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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Functional Verification	All functions operate as designed and intended.	Verified to operate as designed and intended.
Parameter Accuracy	Measured parameters meet required ranges and accuracies.	Measured parameters met required ranges and accuracies.
Electrical Safety	Compliance with internationally accepted standards for electrical safety.	Complied with the requirements of these standards.
Electromagnetic Compatibility (EMC)	Compliance with internationally accepted standards for EMC.	Complied with the requirements of these standards.
Intended Use	Device functions as a neonatal lung function measurement system utilizing a bodyplethysmograph for babies and premature infants, under physician direction.	Confirmed by device description and intended use statement.
Non-Life Support Role	Not to be used as a life support device/system or critical component thereof.	Stated explicitly in the intended use.

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.

Summary

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02 37096

Summary of Safety and Effectiveness

MAR 0 3 2003

Date of Preparation: October 29, 2002

Erich Jaeger GmbH Submitter: Leibnizstasse 7 D-97204 Hoecherg Germany
Earl Draper Contact: SensorMedics Corp. Phone: (714) 283 2228 extension 8461 Fax: (714) 283 8426

Alternate (Germany) Elmar Niedermeyer Erich Jaeger GmbH Phone: 01149 931 4972-361 Fax: 01149 931 4972-62361

Device Trade Name: MS PAED – BABY BODY

Device Common/Classification Name: The MS PAED – BABY BODY is an Erich Jaeger GmbH device classified under 73 CCM, "Plethysmograph, Pressure", per Regulation No. 868.1750.

Predicate Device: INFANT BODY TEST (K853390)

Intended Use:

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.

Devise Description:

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

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Comparison to Predicate Device:

The MS PAED - BABY BODY is similar to the Jaeger INFANT BODY TEST as follows: it transduces physiological signals into electrical signals. Also, the recorded data is analyzed and presented graphically and numerically. Both devices record the same physiological parameters relevant to pulmonary disease.

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 MS PAED - BABY BODY complied with the requirements of these standards.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 3 2003

Erich Jaeger GmbH C/O Mr. Earl Draper SensorMedics, Incorporated 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645

Re: K023796

Trade/Device Name: MS PAED-Baby Body Regulation Number: 868.1750 Regulation Name: Pressure Plethysmograph Regulatory Class: II Product Code: CCM Dated: February 18, 2003 Received: February 21, 2003

Dear Mr. Draper:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Draper

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Punnen

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K02379K 510(k) Number:

MS PAED - BABY BODY Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infestion Control, Dental DevicesInfection Control, Dental Devices

510(k) Number ._______________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.1750 Pressure plethysmograph.

(a)
Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.(b)
Classification. Class II (performance standards).