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ArtUs is a general purpose diagnostic ultrasound imaging system intended for use by qualified and appropriately trained healthcare professionals to conduct ultrasound scan process or fluid flow analysis of the human body.

It is intended to be used for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles), Musculo-Skeletal Conventional and Superficial, Cardiac (adult and pediatric), Adult Cephalic, and Peripheral Vascular.

Modes of operation include B, M, Pulse Wave Doppler (CFM), Power Doppler (CFM), Power Doppler (PDI), Directional Power Doppler (DPDI), Combined modes (B+B, B+M, 4B, B+PWD (Duplex), B+CFM/PDI/DPDI+PWD (Triplex)), Tissue Harmonic Imaging (THI) and Inverted Tissue Harmonic Imaging (ITHI).

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

ArtUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.

ArtUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz.

The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed.

The ArtUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the ArtUs via USB 3.0. Minimum requirements are given for the PC.

The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.

The device variant is:

• ArtUs EXT-1H ultrasound system utilizing as hardware an ultrasound engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply;
  The ArtUs can be used together with the appropriate transducers for the entire ultrasound diagnostic (2MHz to 15MHz probes).

This document is a 510(k) Pre-market Notification for the ArtUs ultrasound system. It claims substantial equivalence to predicate devices and focuses on technical specifications, safety, and regulatory compliance.

Crucially, this document does not contain information about studies proving the device meets specific acceptance criteria related to its diagnostic performance. It focuses on engineering acceptance criteria (e.g., meeting safety standards, biocompatibility, acoustic output, software functionality) and demonstrating substantial equivalence to previously cleared devices rather than novel diagnostic efficacy.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain the required information for diagnostic performance studies.

Here's what can be extracted and what cannot:

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

Since this is a submission for substantial equivalence based on safety and technical performance rather than diagnostic accuracy, the acceptance criteria are generally related to compliance with standards and equivalence to predicate devices. No diagnostic performance metrics (e.g., sensitivity, specificity) are provided.

For points 2 through 9, the document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices." This means there was no diagnostic performance study with a test set of patients to establish accuracy metrics such as sensitivity, specificity, or reader performance.

Therefore, the following points cannot be addressed from the provided text:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* Not applicable, no diagnostic performance test set described.

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, no ground truth for a diagnostic test set described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* Not applicable, no diagnostic test set 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
* Not applicable. This document describes an ultrasound device, not an AI-powered diagnostic algorithm for clinical interpretation. It does not mention AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is not an AI algorithm submission seeking standalone diagnostic performance clearance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not applicable for diagnostic performance. Ground truth for safety and technical performance would be based on standard engineering and biocompatibility testing procedures.

8. The sample size for the training set
* Not applicable. This document is not for an AI algorithm that would typically have a training set.

9. How the ground truth for the training set was established
* Not applicable. This document is not for an AI algorithm.

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SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at thebedside systems, for navigatedmedical application, in operating rooms/critical care units.

SmartUs EXT-1M/3M system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. SmartUs EXT-1M/3M system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode, M-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed. SmartUs EXT-1M/3M only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the SmartUs EXT-1M/3M via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC. The device modifications are: - SmartUs EXT-1M ultrasound system utilizing as hardware an ultrasound ● engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply; - SmartUs EXT-3M ultrasound system -modification with 3 probe ports ● The SmartUs EXT-1M/3M can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes). - . probe L15-7L40H-5, linear array, at a central ultrasonic frequency of approx. 12 MHz; - probe C5-2R60HI-5, convex array at a central ultrasonic frequency of approx. 3.5 MHz; ● - probe P5-1L15SI-6, phased array at a central ultrasonic frequency of approx. 4 MHz. ●

The provided document describes a 510(k) premarket notification for the SmartUs EXT-1M/3M ultrasound imaging system.

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

Key Takeaway: The submission makes a case for substantial equivalence to predicate devices. This means the primary "study" proving the device meets acceptance criteria is a comparison to already cleared devices and adherence to relevant safety and performance standards, rather than a standalone clinical efficacy study for novel indications.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a test set with patient data for clinical performance evaluation. The "study" here is primarily a demonstration of compliance with national and international safety and performance standards and a comparative analysis to predicate devices.

• Sample Size: Not applicable in the context of a clinical test set. The evaluation focuses on engineering and regulatory compliance, and a comparison to predicate devices, which implies the predicate devices' prior clinical performance supports the current device's claims.
• Data Provenance: Not specified, as no clinical data set is referenced for the SmartUs EXT-1M/3M itself beyond the compliance with standards. It relies on the established performance of the predicate devices.

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

Not applicable. There is no specific test set requiring expert-established ground truth for the SmartUs EXT-1M/3M itself for efficacy. The "ground truth" for substantial equivalence rests on the established regulatory classifications and performance of the predicate devices and general consensus on ultrasound imaging principles.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set 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

Not applicable. The device described is a general diagnostic ultrasound imaging system, not an AI-powered diagnostic system requiring an MRMC study to evaluate AI assistance.

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

Not applicable. The system is an ultrasound imaging device, which requires a human operator (sonographer/clinician) to acquire and interpret images. There is no mention of a standalone algorithm for automated diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the SmartUs EXT-1M/3M, the "ground truth" for its acceptance is based on adherence to established engineering and medical device safety standards, and the precedent set by predicate devices that have already demonstrated safety and effectiveness in clinical use. No new specific clinical "ground truth" (e.g., pathology, outcomes) was generated for this 510(k) submission for efficacy claims.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound machine, not a machine learning or AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for an AI algorithm.

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MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigation, in operating rooms/critical care units.

MicrUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.

MicrUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 15 MHz.

The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, inclusive of the predicate devices so claimed.

The MicrUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the MicrUs via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived.

The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.

The basic modification MicrUs EXT-1H ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port.

The MicrUs can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).

The provided text describes the MicrUs ultrasound imaging system and its intended use, as well as regulatory information from an FDA 510(k) premarket notification. However, it does not explicitly detail specific acceptance criteria or a study designed to prove the device meets performance criteria in the way a clinical performance study would for an AI/ML device.

This document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through new performance studies. The performance standards mentioned are related to safety and effectiveness broadly, not specifically to detailed clinical performance metrics like sensitivity or specificity for a diagnostic algorithm.

Therefore, many of the requested elements for describing acceptance criteria and a study proving their achievement are not present in the provided text.

Here's what can be extracted and what is explicitly not available:

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

The document does not explicitly state quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML algorithm, nor does it report device performance against such criteria. The "performance standards" listed are related to general safety and operational standards (e.g., IEC, ISO, NEMA) rather than specific diagnostic performance metrics for an AI-powered diagnostic output.

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

• Not Applicable/Not Provided. The document does not describe a test set or data derived from a clinical study to evaluate diagnostic performance. The submission is based on demonstrating substantial equivalence through compliance with safety standards and a comparison to predicate devices, not on a new clinical performance study.

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. No test set requiring expert-established ground truth is described.

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

• Not Applicable/Not Provided. No test set requiring adjudication 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

• Not Applicable/Not Provided. The document is for an ultrasound imaging system, not an AI-assisted diagnostic tool requiring an MRMC study for improved human reader performance.

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

• Not Applicable/Not Provided. The device is an ultrasound imaging system, not a standalone diagnostic algorithm.

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

• Not Applicable/Not Provided. No ground truth data is discussed as there is no specific diagnostic performance study mentioned for a new diagnostic algorithm.

8. The sample size for the training set

• Not Applicable/Not Provided. The document describes an ultrasound imaging system, not an AI/ML device requiring a training set for an algorithm.

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

• Not Applicable/Not Provided. No training set is discussed.

Summary from the provided text:

The MicrUs is an "ultrasonic pulsed echo imaging system" intended for various applications including fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic cardiac adult, and peripheral vessel imaging. It supports B and M-mode imaging, including for needle guidance. The submission focuses on demonstrating compliance with safety and effectiveness standards and substantial equivalence to predicate devices (TELEMED; Echo Blaster K102253).

The "Performance Standards" section (pages 9-10) lists the following criteria, which are primarily related to general safety and technical performance of the ultrasound device, not diagnostic accuracy metrics:

• IEC 60601-1: 2005 (General requirements for basic safety and essential performance)
• IEC 60601-1-2: 2007 (Electromagnetic compatibility)
• IEC 60601-2-37:2007 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment)
• ISO-10993-1:2009, ISO-10993-5, ISO-10993-10:2010 (Biological Evaluation of Medical Devices)
• IEC 62304: 2006 (Medical device software -- Software life cycle processes)
• NEMA UD 2-2004: 2003 (Acoustic Output Measurement Standard)
• NEMA UD 3-2004: 2004 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices)
• AIUM MUS: 2002 (Medical Ultrasound Safety)
• Essential Requirements of Council Directive 93/42/EEC (Medical Device Directive)
• Acoustic output "in accordance with ALARA principle (as low as reasonably achievable)" and below FDA recommended limits.

The document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison." This reinforces that the submission is for an established technology proving equivalence, not for a new diagnostic algorithm requiring dedicated clinical performance studies with acceptance criteria for sensitivity/specificity/accuracy.

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The TM eCloud ECG Analysis System, using proprietary algorithm, is intended for use in adults and children of any age from birth upwards. The Program makes significant use of the patient's age and gender and will provide a unique diagnosis if age differs only by a few days in the case of neonates. It is a program that is based on normal limits derived using the algorithm itself with this applying to criteria for subjects of all ages, including neonates.

TM eCloud ECG Analysis System is qualified to evaluate, detect, and aid in the physician diagnosis of the following cardiac arrhythmias and/or conduction defects:

• o Evaluation of symptoms that may be caused by cardiac arrhythmia and /or conduction disturbances
• Evaluation of symptoms that may be due to myocardial ischemia
• Detection of ECG events that alter prognosis in certain forms of heart disease
• Detection and analysis of indirect pacemaker function and failure
• Determination of cardiac response to lifestyle
• Evaluation of therapeutic interventions
• . Investigations in epidemiology and clinical trials
• Evaluation of heart rate variability in the assessment of heart disease

TM eCloud ECG Analysis System is intended to provide an interpretation of up to 12-channel ECG in all situations including resting and ambulatory ECG including Holter, cardiac event, and mobile cardiac telemetry. This software qualifies to be used in hospitals, physician offices, and scanning services. It is designed for acquisition, analysis, edit, review, report and storage of all ECG and multi-parameter data. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), acute MI, ventricular hypertrophy, abnormal ST-T changes, lethal arrhythmias, and common rhythm abnormalities.

TM eCloud ECG Analysis System can analyze recordings performed on newborns, children, and adults.

TM eCloud ECG Analysis System's interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG that may be detected. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The TM eCloud ECG Analysis System consists of a (1) server-side, application Platform as a Service (PaaS) cloud based system, a (2) desktop client-side application, and (3) a web-based Physician Portal website.

The (1) server-side, application PaaS component collects, stores, performs arrhythmia analysis on ECG uploads, and transfers data to and from the client-side application.

The (2) desktop client-side application is a workstation system which allows technicians to review ECG, edit the analysis results produced by the (1) server-side, application PaaS component, and generate reports for the ECG study. The edited results and reports are uploaded to the (1) server-side, application PaaS component. It also allows notifications and updates to (3) Physician Portal website.

The TM eCloud ECG Analysis System is capable of processing and performing arrhythmia analysis on ten seconds to 60 days of recorded ECG from one to 12 channels. The system is designed to be compatible with any stationary or ambulatory ECG device having the ability to export ECG. Typical compatible devices interfaces include Cardiac Mobile Telemetry, Event recorders, and Holter recorders but is not limited to a particular ECG device. ECG interfaces from desperate devices are translated by Telemed Adapters which convert proprietary formats to the Physionet WFDB MIT format but vendors may choose to provide the Physionet WFDB directly and bypass the use of an adapter.

The purpose of the TM eCloud ECG Analysis System is to determine if any irregular rhythms, irregular beats, conduction defects, or ST depression occurred during the recording or monitoring. A qualified physician can then use the results of the analysis report to determine what action needs to be taken to help the patient reduce or prevent the occurrence of these abnormalities.

The users may upload ECG to the TM eCloud ECG Analysis System via a cellular network, REST web service, or FTP from any computer or cellular equipment. The system performs analysis on the uploaded ECG using the proprietary 12 Lead Diagnostic EKG Analysis Engine or proprietary algorithm Reduced Lead 1-7 lead Analysis Engine and downloads the results to the client.

If detected, the ECG engine will report on the following arrhythmias: ventricular ectopy, atrial ectopy, pauses, heart block, junctional rhythms, hemiblock, LBBB, RBBB, ST anomalies, and prolonged QT. It will display up to 900 statements including atrial fibrillation, ventricular fibrillation/flutter, and WPW.

The (2) client workstation software employs several screens to display the ECG data. These screens include: 5-Minute View, Hourly view, or Daily view, 8-Second View, Arrhythmias Only View, time and frequency domain HRV, ST changes, AF burden. All analyzed data is saved in a database. From there data can be organized into a report that can be printed on paper or distributed electronically.

Although the analysis engine reports arrhythmias and abnormalities with a high rate of accuracy, all results need to be reviewed and/or edited by a qualified medical professional.

The provided document is a 510(k) premarket notification summary for the TM eCloud ECG Analysis System. It outlines the device's indications for use, its description, and non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

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

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

The document does not explicitly present a table of "acceptance criteria" alongside specific reported device performance metrics in a pass/fail format. Instead, it details that testing was performed according to ANSI/AAMI EC57:2012 - Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms. This standard itself defines methodologies and expectations for performance. The summary states that "Accuracy of QRS detection analysis," "Accuracy of heart rate measurements (HRV)," "Accuracy of VEB detection analysis," "Accuracy of Ventricular Flutter or Fibrillations," "Accuracy of supraventricular ectopic beats and Atrial Flutter or Fibrillations," and "Accuracy of ST segment deviations or to detect ST changes" were tested.

However, the document does not report specific quantitative performance values (e.g., sensitivity, specificity, accuracy percentages, or limits of agreement) for any of these metrics for the TM eCloud ECG Analysis System. Therefore, a table comparing reported performance against acceptance criteria cannot be constructed from this document. The conclusion merely states that the "results show that... the software is equivalent in safety and effectiveness."

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

The testing was conducted using several publicly available datasets, which serve as the test sets for different aspects of the algorithm. The provenance and sample sizes for these databases are:

• CSE (Common Standards for Quantitative Electrocardiography) Database:
  • Sample Size: 1220 ECGs
  • Provenance: Recorded from individuals living in several European countries.
  • Nature: Retrospective (as it's an existing database).
• Glasgow 1000 ECG Database:
  • Sample Size: 1000 ECGs
  • Provenance: Implied to be from Glasgow, UK.
  • Nature: Retrospective. Widerange of normal and abnormal ECGs, including arrhythmias, conduction defects.
• Glasgow Adult Normal Database:
  • Sample Size: 1498 ECGs
  • Provenance: Implied to be from Glasgow, UK.
  • Nature: Retrospective. From apparently healthy individuals examined by a physician, with no evidence of heart disease or conditions like diabetes. Used for determining normal limits of ECGs (e.g., QT interval).
• Glasgow Pediatric ECG Database:
  • Sample Size: 840 ECGs
  • Provenance: Implied to be from Glasgow, UK.
  • Nature: Retrospective. From neonates, infants, and children referred or admitted to hospital for investigation.
• Glasgow Pacemaker ECG Database:
  • Sample Size: 47 ECGs
  • Provenance: Implied to be from Glasgow, UK.
  • Nature: Retrospective. Selected where pacemaker stimuli were correctly detected by inspection.
• Glasgow Atrial Fibrillation Database:
  • Sample Size: 72 additional cases (supplementing the 1000 ECGs database).
  • Provenance: Implied to be from Glasgow, UK.
  • Nature: Retrospective. Used to supplement cases of atrial fibrillation for rhythm analysis assessment.
• MIT-BIH Arrhythmia Database:
  • Sample Size: Not specified directly in the document, but it's a well-known public database for arrhythmia analysis.
  • Provenance: Not specified.
  • Nature: Retrospective. Used for QRS detection, HR measurements, VEB detection, Ventricular Flutter/Fibrillations, supraventricular ectopic beats, Atrial Flutter/Fibrillations.
• AHA Database of Evaluation of Ventricular Arrhythmia Detectors:
  • Sample Size: Not specified.
  • Provenance: Not specified.
  • Nature: Retrospective. Used for QRS detection, HR measurements, VEB detection, Ventricular Flutter/Fibrillations.
• Noise Stress Test Database:
  • Sample Size: Not specified.
  • Provenance: Not specified.
  • Nature: Retrospective. Used for QRS detection, HR measurements, VEB detection, supraventricular ectopic beats, Atrial Flutter/Fibrillations.
• Congestive Heart Failure RR Interval Database:
  • Sample Size: Not specified.
  • Provenance: Not specified.
  • Nature: Retrospective. Used for heart rate variability (HRV) analysis.
• Creighton University Ventricular Tachyarrhythmia Database (CU):
  • Sample Size: Not specified.
  • Provenance: Not specified.
  • Nature: Retrospective. Used for Ventricular Flutter or Fibrillations.
• European ST-T Database:
  • Sample Size: Not specified.
  • Provenance: Not specified.
  • Nature: Retrospective. Used for ST segment deviations or ST changes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

The document does not explicitly state the number or qualifications of experts used to establish ground truth for these pre-existing databases. These databases are generally compiled with established and widely accepted ground truths, often based on expert consensus, but the specific number and qualifications of those who performed the original annotations are not detailed in this submission. For example, the Glasgow Adult Normal Database indicates ECGs were taken from individuals "examined by a physician," but this pertains to patient selection, not ground truth annotation for algorithm testing.

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

The document does not specify the adjudication method used for establishing the ground truth of the various databases. Publicly available databases often have their ground truth established by expert review, sometimes with multiple readers and an adjudication process, but this information is not provided within this 510(k) summary.

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:

The document describes standalone algorithm performance testing against established databases, not a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no reported effect size of human readers improving with AI vs. without AI assistance. The device is designed to provide an interpretation on an "advisory basis only" to physicians and clinicians.

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

Yes, a standalone algorithm-only performance study was done. The sections "Databases used for Non-Clinical Testing" and "Reduced lead testing was performed in accordance with ANSI/AAMI EC57/Ed.3" clearly describe the algorithm being tested against various established ECG databases for accuracy in detecting different cardiac events. The "Conclusions from Non-clinical Testing" refer to the "software" (the algorithm) being equivalent to predicate devices.

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

The ground truth for the test sets (the various databases) is generally based on expert consensus interpretation of the ECGs, established at the time the databases were created. For example, the MIT-BIH Arrhythmia Database is renowned for its rhythm annotations made by cardiologists. The Glasgow databases would also rely on expert interpretation. The document doesn't mention pathology or outcomes data as the primary ground truth for the ECG interpretation accuracy testing.

8. The sample size for the training set:

The document does not specify the sample size for the training set used for the TM eCloud ECG Analysis System's proprietary algorithm. It only details the databases used for non-clinical testing (i.e., the test sets).

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

The document does not provide information on how the ground truth for the training set was established, as the training set details are not included in this summary. It only refers to a "proprietary algorithm" and "proprietary 12 Lead Diagnostic EKG Analysis Engine or proprietary algorithm Reduced Lead 1-7 lead Analysis Engine," but not their development or training methodology.

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The LogicScan 64 / LogicScan 128 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The applications are: cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

LogicScan 128 / LogicScan 64 color diagnostic systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. LogicScan 128 / LogicScan 64 is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 12 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. USB 2.0 connection between the beamformer and PC is a novel feature for ultrasound systems. The LogicScan 128 / LogicScan 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the LogicScan 128 / LogicScan 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the LogicScan 128 / LogicScan 64. All sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the LogicScan 128 / LogicScan 64. Software able to reside in a Windows-based PC. The LogicScan 128 / LogicScan 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 12MHz probes). Two probes can work simultaneously for LogicScan 128 2Z modifications.

This 510(k) submission for the TELEMED LogicScan 64/LogicScan 128 ultrasound systems is a predicate device comparison and does not describe an AI/ML device or present specific acceptance criteria and a study to prove performance metrics in the typical sense of AI/ML device evaluations.

Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices by showing compliance with established safety and performance standards for diagnostic ultrasound equipment. The "acceptance criteria" here are the regulatory and safety standards, and the "study" is the design and testing for compliance with these standards.

Therefore, the requested information elements related to AI/ML performance, ground truth, sample sizes for AI training/testing, expert adjudication, or MRMC studies are not applicable to this document.

Here's a breakdown of the relevant information provided in the document:

1. A table of (not applicable to AI/ML performance, but regulatory compliance):

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

• Not applicable. This submission is based on engineering design, compliance with international standards, and comparison to predicate devices, not on a clinical performance study with a test set of patient data.

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. No clinical test set with ground truth established by experts is described for performance evaluation in this 510(k) submission.

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

• Not applicable. No clinical test set 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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. The "ground truth" for this submission are the established regulatory and safety standards for ultrasound devices, against which the device's design and physical properties were evaluated for compliance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" to prove the device meets acceptance criteria, in this context, is the demonstration of compliance with a comprehensive set of international and national safety and performance standards for medical devices, particularly diagnostic ultrasound equipment. This includes:

• Design and Engineering Compliance: The LogicScan family was designed to meet standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, AIUM MUS, ISO 10993 series (for biocompatibility), IEC 62304 (for software), and ISO 14971 (for risk management).
• Verification and Testing: The document states that "Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness." This indicates internal verification and validation testing against the specified standards.
• Predicate Device Comparison: The core of a 510(k) submission for this type of device is the argument of "substantial equivalence" to legally marketed predicate devices (SAMSUNG MEDISON CO., LTD MySono U5 Diagnostic Ultrasound System K100186 and SonoAce R7 Diagnostic Ultrasound System K112646). The applicant asserts that there are "no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound." This comparison serves as the primary "proof" for market clearance, rather than a novel clinical effectiveness study for a new technology.
• No Additional Clinical Testing Required: The submission explicitly states, "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices."

In conclusion, the TELEMED LogicScan 64/LogicScan 128's acceptance criteria are regulatory and safety standards, and the proof of meeting these criteria is via design for compliance, internal validation testing, and demonstration of substantial equivalence to existing, legally marketed ultrasound devices.

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The TMC Health Monitor is intended to facilitate monitoring and transmission to a remote server of certain physiological parameters relevant to the remote management of health status and chronic disease conditions.

The TMC Health Monitor is a system that provides:

• Monitoring and display of vital signs/health parameters.
• Management and scheduling of clinical measurements and questionnaires.
• A web connection to patient health information.
• Reporting to clinicians and allied health workers.

The device has been designed to provide the user with information to assist with an appropriate treatment program or further investigation.

The TeleMedCare Health Monitor is designed to be used in the home or community setting to enable remote care management of patients with chronic illness.

The TeleMedCare Health Monitor is an ergonomic design table top device with a touch screen and associated measurement components that may be integral or connected to it wirelessly or by cable. After measurements are recorded, the data is viewed and stored on the device then automatically transmitted via telephone modem or local area network (LAN) to a secure remote server. This data is then able to be viewed remotely over the web by the user's health care professional to assist them with chronic care management. Access to information stored and processed by the device is by means of password protection, encryption and use of collocated secure servers.

The device also provides a means of messaging and video teleconferencing between the patient and carer to discuss their health and treatment. Questionnaires may also be configured by the carer to gauge other aspects of a patients well being.

TeleMedCare software, captures, stores and transmits health data and access controlled carer's may set upper and lower limits to allow notification to them when these limits are exceeded to review health care management. The device however does not offer critical care or emergency support and requires professional medical interpretation for treatment of prescribed users.

The System has functionality and devices to record, store and transmit data for body blood pressure, glucose and oximetry, heart rate (ECG), lung function (Spirometry), body temperature and weight.

Power to the device is supplied by a medical grade power supply delivering 12 volts D.C to the system via a cable plugged into the back of the unit along with connection to tethered external measurement modules and the internet. The TeleMedCare Health Monitor has been tested and complies with international standards for electrical and electrocardiograph safety, electromagnetic compatibility and telecommunication standards.

The TeleMedCare Health Monitor is a patient monitoring system designed for remote care management of patients with chronic illnesses. The provided summary states that the device has undergone extensive internal bench testing, independent clinical trials, and product evaluations. It has been cleared for use in Australia, New Zealand, and Europe and is CE marked. The submission focuses on substantial equivalence to predicate devices rather than providing specific detailed acceptance criteria and a dedicated study report proving those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include an explicit table of acceptance criteria with corresponding performance metrics from a specific study. Instead, it relies on substantial equivalence to predicate devices and general compliance with recognized standards. The acceptance criteria are implicitly met through:

2. Sample Size for the Test Set and Data Provenance

The 510(k) summary does not specify a distinct "test set" and its sample size or data provenance in the context of a formal clinical validation study for the US submission. The emphasis is on:

• "Extensive internal bench testing": No details provided on sample size or how this relates to a test set.
• "Independent clinical trials and product evaluations by various health institutions and government and nongovernment organizations": These are reported to have been conducted since 2001 in Australia, New Zealand, and Europe. The specific sample sizes and detailed data provenance (e.g., country, retrospective/prospective nature) for these trials are not provided in this summary. However, it is stated that "hundreds of thousands of measurements have reliably been accumulated."

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

The 510(k) summary does not provide any information regarding the number or qualifications of experts used to establish ground truth for a discrete test set. The device itself is designed for "professional medical interpretation for treatment of prescribed users." The focus of the submission is on the device's technical and safety performance, and its substantial equivalence to other patient monitors.

4. Adjudication Method for the Test Set

No information is provided about an adjudication method for a test set, as a specific, detailed performance study with a test set and associated ground truth is not elaborated upon in this 510(k) summary.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided 510(k) summary. The document does not describe the device as an AI-powered diagnostic tool where human reader performance would be enhanced with AI assistance. It is a data collection and transmission system.

6. Standalone Performance Study

No specific standalone performance study (algorithm only without human-in-the-loop performance) is described in the provided summary. The device's performance is gauged by its reliability in data collection, storage, and transmission, and its compliance with relevant safety and technical standards as demonstrated over years of use in other markets and through general testing.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, outcomes data) is not directly applicable or discussed in this 510(k) summary. The device's function is to monitor and transmit physiological parameters, not to provide diagnostic interpretations. The "truth" for its claims would relate to the accuracy of its measurements and the reliability of its data transmission, which are addressed by compliance with standards and a history of reliable operation.

8. Sample Size for the Training Set

No information regarding a "training set" or its sample size is provided. The device described is a hardware and software system for data collection and transmission, not an AI/machine learning model that typically undergoes a training phase.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (since this is not an AI/ML device in the context of the summary), there is no information on how ground truth for such a set would have been established.

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Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid and testicles), cephalic (neonatal and adult), musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see ch.1.3). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Echo Blaster 128 / Echo Blaster 64 systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. Echo Blaster 128 / Echo Blaster 64 system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 10 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed. The Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Echo Blaster 128 / Echo Blaster 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the Echo Blaster 128 / Echo Blaster 64. All Sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave software was especially designed for the Echo Blaster 128 / Echo Blaster 64. Software able to reside in a Windows-based PC. The Echo Blaster 128 / Echo Blaster 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 10MHz probes can work simultaneously for Echo Blaster 128 2Z modifications.

The Telemed Echo Blaster 64 and 128 are ultrasound imaging systems. This 510(k) submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices by demonstrating compliance with safety and performance standards. The information provided does not detail a study involving clinical performance metrics typically associated with AI/algorithm-driven devices, as the product is a general-purpose ultrasound system.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established international and national safety and performance standards for medical electrical equipment and diagnostic ultrasound, rather than specific clinical performance metrics like sensitivity or specificity. The "reported device performance" is the assertion of full compliance with these standards.

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

The submission does not describe a clinical performance study with a "test set" in the context of an AI/algorithm-driven device. The device is a general-purpose ultrasound system. The "testing" involved compliance with established engineering, safety, and performance standards. Therefore, information about clinical test set sample size, country of origin, or retrospective/prospective nature is not applicable here.

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

Not applicable. As noted above, this submission doesn't describe a clinical performance study requiring expert-established ground truth for a test set. Evaluation was against technical standards.

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

Not applicable. No adjudications for a clinical test set are 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. This submission describes a general-purpose ultrasound imaging system, not an AI-assisted diagnostic algorithm. Therefore, no MRMC study comparing human reader performance with and without AI assistance was conducted or is relevant to this submission.

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

No. This is a hardware and software system for real-time ultrasound imaging operated by a human, not a standalone algorithm performing diagnostic tasks.

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

Not applicable. For this type of device (general-purpose ultrasound), "ground truth" relates to compliance with engineering specifications, safety limits and image quality parameters defined by industry standards, rather than clinical diagnostic accuracy against a specific pathology.

8. The sample size for the training set

Not applicable. This device is an ultrasound system; it does not involve AI model training on a "training set" of medical data in the way a diagnostic AI algorithm would.

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

Not applicable, as there is no mention of a "training set" for an AI model in this submission.

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The VitalLink3 Mobile Vital Signs Monitor is intended for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs data from patients in remote locations and transmit that data, in real time, to a medical professional located at a call centre / different location in order to help determine the patients transport needs.

The VitalLink3 (VL3) Mobile Vital Signs System is intend for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs from patients in remote locations and transmit the data, real time, to a medical professional at a Medical Call Center / Medical Service Provider in order to help determine the patient's transportation needs.

The VitalLink3 System is a modular hardware/software system for acquiring, monitoring and/or communicating patient vital signs data.

The VitalLink system acquires vital signs date from patients in remote locations (on land, in aircraft or on ships at sea) and communicates the data in real time to a medical professional at a call centre (Medical Service provider) in order to help determine the patient's need for transportation to a medical facility.

The VitalLink® System is comprised of the following discrete units:

a. The VitalLink3 (VL3) monitors 4 vital sign parameters: 6/12 lead EKG, Non-invasive blood pressure (NiBP), blood oxygen saturation (SpO2), pulse rate and core temperature. The VitalLink user interface includes a built in display for viewing collected data real time and a series of programmable soft keys for choosing communication preferences and manage communications with a medical service provider. The VitalLink also has onboard memory for storing the data collected from the parameters.
The Vitall ink is delivered to users in a fabric case with integrated compartments for the VitalLink3, the sensor components, battery chargers, labelling, and consumable accessories.

b. Parameters: The EKG and SpO2 parameters identified in "6.a" above communicate with the VitalLink3 via a Bluetooth RF link. The parameters are paired with a VitalLink3 and the RF link tested just prior to when the device is packaged for shipping.

c. Clinical Interface: The Clinical Interface is a TeleMedic Systems developed proprietary software application that receives data from a VitalLink®, decrypts the data and displays the information for use by medical professional / clinician in making a patient transport decision. The Clinical interface application is installed on a computer at the clinician's location.

d. Communication Options: There are six (6) possible means by which the VitalLink® can be configured to communicate with the Clinical Interface: Dialup telephone landline, direct wired connection to an IP network (Ethernet), satellite phone, satellite based data services, cellular phone and wireless 802-11 b/g networks.

This document describes the TeleMedic Systems VitalLink3 Mobile Vital Signs System, primarily focusing on its regulatory submission (510(k) summary) rather than a detailed performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance study details (like sample size, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth for training) is not explicitly present in the provided text.

Based on the information provided, here's what can be extracted:

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

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or precision) and corresponding reported device performance. Instead, it references adherence to recognized voluntary performance standards and mentions substantial equivalence to a predicate device.

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

The document does not provide details about a specific clinical "test set" in terms of patient sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating adherence to voluntary performance standards and substantial equivalence to a predicate device rather than presenting a de novo clinical performance study.

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

This information is not provided in the document. Given the nature of a 510(k) submission focused on substantial equivalence and compliance with engineering standards, a formal clinical study with expert-established ground truth as one might see for an AI diagnostic device is not detailed.

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

This information is not provided.

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 document does not describe an MRMC comparative effectiveness study or any AI components that would assist human readers. The VitalLink3 is a vital signs monitor and communication system, not an AI-assisted diagnostic tool in the typical sense.

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

The device is described as acquiring and transmitting vital signs data for a medical professional to "determine the patient's transport needs." This inherently involves a human-in-the-loop for clinical decision-making. There is no mention of a standalone algorithm performance without human interpretation or action.

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

The document does not detail specific "ground truth" types in the context of a clinical performance study. For a vital signs monitor, the "ground truth" would typically refer to the accuracy of the physiological parameter measurements themselves, which are assessed through calibration and comparison to reference standards (implied by adherence to standards like IEC60601-2-27 for EKG).

8. The sample size for the training set

The document does not describe a "training set" as it would for a machine learning or AI-driven device.

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

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

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The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dillatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

The PPD Balloon Dilatation Catheter consists of a polymer balloon mounted on a plastic shaft. The balloon can be inflated to different diameters depending on the inflation pressure; each balloon is capable of inflation to three or four distinct and progressively larger sized diameters at the recommended pressures. Proximal luer connectors are provided for balloon inflation and quidewire passage.

Here's a breakdown of the acceptance criteria and study information based on the provided documents:

Acceptance Criteria and Device Performance

Study Details

The provided documents describe a Special 510(k): Device Modification submission for the TeleMed Systems PPD™ Balloon Dilatation Catheter. This type of submission generally relies on bench testing (laboratory studies) and comparison to predicate devices, rather than clinical trials with human participants, especially for Class II devices with established mechanisms of action.

Given this context, many of the typical elements of a clinical study (like sample size for test sets, ground truth establishment for AI, MRMC studies) are not applicable here.

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

   • Test Set Sample Size: Not explicitly stated in terms of a "test set" from a patient population, as this was primarily bench testing. The "sample size" would refer to the number of catheters tested in each bench test (e.g., how many balloons were burst, how many were tested for pressure-diameter). This information is not provided in the summary.
   • Data Provenance: The data provenance is from bench testing performed by TeleMed Systems, Inc. at their manufacturing site in Hudson, MA, USA. This is retrospective in the sense that the studies were performed on the device after its design, but not on patient data.

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

   • Not applicable. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies (e.g., a balloon bursts or it doesn't; it inflates to a certain diameter at a given pressure or it doesn't). Expert consensus in a clinical sense is not relevant for this type of testing.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretations of patient data. For bench testing, results are typically objective measurements.

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. This is a medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

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

6. The type of ground truth used:

   • The "ground truth" for the performance testing (balloon burst, pressure vs. diameter, scope passage) would be engineering specifications and physical measurements demonstrating the device's ability to meet its design requirements and function safely as intended.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable. As above, no training set is involved.

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The TeleMed Systems 3-Lumen Occlusion Balloon Catheter is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.

The 3-Lumen Occlusion Balloon consists of a compliant polymer balloon mounted on a plastic shaft. The shaft has 3 internal lumens, each of which terminates in a proximal connector and connection tube. The lumens are used for balloon inflation, guidewire passage and distal fluid injection.

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a Special 510(k) for a device modification, focusing on proving substantial equivalence to a predicate device rather than setting new performance acceptance criteria for a novel device. Therefore, explicit, quantifiable acceptance criteria with corresponding reported performance values like sensitivity, specificity, or accuracy are not present as they would be for an AI/ML diagnostic.

Instead, the "acceptance criteria" are implied to be adherence to design specifications and demonstration that the modified device is as safe and effective as the predicate device. The "reported device performance" is the successful completion of Design Verification and Validation (V&V) testing.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document refers to "Design Verification and Validation testing" but does not detail the number of units or data points used in this testing.
• Data Provenance: Not specified. Given the nature of a medical device modification (Occlusion Balloon Catheter), the V&V testing would likely involve bench testing, simulated use, and potentially pre-clinical animal studies, but the origin (e.g., country) of any data used is not mentioned. It is implicitly prospective testing as it's part of design validation for a new modification.

3. Number of Experts and Qualifications:

Not applicable. This is a medical device submission for an occlusion balloon catheter, which does not involve interpretation of medical images or data by human experts for ground truth establishment in the way AI/ML diagnostic devices do.

4. Adjudication Method:

Not applicable. See point 3.

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

Not applicable. See point 3. This device is a physical medical instrument, not a diagnostic AI/ML algorithm.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. See point 3. This is not an algorithm but a physical device.

7. Type of Ground Truth Used:

The "ground truth" for this device is derived from engineering specifications, material properties, mechanical testing results, and functional performance benchmarks against the predicate device. For example, balloon inflation pressures, lumen patency, material strength, and sterilization efficacy would be assessed against predefined criteria. It is based on objective, measurable physical properties and functional outcomes rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the design and manufacturing process, where iterations and physical testing lead to the final design.

9. How Ground Truth for Training Set was Established:

Not applicable. As this is not an AI/ML device, there is no "training set." The design and manufacturing processes are guided by regulatory standards, engineering principles, internal quality management systems (e.g., 21 CFR 820.30 Design Control), and the performance characteristics of the predicate device. Ground truth for these processes is established through engineering design reviews, risk analysis, material specification, and rigorous physical testing of prototypes and production samples.

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