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AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices.

AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians.

The AUDICOR CA300/CC100 Analyzer with SDB software is intended for use on adults 18 years of age and older. The SDB analysis and reporting is intended for use on adult patients as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's screened for SDB should have periods of sleep of at least 4 hours duration.

AUDICOR CA300/CC100 Analyzer with SDB is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.

AUDICOR CA300/CC100 Analyzer is a software-only system for the analysis of physiologic signals acquired through AUDICOR-compatible recording devices. Analysis results from ECG, heart sound, sleep-disordered breathing, snoring sounds, body position and activity levels are automatically interpreted. The AUDICOR CA300/CC100 software system allows for the review, edit, and storage of the analysis results. Reporting of analysis results is provided, together with patient data and notable events for review by the clinician.

The AUDICOR Analyzer software analyzes and reports the following parameters:

• Heart rate including bradycardia and tachycardia events .
• Atrial fibrillation ●
• ECG beat classification and morphology grouping with user-editing ●
• Heart rate variability ●
• Snoring detection ●
• Sleep disordered breathing events
• Sleep disordered breathing score
• Activity level ●
• Body Position
• Heart sound and combined ECG/heart sound measurements
• Heart rate distributions of heart sound parameters ●

Here's a breakdown of the acceptance criteria and study information for the AUDICOR CA300/CC100 Analyzer with SDB, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the device's performance in a table format. Instead, it describes capabilities and then broadly concludes that non-clinical and clinical testing demonstrate the device's functionality and performance are comparable (for non-clinical) and statistically equivalent (for clinical, regarding a specific new feature) to the predicate device.

However, based on the narrative, the implicit acceptance criterion for the clinical study was statistical equivalence between the subject device's new aggregation method and the predicate device's aggregation method.

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

• Sample Size for Test Set: 252 subjects
• Data Provenance: Retrospective analysis of AUDICOR AM data. The country of origin is not specified, but the submission is to the U.S. FDA, implying the data might be from the US or a region with similar clinical practices.

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

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set in the clinical study. It mentions the study subjects included a cohort "clinically diagnosed with heart failure" and a cohort "determined to be negative for heart failure." This suggests that the clinical diagnoses used as ground truth were established by medical professionals in a clinical setting, but the specifics of who and how many made these diagnoses for the purpose of this study's ground truth are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the test set. It mentions cohorts "clinically diagnosed" or "determined to be negative" for heart failure, implying standard clinical diagnostic processes were followed, rather than a specific adjudication protocol by a panel for the study.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The clinical testing focused on the statistical equivalence of the device's aggregation method compared to the predicate's aggregation method for heart sound measurements, not on human reader improvement with or without AI assistance.

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

Yes, the clinical testing described is primarily a standalone (algorithm only) performance study. It evaluated the device's "new capability of aggregating periodically sampled heart sound measurements" by comparing its statistical output to that of the predicate device. This assessment does not appear to involve human readers interpreting the output in a loop, but rather directly comparing the analytical results of the algorithms.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on clinical diagnosis (subjects "clinically diagnosed with heart failure" and "determined to be negative for heart failure"). This is a form of patient outcome/diagnosis data.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The clinical study described refers to a "total study population of 252 subjects" used for retrospective analysis, which appears to be the evaluation (test) set for the clinical performance claim. It is possible that the algorithm was trained on other data not described in this summary or that it was an update to an existing algorithm.

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

Since a training set is not explicitly mentioned or described, the method for establishing its ground truth is also not provided in this document.

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The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The AUDICOR System employs the AUDICOR AM (Home) ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sound, sleep-disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician.

The AUDICOR System analyzes and reports the following parameters:

• Heart rate including bradycardia and tachycardia events .
• Atrial fibrillation .
• ECG beat classification and morphology grouping with user-editing .
• Heart rate variability .
• . Snoring detection
• . Sleep disordered breathing (apnea/hypopnea) events
• . Sleep disordered breathing score
• Activity level .
• Heart sound and combined ECG/heart sound measurements .
• Heart rate distributions of heart sound parameters .

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

Here's a breakdown of the acceptance criteria and study details for the AUDICOR System - CPAM with SDB (Accelerometer Based), based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary states that the study demonstrates the "substantial equivalence of the subject device's algorithm performance to that of the predicate device" regarding SDB detection. This implies that the acceptance criterion was likely to show a statistically equivalent or non-inferior performance compared to the previously cleared predicate device (K120462).

The exact performance metrics (e.g., sensitivity, specificity, accuracy) and specific thresholds for acceptance are not explicitly listed as quantitative acceptance criteria in the provided text. Instead, the focus is on a comparative statistical analysis.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 77 recordings
• Data Provenance: Prospective clinical testing conducted at Taipei Veterans General Hospital in Taipei, Taiwan.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. It mentions "Physician-overread results from concurrent polysomnography recordings" as the clinical gold standard. This implies that medical professionals (likely sleep physicians or trained polysomnography technologists) were involved in interpreting the PSG data to determine SDB positive and negative cohorts.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. It only mentions "Physician-overread results from concurrent polysomnography recordings" for establishing the clinical gold standard. It does not detail if multiple physicians reviewed, if there was a consensus process, or if a single reading was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on comparing the algorithm's performance (subject device vs. predicate device) against a clinical gold standard (physician-overread PSG), not on how human readers improve with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The study compared the "AUDICOR SDB detection performance of the predicate device (K120462) to that of the subject device" using their respective algorithms applied to concurrent data. This directly assesses the algorithm's performance without human intervention in the SDB detection process itself.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus / physician-overread polysomnography (PSG) results. Specifically, "Physician-overread results from concurrent polysomnography recordings on the test subjects was the clinical gold-standard used for establishing PSG-AHI positive and PSG-AHI negative cohorts."

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only mentions the "test set of 77 recordings." The study appears to be an evaluation of an already developed algorithm, not the training process itself.

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 it focuses on the evaluation (test) phase of the device's modification.

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The AUDICOR System when used with an AUDICOR Sensor on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, body position, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians.

The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The AUDICOR System employs the Hemo ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sounds, body position, sleep disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician.

The AUDICOR System analyzes and reports the following parameters:

• Heart rate including bradycardia and tachycardia events .
• Atrial fibrillation .
• ECG beat classification and morphology grouping with user-editing l
• . Heart rate variability
• Snoring detection .
• Sleep disordered breathing (apnealhypopnea) events
• . Sleep disordered breathing score
• Activity level .
• . Body position
• Heart sound and combined ECG/heart sound measurements .
• Heart rate distributions of heart sound parameters

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The AUDICOR System has two primary components for which clinical performance testing was conducted: "Body Position" and "Single Sensor Heart Sound."

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for either the Body Position or Single Sensor Heart Sound studies. Instead, it relies on demonstrating substantial equivalence to predicate devices.

Body Position:

Single Sensor Heart Sound:

2. Sample Size and Data Provenance

• Body Position: "a group of subjects representative of those intended to use the device." No specific number is provided. The study was retrospective. No country of origin is explicitly stated, but given the FDA submission, it's likely US-based or compliant with US standards.
• Single Sensor Heart Sound: "reemployed datasets initially used for obtaining FDA clearance for the two-sensor system on a group of patients representative of those the device is intended for." No specific number is provided. The study was retrospective. No country of origin is explicitly stated, but similar to the Body Position study, likely US-based.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the Body Position or Single Sensor Heart Sound studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for establishing ground truth in the test sets.

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

No MRMC comparative effectiveness study is mentioned. The studies focus on device performance against a "gold standard" or a predicate device, not on how human readers improve with AI assistance.

6. Standalone (Algorithm Only) Performance

The studies described are standalone (algorithm only) performance evaluations.

• For Body Position, the AUDICOR "automated signal processing algorithm" processes accelerometer signals to determine body position, which is then compared to a "gold-standard performance."
• For Single Sensor Heart Sound, the "AUDICOR heart sound algorithms modified for use with a single sensor" are evaluated for their performance compared to the two-sensor system.

7. Type of Ground Truth Used

• Body Position: The document mentions "idealized gold-standard performance" for body position accuracy, but it doesn't specify how this gold standard was established (e.g., manual observation, another validated device, expert annotation). Given the reliance on accelerometer signals, it's likely a comparison to a highly accurate reference system for body position.
• Single Sensor Heart Sound: The ground truth for the comparison was the performance of the predicate two-sensor AUDICOR system. The study aimed to show "statistical equivalency" to this established system.

8. Sample Size for the Training Set

The document does not provide specific sample sizes for the training sets for either the Body Position algorithm or the Single Sensor Heart Sound algorithm. It mentions "retrospective clinical tests" were performed and "reemployed datasets" for the heart sound study, which implies existing data was used, potentially for training and/or testing.

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

The document does not explicitly describe how the ground truth for any training set was established. Given the retrospective nature of the studies and the comparison to a predicate device, it's plausible that the ground truth for training (if separate from testing) would have also been derived from established clinical data or the performance of the prior AUDICOR system.

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The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score.

Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic.

The device is intended for use only under the direct supervision of a physician.

The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System analyzes and reports the following parameters: Heart rate including bradycardia and tachycardia events . Atrial fibrillation . ECG beat classification and morphology grouping with user-editing . . Heart rate variability . Snoring detection Sleep disordered breathing (apnea/hypopnea) events . Sleep disordered breathing score . Activity level - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ●

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. It primarily describes the device, its intended use, and states that it complies with certain standards. There is no information on sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Here's a breakdown of what could be extracted and what is missing, based on the input:

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

• Acceptance Criteria: Not explicitly stated in measurable terms (e.g., sensitivity, specificity thresholds). The document mentions compliance with standards (EN 60601-1, EN 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57) which likely contain performance requirements, but these are not detailed here. For the sleep disordered breathing analysis, it states it's intended "as a screening device...to determine the need for evaluation by polysomnography based on the patient's score," which implies a screening performance standard, but none is provided.
• Reported Device Performance: Not reported in quantitative terms (e.g., specific sensitivity, specificity, accuracy values for any of the detected parameters).

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not 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

• MRMC Study: Not mentioned. The document primarily focuses on the device's technical specifications and equivalency to predicates, not its impact on human reader performance.
• Effect Size: Not applicable as no MRMC study is reported.

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

• The document implies a standalone algorithm performance for features like sleep disordered breathing detection as it mentions "analysis and reporting" and "interpretation of the data in an integrated report for consideration by physicians," suggesting the algorithm generates an interpretation before physician review. However, specific performance metrics for this standalone functionality are not provided.

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

• Type of Ground Truth: Not explicitly stated. For sleep disordered breathing, it implies comparison to polysomnography ("screening device to determine the need for evaluation by polysomnography"), which would likely be the ground truth for that specific function, but this is not confirmed.

8. The sample size for the training set

• Sample Size: Not mentioned.

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

• Ground Truth Establishment: Not mentioned.

In summary, the provided text from the 510(k) K120462 document is a submission for a medical device modification (AUDICOR System - CPAM with SDB). It details the device's capabilities, intended use, and declares substantial equivalence to predicate devices, along with compliance with relevant safety and performance standards. However, it does not include the detailed study design, acceptance criteria, test set specifics, or performance metrics that would be necessary to populate the requested table and answer the study-related questions. Such information would typically be found in more detailed technical reports or clinical study summaries, which are not part of this "Summary of Safety and Effectiveness."

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The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic.

The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over-read as well as consideration of other relevant patient data.

The device is intended for use only under the direct supervision of a physician.

The Audicor System is an ambulatory device that can be used to capture up to 48 hours of continuous data or 10-second snapshots of ECG and heart sounds data. The Audicor System includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The analysis package includes heart rate variability and performs ECG beat classification, editing and reporting of arrhythmias.

The Audicor System analyzes and reports the following parameters:
Heart rate distributions of heart sound parameters
Heart rate and associated events
Atrial fibrillation
ECG beat classification and morphology grouping
Ventricular and atrial ectopic beat arrhythmias
Heart rate variability

The Inovise Medical, Inc. 510(k) Notification for the AUDICOR System describes the device's functionality and its substantial equivalence to predicate devices, focusing on regulatory compliance and intended use rather than specific acceptance criteria for performance metrics. Therefore, a table of acceptance criteria and reported device performance, information about sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance information, and ground truth definitions cannot be fully extracted from the provided text.

Based on the document, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance values against those criteria. Instead, it states that the Audicor System has been tested to applicable requirements of several standards and "shown to comply." It also asserts "substantial equivalence" to predicate devices for specific functionalities. This suggests that the acceptance criteria are implicitly met by complying with these standards and demonstrating equivalence to already approved devices.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on compliance with established industry standards and internal protocols rather than a specific clinical validation study to establish performance metrics against a defined patient dataset.

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. The regulatory submission focuses on engineering and regulatory compliance, and equivalence to predicate devices, rather than detailed performance studies with expert-adjudicated ground truth.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document refers to the device's role in providing interpretations "for consideration by physicians" and emphasizes that measurements and interpretations "are only significant when used in conjunction with physician over-read." This indicates the device is an aid, but no study on the effect of this aid on human reader performance is detailed.

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

The document describes the Audicor System as performing "ECG beat classification, editing and reporting of arrhythmias" and providing "interpretation of the data." While this implies standalone algorithmic functions, no specific standalone clinical performance study to quantify these algorithms' accuracy (e.g., sensitivity, specificity) is provided in the text. The emphasis is on physician oversight ("under the direct supervision of a physician" and "physician over-read").

7. The type of ground truth used

The type of ground truth used for any potential testing is not specified. Given the focus on compliance with standards like ANSI/AAMI EC38 and EC57, it's likely that the "ground truth" for the technical aspects (e.g., arrhythmia detection accuracy) would be based on expertly annotated ECG databases or simulated signals as per those standards, but this is not explicitly stated.

8. The sample size for the training set

The document does not provide any information about the sample size used for training the device's algorithms.

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

The document does not provide any information on how the ground truth for any training set was established.

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The Audicor ™ Sensors with Adapters are a family of dual-function transducers for use on patients where combined ECG/heart sounds data are needed for the evaluation of patient status, to aid in diagnosis and determine effects of treatment on ECG and hemodynamics. Audicor Sensors with Adapters may be used only with a compatible Audicor System.

There are disposable and reusable versions of the Audicor Sensor component. Both can be used in the recording of resting ECG / heart sound reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.

The Audicor sensors/adapters included in this submission are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data. The mating cable adapter for Sensor 4.0 includes an accelerometer for detection of heart sounds. The sensor and adapter devices are intended for use on the chest wall in the V3 and V4 positions. Audicor sensors are available in two versions: 1) Single-use disposable sensors, for use up to 48 hours (Sensor 2.0 and Sensor 4.0) 2) Reusable sensors (Sensor 3.0)

The provided text describes a 510(k) summary for a medical device called the AUDICOR™ Sensor 4.0 with Adapter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.

Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth methodologies for a specific study is not available within the provided text.

Here's what can be extracted based on your requested format, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The document describes testing against engineering standards (ANSI/AAMI EC12:2000, ISO 10993-1:2009), not a clinical test set with patient data for diagnostic evaluation.

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

• Number of Experts: Not applicable. The "testing" referred to in the document is against engineering standards, not against a clinical ground truth established by experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study Done: No. The document does not mention any MRMC study.
• Effect Size with AI vs. Without AI: Not applicable. This device is a sensor, not an AI diagnostic tool that assists human readers in interpretive tasks.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: No. The document focuses on the device's technical specifications and equivalence to a predicate device.

7. Type of Ground Truth Used

• Type of Ground Truth: The document refers to compliance with engineering and biocompatibility standards (ANSI/AAMI EC12:2000 for disposable ECG electrodes and ISO 10993-1:2009 for biological evaluation). There is no mention of a "ground truth" in the diagnostic or clinical sense.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This document does not describe an AI/machine learning model that would require a training set.

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

• How Ground Truth Was Established: Not applicable.

Summary of what the document does provide:

• Performance Standards: The device was tested to and shown to comply with:
  • ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
  • ISO 10993-1:2009 – Biological Evaluation of Medical Devices - Evaluation and testing.
• Substantial Equivalence: The primary basis for this 510(k) submission is to demonstrate substantial equivalence to the AUDICOR™ Sensor 2.0 (K080602), based on modifications such as replacing the microphone transducer with an accelerometer and moving the heart sound transducer function to the adapter.
• Intended Use: Dual-function transducers for combined ECG/heart sounds data for evaluation of patient status, diagnosis aid, and determining treatment effects on ECG and hemodynamics.
• Device Description: Sensors designed with conductive patient-contact surfaces for ECG data and an accelerometer in the mating cable adapter for heart sounds. Used on the chest wall in V3 and V4 positions. Available in disposable and reusable versions.

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The Audicor® Sensors are a family of dual-function sensors for use on adult patients (≥ 18 years) for acquisition of both heart sounds and ECG electrical signals and to transmit these signals to a compatible Audicor system to allow for the evaluation of patient status, to aid in diagnosis, and to determine effects of treatment on ECG and hemodynamics.

There are disposable and reusable versions of the Audicor Sensor. Both can be used in the collection of resting ECG reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.

The Audicor Sensors are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data, and include a microphone for detection of heart sounds. The devices are intended for use on the chest wall in the V3 and/or V4 positions.
Audicor sensors are available in two versions:

1. Single-use disposable sensors, for use up to 48 hours
2. Durable reusable sensors

Here's an analysis of the provided text regarding the acceptance criteria and study for the Inovise Medical, Inc. AUDICOR Sensor 2.0 and 3.0:

The provided document is a 510(k) premarket notification summary and approval letter, which primarily focuses on establishing substantial equivalence to a predicate device based on performance standards and technological characteristics. It does not contain information about a clinical study involving a test set, ground truth established by experts, or efficacy measures like sensitivity, specificity, or reader improvement.

The "Test Summary & Conclusion" section refers to compliance with performance standards rather than a clinical performance study measuring diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the provided document (510(k) summary for substantial equivalence), the "acceptance criteria" discussed are primarily related to compliance with recognized standards for safety and basic functionality, rather than specific performance metrics like sensitivity or specificity of a diagnostic algorithm.

Note: These are compliance standards, not diagnostic performance metrics or clinical acceptance criteria in the typical sense of AI/CADe device evaluation. The document highlights "substantial equivalence" to the predicate device (Audicor™ COR Sensor, K030316) through technological characteristics.

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

Not applicable. The document does not describe a clinical study with a test set of patient data to evaluate the device's diagnostic performance. The testing mentioned refers to compliance with electrical and biocompatibility standards.

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

Not applicable. No clinical study involving expert-established ground truth is described in the provided material.

4. Adjudication Method for the Test Set

Not applicable. No clinical study with a 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. The document does not describe an MRMC study or any study evaluating reader improvement with AI assistance. The device in question is a sensor for acquiring signals, not an AI interpretation system.

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

Not applicable. The device is a sensor, not an algorithm for standalone diagnostic performance. Its function is to acquire and transmit signals to a compatible Audicor system. The compliance testing mentioned is for the sensor itself (electrical safety, biocompatibility) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

Not applicable. As no clinical performance study for diagnostic accuracy is described, no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned. The "ground truth" for the tests performed would be the specifications outlined in the standards (e.g., impedance values, biocompatibility metrics).

8. The Sample Size for the Training Set

Not applicable. The device is a sensor; it does not involve machine learning or an "algorithm" in the sense of one that requires a training set. The reference to "Audicor-enabled ECG/heart sounds systems" implies that the system may have interpretive capabilities, but the submission is for the sensors only.

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

Not applicable. As there is no training set for an algorithm, there is no discussion of how ground truth would be established for it.

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The Audicor® System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI.

Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device.

ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.

The device is intended for use only under the direct supervision of a physician and is for use on adults (≥ 18 years).

The Audicor 200 is a stand-alone device that can be used to capture 10-second snapshots of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome.

The Audicor TS system, a combination of the Audicor 200 with an Audicor-enabled laptop computer, is used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.

The Audicor system, when used with either a 10 wire or 4 wire patient cable analyzes and reports the following advanced parameters and a systolic dysfunction index (SDI) calculated from advanced parameters:

LVST ( Left Ventricular Systolic Time )
LVDT (Left Ventricular Diastolic Time)
PADT (Pre-atrial Diastolic Filling Time)
AAFT (Accelerated Atrial Filling Time )
EMAT (QS1, Electromechanical Activation Time)
QS2
R-R Interval
S3 Strength
S4 Strenth
SDI (Systolic Dysfunction Index)

The Audicor-enabled laptop computer also accepts, analyzes and displays trended data from an optional ambulatory data collection harness for trend and event analysis.

The provided text describes modifications to the AUDICOR 200 system and the addition of an AUDICOR Hemo Ambulatory Monitor. However, it does not explicitly detail acceptance criteria or a study designed to prove the device meets specific performance criteria through statistical metrics (like sensitivity, specificity, or AUC) against a defined ground truth.

Instead, the document focuses on regulatory compliance and substantial equivalence to predicate devices, particularly regarding safety standards and technological characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document lists compliance with various safety and electrical standards (e.g., ANSI/AAMI EC-11, EN 60601-1, IEC 60601-2-25, IEC 60601-2-51, ANSI/AAMI EC38:1998 for the ambulatory component). While these are "performance standards" in the context of device safety and functionality, they are not framed as specific clinical acceptance criteria for diagnostic performance (e.g., a device must achieve X sensitivity for detecting Y condition).

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

This information is not provided. The document describes the device and its intended use but does not detail any specific clinical performance study with a test set of patients.

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.

4. Adjudication method 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

A MRMC comparative effectiveness study is not mentioned. The document describes the device's role in acquiring, analyzing, and reporting data for physicians' consideration, but it does not evaluate how the device "assists" human readers or the effect size of such assistance.

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

A standalone performance study focused on algorithm-only performance with clinical metrics is not described. The device is intended "only when used in conjunction with physician over read as well as consideration of other relevant patient data." This strongly implies it is not a standalone diagnostic device.

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

This information is not provided as no specific clinical performance study for diagnostic accuracy is detailed.

8. The sample size for the training set

This information is not provided as no machine learning algorithm training is explicitly described with specific data sets. The device "analyzes and reports" data, but the method of analysis for parameters like SDI is not detailed as a trained algorithm.

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

This information is not provided.

Summary of Device and Regulatory Context (based on provided text):

The document is a "Summary of Safety and Effectiveness" for an update to the Inovise Medical AUDICOR 200 and the addition of the AUDICOR Hemo Ambulatory Monitor. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily the GE Medical Systems SEER Light Holter Recorder.

The substantial equivalence argument for the ambulatory component centers on:

• Technological characteristics: Both are small, wearable, battery-powered devices that acquire ECG data using limited leads and store data in non-volatile memory for download.
• Differences: The Audicor system requires proprietary sensors and performs analysis on recorded data, whereas the GE SEER Light does not.

The "study" referenced in the document is the set of tests performed to ensure compliance with recognized electrical and safety standards (e.g., AAMI, EN, IEC standards for electrocardiographs and ambulatory ECG devices). This means the device was demonstrated to operate safely and within electrical specifications, but not necessarily to achieve specific clinical diagnostic accuracy metrics in a patient population.

The device's intended use explicitly states that the ECG and heart sound data are "only significant when used in conjunction with physician over read as well as consideration of other relevant patient data," and it is for use "only under the direct supervision of a physician." This positions the system as a data acquisition and reporting tool that aids physicians, rather than a standalone diagnostic or interpretative device with its own diagnostic accuracy claims against a ground truth.

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The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.

The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.

The device is intended for use only under the direct supervision of a physician, and is for use on adults (>= 18 years).

The Audicor 200 is a stand-alone device that can be used to capture 10-second evaluations of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome. In addition the system can be connected to a compatible laptop computer and used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.

The provided text is a 510(k) summary for the "SDI Modification to AUDICOR 200 System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics for a novel algorithm.

Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is largely not present within the provided document. The submission references compliance with performance standards for medical electrical equipment (AAMI EC-11, EN 60601-1, etc.), which are general safety and performance standards for electrocardiographs, not specific performance metrics for the SDI algorithm or its interpretive statements.

However, I can extract and infer some related information:

Description of the Device and its New Features

The "SDI Modification to AUDICOR 200 System" adds a new parameter, the Systolic Dysfunction Index (SDI), and associated interpretive statements. These statements are:

• "Prolonged EMAT, consider LV systolic dysfunction"
• "Consider LV systolic dysfunction [reason block]"
• "Consider severe LV systolic dysfunction with diastolic dysfunction [reason block]"
• "Consider elevated LV filling pressure"
• "S3 detected -consider acute heart failure in presence of dyspnea"
  These statements are only for patients over 40 years of age.

The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (AUDICOR® 200 system K043074, with Audicor Advanced Parameters K051450). It states that the new device and the predicate are "technologically equivalent" in their ability to acquire and display ECG and heart sound data, and analyze "Advanced Parameters."

Addressing Your Specific Questions based on the Provided Text:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics for the SDI modification. The document indicates compliance with general medical device standards (AAMI EC-11, EN 60601-1, IEC 60601-2-25) related to electrocardiograph safety and performance, which are not specific to the diagnostic accuracy of the new SDI parameter or interpretive statements.
   • Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, AUC) for the SDI or its interpretive statements are provided. The only "performance" discussed is compliance with the aforementioned general safety and device standards.

   Table (Based on Inference - No Specific AI Performance Metrics Found):

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

   • This information is not provided in the document. 510(k) summaries for modifications of existing devices often rely on the predicate device's data or general engineering tests rather than new clinical trials with specified test sets for performance of new algorithms.

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

   • This information is not provided. As no specific clinical test set for the SDI algorithm's performance is detailed, the method of establishing ground truth is not described.

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:

   • No MRMC comparative effectiveness study is mentioned. The device's interpretive statements are "for consideration by physicians" and "are only significant when used in conjunction with physician over read," indicating the device is intended as an aid, but no study on physician improvement with this aid is presented.

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

   • A standalone performance study for the SDI or its interpretive statements is not described. The document explicitly states the interpretations "are only significant when used in conjunction with physician over read."

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

   • This information is not provided.

8. The sample size for the training set:

   • This information is not provided. The document describes a "modification" to an existing system, implying the underlying algorithms were likely developed and validated prior to this specific submission, or that the new SDI parameter was developed based on existing clinical understanding rather than a large-scale machine learning training effort documented here.

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

   • This information is not provided.

In conclusion, this 510(k) summary focuses on demonstrating the safety and technological equivalence of a device modification (adding an SDI parameter and interpretive statements) to a previously cleared predicate device, rather than providing detailed clinical performance data for a new AI algorithm. It adheres to general device standards but does not offer specific acceptance criteria or study results for the diagnostic accuracy of the new features.

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The Extended Measurements System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians. In addition the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data.

The Extended Measurements System can be used as an add-on device to work in conjunction with an AUDICOR-enabled device, or as a stand-alone electrocardiograph.

The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.

The device is intended for use only under the direct supervision of a physician, and is for use on adults (≥ 18 years).

The Extended Measurements System is a software-based device that that can be installed into a compatible computer to communicate with an AUDICOR-capable device via a Blue tooth interface. The Extended Measurements system will also be offered as a stand-alone electrocardiograph/ monitoring device.

The provided text does not contain acceptance criteria or a
description of a study that proves the device meets acceptance criteria.
Instead, it is a 510(k) premarket notification summary for the AUDICOR® Extended Measurements System.

This document focuses on establishing substantial equivalence to a
predicate device (AUDICOR® 200 system, K043074) based on technological
characteristics and intended use, rather than presenting a performance
study against predefined acceptance criteria.

The "Test Summary & Conclusion" section mentions that the device was
tested to applicable requirements of certain standards (like ANSI/AAMI EC-11) and shown to comply. However, it does not
provide details of specific acceptance criteria for performance
metrics, nor the results of such tests in the context of what you're
asking for.

Therefore, I cannot provide the requested table or detailed study
information as it is not present in the given text.

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