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510(k) Data Aggregation
(30 days)
VIASYS HEALTHCARE GMBH
The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
SpiroPro® is a recording and diagnostic system for measurement, recording and assessment of the Flow-Volume curve and Flow-Volume parameters. The analyzed data can be immediately printed out or saved to the internal memory.
The portable spirometer is small, easy to handle and allows determination of inspiratory and expiratory lung volumes (VCin, FVC, FEV1, MEF50, ... ) including pre and post measurement with date and time display. An interpretation program automatically assesses the measured data. Optionally, the measurement of the oxygen saturation of the blood (SpO2) and the pulse rate are available and a 6-minute walk test can be performed. The graphic LCD and the menu-guided graphical user interface comply with the latest technological developments. Just touch the appropriate icon with your finger to enter patient data or to select menu items (touch screen). Selfexplanatory icons and the logical menu structure safely guide you through the procedure Storage capacity is high: up to 550 measurements can be saved in the internal database.
The rechargeable lithium-ion battery allows operation of the SpiroPro® for approximately two weeks. A charging unit, able to charge the battery within two hours, is included in the delivery.
Patient data, recording results and graphs can be directly printed out on a PCL-compatible printer (for example HP DeskJet series). Of course, data transfer to a PC and vice versa is possible via the serial interface and the Bluetooth interface. The optional software package "SpiroPro® for Windows®" allows automatic transfer of data which are then saved on the PC. The easy-to-exchange, high-quality pneumotach guarantees a high degree of patient safety and provides precise recording results.
Here's a breakdown of the acceptance criteria and study information based on the provided text for device K092324 (SpiroPro):
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a defined set of "acceptance criteria" for the SpiroPro. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SpiroPro SpO2, K031515) through a comparison of technological characteristics and adherence to relevant standards.
The primary performance "criteria" are implied to be compliance with ATS standards for spirometry measurements and successful biocompatibility testing for new materials.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ATS (American Thoracic Society) spirometry standards | Device can apply ATS 1994 and ATS-ERS 2005 criteria for evaluation of measurements. |
| Biocompatibility of new mouthpiece material (Bormed GR 835 MO) | Biocompatibility test according to ISO 10993-1 was successful. |
| Efficacy of disinfection for reusable pneumotach | Validated for disinfection with an FDA approved disinfectant ("Cidex OPA Solution" with 510(k) K030004). |
| Safety requirements and mitigation of identified hazards | Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. |
| Compliance with Electromagnetic Compatibility (EMC) standards | EMC testing performed according to EN 60601-1-2. |
| Functional equivalence of Bluetooth data transmission | Bluetooth module (Mitsumi WML-C46) is identical to a previously cleared device (AM1+ / AM1+ BT, K090486). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The primary evaluation method is a comparison to a predicate device and adherence to technical standards. There is no mention of a specific sample size for a test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).
The "testing" referenced is primarily technical verification and validation of changes (e.g., biocompatibility testing of materials, disinfection validation, EMC testing, and functional testing of the Bluetooth module).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. Given the nature of the submission (device modification for substantial equivalence based on technical changes and existing standards), there is no indication of a requirement for a ground truth established by experts in the context of clinical performance data.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided. There is no mention of a clinical "test set" and thus no adjudication method for it.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
An MRMC study was not done. This device is a spirometer and oximeter, not an AI-assisted diagnostic tool for image interpretation or similar applications where MRMC studies are typically employed. There is no AI component mentioned that would assist human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Only parts of the device's performance are "standalone" in the sense that they are technical measurements or functions. For example, the spirometry measurements themselves (lung function parameters like FEV1, FVC) are generated by the device's algorithms based on sensor input. However, the device is intended for use by or with oversight from medical professionals (physicians in office/hospital, occupational medicine, or patients in the home under guidance). The document does not report on a standalone performance study in a clinical context separate from human-in-the-loop usage.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the core spirometry measurements, the "ground truth" is inherently defined by physical measurement standards and the ATS (American Thoracic Society) criteria. The device's accuracy for these measurements is presumably validated against calibrated instruments and the performance of the predicate device (SpiroPro SpO2, K031515), which was already cleared. For the new material and reusable pneumotach, the ground truth is established by biocompatibility testing standards (ISO 10993-1) and efficacy of FDA-approved disinfectants.
8. The Sample Size for the Training Set:
The document does not mention a training set. This type of submission (modification to an existing device, focusing on substantial equivalence for technical changes) generally does not involve machine learning or AI models that require training sets in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided as no training set is discussed.
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(100 days)
VIASYS HEALTHCARE GMBH
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population:
Children scale / 50 – 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
Adult scale / 50 - 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use: Places where a patient may require the measurement of their peak expriatory flow rate.
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
Here's a summary of the acceptance criteria and the study information based on the provided text for the Clean Peak Flow Meter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (Clean Peak Flow Meter) |
|---|---|
| Range: 60 - 900 L/Min | Range: 50 - 800 L/Min (adult), 50 - 380 L/Min (children) |
| Accuracy: +/- 10% | Accuracy: +/- 10% |
| Intra-device Precision: +/- 5% | Intra-device Precision: +/- 5% |
| Inter-device Precision: +/- 5% | Inter-device Precision: +/- 5% |
Note: The differences highlighted indicate a slightly different measurement range for adults and a specific range for children, as well as a change in mouthpiece material. The accuracy and precision criteria remain the same and are met by the new device.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document states that the Clean Peak Flow Meter was "developed in accordance with the Cardinal Health development standard operating procedures (000490 06 – Design Control)" and that "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards." However, no details about specific testing methodologies, number of devices tested, or the nature of the data collected during these tests are provided within the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described primarily pertains to engineering performance characteristics of the device, not clinical performance requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. As stated above, the listed tests are performance specification tests, not clinical evaluations that would typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a peak flow meter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Yes, in essence, the performance testing described for the Clean Peak Flow Meter is a standalone assessment of the device's accuracy and precision according to its specifications. The device itself is an analog, mechanical measuring tool; there is no AI algorithm involved. The listed performance criteria (Range, Accuracy, Intra-device Precision, Inter-device Precision) represent the device's capabilities when used as intended, without human intervention affecting its measurement output beyond the patient's breath.
7. The Type of Ground Truth Used
For the performance criteria (Range, Accuracy, Intra-device Precision, Inter-device Precision), the ground truth would typically be established by:
- Reference Standards/Calibration Devices: Highly accurate calibration equipment or standardized airflow generators are used to provide known input values against which the peak flow meter's readings are compared. This allows for validation of its accuracy and precision.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Clean Peak Flow Meter is a mechanical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and therefore not provided, as there is no "training set" for this mechanical device.
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(20 days)
VIASYS HEALTHCARE GMBH
The Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Cor12+ acquires, digitizes and stores data to be analyzed on a computer with special software.
The Cor12+ is indicated for use:
in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.
The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.
The digital Holter ECG recorder Cor12+ is a portable battery operated ECG amplifier with build in data storage on memory card (Mini SD size):
- Single dual color (green/yellow) LED .
- Button control (one Button) to activate communication interface, event . recording
- Two standard size AA batteries .
- Speaker for voice output for alarm messages .
- PC program to set-up recorder via blue-tooth communication interface 0
Here's a breakdown of the acceptance criteria and study information for the Cor12+ Holter Recorder based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, the device's performance is established through substantial equivalence to predicate devices, particularly the H12+ Holter Recorder. The "acceptance criteria" here are implied by meeting or exceeding the performance characteristics of the predicate device, or by demonstrating that differences do not raise new questions of safety or effectiveness.
Therefore, the table below highlights key performance characteristics compared to the primary predicate device, the H12+. Where performance is improved, it is noted.
| Performance Characteristic | Predicate Device (H12+) Performance | Cor12+ Holter Recorder Performance | Acceptance/Equivalence |
|---|---|---|---|
| Indications for Use | Ambulatory monitoring up to 48 hours. No cardiac analysis itself. | Ambulatory monitoring up to 24 hours. No cardiac analysis itself. Patient population: 4 years on, min 10kg. | Substantially Equivalent (with reduced monitoring duration and explicit patient population) |
| Patient Population | 4 years on and older | 4 years on and older. Minimum weight of 10kg. | Substantially Equivalent |
| Input Dynamic Range | +/- 300mV @ DC | +/- 1300mV @ DC | Improved (Allows recording with increased baseline drift) |
| Frequency Response/Bandwidth | 0.05 - 150 Hz (According to EC11 and IEC 60601-1) | Identical | Substantially Equivalent |
| A/D Conversion | 20 bit | 24 bit | Improved |
| Sampling Rate for Data Storage | 1000 Hz or 180 Hz | 1000 Hz or 250 Hz | Improved (Lower rate slightly higher, beneficial for accuracy) |
| Leads | 12 Standard - US color coding | Identical | Substantially Equivalent |
| Interface (Data Storage) | Compact Flash Memory Card | SD Memory Card | Different technology, but serves same function. Considered equivalent. |
| Interface (Programming) | Compact Flash Memory Card (or keypad/display) | Bluetooth (for programming only) | Different technology, but serves same function. Considered equivalent. |
| Energy Type | 1 x 1.5 V (AA size) | 2 x 1.5 V (AA size, Lithium) | Different, but considered equivalent regarding function. |
| Mode of Operation | Manual, Manual delayed, Automatic recording | Automatic recording | Different (fewer modes), but still considered equivalent for intended use. |
| Electrode Impedance | Not explicitly stated as a feature of H12+. | Impedance measurement for electrode contact quality (similar to MasterScope ECG). | Equivalent to MasterScope ECG. This is an added feature for quality. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical study with a "test set" in the traditional sense for evaluating device performance against pre-defined clinical endpoints or ground truth.
Instead, the submission relies on:
- Bench testing: "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards."
- Compliance with standards: "The EMC testing was performed according EN 60601-1-2 and EN 60601-2-47. Electrical Safety testing was performed according IEC 60601-1 and IEC 60601-2-47."
- Substantial equivalence arguments: Comparing technical specifications to predicate devices.
Therefore, there is no specific sample size for a clinical "test set" or information about data provenance (e.g., country of origin, retrospective/prospective) for a study directly proving the device meets performance claims through patient data. The evaluation methodology is primarily non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there was no clinical "test set" with ground truth established on patient data, this information is not applicable and not provided in the document. The evaluation focuses on engineering, safety, and performance characteristic comparison.
4. Adjudication Method for the Test Set
As no clinical "test set" requiring ground truth and expert adjudication was conducted, this information is not applicable and not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses the impact of an AI algorithm on human reader performance, which doesn't apply here as the Cor12+ is a data acquisition device, not an analytical AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Cor12+ is described as a "Holter Recorder" that "performs no cardiac analysis by itself; it solely records the ECG signals." Therefore, there is no standalone algorithm performance to evaluate. Its function is data acquisition, digitization, and storage, not diagnostic analysis.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on demonstrating compliance with recognized electrical safety and EMC standards and showing technical equivalence or improvement over predicate devices in terms of physical and performance specifications for ECG signal recording, rather than clinical outcomes or expert consensus on diagnostic accuracy.
8. The Sample Size for the Training Set
Since the device does not employ machine learning or AI algorithms requiring a training set for analysis, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this information is not applicable and not provided.
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(325 days)
VIASYS HEALTHCARE GMBH
The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.
The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.
MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics:
- Mains operation .
- Trolley for device and Baby Body box .
- Personal Computer System .
- Graphic user interface Windows XP Professional .
- Powerful database for storing patient- and test data .
- Tidal Breathing Analysis .
- Baby-Body Plethysmography .
- Baby Resistance / Compliance .
- Rapid Thoracic Compression (RTC) .
- Raised Volume Rapid Thoracic Compression (RV-RTC) .
- Spirometry / Flow Volume / MVV for children and adolescents ◆
- Airway Resistance (R Occlusion) for children and adolescents .
- P.01 / PImax / PEmax for children and adolescents .
The provided 510(k) summary for the MasterScreen Paed - Baby Body (K081823) does not describe a clinical study comparing the device's performance against specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, patient population, performance (measurements), software, device specifications, and accessories.
The summary highlights that the new options for the device were developed in accordance with VIASYS's standard operating procedures (Design Control), and that risk analysis (FMEA), safety test procedures, software development (IEC 601-1-4), and EMC testing (EN 60601-2) were performed. However, these are general compliance and engineering validation activities, not a detailed clinical study with performance metrics and acceptance criteria as typically found in a comparative effectiveness or standalone performance study for an AI/CADx device.
Therefore, the specific information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as such a study is not described.
The comparison tables provided in the document indicate that the new features offer "Identical" performance to the predicate devices in terms of specific measurement capabilities, but they do not define numerical acceptance criteria or present data from a study to prove these criteria were met.
In summary, the 510(k) relies on demonstrating equivalency to existing, legally marketed devices and adherence to relevant standards for design, safety, software, and EMC, rather than presenting a novel clinical study with explicit acceptance criteria for device performance.
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(177 days)
VIASYS HEALTHCARE GMBH
The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below.
· Differential diagnosis (heart/lungs)
· Disability assessment
• Rehabilitation evaluation
- · Exercise prescription
- · Sports medicine/research
- · Energy assessment, substrate utilization
- · Assessment of supplemental O2 requirement
- · Evaluation of medication effects
- · Pulmonary Function testing for adults and children
- · Document effectiveness of bronchodilator therapy
- Pulmonary disability evaluation
- · Industrial surveillance · Bronchial challenge testing
- · Exercise induced bronchial spasm
- · Pre-surgical risk evaluation
- Bedside lung function
Not Found
This document is an FDA 510(k) clearance letter for the VIP Pulmonary Function System (K080510). It does not contain the information requested about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (listed on page 2). It outlines regulatory requirements and informs the manufacturer that they can market the device.
Therefore, I cannot provide the requested information from the given text.
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(104 days)
VIASYS HEALTHCARE GMBH
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.
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(270 days)
VIASYS HEALTHCARE GMBH
The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.
MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).
MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) premarket notification letter from the FDA to VIASYS Healthcare GmbH concerning their MasterScreen PFT devices. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.
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(51 days)
VIASYS HEALTHCARE GMBH
The Viasys MASTERSCREEN CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The MASTERSCREEN CPX system allows the monitoring of metabolic parameters. The MASTERSCREEN CPX system is intended to use with adults and children over the age of 14 years.
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This document is a letter from the FDA to Viasys Healthcare GmbH regarding the clearance of their device, the MasterScreen CPX. It primarily focuses on the regulatory clearance process and does not contain detailed information about acceptance criteria or specific study results showing device performance.
Therefore, I cannot extract the requested information from the provided text. The document confirms the device's substantial equivalence to a predicate device but does not include the technical performance study details that would typically define acceptance criteria and prove their fulfillment.
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(47 days)
VIASYS HEALTHCARE GMBH
The Masterscreen Pneumo / Masterscope is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flowvolume measurements. Mostly it will be used for COPD and Asthma patients.
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
The Masterscreen Pneumo / Masterscope is powered from 100-240V / 50-60Hz wall outlets. No energy is transferred to the patient.
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This document is an FDA 510(k) clearance letter for the Maserscreen Pneumo / Masterscope device. It does not contain the detailed technical information required to answer your questions about acceptance criteria or study results. Specifically, the letter:
- Identifies the device: Maserscreen Pneumo / Masterscope.
- States its purpose: Measurement and data collection of lung function parameters, performing cooperation-dependent flow-volume measurements.
- Provides indications for use: For COPD and Asthma patients, from 4 years old and older who can cooperate, under the direction of a physician.
- Declares substantial equivalence to a predicate device, which is the basis for its clearance.
The document does NOT include any of the following information you requested:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
To obtain this information, you would typically need to refer to the 510(k) submission document itself, which is often much more extensive than just the clearance letter. The clearance letter only announces the FDA's decision based on that submission.
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(298 days)
VIASYS HEALTHCARE GMBH
The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
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The provided text is a 510(k) premarket notification letter from the FDA to Viasys Healthcare GmbH regarding their FlowScreen device. This document primarily focuses on the regulatory approval process and does not contain detailed information about acceptance criteria or the specific study that would prove the device meets these criteria. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing, but it does not elaborate on the technical performance data or studies that led to this determination.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert involvement from this document. The document confirms the device name, intended use, and regulatory classification but does not provide the technical study data.
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