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MultiView is a software application that is intended for use in processing, manipulating, and displaying magnetic resonance imaging (MRI) images as well as other multi-modality DICOM medical images and data that it receives from various sources (e.g. CT. US, secondary capture devices, scanners, imaging sources, and imaging gateways).

MultiView provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis. These computer-aided and/or userdefined processing functions include artifact minimization, image subtractions, multi-planar reformats, and maximum intensity projections. It also includes the following automatic functions: physiological analysis tools, diffusion analysis, and segmenting of lesions. MultiView also provides tools for automated targeting for breast interventional procedures.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.

MultiView is typically used by trained professionals, including radiologists. technologists and clinicians and may provide information to be used for screening, diagnostic and interventional procedures. Patient management decisions should not be made solely on the results of MultiView analvsis.

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The provided text is a 510(k) clearance letter from the FDA for the device "MultiView." It describes the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed acceptance criteria for the device's performance, nor does it describe the specific study that would prove the device meets these criteria.

The 510(k) clearance focuses on regulatory equivalence, not a detailed technical performance study with acceptance criteria and results. Such detailed information would typically be found in the manufacturer's 510(k) submission document itself, which is not provided here.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document states what the device is, its regulation, and the FDA's regulatory decision, but not how its performance was evaluated against specific metrics.

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The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.

Use of the Infinity MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• Heart rate .
• ECG Arrhythmia Analysis .
• Arterial oxygen saturation .
• Pulse rate .
• ST segment analysis .

Infinity Telemetry Pacer Fusion

Infinity MultiView Telemetry with VF6 software supports the new pacer detection mode, Fusion. The Pacer Fusion mode has increased sensitivity to psuedofusion paced beats, sometimes known as fused beats.

Infinity Symphony

The MultiView WorkStation with VF6 supports the new web-based browser application, Infinity Symphony, for enhanced full disclosure review. Infinity Symphony provides users with retrospective reviews of stored continuous and episodic patient information -- continuous physiologic waveforms and other stored data over an extended period of time -- to provide review, analysis, and documentation of the patient's condition.

The provided text is related to a 510(k) summary for a medical device called "Infinity MultiView Workstation and Telemetry" manufactured by Draeger Medical Systems, Inc. However, it does not contain any information about acceptance criteria, device performance, sample sizes used for testing, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, type of ground truth used, or details about the training set.

The document primarily describes:

• The device name and classification.
• The submitter's information.
• A brief description of the device's features (Pacer Fusion mode, Infinity Symphony web-based browser application).
• The intended use of the device as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems, measuring vital signs like heart rate, ECG arrhythmia analysis, arterial oxygen saturation, pulse rate, and ST segment analysis.
• A statement regarding substantial equivalence, noting that "Verification and validation testing performed indicates that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." It explicitly states "Assessment of clinical performance data for equivalence: Not applicable".
• The FDA's letter of clearance stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table and study details as that information is not present in the provided text.

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The Leksell GammaPlan 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.

The Leksell GammaPlan 4C with MultiView adds support for frameless images by means of co-registration of image series. This simplifies stereotactic radiosurgery procedures as only one image series needs to be acquired with the Leksell stereotactic frame. Leksell GammaPlan 4C with MultiView also adds support for brain altas structures and visualization of color mapped PET images for use in preoperative planning.

The provided text describes a Special 510(k) submission for the "Leksell GammaPlan 4C with MultiView" device. This submission focuses on demonstrating substantial equivalence to a predicate device ("Leksell GammaPlan", K973441) and highlights new features like support for frameless images via co-registration and visualization of color-mapped PET images.

However, the document does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria. It primarily details the device description, intended use, and substantial equivalence claim, which is a regulatory pathway for devices that are similar to already legally marketed devices.

Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.

Here's an assessment based on the available information:

1. Table of acceptance criteria and the reported device performance:

   • N/A. The document does not specify acceptance criteria or report performance against such criteria. The submission is a "Special 510(k)" which usually relies on demonstrating substantial equivalence to a predicate device, often without a detailed performance study like a traditional 510(k) might require for novel features.

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

   • N/A. No information on a test set or data provenance is provided.

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):

   • N/A. No information on experts or ground truth establishment for a test set is provided.

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

   • N/A. No information on adjudication methods for a test set is 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:

   • N/A. This device is a dose planning system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

   • The document implies the device is a "computer-based dose planning system" for "health care professionals," indicating human-in-the-loop operation. No standalone performance study details are provided.

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

   • N/A. No information on the type of ground truth is provided.

8. The sample size for the training set:

   • N/A. This document describes a software update for a medical device; it does not detail a machine learning model that would typically have a "training set."

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

   • N/A. As above, no training set is described in the context of a machine learning model.

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The INFINITY MultiView WorkStation, INFINTY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.

The INFINITY MultiView WorkStation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor.

Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• Heart rate
• . ECG Arrhythmia Analysis
• . Arterial oxygen saturation
• . Pulse rate
• ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

With the release of software version VF4, the Infinity MultiView WorkStation can receive ECG data sent from a Reynolds CardioCollect and process Rest ECG reports (K980625) when a CardioCollect is interfaced to a MultiView WorkStation via an RS232 connection. Additionally, when a 12-lead Rest ECG for a TruST monitored patient is successfully acquired and uploaded, the MultiView WorkStation calculates a set of baseline coefficients specific to each patient.

This 510(k) submission (K033305) is for modifications to the INFINITY MultiView WorkStation, specifically with the release of software version VF4 and its integration with the TruST system. This submission primarily focuses on the device's ability to process Rest ECG reports and reconstruct 12-lead ECGs from a reduced electrode set for ST segment analysis.

The document states that a clinical performance study was performed to demonstrate substantial equivalence, but the details of the study, including acceptance criteria and reported device performance metrics, are not provided in the extracted text. The text explicitly says: "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Section J", indicating that these details are elaborated in Section J of the full 510(k) submission, which is not included here.

Therefore,Based on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria comprehensively. The document states that testing was performed in accordance with internal design control procedures and indicates no affect on the safety or efficacy of the MultiView WorkStation, but no specific performance data or acceptance criteria are detailed.

Here's what can be inferred and what cannot be from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in the extract. The document mentions "Assessment of clinical performance data for equivalence: Section J," implying this information is elsewhere in the submission. Without Section J, specific acceptance criteria (e.g., sensitivity, specificity, accuracy for ST segment changes, or interpretive diagnostic statements) and the reported performance metrics are unknown.

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

• Not provided in the extract. The document does not specify the number of patients or ECGs used in any test set, nor the country of origin of the data, or whether it was retrospective or prospective.

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

• Not provided in the extract. The document does not mention the involvement of experts for establishing ground truth, their number, or their qualifications.

4. Adjudication Method:

• Not provided in the extract. There is no information regarding any adjudication method used for the test set.

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

• Not provided in the extract. The document does not mention any MRMC study or the effect size of human readers improving with or without AI assistance. The device is described as providing "interpretive diagnostic statements" and "reconstructed leads intended for real-time assessment of ST segment changes," suggesting an algorithmic function rather than direct human assistance for interpretation.

6. Standalone Performance Study:

• Implied but not detailed. The device is stated to "calculate a set of baseline coefficients specific to each patient" and "provide interpretive diagnostic statements and reports." This suggests standalone algorithmic performance for these functions. However, no specific standalone performance study results (e.g., sensitivity, specificity, or accuracy compared to a gold standard) are provided in the extract.

7. Type of Ground Truth Used:

• Not explicitly stated for performance evaluation. For the interpretive diagnostic statements and ST segment analysis, the ground truth would typically be established by expert cardiologists reviewing full 12-lead ECGs or potentially correlated with clinical outcomes or pathology, but the document does not specify which was used.

8. Sample Size for the Training Set:

• Not provided in the extract. The document does not mention any training set or its size.

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

• Not provided in the extract. As no training set is mentioned, the method for establishing its ground truth is also not specified.

In summary, the provided text from the 510(k) summary (K033305) indicates that a clinical performance assessment was conducted (referenced in Section J), but it does not contain the specific details required to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. The focus of this specific summary is on the modifications to the software for existing functionalities related to ECG processing and ST segment analysis.

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Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• . Heart rate
• ECG Arrhythmia Analysis ●
• Arterial oxygen saturation ●
• Pulse rate
• ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

Siemens' INFINITY MultiView WorkStation Telemetry with TruST enables continuous 12-lead ECG monitoring with a reduced number of electrodes. With TruST only 6 lead wires are required to acquire 12 leads of ECG. TruST relies on conventional lead placement and the INFINITY TruST telemetry transmitters. The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads.

Here's a breakdown of the acceptance criteria and study information for the Siemens Infinity MultiView WorkStation Telemetry System with TruST, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical performance acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) or precise reported device performance metrics for the TruST feature. Instead, it relies on substantial equivalence to predicate devices and describes the intended functionality. However, we can infer the acceptance criteria are met if the device demonstrates equivalent performance to the predicate devices in terms of its ability to monitor 12-lead ECG with a reduced set of electrodes and reconstruct leads for real-time ST segment assessment.

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

The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Assessment of clinical performance data for equivalence: Section J," implying that clinical data was submitted in that section, but the summary document itself does not contain those details.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with vs. without AI assistance. The focus of this 510(k) is on the device's technical capability to reconstruct leads and monitor ST segments, implying a standalone performance assessment or equivalence claim rather than a human-in-the-loop improvement study.

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

The description of the TruST system, specifically that "The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads" and that "Reconstructed leads are intended for real-time assessment of ST segment changes," strongly suggests that a standalone (algorithm-only) performance assessment would have been done to validate the accuracy of these reconstructed leads against a conventionally acquired 12-lead ECG. However, the summary document does not explicitly describe this study or its results in detail. The focus is on establishing substantial equivalence.

7. Type of Ground Truth Used (Test Set)

The document does not explicitly state the type of ground truth used for the test set. Given the nature of ECG monitoring and ST segment analysis, it's highly probable that the ground truth would have been established by:

• Comparison to conventionally acquired 12-lead ECGs (e.g., a full 12-lead ECG from the same patient at the same time, reviewed by experts).
• Expert consensus based on interpretation of conventional 12-lead ECGs.
• Potentially, correlation with clinical outcomes or pathology if the clinical study was designed to assess diagnostic accuracy for specific conditions (though this is less likely for a 510(k) summary focused on technical equivalence for monitoring).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not describe how the ground truth for any potential training set was established. Since the TruST system involves "general reconstruction coefficients," it implies a model or algorithm was developed. For such a model, a training set would typically have ground truth established by:

• Conventionally acquired 12-lead ECGs that are considered the gold standard for full 12-lead information.
• Expert cardiologists or electrophysiologists who interpret these full 12-lead ECGs and potentially correlate them with patient data or outcomes to develop the "ground truth" for ST segment morphology and deviation.

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Siemens INFINITY MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

The INFINITY MultiView WorkStation (MVWS) software version VF3 modifications include: Waveform Export, Calipers, Selected Strip Report, and Second SpO2 and Pulse Parameter Support.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the INFINITY MultiView WorkStation, detailing its trade name, common name, classification, legally marketed predicate devices, device description (including new features like Waveform Export, Calipers, Selected Strip Report, and Second SpO2 and Pulse Parameter Support), and intended use. The document explicitly states "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable," which indicates that a detailed clinical study with performance metrics and acceptance criteria was not part of this 510(k) submission. Therefore, I cannot generate the requested table and study details from the provided text.

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The Storz Modulith® Lithotripter Model SLK with Multiview option is intended for noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

The Storz Modulith® Lithotripter Model SLK with Multiview option is an extracorporeal pressure wave lithotripter. The Multiview option facilitates the additional display of up to two imaging systems on the Lithotrack® monitor.

This looks like a 510(k) summary and FDA clearance letter for a medical device called the "Storz Modulith® Lithotripter Model SLK with Multiview option." This document asserts substantial equivalence to a predicate device rather than providing a detailed study demonstrating that the device meets specific acceptance criteria through performance data.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not present in the provided text. This is typical for a 510(k) submission where the primary argument for clearance is substantial equivalence to an already legally marketed device, rather than novel clinical performance data.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Available. The document does not provide a table of acceptance criteria or reported device performance metrics tied to specific criteria. The clearance is based on substantial equivalence.

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 Available. No specific test set data is provided for the "Storz Modulith® Lithotripter Model SLK with Multiview option" to demonstrate its performance against acceptance criteria. The clearance relies on the equivalence to a predicate device.

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 Available. No ground truth establishment for a test set of the new device is discussed.

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

• Not Applicable / Not Available. No test set or adjudication method is mentioned for the new device.

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

• Not Applicable. This device is a lithotripter, which fragments urinary calculi. It is not an AI-assisted diagnostic imaging device, so an MRMC study with human readers improving with AI assistance would not be relevant.

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

• Not Applicable. This device is a physical lithotripter, not an algorithm, so standalone algorithm performance is not relevant.

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

• Not Applicable / Not Available. As no new performance study for the device is presented, no ground truth type for such a study is mentioned. The clearance is based on the previously established performance and safety of the predicate device.

8. The sample size for the training set

• Not Applicable. This is a hardware device (lithotripter) and not a software algorithm that would require a training set.

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

• Not Applicable. As per point 8, there is no training set for this type of device.

Summary based on the provided text:

The provided documents (510(k) Summary and FDA Clearance Letter) for the "Storz Modulith® Lithotripter Model SLK with Multiview option" do not describe a study to prove the device meets specific acceptance criteria through performance data. Instead, the clearance is based on a demonstration of substantial equivalence to an existing predicate device. The statement explicitly says: "The Storz Modulith® Lithotripter Model SLK with Multiview option for lithotripsy is substantially equivalent to the predicate device since the basic features and intended use are identical, and the design is similar. The minor differences between the Storz Modulith® Lithotripter Model SLK with Multiview option and the predicate device raises no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

Therefore, the requested information pertaining to studies, sample sizes, ground truth establishment, and expert involvement for a new performance study is not applicable and not present in this type of submission.

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Use of the MultiView WorkStation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• Heart rate
• ECG Arrhythmia Analysis
• Arterial oxygen saturation
• Pulse rate
• ST segment analysis

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.

The provided document is incomplete and only describes a 510(k) submission for a device modification, but it does not contain the actual study or acceptance criteria. The information provided here focuses on the administrative aspects of a 510(k) application, such as the device's trade name, common name, classification, and intended use. It also mentions that the modification enables "Pause, Bradycardia, and Tachycardia Arrhythmia calls."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.

To answer your request, I would need a document specifically detailing the verification and validation (V&V) testing performed for the device modification, which would include:

• Acceptance Criteria: Specific thresholds or performance metrics that the device must meet.
• Study Design: How the test was conducted.
• Device Performance: The results observed during the study.
• Sample Size and Data Provenance: Details about the dataset used.
• Ground Truth: How the reference standard was established.
• Expert Details: Qualifications and number of experts involved.
• Adjudication Method: If applicable.
• MRMC or Standalone Studies: If such studies were performed.
• Training Set Details: If applicable for an AI/algorithm.

Without this information, I cannot complete the table or answer the specific questions about the study.

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This device is capable of connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability.

This device is intended for use with adults and pediatrics in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Siemens MultiView (SC3000) WorkStation™ enhanced with Diagnostic Statements (Rest ECG) is a modified version of the MultiView (SC3000) WorkStation granted clearance under 510(k) # K955059. This enhancement enables the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations.

The Siemens MultiView WorkStation™ Enhanced with Diagnostic Statements (Rest ECG) is a modified version of the MultiView (SC3000) WorkStation, which was previously cleared under 510(k) # K955059. This enhancement allows the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations. The device collects preprocessed ECG data from SC9000/SC9015 bedside monitors, analyzes it, and produces reports and potential patient diagnoses for physician review.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided document does not explicitly state specific quantifiable acceptance criteria for the diagnostic statements and reports. Instead, it relies on demonstrating equivalence to a predicate device and testing against a standard clinical database as per AAMI recommendations.

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

The document states, "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." However, it does not provide specific details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the clinical database.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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 does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating the device's ability to provide interpretive diagnostic statements and reports, and its equivalence to a predicate device, rather than on quantifying human reader improvement with AI assistance.

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

The entire premise of the device – "The device is suitable for use in resting ECGs and is capable of analyzing the data and providing output with interpretation" and "produce reports and possible patient diagnosis for review by the physician" – indicates that the algorithm does perform in a standalone capacity by generating interpretive diagnostic statements and reports before physician review. The qualification "Performance was qualified by testing versus a standard clinical database per AAMI recommendations" would inherently relate to the standalone performance of the algorithm in interpreting the ECG data.

7. The type of ground truth used

The ground truth for the performance qualification was established through a "standard clinical database per AAMI recommendations." While the exact nature of this ground truth (e.g., expert consensus, pathology, outcomes data) is not explicitly detailed, "standard clinical database" suggests a collection of cases with established diagnoses or interpretations, likely based on expert consensus or established clinical practice/guidelines that the AAMI standard would dictate.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set. It primarily discusses performance qualification rather than the development or training of the underlying ECG interpretation algorithm. Given the K980623 filing in 1998, and the use of the "Megacart Algorithm" which is also present in the 1991 predicate device (K915225), it's highly probable that the core algorithm was developed and trained much earlier.

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 mentioned, the core "Megacart Algorithm" predates this submission, so details regarding its original training and ground truth establishment would not be expected in this 510(k) summary.

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