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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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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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