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The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters. The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years.

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The provided document is a 510(k) premarket notification letter from the FDA for the Oxycon Mobile device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details typically associated with the rigorous testing and validation of a new AI/medical device. This type of letter is an approval for marketing based on substantial equivalence, not a detailed technical report of the device's performance or a study proving its meeting of specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter.

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The MS PAED - BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants.

The MS PAED – BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.

The MS PAED - BABY BODY is a local moveable device for the determination of airway resistance, absolute lung volume at FRC and tidal breathing patterns of babies and infants. Equipped with a computer and the Baby-Bodyplethysmography program the software is extremely easy to use, allows you to very quickly make several measurements and tolerates less experienced operators. The operator is to be guided through the program.

The built in quality checks of the program prompt the user about a bad performed manoeuvre or an unacceptably low quality of the measurement.

The body plethysmography measurement is provided with a reanalysis mode, which means that the physician can modify all data whenever required thereby eliminating the need for patients to return for additional measurements.

Here's an analysis of the provided text regarding the MS PAED – BABY BODY device, focusing on the acceptance criteria and study information:

Assessment of Provided Information:

The provided document is a 510(k) Pre-Market Notification, which is typically a submission to the FDA demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission often focuses on comparison to a predicate and performance testing to device specifications and recognized standards, rather than extensive clinical studies for novel effectiveness claims.

Crucially, the document explicitly states: "Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies." It also mentions compliance with electrical safety and electromagnetic compatibility standards.

Therefore, the "study that proves the device meets the acceptance criteria" in this context is most likely a series of internal, laboratory-based performance verification tests, rather than a clinical trial with human subjects.

Given this, much of the requested information (like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance with clinical data, and training set details) is either not applicable or not detailed in this type of regulatory submission. The FDA 510(k) process for a device like this would generally not require or include such granular detail from clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly tied to the device's specifications, its intended use, and compliance with recognized standards. The "reported device performance" is a general statement of compliance.

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

• Sample Size: Not specified. This would typically be a set of measurements or tests conducted in a lab environment rather than a patient sample size.
• Data Provenance: Laboratory testing. No country of origin for data is specified, but the submitter is Erich Jaeger GmbH, located in Germany. These tests are inherently prospective in the sense that they are performed to confirm the device's adherence to design specifications before market release.

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

• Number of Experts: Not specified. For laboratory performance testing, "ground truth" would be established by validated reference methods or calibrated equipment against which the device's measurements are compared. This typically involves engineers and technicians, not clinical "experts" in the sense of physicians establishing diagnoses.
• Qualifications of Experts: Not specified. Presumed to be qualified engineers and technicians experienced in medical device testing, calibration, and relevant international standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of purely laboratory-based performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth. Here, results are compared to known reference values or specifications.

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: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This device is a measurement system, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Yes, in essence, the "performance testing" described is a standalone evaluation of the device's accuracy and functionality based on its internal algorithms and hardware. The device itself is the "algorithm only" in this context, generating measurements. The text explicitly mentions "built in quality checks of the program" and that the "operator is to be guided through the program," implying the software's inherent standalone function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the performance testing, the ground truth would be established through:
  • Reference Standards: Calibrated equipment providing known inputs or outputs.
  • Device Specifications: The pre-defined acceptable ranges and accuracies for each measured parameter.
  • International Standards: Requirements for electrical safety and electromagnetic compatibility (e.g., IEC standards).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a measurement system and does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense of developing a predictive model. Its "program" functions based on established physiological principles and algorithms, not data-driven learning.

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

• Ground Truth for Training Set: Not applicable, as there is no mention or indication of a training set for machine learning.

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The SleepScreen and ApnoeScreen Cardio are portable physiological signal recording devices intended to be used for testing patients suspected of having sleep-related breathing disorders. They are intended to be used under the direction of a physician. The devices may be used in the home, clinic, doctor's office or hospital.

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as an apnea monitor or as a component in an apnea monitoring system.

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.

The SleepScreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The SleepScreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital.

The SleepScreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the SleepScreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.

The ApnoeScreen Cardio is the ApnoeScreen Pro (K000396) with the addition of two AC channels. The additional AC channels may be used to record electro-oculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).

The SleepScreen is the ApnoeScreen Pro (K000396) with the addition of eight AC channels. The additional AC channels may be used to record electrooculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).

The provided document, K021138, for the SleepScreen and ApnoeScreen Cardio devices, describes their intended use and comparison to a predicate device but does not contain detailed information regarding specific acceptance criteria for performance metrics, the results of a formal clinical study to prove these criteria, or any of the detailed aspects of such a study as requested in the prompt.

Instead, the document states:

"Summary of Performance Testing: Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electromagnetic compatibility were performed: the SleepScreen/ApnoeScreen Cardio complied with the requirements of these standards."

This statement indicates that laboratory-based performance testing was conducted against device specifications and international standards for electrical safety and electromagnetic compatibility. However, it does not provide the specific numerical acceptance criteria or the reported performance data in a quantifiable manner, nor does it detail a clinical study as typically understood for AI/algorithm-based devices.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a traditional medical device submission focusing on hardware functionality, safety, and equivalence to a predicate device, rather than the performance of an algorithm against ground truth data.

Based on the provided text, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a quantifiable table format. The document generally states that "measured parameters met required ranges and accuracies" and that the device complied with electrical safety and electromagnetic compatibility standards, but no specific numerical targets or results are given.

2. Sample size used for the test set and the data provenance: This information is not provided. The "performance testing" described appears to be laboratory-based functional testing, not a clinical study with a defined patient test set.

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. As no clinical test set is detailed, the concept of establishing ground truth by experts is not addressed.

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: This information is not provided. The device is a physiological signal recording device, not an AI-assisted diagnostic tool as implied by an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided. The device is described as recording physiological signals, implying human interpretation of these signals for diagnosis. It is not an AI algorithm performing standalone diagnoses.

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 device does not appear to involve machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established: This information is not provided.

In summary, the provided document is a 510(k) premarket notification for a physiological signal recording device. It focuses on demonstrating substantial equivalence to a predicate device and confirming basic laboratory performance, electrical safety, and electromagnetic compatibility. It does not detail the type of clinical performance study or AI algorithm validation that would require the specific information requested in the prompt.

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The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.

The AM2 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.

The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.

The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.

The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.

The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.

The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.

The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The provided document (K980876) is a 510(k) clearance letter for the "Asthma Monitor AM2" and an "Indications For Use" statement. It does not contain a study describing acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a clinical study as requested.

The document indicates that the device is substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness were likely established based on its similarity to existing devices, rather than a new standalone clinical study with detailed acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information from this document.

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