AMBU NEONATE SILICONE RESUSCITATOR by AMBU, INC.

The provided document is a 510(k) clearance letter from the FDA for the Ambu Neonate Silicone Resuscitator. It does not contain the acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the way a performance study for an AI/ML device would.

Instead, this document grants clearance based on the determination that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA reviewed information submitted by Ambu (in their 510(k) submission, not provided here) and concluded that the new device is as safe and effective as existing devices on the market for its intended use.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies for this particular document, as those details are not part of a 510(k) clearance letter. These types of studies and criteria are typically associated with performance testing for new and complex medical devices, especially AI/ML-driven ones, and are included in the underlying 510(k) submission, not the clearance letter itself.

The key information from this document is:

Device Name: Ambu Neonate Silicone Resuscitator
Regulatory Class: II (two)
Product Code: 73 BTM
Indications For Use: The Ambu Neonate Silicone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).
Approval Date: May 17, 2000
Basis for Approval: Substantial equivalence to legally marketed predicate devices.

If this were a description of an AI-driven device and its performance study, the information would be structured as follows:

(Hypothetical Example if the document did contain the requested information for an AI device)

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Primary Endpoints
[Metric 1, e.g., Sensitivity for X]	> [Value, e.g., 90%] with 95% CI	[Reported Value, e.g., 92.5% (95% CI: 90.1-94.2%)]
[Metric 2, e.g., Specificity for Y]	> [Value, e.g., 85%] with 95% CI	[Reported Value, e.g., 86.1% (95% CI: 83.9-88.0%)]
Secondary Endpoints
[Metric 3, e.g., AUC]	> [Value, e.g., 0.90]	[Reported Value, e.g., 0.93]
[Metric 4, e.g., Time to Detection]	< [Value, e.g., 5 seconds]	[Reported Value, e.g., 3.2 seconds]

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): [Number] cases (e.g., 500 images)
Data Provenance: [Country of origin (e.g., USA, multi-national across Europe and Asia), Retrospective/Prospective, (e.g., Retrospective, de-identified chest X-rays from hospitals in the US and Germany)]

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: [Number, e.g., 3 or 5]
Qualifications: [e.g., Board-certified Radiologists with >10 years of experience in pulmonary imaging, and 2 expert thoracic surgeons.]

4. Adjudication method for the test set:

[e.g., 2+1 (two initial readers, third adjudicator for disagreement), 3+1 (three initial readers, 4th adjudicator for disagreement), Simple majority, Consensus meeting, No adjudication (single reader for ground truth)]

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:

[Yes/No]
Effect Size: [e.g., Human readers' sensitivity for lesion detection improved by an average of X% (e.g., 15%) when using AI assistance (from Baseline Y% to Z%), accompanied by a reduction in reading time by A% (e.g., 20%).]

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

[Yes/No]

7. The type of ground truth used:

[e.g., Expert consensus (as described in #3), Pathology reports (biopsy-confirmed), Clinical outcome data (validated by long-term follow-up), Surgical findings, Combination of the above.]

8. The sample size for the training set:

Sample Size (Training Set): [Number] cases (e.g., 50,000 images)

9. How the ground truth for the training set was established:

[e.g., Each case was annotated by a single board-certified radiologist, followed by a double-check by a senior radiologist. Automated extraction from electronic health records, where diagnoses were confirmed by at least two independent clinical notes. Utilized a combination of expert labeling and pathology reports for a subset of the data.]

Summary

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Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the edge. In the center of the circle is a symbol consisting of three parallel lines that curve and taper to a point, resembling a stylized bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2000

Mr. Sanjay Parikh Ambu, Inc. 611 North Hammonds Ferry Road Linthicum, MD 21090-1356

Re: K993278 Ambu Neonate Silicone Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: March 9, 2000 March 10, 2000 Received:

Dear Mr. Parikh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Sanjay Parikh

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours

sincerely yours,

Mark n Melkum

James E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993278 510(k) Number (if known):

Dovice Namo: Ambu Neonate Silicone Resuscitator

Indications For Use:

The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Melkerson

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

(Optior al Format 3-10-98)

PRESCRIPTION USE

510(k) Number .

OVER - THE- COUNTER USE

Regulation Number and Section

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).