(104 days)
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.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (FlowScreen / FlowScreen ECG) | Result |
|---|---|---|---|
| Pulmonary Function | Identical to FlowScreen K062011 | Identical across all listed parameters | Met |
| Intended Use | Diagnostic Spirometry (VCin, VCex, etc.) | Diagnostic Spirometry (VCin, VCex, etc.) | Identical |
| Patient population | Screening device for pulmonary function disorders | Screening device for pulmonary function disorders | Identical |
| Performance | Slow Spirometry, Forced Spirometry, Flow-Volume, MVV, Pre/Post Tests, Trending, Interpretation modules | Slow Spirometry, Forced Spirometry, Flow-Volume, MVV, Pre/Post Tests, Trending, Interpretation modules | Identical |
| Patient user interface | Ultrasonic handle or pneumotach handle | Ultrasonic handle or pneumotach handle | Identical |
| Material of patient user interface | Matches predicate device (Ultem 1010R, Romira ABS 1001 FRVO, Polypropylene RG835MO, Luran S778 TE, HDPE Eraclene MS 80U) | Matches predicate device | Identical |
| Patient contacting accessories | Mouthpiece, Nose clip, Nose pads | Mouthpiece, Nose clip, Nose pads | Identical |
| Material of patient contacting accessories | Nose clip: Polyacetal, Nose pads: Ethylene Vinyl Acetate | Nose clip: Polyacetal, Nose pads: Ethylene Vinyl Acetate | Identical |
| Dimensional specification | 455 x 280 x 380 (W x H x D) | 455 x 280 x 380 (W x H x D) | Identical |
| Software | Data acquisition, calculation, predicted values, analysis, interpretation, storage, output, input | Data acquisition, calculation, predicted values, analysis, interpretation, storage, output, input | Identical |
| ECG Function | Identical to CorScreen K070614 | Identical across all listed parameters | Met |
| Intended Use | 3/6- or 12-channel surface ECG recording device | 3/6- or 12-channel surface ECG recording device | Identical |
| Input dynamic range | +/- 300mV @ DC | +/- 300mV @ DC | Identical |
| Frequency response Bandwidth | 0.05 - 150 Hz / According to EC11 and IEC 60601-2-51 | 0.05 - 150 Hz / According to EC11 and IEC 60601-2-51 | Identical |
| A/D conversion | 24 bits | 24 bits | Identical |
| Leads | 12 Standard | 12 Standard | Identical |
| Paper Speed | 25-50 mm/s +/-5% According to EC11 | 25-50 mm/s +/-5% According to EC11 | Identical |
| Recorder Sensitivity | 5, 10, 20 mm/s According to EC11 | 5, 10, 20 mm/s According to EC11 | Identical |
| Writing System | Ink-printer US-letter and DIN-A4 size | Ink-printer US-letter and DIN-A4 size | Identical |
| Printed Channels | 1/2/6/12 | 1/2/6/12 | Identical |
| Paper | US-Letter and DIN-A4 | US-Letter and DIN-A4 | Identical |
| Mode of operation | Manual | Manual | Identical |
| Input/output | SD Memory card | SD Memory card | Identical |
| Display Size | 320 x 240 pixels | 320 x 240 pixels | Identical |
| No. of displayed channels | 1/3/6/12 | 1/3/6/12 | Identical |
| Trace speeds | 5, 10, 25, 50 mm/s | 5, 10, 25, 50 mm/s | Identical |
| Sensitivity | 5, 10, 20, 40 mm/mV | 5, 10, 20, 40 mm/mV | Identical |
| Hardware/Software Platform | Identical to predicate device components | Identical across all listed components | Met |
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.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).