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The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Federal U.S. law restricts this device to sale by or on the order of a physician.

FlowScreen is an active medical device providing following characteristics:

Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card

a) pulmonary functions

Measurement with ultrasonic handle or pneumotach handle .
Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... )
Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
Flow-Volume and Volume-Time Loop, pre/post tests .
MVV measurement
Trending capabilities
Patient Incentive animations
Interpretation modules .

b) ECG functions

. Simultaneous acquisition of the 12 standard leads
Storage of 10 seconds of acquired ECG signal .
Digital filters for base-line drift and mains interference suppression
Interpretation program Hanover ECG System (HES) providing the following . additional information:
Representatives templates of each lead including markers on fiducial O points
Summary of mean measurements O
Rhythm Analysis statements O
Signal noise detection and information O
Specific findings on QRS complex
Conduction statements O
QRS T diagnostic statements O
Arrhythmia monitoring detection o
Heart Rate Variability 0

The provided document (K080734) is a 510(k) premarket notification for a medical device called FlowScreen / FlowScreen ECG / FlowScreen CT. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Therefore, the study design elements typically found in a PMA (like sample sizes for test sets, data provenance for clinical trials, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for training sets) are not present in this 510(k) submission.

The "acceptance criteria" in this context are primarily related to meeting the performance characteristics of the predicate devices and demonstrating compliance with relevant standards and risk analysis. The "study" refers to non-clinical performance tests and comparisons to predicate devices to establish substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implied by the comparison to predicate devices and compliance with relevant standards. The performance is reported in terms of being "identical" to the predicate devices across various parameters.

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

Not applicable in this 510(k) submission as it relies on substantial equivalence to predicate devices and non-clinical performance and safety testing. There is no mention of a clinical "test set" with patient data in the context you would expect for an AI/CADe device. The document mentions "validation test script" and "validation test log" for non-clinical performance.

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

Not applicable. This is not mentioned as part of the 510(k) submission. For ECG interpretation, the device includes an "interpretation program Hanover ECG System (HES)" which provides "suggestions for the interpretation." The document explicitly states: "A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements." This indicates the device is a diagnostic aid, and expert human review is mandated, rather than relying on an expert consensus for algorithmic ground truth.

4. Adjudication method for the test set

Not applicable. No clinical test set with human expert review and 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. No MRMC study or assessment of human reader improvement with AI assistance is mentioned. The device's ECG interpretation software is described as providing "suggestions" to "support the physician," implying it's an aid, but no comparative effectiveness study is presented.

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

The device does perform "automatic analysis" and "suggestions for the interpretation" for 12-channel ECGs. However, the regulatory submission does not provide specific standalone performance metrics (e.g., sensitivity, specificity) for this automatic analysis compared to a ground truth established by experts. Instead, it relies on the substantial equivalence of the ECG module to the predicate CorScreen K070614, which presumably had its performance validated earlier. Critically, the device explicitly states that a "qualified physician has to reassess all FlowScreen measurements," meaning it's not approved for standalone interpretation without human oversight.

7. The type of ground truth used

For the non-clinical performance tests ("validation test script" and "validation test log"), the ground truth would be against engineering specifications and industry standards (e.g., IEC 60601-1, IEC60601-2-25, EN60601-2 for safety and EMC, and EC11 for ECG paper speed and sensitivity). For the inherent 'intelligence' (like the HES interpretation program), the ground truth and its establishment are not detailed in this submission; it's assumed to be part of the predicate device's prior approvals or an established algorithm.

8. The sample size for the training set

Not applicable. This 510(k) submission does not provide information about a training set for an AI algorithm. The predicate HES interpretation program's training data (if any) is not discussed here.

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

Not applicable. As no training set information is provided, how its ground truth was established is also not detailed.

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CorScreen is an active medical device and is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

CorScreen can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. CorScreen is intended for use in routine ECG recording by trained physicians in the office or hospital. CorScreen is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.

Intended use is equivalent to the intended use of the predicate device AB Cardiette Daedalus View Hes.

A qualified physician has to reassess all CorScreen measurements. An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CorScreen represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

CorScreen is an electrocardiograph providing the following characteristics:

• Mains operation .
• Simultaneous acquisition of the 12 standard leads ◆
• Colour LCD display for user interface and ECG visualisation .
• Alphanumerical keyboard .
• Colour ink-printer for printouts of ECG and interpretation reports in US-letter and DIN A4 size .
• Digital filters for base-line drift and mains interference suppression .
• Interpretation program Hanover ECG System (HES) providing the following additional . information:
  • Representatives templates of each lead including markers on fiducial points .
  • Summary of mean measurements .
  • Summary of measurements performed on each lead .
  • Rhythm Analysis Statements .
  • . Signal noise detection and information
  • . Specific findings on QRS complex
  • Conduction statements .
• QRS T Diagnostic statements .
• . Arrhythmia monitoring detection
• Heart Rate Variability .
• . Storage of 10 seconds of acquired ECG signal
• . Patient information and ECGs are stored in an internal database
• Data can be stored on an SD memory card

The provided document is a 510(k) premarket notification for the CorScreen electrocardiograph. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/ML device.

Here's an analysis based on the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of performance metrics for the interpretive software, nor does it report specific performance outcomes like sensitivity, specificity, or accuracy against a ground truth. Instead, the submission focuses on demonstrating that the CorScreen, including its interpretive software (Hanover ECG System - HES), is substantially equivalent to a legally marketed predicate device (AB CARDIETTE Daedalus View Hes) which also uses HES.

The "performance" is implicitly demonstrated through the comparison table (Section 5.12) which shows that the CorScreen either matches the predicate device's specifications or has differences that are deemed "not relevant for safety and effectiveness."

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

The document does not describe a clinical study with a "test set" in the context of evaluating interpretive software performance. There's no mention of a separate dataset of ECGs analyzed by the CorScreen and compared against a ground truth.

The "testing" mentioned in Section 5.13 ("Summary of Device Testing") refers to compliance with electrical safety and performance standards (EN 60601-1, IEC 601-2-25), not clinical performance for the interpretive software itself.

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)

Since no clinical "test set" or performance validation study for the interpretive software is described, there's no mention of experts establishing a ground truth. The justification for the interpretive software's performance relies on it being the same software (Hanover ECG System - HES) as used in the legally marketed predicate device.

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

Not applicable, as no clinical performance study for the interpretive software with a 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

No such MRMC study is mentioned. This type of study is more common for AI/ML diagnostic aids where the objective is to show the clinical benefit of the AI "assistance" to human readers. Here, the interpretive software is presented as a component of the ECG device, equivalent to that of the predicate.

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

No standalone algorithm performance study for the HES interpretive software is presented in this document. The submission hinges on the fact that the HES software is already commercially available and integrated into an equivalent predicate device. The device is explicitly designed to support physicians, stating "A qualified physician has to reassess all CorScreen measurements" and "An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings." This indicates an "AI-in-the-loop" design where the software provides suggestions rather than making final diagnoses independently.

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

Not discussed, as no specific clinical performance study requiring a ground truth for the interpretive software is detailed.

8. The sample size for the training set

The document does not provide any information about a training set for the Hanover ECG System (HES). This is likely because the HES software itself is a pre-existing, established technology, not a novel algorithm being developed and trained for this particular 510(k) submission.

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

Not discussed, as no training set information is provided.

In summary:

This 510(k) submission for the CorScreen relies heavily on demonstrating substantial equivalence to a predicate device (AB CARDIETTE Daedalus View Hes). The key argument regarding the interpretive software is that it uses the same underlying software (Hanover ECG System - HES) as the predicate. Therefore, the submission does not present new clinical performance studies or specific acceptance criteria for the interpretive algorithm's accuracy, sensitivity, or specificity. Instead, it focuses on general device specifications and compliance with electrical safety standards, asserting that any differences are not relevant to safety or effectiveness.

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