The Hi-Ox® is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 lpm. It is a simple device consisting of a central manifold section where the patient mask, oxygen tubing and an oxygen reservoir bag attach. The triple valving in the manifold directs the oxygen to the patient and acts as an anti-asphyxiation valve removing the need for ventilation holes in the mask itself, thus allowing for delivery of high FiO2's. Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation. The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1.5 cmH,O, typically ~ 1.07 cmH,O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve's resistance is specified to be less than 3 cmH2O/I/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.

AI/ML Overview

The provided text describes the Hi-Ox® High FiO2 Mask and a 510(k) submission to the FDA. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a clinical trial or a formal validation study for a software algorithm would.

Instead, the document details the design principles and bench testing of a physical medical device (an oxygen mask) to demonstrate its functionality and safety compared to existing devices. The "tests" mentioned are primarily engineering validations and performance measurements of the mask's components.

Therefore, I will extract what I can from the provided text, but many of the requested sections (e.g., sample size for test set, ground truth experts, MRMC, training set) are not applicable to the type of device and testing described.

Here's the information derived from the provided text, addressing the points as best as possible:

Acceptance Criteria and Device Performance for Hi-Ox® High FiO2 Mask

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Design Target)	Reported Device Performance
FiO2 values	In excess of 90% and over 80% at all times (monitored via sampling port)
Inhalation/Exhalation Valve Flow Resistance	Less than 1.5 cmH₂O at 60 lpm (0.025 cmH₂O per lpm)
Sequential Dilution Valve Resistance	Less than 3 cmH₂O/I/sec
Work of Breathing	Little to no effort (Subjective testing)
Valve Flow Resistance after extreme storage	Unchanged from room temperature
Seal to face	Improved seal due to dual straps, softer material, foam, and metal strip
Absence of holes	No holes in the mask

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

Sample Size: Not explicitly stated for FiO2 testing. The text refers to "experiments conducted" but does not quantify the number of "users" or "tests" beyond indicating a sampling port was used directly in front of "a user's nose."
Data Provenance: The tests appear to be laboratory bench tests and subjective evaluations conducted by SensorMedics. The text does not specify the country of origin for the data (beyond SensorMedics being a US company) or if it was retrospective or prospective in a clinical sense. Given the nature of the device (physical mask), it's likely a controlled lab environment.

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

Number of Experts: Not applicable or mentioned. The "ground truth" for these tests relates to physical measurements (FiO2, flow resistance) and subjective reports ("little or no effort required for breathing"). These are direct measurements or user experiences, not expert consensus on interpretations.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The tests are based on physical measurements of device characteristics (e.g., FiO2, flow resistance) or direct subjective feedback. There is no mention of ambiguous cases requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, this is not an MRMC study. MRMC studies are typically used for diagnostic imaging or AI systems where multiple human readers interpret cases. This document describes a physical oxygen mask.

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

Standalone Performance: Not applicable. This device is a physical mask, not an algorithm. The performance measured is that of the physical device's characteristics (e.g., FiO2 delivery, valve resistance).

7. The type of ground truth used

Ground Truth Type:
- Direct Measurement: For FiO2, it was measured using a "SensorMedics 229 metabolic measurement system" via a sampling port. For valve resistance, it was measured using specialized equipment.
- ASTM Standard: Valve flow resistance after extreme temperature exposure was validated using established ASTM F920 test protocols.
- Subjective Report: Work of breathing was assessed via "subjective testing" where users reported "little or no effort required for breathing."

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The design and validation are based on engineering principles and bench testing.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary

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SMDA Summary:

Hi-Ox® - Summary of Safety and Effectiveness

Company:	SensorMedics Corporation
Address:	22705 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone	714 283-1830
Fax	714 283-8493

Contact:

Earl Draper

Proprietary Name: Hi-Ox80

Common Name:

High FiO2 Mask

Intended Use:

The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

Description of the Device:

Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation.

The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1.5 cmH,O, typically ~ 1.07 cmH,O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution

SensorMedics

Special 510(k) Submission Addition of Pediatric Mask to HiOX80

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valve's resistance is specified to be less than 3 cmH2O/I/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.

Clinical and Non-Clinical Tests of Equivalency:

Most oxygen masks dilute the inspired oxygen because of two reasons. One is the presence of two entrainment ports on the mask that patients exhaled through, and the other is gas leaking due to poor fit of the mask to the face.

On inspiration, these entrainment ports provided a large source of dilution. particularly when the flow path between the inspired reservoir and the mask is of higher resistance than the holes. The Hi-Ox® mask has no holes in the mask, thereby eliminating this major source of oxygen dilution.

The Hi-Ox® mask has dual straps (one above and one below the ear) to achieve better sealing between the mask and the face. Additionally, the lower durometer mask material allows the mask to conform better to the face. The use of foam on the inside of the nose bridge portion of the mask and a metal strip further improve the seal across the bridge.

By positioning a sampling port (probe) through a hole on the side of the mask and directly in front of a user's nose, the oxygen concentration of the inhaled gas can be monitored. In experiments conducted using a SensorMedics 229 metabolic measurement system, we observed FiO2 values in excess of 90% and over 80% at all times. These tests are reported in Appendix 7a.

Flow resistance of all the one-way valves employed have been found to be well below the design target of 1.5 cmH,O at flows of 60 lpm, i.e. 0.025 cmHJO per lpm. Typical pressure drops are in the range of 1.07 cmHJ,O at 60 lpm. Subjective testing also confirm little or no effort required for breathing through the Hi-Ox® oxygen mask assembly.

The valve flow resistance performance after exposure to extreme storage temperatures has been found to be unchanged from room temperature. This validation was completed with the help of a nationally recognized test laboratory (NRTL) and following the established ASTM F920 test protocols.

SensorMedics

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2003

Mr. Earl W. Draper Director of Quality Systems & Regulatory Affairs SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887

Re: K030943

Trade/Device Name: Hi-Ox® High FiO2 Mask Regulation Number: 868.5870 Regulation Name: Non-Rebreathing Valve Regulatory Class: II Product Code: CBP and KGB Dated: March 24, 2003 Received: March 26, 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.

Supr Ruass

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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Indications For Use Enclosure:

Indication for Use

Page of 1

510(k) Number (if known): Ko30943

Device Name: Hi-Ox80 High FiO2 Mask

Indications For Use:

The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

SAWutroh

on of Anesthesiology. General Hospital. Infection Control, Dental D

510(k) Number:

SensorMedics

Special 510(k) Submission Addition of Pediatric Mask to HiOX®º

Regulation Number and Section

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).