The patient valve directs the ventilation air through a patient connector into the patient airway and directs the patient expiration air through an expiration connector. The patient connector is constructed to turn around its own axis enabling the resuscitator to turn in relation to connected masks or endotracheal tubes.

A pressure limiting valve (40 cmHzO) with an override mechanism is placed in the patient valve housing of all Pediatric and Infant resuscitators. For the Adult resuscitators a pressure limiting valve is optional.

M-Port is mounted in the patient valve housing and provides access to the inspiratory and expiratory gas flow allowing connection of a syringe for drug delivery or a qas sampling line for measuring side stream EtCO2. When the M-Port is not used it is sealed with a cap and the resuscitator operates as a resuscitator without the M-Port. The M-Port is an optional feature.

The bag of the resuscitator is made of a flexible and elastic material. which ensures the bag to have sufficient compression and recoiling properties. When the bag is compressed, air is delivered via the patient valve to the patient.

The inlet valve allows ambient air to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.

The reservoir consists of either a reservoir bag (closed reservoir) or a reservoir tube (open reservoir) attached to the inlet valve.

Supplementary oxygen can be supplied through the oxygen tube attached to the oxygen connector (reservoir bag) or mounted inside the inlet valve assembly (reservoir tube). Supplementary oxygen flows into the reservoir attached to the inlet valve assembly.

A Face mask, Endotracheal Tube or Larynqeal Mask/Combitube can be connected to the patient connector of the resuscitator to ensure contact to the patient's airway.

The Ambu SPUR II Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the Ambu SPUR II Resuscitator. This document is a regulatory submission for a medical device and describes the device's technical specifications and how it demonstrates substantial equivalence to existing devices. It does not describe an AI/ML-driven medical device, nor does it detail a study that proves an AI/ML device meets specific acceptance criteria in the context of clinical performance or human reader improvement.

Therefore, the requested information, specifically regarding acceptance criteria and studies related to AI/ML device performance (like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, training set details, etc.), cannot be extracted from this document, as it pertains to a manual medical device (resuscitator) and not an AI-powered diagnostic or assistive tool.

The document primarily focuses on bench testing and compliance with recognized consensus standards to demonstrate the safety and effectiveness of the manual resuscitator in comparison to predicate devices, rather than AI-related performance metrics.

However, I can extract the acceptance criteria and performance data for the manual resuscitator itself, as presented in the document, though it won't be AI-related.

Here's an attempt to answer the request based only on the provided document, interpreting "acceptance criteria" as the performance parameters tested for this manual device:

Device: Ambu SPUR II Adult, Pediatric, and Infant Resuscitator (a manual medical device, not an AI/ML device)

The document describes the device's substantial equivalence to predicate devices based on its intended use, operation, technological characteristics, and performance testing. The "acceptance criteria" here refer to the successful passing of various performance tests as per recognized consensus standards for manual resuscitators.

Table of Acceptance Criteria and Reported Device Performance (for the Manual Resuscitator)

Acceptance Criteria Category/Parameter	Reported Device Performance/Result
Compliance with Standards:
- ISO 10651-4: Particular requirements for operator-powered resuscitators	Passed. All tests described in the standard were performed, and the device demonstrated conformity.
- ISO 5356-1: Anaesthetic and respiratory equipment Conical connectors - Part 1: Cones and sockets	Passed. All tests described in the standard were performed, and the device demonstrated conformity.
Connectors Functionality:
- Patient connection port connector	Passed. Tested for functionality and compliance.
- Expiratory port connector for breathing gases	Passed. Tested for functionality and compliance.
- Face mask connectors	Passed. Tested for functionality and compliance.
- Oxygen tube connector and pressure gauge connector	Passed. Tested for functionality and compliance.
Operation Requirements:
- Patient valve function after contamination with vomits	Passed.
- Mechanical shock	Passed.
- Drop test	Passed.
- Immersion in water	Passed.
Ventilatory Requirements:
- Supplementary oxygen and delivered oxygen concentration	Passed.
- Expiratory resistance	Passed. (Adjusted to fulfill ISO 10651-4:2009 for Pediatric and Infant models).
- Inspiratory resistance	Passed.
- Patient valve malfunction	Passed.
- Patient valve leakage Forward leakage	Passed.
- Resuscitator dead-space and rebreathing	Passed.
Ventilation Performance:
- Minimum delivered volume	Passed. (Stroke volume specification updated for Adult model to show compliance with ISO 10651-4:2009).
- Pressure limitation	Passed.
Storage and Operation (tested at time zero and after accelerated aging):
- Inspiratory/Expiratory resistance test	Passed.
- Stroke volume test	Passed.
- Patient valve malfunction test	Passed.
- Supplementary oxygen and delivery oxygen concentration	Passed.
- Pressure limitation test	Passed.
Additional Performance Data:
- CO2 monitoring (M-port suitability)	Passed with at least 0.4 liter of tidal volume. Acceptance criteria: Maximum deviation of 5% at a confidence level of 95% in comparison to the Philips Side Stream Adapter.
- MR Conditional properties (Magnetic Field Interaction Testing per ASTM F2503-05)	Passed. Ambu SPUR II is MR Conditional and can be used in a MRI environment under specified conditions.
Biocompatibility (compliance with ISO 10993-1):
- Cytotoxicity (ISO 10993-5)	Passed.
- Sensitization (ISO 10993-10)	Passed.
- Intracutaneous reactivity test (ISO 10993-10)	Passed.
- Extractable and Leachable (E&L) testing	Passed.

AI/ML Specific Questions (Cannot be answered from the provided document as it is for a manual medical device)

Since this document describes a manual medical device (resuscitator) and not an AI/ML diagnostic or assistive device, the following points regarding AI/ML studies are not applicable and thus, no information can be extracted:

Sample sizes used for the test set and the data provenance: Not applicable. The document refers to engineering bench tests, not clinical data sets for AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
Adjudication method for the test set: Not applicable.
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: No, this was not done as it's not an AI device. The document explicitly states "No Clinical tests are performed."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is objective measurements against engineering standards.
The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission for a traditional, manual medical device. It thoroughly outlines the bench testing and compliance with established standards to demonstrate safety and effectiveness. However, it does not contain any information related to AI/ML device performance, human-AI interaction studies, or the methodologies typically employed for AI/ML model validation.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2016

Ambu A/S % Mr. Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045

Re: K152931

Trade/Device Name: Ambu SPUR II Adult Resuscitator Ambu SPUR II Pediatric Resuscitator Ambu SPUR II Infant Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: Class II Product Code: BTM Dated: June 26, 2016 Received: July 27, 2016

Dear Mr. Sanjay Parikh:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152931

Device Name Ambu SPUR II Adult Resuscitator Ambu SPUR II Pediatric Resuscitator Ambu SPUR II Infant Resuscitator

Indications for Use (Describe)

The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation.

The range of application for each version is:

-Adult: Adults and children with a body weight more than 30 kg (66lbs).

-Paediatric: infants and Children with a body weights up to 30 kg (66lbs).

-Infant: Neonates and infant with a body weight up to 10kg (22lbs).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Form Approved: OMB No. 0910-0120

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See PRA Statement below.

PSC Publishing Services (301) 443-6740 EF

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Section 5 - 510(k) Summary

This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the 510(k) has been prepared in accordance with 21 CFR 807.92

5.1 Submitter

Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark Tel.: +45 7225 2000 Fax.: +45 7225 2055

5.2 Contact Person

Name: Line Kagenow Svenstrup Job Title: Regulatory Affairs Professional Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup Telephone number: +45 7225 2217 Fax number: +45 7225 2055

5.3 Date summary Prepared

August 22, 2016

5.4 Device Trade name

Ambu SPUR II Adult Resuscitator Ambu SPUR II Pediatric Resuscitator Ambu SPUR II Infant Resuscitator

5.5 Device Common Name

Manual Resuscitator (Single Patient Use)

5.6 Classification name

Ventilator, Emergency, Manual (Resuscitator)

Device Class:	II
Classification regulation:	21 cfr 868.5915
Product code:	BTM
The panel is:	Anesthesiology

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5.7 Legally Marketed Devices to which the device is substantially equivalent:

Ambu SPUR II Adult Resuscitator:

Manufacturer	Trade Name	510knumber	Productcode
AMBU A/S	Ambu® SPUR® II Adult	K042682	BTM

Ambu SPUR II Pediatric Resuscitator:

Manufacturer	Trade Name	510knumber	Productcode
AMBU A/S	Ambu® SPUR® II Pediatric	K042843	BTM

Ambu SPUR II Infant Resuscitator:

Manufacturer	Trade Name	510knumber	Productcode
AMBU A/S	Ambu® SPUR® II Infant	K042843	BTM

5.8 Description of the Device

Ambu SPUR II Resuscitator is intended for manual pulmonary resuscitation. It is a disposable device intended for Single Patient Use only.

Ambu SPUR II Resuscitator is available in three sizes: Adult, Pediatric and Infant.

The main components of the product are a patient valve, a bag, an inlet valve, a reservoir bag/tube and an oxygen tube.

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sealed with a cap and the resuscitator operates as a resuscitator without the M-Port. The M-Port is an optional feature.

The inlet valve allows ambient air to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.

The reservoir consists of either a reservoir bag (closed reservoir) or a reservoir tube (open reservoir) attached to the inlet valve.

A Face mask, Endotracheal Tube or Larynqeal Mask/Combitube can be connected to the patient connector of the resuscitator to ensure contact to the patient's airway.

The Ambu SPUR II Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.

5.9 Intended Use

The Ambu SPUR II resuscitator is a sinqle patient use resuscitator intended for pulmonary resuscitation.

The range of the application for each version is:

Adult: Adults and children with a body weight more than 30kg (66lb). -
-Pediatric: Infant and children with a body weight up to 30kg (66lb).
-Infant: Neonates and infant with a body weight up to 10kg (22lb).

5.10 Summary of the technological characteristics in comparison to the predicate devices

Ambu SPUR II Resuscitator is substantially equivalent to:

Ambu® SPUR® II Adult Resuscitator (K042682); ●
. Ambu® SPUR® II Infant & Pediatric Resuscitator (K042843)

There are the following differences between the predicate devices and the subject devices:

Ambu SPUR II Resuscitator, All Sizes

The intended use of the subject devices does not include "emergency . support" This use is thus covered by the term "pulmonary resuscitation" and the change will not affect the use of the products.
The material of the bag has been changed. The change has been verified through bench testing and Biocompatibility Evaluation and does not affect the safety and performance of the resuscitators.
. Differences in standards used - ASTM F920-93 has been withdrawn without replacement. ISO 8382 has been replaced by ISO 10651-4:2009. ASTM

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F1054-87 has been replaced by ISO 5356-1:2004. The New Ambu SPUR II Resuscitators also complies with EN 13544-2:2009.

. The Ambu SPUR II Resuscitators are MR Conditional. Magnetic Field Interaction Testing had been performed to confirm that the Resuscitator can be used in a MRI environment under certain conditions.

Ambu SPUR II Resuscitator Adult

The M-port of the subject device has an additional function of EtCO2 (end . tidal CO2) side stream measurement. On the predicate device, the M-port was used only for medication delivery. The product risk evaluation and verification of this design change indicate that adding of this function does not introduce any new risk to the product and will not affect the safety and effectiveness of the device.
. The following changes are only changes to the specifications given to the user; they do not have any impact on the design itself. The following specifications have been updated to show compliance with ISO 10651-4:2009:
- o The stroke volume specification
- The dead space specification o
- The operating temperature O

Ambu SPUR II Resuscitator Pediatric and Ambu SPUR II Resuscitator Infant

· The following change is only a change to the specifications given to the user; it does not have any impact on the design itself:
- o The expiratory resistance specification. This specification has been adjusted in order to fulfil the requirements from the Resuscitator Standard ISO 10651-4:2009.

The above differences have been evaluated and the conclusion is that they do not affect the performance and safety of the subject devices, the New Ambu SPUR II Resuscitator Adult, Pediatric and Infant, compared to the predicate devices in any undesirable way. The operation and technological characteristics of Ambu SPUR II Resuscitators are considered substantial equivalent to the predicate devices operation and technological characteristics. All devices have the same intended use.

Ambu concludes that the Ambu SPUR II Resuscitators are substantially equivalent to the predicate devices.

5.11 Performance Data - Bench

Ambu has demonstrated conformity with to the following recognized consensus standards;

ISO 10651-4 Lung ventilators Part 4: Particular requirements for operator-. powered resuscitators
ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors -● Part 1: Cones and sockets

All tests have been performed as described in the standards. Result: All tests were passed.

Connectors

Patient connection portconnector, .
Expiratory port connector for breathing gases .
Face mask connectors (connectors of facemask) ●

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. Oxygen tube connector and pressure gauge connector
Operation requirements
Patient valve function after contamination with vomits .
Mechanical shock ●
Drop test ●
Immersion in water ●

Ventilatory requirements

Supplementary oxygen and delivered oxyqen concentration ●
Expiratory resistance ●
Inspiratory resistance
Patient valve malfunction ●
Patient valve leakage Forward leakage ●
Resuscitator deadspace and rebreathing ●

Ventilation performance

Minimum delivered volume .
Pressure limitation .

Storage and Operation, tested at time zero and after accelerated aging

Inspiratory/Expiratory resistance test ●
Stroke volume test
Patient valve malfunction test ●
Supplementary oxygen and delivery oxygen concentration ●
. Pressure limitation test

Additional performance data was submitted to document the following properties of Ambu SPUR II:

CO2 monitoring

Suitability of the M-port to be used for CO2 monitoring (accept criteria: . Maximum deviation of 5% at a confidence level of 95% in comparison to the Philips Side Stream Adapter).
Result: Passed with at least 0.4 liter of tidal volume.

MR Conditional

. MR Conditional properties (Magnetic Field Interaction Testinq was performed in according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)
Result: Passed, Ambu SPUR II is MR Conditional and can be used in a MRI environment under specified conditions.

Test reports for Biocompatibility shows that the devices complies with the requirements of ISO 10993-1:

Cytotoxicity (ISO 10993-5) .
Sensitization (ISO 10993-10) ●
. Intracutaneous reactivity test (ISO 10993-10)

In addition Extractable and Leachable (E&L) testing has been performed.

Result: All tests were passed

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Since the device is in compliance with the listed standards and has passed the listed performance tests, it is concluded that technological characteristics of Ambu SPUR II is as safe and as effective as the currently marketed predicate devices.

5.12 Performance Data - Clinical

No Clinical tests are performed.

5.13 Conclusion

Based on the Intended use, operation and technological characteristics, and performance testing, it has been concluded that the Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator and Ambu SPUR II Infant Resuscitator is substantial equivalent to the predicate devices.

It is concluded that the Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator and Ambu SPUR II Infant Resuscitator are as safe and as effective as the legally marketed predicate devices.

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).