac Technicians (CCTs)". This implies multiple CCTs were likely involved in adjudicating the data.
• Qualifications of Experts: Certified Cardiac Technicians (CCTs). The document doesn't provide further detail on their experience level (e.g., years of experience).

4. Adjudication Method for the Test Set

• The data from all 87 subjects were "adjudicated by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard."
• This suggests a single-reader adjudication process per case by a CCT to establish the ground truth, rather than a multi-reader consensus method like 2+1 or 3+1.

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 reported. The study focused on the performance of the "Software Platform's sensitivity and positive predictivity" against a CCT reference, which is a standalone performance evaluation, not a human-in-the-loop study comparing human performance with and without 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 "Software Platform's sensitivity and positive predictivity were calculated using ANSI/AMI/IEC EC57:2012 methods" against the CCT-adjudicated reference standard. This directly assesses the algorithm's performance.

7. The Type of Ground Truth Used

• The ground truth was established through "expert consensus" in the form of "adjudication by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard." This is a form of expert consensus based on established clinical procedures (Holter analysis).

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only describes the clinical validation study (test set).

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

• The document does not state how the ground truth for the training set was established. It only describes the ground truth process for the independent test set used for performance validation.

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