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GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to EEG instruments and computer equipment. GT5 conductive & abrasive gel is for use with external electrodes only.

GT5 conductive & abrasive gel is an off-white color, opaque, no adverse smell gel with sodium chloride as the conductive material combined with thickening agents, emulsifiers, humectants, preservatives and abrasive particles. With the abrasive particles in the gel, the gel can be also used as skin preparation by being applied to the skin surface to rub the skin lightly in order to reduce skin impedance efficiently and increase signal quality recorded with EEG electrodes.

The composition of GT5 conductive & abrasive gel is as follows:

Glycerin, Sodium chloride, Water, Methylparaben, Sodium Carboxymethyl cellulose, Alkyl indican, Aluminum Oxide.

The pH range is 6.5-7.5, and the impedance at 10Hz is 0.2K Ohm or less. The conductivity is 18±0.5 mS/cm. GT5 conductive & abrasive gel is available in the following sizes: a pre-filled syringe of 20g, a tube of 100g, a bottle container of 473g, a bottle container of 946g. Shelf life is 3 years if stored properly, i.e. kept with containers tightly closed and at room temperature.

The provided text describes the regulatory submission for the GT5 conductive & abrasive gel. It is a Class II medical device (electroconductive media) and the submission (A 510(K) premarket notification) attests to its substantial equivalence to previously cleared predicate devices.

The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance. Instead, it details the acceptance criteria for the physical and chemical properties of the gel and internal performance testing to demonstrate these criteria are met. Therefore, many of the requested elements for an AI/ML algorithm study cannot be populated from the provided text.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the physical and chemical properties of the conductive gel, not the performance of an AI/ML diagnostic algorithm.

2. Sample size used for the test set and the data provenance:
This information is not applicable and not provided. The testing relates to the physical and chemical properties of the gel, not a data-driven AI/ML test set. The shelf-life testing involved "accelerated aging," but the sample size of tested units is not specified. All testing appears to be internal ("tested internally").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and not provided. "Ground truth" in this context would refer to established chemical and physical standards or measurements, not expert radiographic reads.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically employed in clinical studies involving human interpretation or consensus for ground truth, not for physical property testing of a gel.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a conductive and abrasive gel, not an AI-powered diagnostic tool, so no MRMC study would be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a conductive and abrasive gel, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the physical and chemical properties of the gel would be established by standard analytical chemistry and materials science methodologies, such as:

• pH measurement: Using a calibrated pH meter.
• Impedance/Conductivity measurement: Using appropriate electrical testing equipment validated against known standards.
• Appearance/Color/Odor: Visual and olfactory inspection against a defined standard or reference.
• Shelf-life: Stability testing over time (accelerated aging).

8. The sample size for the training set:
This information is not applicable and not provided. There is no AI/ML model involved requiring a training set.

9. How the ground truth for the training set was established:
This information is not applicable. There is no AI/ML model involved.

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The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.

The device is contraindicated for use on critical care patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

The Life Sensor Cardiac Monitor (CM) Platform is a wireless data collection system that monitors physiological data (electrocardiograph and heart rate) and consists of the following sub-systems:

Life Sensor Electrode (includes Life Sensor Patch and Life Sensor Module)
Life Sensor Firmware
Life Sensor Application

Life Sensor Electrode

• Life Sensor Patch: The Life Sensor Patch is the single-use, self-adhesive interface to a patient that is attached to the patient's upper torso region just above the heart.
• . Life Sensor Module: The Life Sensor Module attached to the Life Sensor Patch, contains the battery powered electronics and sensing apparatus necessary to operate the system. The Life Sensor Module automatically performs all the processing functions related to capturing the required physiological data from the body and performs encrypted, bi-directional communication to the Life Sensor Application, using Bluetooth Low Energy (BLE), when in range of the Life Sensor Application installed on a paired iOS device.
• Life Sensor Firmware:

The Life Sensor Firmware is the software installed on the Life Sensor Module. The Life Sensor Firmware manages bi-directional communication between the Life Sensor Module and the Life Sensor Application. Encrypted data is transmitted to and from the Life Sensor Module and the Life Sensor Application.

• . Life Sensor Application: The Life Sensor Application, installed on a paired iOS device, interacts with the Life Sensor Firmware and manages the upload, processing, and display of the physiological data transmitted by the Life Sensor Module.
  When installed on a compatible hardware, the Life Sensor Application establishes connection to any of the Life Sensor Electrode through pairing process.

Life Sensor Application has visual alarms to alert clinical personnel when heart rate of the person being monitored is outside the set limits, lead off, asystole, tachycardia and bradycardia, when the battery is low, or when there is loss of communication between the Life Sensor Application and the Life Sensor Electrode.

The provided text describes the Life Sensor Cardiac Monitor (CM) Platform and its 510(k) summary, comparing it to a predicate device, the LifeSignals WiPatch & WiApp System (K172011).

However, the document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with specific statistical results to "prove" the device meets acceptance criteria in the way a clinical trial or algorithm performance study might. The information provided is primarily related to non-clinical testing for safety and basic performance.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the form of specific quantitative thresholds in a table for most performance aspects. Instead, it states technical specifications and implies compliance with standards.

Missing Information/Detail:

• Specific numerical acceptance criteria for biocompatibility, electrical safety, software V&V, and usability are not detailed, only that the device "complies" with the relevant standards.
• The exact results of the shelf life, packaging integrity, and operation/storage conditions bench testing are not provided.
• The document does not include any clinical performance data or studies comparing the device's accuracy in detecting medical conditions (as it states it "does not detect or diagnose medical conditions"). The focus is on accurate physiological data monitoring.

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

The document does not describe a "test set" or "training set" in the context of an algorithm's performance on patient data. The non-clinical testing mentioned (biocompatibility, electrical safety, software V&V, usability, bench testing) would have their own sample sizes (e.g., number of units tested for electrical safety, number of participants for usability) but these are not provided in the summary.

Data provenance: Not applicable in the context of algorithm performance on patient data, as no such study is described. The non-clinical tests would have been performed in a laboratory or controlled environment.

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

Not applicable, as no algorithm performance or diagnostic study on a test set (with human-established ground truth) is described.

4. Adjudication Method for the Test Set

Not applicable, as no algorithm performance or diagnostic study on a test set is described.

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

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The device is a "monitor" and does not perform diagnostic interpretations that would typically involve human readers.

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

No, a standalone algorithm performance study is not mentioned or described. The device's primary function is to monitor and transmit physiological data (ECG and heart rate) for review by healthcare professionals on an iOS application. It explicitly states, "The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions."

7. The Type of Ground Truth Used

For the basic physiological measurements (heart rate, ECG display), the "ground truth" would implicitly be derived from highly accurate, calibrated reference measurement devices used during "bench testing" or controlled physiological simulations, rather than pathology, expert consensus, or outcomes data, as the device is not for diagnosis. However, the details of how accuracy was measured against a reference are not provided, only the specified accuracy range.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm requiring a "training set" for diagnostic or predictive purposes is described.

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

Not applicable, as no machine learning algorithm requiring a "training set" is described.

Summary of Device Purpose:
The Life Sensor Cardiac Monitor is presented as a wireless monitoring system for healthcare professionals to monitor physiological data (heart rate and ECG) in healthcare settings. It transmits data to an iOS application for review. The focus of the 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (LifeSignals WiPatch & WiApp System) through non-clinical testing for safety and basic performance (biocompatibility, electrical safety, software V&V, usability, bench testing), rather than through clinical trials or algorithm performance studies that would involve large patient datasets and established ground truths for diagnostic accuracy. The device monitors, but does not detect or diagnose medical conditions.

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The LifeSignals WiPatch & WiApp system is intended for spot check and short-term monitoring of ECG & heart rate of patients at rest or patients who can be transported within the range of the antenna network. The WiPatch & WiApp system has visual and audio alarms to alert clinical personnel when heart rate falls outside the set limits. The device is intended for use on general care patients of 18 years or older. The device is not intended for use on critical care patients.

The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD) & left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.

The LifeSignals WiPatch & WiApp System consists of the 1) LifeSignals WiPatch 2) LifeSignals WiApp System and 3) Access Point as described below.

The LifeSignals WiPatch:

• is a wireless ECG patch that--when attached to the upper left chest of a patient -continuously acquires physiological signals and transmits these signals wirelessly to any compatible receiver.
• is disposable and integrated with four adhesive electrodes for body interface.
• acquires two channels of electrocardiograph (ECG-A and ECG-B) signals
• transmits acquired signals after initial pre-processing to a compatible receiver wirelessly using the 802.11b communication protocol (2.4 GHz).
• is powered by two-coin cell batteries (zinc air) with an operating life up to 72 hours.
• has an integrated switch to power it on, and has bi-color LED indicators to indicate the communication status with the receiver.

The LifeSignals WiApp System:

• consists of a LifeSignals WiApp Software App (WiApp SW), and a compatible commercial iOS device (iPad, iPad 2, iPad Air or iPad Air 2)
• software, when installed on a compatible hardware, establishes a connection to any one of the LifeSignals WiPatches connected to the same wireless network/Access Point through a pairing process.
• receives the transmitted signals from the paired WiPatch wirelessly, processes the signals and displays heart rate, ECG (ECG-A and ECG-B) waveforms on its LCD display for monitoring purposes by trained clinical personnel.
• has audio and visual alarms to alert clinical personnel when heart rate of a patient is outside the set limits, lead off, when the battery is low (either the WiPatch or the WiApp System - iPad), or when there is a loss of communication link between the WiApp System and the WiPatch.

Access Point:
An access point is a commercially available hardware device (a.k.a wireless router) that allows wireless capable devices connect through a wireless standard (e.g. 802.11b). LifeSignals WiPatch and WiApp system communicate through an access point.

The provided text describes the 510(k) summary for the LifeSignals WiPoint Biosensor iOS Receiver App System (LifeSignals WiPatch & WiApp System), which is intended for spot check and short-term monitoring of ECG & heart rate in adult patients (18 years or older) at rest or transportable within an antenna network.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies heart rate accuracy.

Note 1: These values are explicitly stated in the "Table of Comparison" and the subsequent "Note 1" section.

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

The document mentions "a non-randomized, self-control comparative clinical study" for validating heart rate accuracy and on-body adhesion. However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

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

The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone (Algorithm Only) Performance

The document details performance testing for the "LifeSignals WiPatch & WiApp System" which includes the "WiPatch" (hardware sensor) and the "WiApp Software App" (algorithm/software). The performance metrics for heart rate accuracy are presented for the overall system, not solely for the algorithm in isolation without human interaction. Therefore, a standalone (algorithm only) performance is not explicitly detailed as such, though the heart rate accuracy is a measurement of the system's output.

7. Type of Ground Truth Used

The document mentions a "Simulator study" and an "on-body performance study" for heart rate accuracy. This implies the ground truth for the simulator study would be from the simulator's known output, and for the on-body study, it would be from a reference device or method used to establish true heart rate during the clinical study. However, the exact nature of this reference method is not explicitly stated (e.g., gold standard ECG, manually counted pulses, etc.).

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This is common for 510(k) summaries which focus on validation rather than development.

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

As no training set sample size is provided, the document similarly does not provide any information on how the ground truth for a training set was established.

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• The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.
• The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link. When operating Rooti Rx System, medical professionals should use disposable, off the shelf, standard ECG electrodes which are not claimed in the system.

The provided text describes the Rooti Rx System, an ECG event recorder, and its comparison to a predicate device (Zephyr Technology, BIOMODULE 3-M1) to demonstrate substantial equivalence for FDA 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on several of the requested points.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

Missing Information:

The document primarily focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state specific acceptance criteria for the Rooti Rx System's performance in terms of diagnostic accuracy or clinical utility. Consequently, it also does not detail a study proving device performance against such criteria.

Specifically, the following requested information is not available in the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the test set.
• Sample size for the training set.
• How the ground truth for the training set was established.

Information Extracted from the Document:

Therefore, I can only provide limited details based on the available text:

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

   • Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" discussed in this document relate to demonstrating substantial equivalence to a predicate device (Zephyr Technology, BIOMODULE 3-M1) based on intended use, indications for use, and technological characteristics. The document implies that the device meets these criteria if the differences are "incidental and not significant which do not raise any new issues of safety or efficacy."
   • Reported Device Performance (Comparative Information): The document provides a comparison table between the Rooti Rx System and the predicate device. This is not "reported device performance" against explicit acceptance criteria in the typical sense of a clinical or performance study outcome, but rather a comparison of specifications.

   Feature	Predicate Device (BIOMODULE 3-M1)	Rooti Rx System	Comparison
   Intended Use	General Ward Monitoring (detecting, storing, transmitting physiological data)	Record single-lead ECG data for post-analysis by medical professionals	Similar
   Indication For Use	Monitoring ambulatory patients in alternate care settings; general patient monitor	Record single-lead ECG data for post-analysis; for general care patients ≥21 years old	Similar
   Data Storage Capacity	140 hrs	7 days	Rooti Rx System has more capacity
   Method Of Application	Off the shelf adhesive electrode	Off the shelf adhesive electrode	Same
   Number of ECG leads	1	1	Same
   ECG resolution	12	24	Rooti Rx (implies higher resolution)
   ECG sampling rate (Hz)	1000	500	Both are more than double the highest useful frequency component (40Hz).
   Water resistant	Yes	Yes	Same
   Data transmission	Wireless	Wireless	Same
   Power source	Rechargeable battery	Rechargeable battery	Same
   Weight (g)	33	14	Rooti Rx System is lighter
   Dimensions (mm)	88 x 48 x 8	62 x 22.5 x 8.45	Rooti Rx System is smaller

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

   • Not specified. The document does not describe a clinical test set or its sample size or provenance for direct performance evaluation. The "performance testing results" mentioned in the Conclusion likely refer to bench testing or engineering verification against electrical and physical standards, rather than clinical performance for ECG interpretation accuracy.

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

   • Not applicable / Not specified. No such information is provided as there's no described clinical test with expert-established ground truth.

4. Adjudication method for the test set:

   • Not applicable / Not specified. No adjudication method is described.

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 study described. The device is an ECG event recorder for post-analysis by medical professionals, implying that the device records the data for human interpretation, rather than providing AI-assisted diagnostic recommendations in a way that would alter human reader performance. The document focuses on the recording and transmission capabilities, not automated ECG interpretation.

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

   • No standalone algorithm performance described. The device's function is to record ECG data for post-analysis by medical professionals. It does not claim to perform automated diagnosis or interpretation independently.

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

   • Not applicable / Not specified for a clinical test set. The substantial equivalence argument relies on the device acquiring and transmitting ECG data similarly to a predicate, not on a ground truth for diagnostic accuracy derived from a clinical population.

8. The sample size for the training set:

   • Not applicable / Not specified. There is no mention of an AI algorithm or a training set for machine learning.

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

   • Not applicable / Not specified. There is no mention of an AI algorithm or a training set for machine learning.

Summary from the provided text:

The information primarily indicates that the Rooti Rx System is a single-lead ECG event recorder designed for home or workplace use, allowing patients to record ECG data for later review by medical professionals. The filing aims to demonstrate its substantial equivalence to an existing predicate device (BIOMODULE 3-M1) by comparing its intended use, indications for use, and technological characteristics. The document asserts that any differences are not significant and do not raise new safety or efficacy concerns. It does not provide details on specific performance studies against clinical diagnostic accuracy acceptance criteria, nor does it describe any AI components or their validation.

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The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.

The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.

The Physiotrace™ Smart device is a wearable ECG monitor. The provided text outlines its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and meeting recognized standards, rather than providing specific quantitative acceptance criteria for ECG performance parameters in a table format. However, based on the text, we can infer some key performance aspects and how "acceptance" was determined:

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

• Sample Size: The document does not explicitly state the sample size (number of participants) used for the clinical study. It mentions "a clinical study was performed," implying a test set was used.
• Data Provenance: The document does not specify the country of origin. The study was described as a "clinical study performed during the exercise scenario." It is presented as a prospective study given it was an evaluation of the device in use.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. It mentions the data is transmitted to "a server for review by healthcare team," implying professional review, but specifics are lacking.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication methods like 2+1, 3+1, etc., for the test set interpretation in the clinical study.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is an ECG monitor, not an AI-powered diagnostic tool, and the focus is on the accuracy of physiological data acquisition and transmission.

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

The document implies a form of "standalone" assessment in that the device acquires and transmits data for "review by healthcare team." While the device itself doesn't perform diagnosis, its ability to accurately record ECG data for up to 60 minutes was evaluated. The performance comparisons against standards (e.g., 60601-2-47) are a form of standalone performance assessment for the device's signal acquisition capabilities.

7. Type of Ground Truth Used:

For the clinical study, the ground truth for device performance (safety and effectiveness) would likely be based on:

• Clinical observation and assessment: To determine safety and effectiveness during exercise.
• Comparison against reference standards/predicate device: The document states "device performance and safety and effectiveness was found to be equivalent or better than the predicate device," suggesting direct comparison.
• Compliance with recognized physiological monitoring standards: As mentioned for ECG performance (e.g., 60601-2-47).

8. Sample Size for the Training Set:

The document does not mention a training set, as this is typically relevant for machine learning or AI-based devices. The Physiotrace™ Smart appears to be a physiological data acquisition and transmission device, not one that relies on a trained algorithm for its primary function.

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

Not applicable, as no training set is mentioned for this device.

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The IDM100 is for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years, except as noted below), adolescent (between 13 years and 17 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous monitoring.
Vital Sign and Cardiopulmonary Tests:
• Signal acquisition and display for 12 lead ECG waveform and 3-lead thythm for evaluation and diagnosis of patient cardiac function. ECG calculation of diagnostic measurements is provided for adult patients only.
• Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
• Patient temperature provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal, and axillary temperatures.
• SpO2 Oximeter for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2), wulse rate, and optional Respiratory Rate.
• Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
• Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient.
• Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient.
• Manual interface for height, weight, respiratory rate, and other manually captured patient information.

The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection. The IDM100 applications range from routine screening in ambulatory care facilities, to physician offices, hospitals and patient homes with traveling HCP (Health Care Professional) or by the patient (layperson). (See indication of use for limitations.) The diagnostic capabilities are designed for the clinical populations described in the indications, including neonatal, pediatric, and adult.

Here's the information regarding the IDM100 device's acceptance criteria and the study that proves it meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Spirometry: Not explicitly stated, but the testing was "performed according with American Thoracic Society (ATS) Standards."
   • Audiometry: Not explicitly stated.
   • ECG Measurements: Not explicitly stated, but involved "three methods: CSE Database Verification, Data Collection, and a Clinical Verification."
   • NIBP Device Evaluation: Not explicitly stated, involved "visual inspections and testing."
   • Tympanic Thermometer: Not explicitly stated, involved "accuracy testing."
   • Low Perfusion SpO2/Pulse Rate Accuracy: Not explicitly stated, involved a "Simulated Low Perfusion Saturation And Pulse Rate Accuracy Study Using A Pulse Simulator."
   • Data Provenance: Not specified, but given the nature of the device and testing, it's likely a mix of lab-based/simulated data and potentially clinical data (for ECG clinical verification). The document does not specify country of origin or whether it was retrospective or prospective.

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

   • Not explicitly stated. Ground truth for most tests appears to be based on established industry standards and reference instruments (e.g., ATS standards for spirometry, ANSI/ASA for audiometers, CSE Database for ECG, EN standards for NIBP, and reference devices for temperature/SpO2). For "Clinical Verification" of ECG, it implies expert review, but the number and qualifications are not detailed.

3. Adjudication method for the test set:

   • Not explicitly stated. The document simply reports that "results were satisfactory" or "validated" against specified standards or reference data.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study is mentioned. This device is a vital signs monitor and diagnostic tool, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies involving human readers and AI. The device's functionality is about data acquisition and display, with some automated measurements (like ECG diagnostics for adults, MAP calculation), not interpretation by human readers that would be augmented by AI in the context of a typical MRMC study.

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

   • The document implies standalone performance testing against standards for each of its functions (ECG measurements, Spirometry, Audiometry, NIBP, etc.). The device itself performs these measurements or calculations without explicit human intervention in the measurement acquisition and initial processing phase, though a healthcare professional is responsible for operating it and interpreting the results.

6. The type of ground truth used:

   • Reference Standards/Devices: For spirometry, ATS standards. For audiometry, ANSI/ASA S3.6-2010. For ECG, CSE Database and clinical verification. For NIBP, EN1060-3. For temperature and SpO2/pulse rate, accuracy testing against reference (simulators or calibrated devices).
   • Clinical Verification: Mentioned for ECG, implying comparison to established clinical methods or expert opinion.

7. The sample size for the training set:

   • Not applicable/Not mentioned. The document describes a medical device for vital sign measurement and diagnostic tests, not a machine learning or AI algorithm that would typically require a training set in the conventional sense for its core functionality. The "Software Validation" refers to general software engineering principles and risk assessment, not AI model training.

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

   • Not applicable, as no training set for an AI model is described.

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The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years &

The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection.

The provided document is a 510(k) Summary for the IDM100 device. While it describes various tests performed for safety and effectiveness, it does not clearly present specific acceptance criteria in a table format for performance metrics or a detailed study proving the device meets these criteria in the way typically expected for a detailed clinical performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Tempus IC2, K152124) by comparing indications for use, technological characteristics, and by performing various verification and validation tests against recognized standards.

Here's an attempt to extract and synthesize the requested information based on the provided text, highlighting where information is not explicitly available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by conformity to specific standards and satisfactory results from various tests, rather than explicit numerical thresholds given in a table. The document focuses on demonstrating that the IDM100's components meet established standards for similar devices or that its overall performance is comparable to a predicate device.

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

• ECG Clinical Testing:
  • Sample Size: "18 normal and abnormal ECG patients" were compared for the 12-lead ECG function.
  • Data Provenance: Not specified (e.g., country of origin). It's described as a "clinical evaluation," suggesting prospective data collection for this specific comparison, but this is not explicitly stated.
• Other Tests (e.g., Low Perfusion, Tympanic Thermometer, NIBP): Sample sizes are not mentioned. These appear to be bench or lab-based tests rather than patient studies.

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

• ECG Clinical Testing: The document states that the IDM100 and the Welch Allyn CP150 (predicate) "provide comparable testing result, with no impact to the interpretation of the patients ECG." This implies that the interpretation was assessed, likely by experts, but the number and specific qualifications of these experts are not provided.
• Other Tests: Ground truth for these tests would typically be established by calibrated instruments or reference standards, not human experts in the conventional sense.

4. Adjudication Method for the Test Set

• ECG Clinical Testing: An explicit adjudication method (e.g., 2+1, 3+1) is not described. The statement "no impact to the interpretation of the patients ECG" suggests an expert review or comparison, but the process is not detailed.
• Other Tests: Adjudication methods are not applicable for these types of technical compliance tests.

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

• A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus human readers without AI assistance, was not mentioned or described in this document. The device itself is a vital signs monitor and data collection system, not an AI interpretation device that assists human readers in diagnostic tasks.

6. Standalone (Algorithm Only) Performance Study

• This device is not an algorithm that provides standalone diagnostic interpretations; it's a medical tablet integrating various diagnostic tools. Therefore, a standalone algorithm performance study, as typically understood for AI/ML devices, was not performed or described. The components (e.g., ECG, NIBP, SpO2) within the IDM100 undergo their own performance evaluations against standards, which implicitly represent their "standalone" capability. The statement "Passing IEC 60601-02-25 confirms the safety and accuracy for IDM100 12-lead and 3-lead IDM ECG testing" relates to the standalone performance of the ECG module.

7. Type of Ground Truth Used

• ECG Clinical Testing: The ground truth for the "normal and abnormal ECG patients" is implicitly their clinical presentation/diagnosis as determined by standard clinical practice and the predicate device's output, which the IDM100 was compared against. It's a comparison to a predicate device's output and clinical interpretation, rather than de novo gold standard like pathology or long-term outcomes.
• Other Tests (e.g., Tympanic Thermometer, NIBP): The ground truth for these tests comes from calibrated reference standards as defined by the respective international standards (e.g., EN1060-3 for NIBP).

8. Sample Size for the Training Set

• This document describes a medical device integrating existing, FDA-cleared diagnostic components and a tablet interface for data collection and transmission. It does not mention the use of a machine learning or AI algorithm that would require a distinct "training set" for an AI model.

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

• As the document does not describe the use of a machine learning or AI algorithm requiring a training set, this question is not applicable.

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The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity.

The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.

The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.

Here's the information about the acceptance criteria and the study for the HMicro Wired C-Patch Electrode, extracted from the provided text:

Acceptance Criteria and Device Performance Study for HMicro Wired C-Patch Electrode

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

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

• Sample Size: 15 volunteers (netting usable ECG tracings data from 13 volunteers).
• Data Provenance: The document does not explicitly state the country of origin. It was an engineering study involving volunteers, implying a prospective study.

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

The document does not mention the use of experts to establish a ground truth or their qualifications. The study focused on the usability of data by comparing ECG tracings from the subject device to a predicate device.

4. Adjudication method for the test set

The document does not describe an adjudication method involving experts for the test set. The comparison appears to have been based on similarity of ECG tracings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an electrode, not an AI-powered diagnostic system, so the concept of human readers improving with AI assistance is not applicable here.

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

This is not applicable as the device is an ECG electrode, not an algorithm. The study evaluated the ability of the electrode to produce usable ECG data.

7. The type of ground truth used

The "ground truth" in this context was established by:

• Comparison to a predicate device: The 3M Red Dot electrodes, a commercially available and legally marketed device, served as the comparative standard.
• Usable ECG tracings: The primary outcome measured was the similarity of the ECG tracings produced by the HMicro C-Patch to those from the predicate device.

8. The sample size for the training set

This is not applicable. The device is hardware (an ECG electrode), not a machine learning algorithm that requires a training set.

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

This is not applicable, as there is no training set for this device.

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The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).

MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.

The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.

The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.

The provided document is a 510(k) premarket notification for the MyHealthPoint TeleHealth Manager, a software platform. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for an AI algorithm.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not available or not applicable to this type of submission:

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: Not specified. The submission describes "extensive bench testing" and "user performance testing" but does not provide any details on the number of cases, data points, or users involved in these tests.
• Data Provenance: Not specified. The document does not mention the country of origin of any data, nor whether it was retrospective or prospective. Given the nature of a 510(k) for a software platform emphasizing substantial equivalence and verification of data transfer/storage, the focus is on functional testing rather than clinical data from a patient population.

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

• Not Applicable / Not Specified. The submission does not detail any expert-derived ground truth or clinical interpretations. The "performance" assessment focuses on the software's ability to capture, transmit, and store data correctly, and the usability of the manual. It's a technical verification, not a clinical validation requiring expert ground truth.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. No adjudication method is mentioned as there's no indication of a diagnostic or interpretive task requiring expert consensus for ground truth establishment.

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

• No. An MRMC study was not done. The device is a data management and communication system, not an AI algorithm performing diagnostic interpretations that would typically be evaluated in an MRMC study. The document states it "does not measure, interpret or make any decisions on the data that it conveys."

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

• Partially Applicable / Not Explicitly Described as "Standalone Study". The "Verification testing that product meets product performance and functional specifications" and "Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly" essentially describe standalone testing of the software's core functionalities (data handling, transmission, storage). However, it's not structured as a typical "standalone algorithm performance study" for an AI diagnostic device, as the MyHealthPoint TeleHealth Manager itself is not an AI diagnostic algorithm.

7. Type of Ground Truth Used

• Functional/Technical Verification. The "ground truth" for the tests described would be based on expected software behavior and data integrity rather than clinical outcomes, pathology, or expert consensus on a medical diagnosis. For example, for data integrity, the ground truth would be that the transmitted data perfectly matches the source data. For functional specifications, the ground truth would be the defined expected behavior of the software.

8. Sample Size for the Training Set

• Not Applicable / Not Specified. The MyHealthPoint TeleHealth Manager is described as a software platform for data collection and display, not a machine learning or AI algorithm that requires a training set. There is no mention of an algorithm being trained on data.

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

• Not Applicable / Not Specified. As there is no mention of a training set or an AI algorithm requiring training, the establishment of ground truth for such a set is not discussed.

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The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.

The BioModule 3-M1 collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods.

The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

The BioModule 3-M1, a physiological sensor / transmitter is composed of:

• proprietary hardware and firmware, enclosed in
• a user case (puck) with a re-chargeable battery. .
• . a adhesive electrode set and
• A cradle (to recharge battery and transfer internally stored date to an ancillary computer).

The BioModule 3-M1 is a physiological transmitter manufactured by Zephyr Technology Corporation with disposable, off the shelf electrodes that transmits data to a qualified receiving station. The BioModule 3-M1 is positioned against the patient's skin with light pressure then pressed to adhere.

The document provided is a 510(k) summary for the BioModule 3-M1, a physiological monitoring telemetry device. It focuses on establishing substantial equivalence to a predicate device (BioHarness 3.0, K113045) rather than on presenting a detailed study proving performance against specific acceptance criteria for the algorithm's accuracy.

Therefore, many of the requested details about acceptance criteria, specific study design elements (like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies), and "reported device performance" in terms of algorithm accuracy, are not present in this type of regulatory submission.

The document primarily states general safety and effectiveness and claims that the device has been tested to confirm these. It emphasizes the similarity in technological characteristics and principles with its predicate device.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is explicitly not available:

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

• The document does not provide a specific table of acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for ECG detection or heart rate measurement) or quantitative reported device performance metrics against such criteria.
• Instead, it states: "A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life." This is a general statement about manufacturing quality control rather than a clinical performance study.
• The primary "performance" discussed is the capability to "detect and transmit single lead ECG signals" and that "Breathing rate values are accurately transmitted only during sedentary periods." These are functional descriptions, not quantitative performance metrics.

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

• Not provided. The document does not describe a test set or clinical study with patient data. It refers to "factory tests."

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)

• Not applicable / Not provided. Since there's no described test set with clinical data requiring expert ground truth, this information is not present.

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

• Not applicable / Not provided. No clinical test set or adjudication process is mentioned.

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 (or at least not described in this document). The device is a physiological sensor/transmitter, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

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

• The document implies that "factory tests" were done to verify signal accuracy. However, no specific standalone algorithm performance study (e.g., sensitivity/specificity for arrhythmia detection) is described. The focus is on the device's ability to capture and transmit physiological signals reliably, rather than the performance of a sophisticated AI algorithm.

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

• Not provided. Given the nature of "factory tests," the "ground truth" would likely be derived from calibrated signal generators or known physiological inputs, rather than clinical data requiring expert consensus or pathology.

8. The sample size for the training set

• Not provided. The document does not describe a machine learning training set.

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

• Not applicable / Not provided. No training set is mentioned.

Summary of what is present:

• Device Description: BioModule 3-M1, a physiological sensor/transmitter composed of hardware, firmware, user case, adhesive electrode set, and a cradle. It captures electrical pulses from the skin via electrodes, converts them to digital signals, processes them, and transmits them.
• Intended Use/Indications for Use: Monitoring ambulatory patients in alternate care settings, providing physiological information (ECG, heart rate, respiration rate, body orientation, activity) as part of a general ward monitoring system. Breathing rate is accurate only during sedentary periods.
• Predicate Device: Zephyr Technology, BioHarness 3.0, K113045.
• Substantial Equivalence Claim: The BioModule 3-M1 is "substantially equivalent" to BioHarness 3.0, with "incidental and not significant" differences. Both use electrodes, convert analog to digital signals, use microprocessors/firmware/signal processing, and transmit signals for ECG waveforms.
• Safety and Effectiveness Justification: "Factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."

In essence, this 510(k) summary focuses on demonstrating that the new device is fundamentally similar to an already cleared predicate device, and that its basic function and manufacturing processes ensure safety and effectiveness, rather than detailing a clinical study with stringent acceptance criteria for an AI algorithm's specific performance metrics.

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