The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is found to be substantially equivalent in that it produces a minimum of 6 liters per minute of 99% pure oxygen for a 15 minute interval, by means of a chemical reaction. The OX-GEN Rigid O2 Generation System is composed of three self-contained chambers that when opened are activated and begin to generate instant, non-pressurized oxygen. The second part of the device consists of the plastic tubing, an inline filter and an oxygen mask, which are attached to the outlet of the oxygen generator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the OX-GEN Rigid O2 Generation System, Model 5-OX-03. This is a medical device submission seeking clearance based on substantial equivalence to existing devices, not a study directly proving performance against acceptance criteria in the way a clinical trial for a novel drug or a new AI algorithm would.

Therefore, many of the requested categories (expert ground truth, sample sizes, MRMC studies, standalone performance of an algorithm) are not applicable to this type of submission. This submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against pre-defined quantitative acceptance criteria through a clinical study.

However, we can infer "acceptance criteria" from the performance characteristics of the predicate devices and the new device. The "study" here is essentially the technical comparison and testing performed by the manufacturer to demonstrate these performance characteristics are met.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations inherent in a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Predicate/Device Description)	Reported Device Performance (OX-GEN Rigid O2 Generation System, Model 5-OX-03)
Minimum oxygen production: 6 liters per minute (LPM)	At least 6 LPM
Oxygen Purity: 99% pure oxygen	99% pure oxygen
Duration of oxygen production: 15 minutes	Maintained for at least 15 minutes
Maximum temperature of oxygen at the mask	33°C
Intended for emergency uses	Intended to produce instant, non-pressurized oxygen for emergency uses
Oxygen generation initiated by chemical reaction	Oxygen generated by a chemical reaction
Provided in kit form with necessary components	Provided in kit form with necessary components
Single-use device	Designed for single use only
Content non-toxic hazard upon disposal	Contents are not a toxic hazard (water, sodium carbonate, manganese dioxide, platinum)
Chemicals contain water, 6.0% hydrogen peroxide, manganese dioxide, platinum powder, and sodium percarbonate	Device uses these chemicals

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

The document does not specify a "test set" sample size in the context of a clinical study or data-driven algorithm validation. Instead, the submission describes the device's technical specifications and performance characteristics, likely derived from laboratory testing and engineering assessments of the physical device.

Sample Size: Not specified in terms of "test set" for a clinical study. It would refer to the number of devices tested during manufacturing and quality control.
Data Provenance: Not explicitly stated, but implies prospective engineering and performance testing carried out by the manufacturer (OX-GEN Corporation) in the US.

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

Not applicable. This is a medical device submission based on substantial equivalence, not an AI or diagnostic device that requires expert-established ground truth for a clinical dataset. The "ground truth" here is the physical and chemical properties of oxygen generation measured by instrumentation.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication by human experts in the context of this submission. Device performance parameters (flow rate, purity, temperature) are objectively measured.

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

Not applicable. This device is a portable oxygen generator, not a diagnostic imaging or AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

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

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance would be objective, quantitative measurements obtained through laboratory testing of the oxygen generated. This would involve:

Gas analyzers to measure oxygen purity.
Flow meters to measure oxygen flow rate.
Timers to measure duration of generation.
Thermometers to measure temperature at the mask.
Chemical analysis to confirm composition of reactants and products.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable. As there is no training set, the concept of establishing ground truth for it does not apply.

Summary

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K033863

AUG 2 2 2005

510(k) PREMARKET SUMMARY

General Information:

1.	Original Date Submitted:	November 10, 2003
2.	Submitted By:	OX-GEN CorporationP.O. Box 5867Boise, ID 83705Tel: (208) 336-0773Fax: (208) 336-0775Contact Person:Frank Fosella, Jr.
3.	Device Trade Name:	OX-GEN Rigid O2 Generation System, Model 5-OX-03
	Common Name:	Portable Oxygen Generator
	Classification Name:	Portable Oxygen Generator
4.	Legal to MarketPredicate Device:	Jet Research Center, Model 415 Oxygen Canister andDispenser, Model 3445-c.510(k): K780020Canogen International LTD., Model 615 PortableOxygen Generator.510 (k): K982243

ડ. Device Description:

1. Indications for Use:
  The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is intended to produce instant, non-pressurized oxygen for emergency uses.

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TECHNOLOGICAL COMPARISON

The OX-GEN Rigid O2 Generation System, the Jet Research Center Model 415 and the TIC OX-OLN Right O7 Seneration Model 615 are all designed to generate oxygen as a Callogen I ortable Oxygen Generatives devices are comprised of a kit containing the result of a enembed reaction. In themicals and accessories to provide oxygen for emergency use.

Jet Research Center Model 415 and the Canogen Portable Oxygen Generator Model 615 see a hard plastic multi-chambered reaction container. The container provides several use a nard plastic many cas the packaging for the Jet Research Center Model 415 and the runctions: I mbl, I be reator Model 615 kits and contains the pre-measured Canogen I oriable Oxygen Ocenond, when oxygen is to be created, it serves as the container enomising the pre-measured chemicals. Third, the container serves as the chamber that houses the chemically created oxygen that is then delivered through the accessories. Finally, the reaction container can be reused.

The Jet Rescarch Center Model 415 and the Canogen Portable Oxygen Generator Model 615 requires combining the chemicals in a sequential process to create oxygen which takes in excess of seven minutes. The initiation of the process is a manual action performed by the user. After mixing the chemicals, the oxygen creation begins immediately.

The OX-GEN Rigid O2 Gencration System Model 5-OX-03 is a rigid three chambered container with the pre-measured chemicals that are needed for the generation of oxygen ebready in place in the appropriate chambers. The top chamber contains water for cooling and cleaning the oxygen that is produced. The middle chamber contains the dilute hydrogen peroxide. The top and middle chambers are connected by a rotary valve with orings, Valve #3, to create a seal between the chambers and the outside of the device. The bottom chamber contains the granular sodium percarbonate. The middle and bottom chambers are connected with a flat valve, Valve #1, which is opened or closed by a rotary cam shaft. The cam shaft has o-rings to seal it from the outside of the device. The flat valve has several o-rings for sealing purposes as well as an area for catalyst storage. The catalysts can also be contained within a special chamber-type valve, Valve #2, located in the bottom chamber area. The three valves are opened in a numbered sequence to allow the chemicals and catalyst to mix and react. The reaction that occurs creates the release of oxygen. The oxygen exits the device by first entering the now empty middle chamber where any foam or bubbles break up. It then enters the top chamber where it bubbles through the water for cooling and scrubbing (cleaning) for removal of any possible carryover of the react chemicals. It leaves the device through the top nipple and is conveyed by the Salter Labs Three-channel Oxygen Safety Tubing to the inline moisture trap/activated carbon filter and then on through more Three-channel tubing to the Slater Labs Oxygen Mask.

The generation of oxygen begins immediatcly when the chemicals mix and increases to a flow rate of at least 6 liters per minute within 1 to 1 ½ minutes. The flow rate of 6 liters per minute or more is maintained for at least 15 minutes and then decreases to zero over the next 10 minutes.

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The maximum tcmperature of the oxygen measured at the mask is 33°C. The water The than an top of the device cools and cleans the oxygen after it is produced by the exothermic reaction of generating chemicals.

The chemical reaction that occurs within the OX-GEN Rigid O2 Generation System Model 5-OX-03 is as follows:

The reaction can be considered a two phase reaction; first the liquid hydrogen peroxide reacts with the catalysts to produce oxygen and water and then that water and the sodium percarbonate and catalysts react to produce additional oxygen.

The chemical formulas are as follows:

$$2 \text{ H}_2\text{O}_2 \xrightarrow[\text{Pt}]{\text{MnO}_2} 2\text{ H}_2\text{O} + \text{O}_2$$

$$2(2\text{Na}_2\text{CO}_3 \cdot 3\text{H}_2\text{O}_2) \xrightarrow[\text{Water}]{\text{MnO}_2 + \text{Pt}} 4 \text{ Na}_2\text{CO}_3 + 6 \text{ H}_2\text{O} + 3 \text{ O}_2$$

The chemicals used in the OX-GEN Rigid O2 Generation System Model 5-OX-03 consist of water in the top chamber, 6.0% hydrogen peroxide in the middle chamber, manganese dioxidc and platinum powder in the flat valve cavity and the chamber-type valve, and sodium percarbonate in the bottom chamber. The catalysts promote the decomposition of the liquid hydrogen pcroxide to water and oxygen and in turn the sodium percarbonate decomposes to sodium carbonate, water, and oxygen. These reactions are exothermic and heat is therefore generated. By the completion of the oxygen generating reaction, the temperature of the reactant products reaches 89 to 90℃.

After the oxygen generating reaction is complete, usually about 27 to 28 minutes, Valve #3 should be closed and the red cap should be replaced on the outlet nipple to seal the device closed. All components of the OX-GEN Rigid O2 Generation System Model 5-OX-03 are designed for single use only and need to be returned to the manufacturer for any recharging. In the event that the unit gets disposed of the contents are not a toxic hazard. They are water, sodium carbonate (soda ash) which is a naturally occurring salt, and the manganese dioxide and platinum which occur naturally in the environment as minerals.

If any of the unreacted chemicals get spilled or leak from the OX-GEN Rigid O2 Generation System Model 5-0X-03 they will be either water, a weak hydrogen peroxide solution, granulated or liquefied sodium percarbonate, and the two catalysts manganese dioxide and platinum. The hydrogen peroxide should be rinsed down with water. The granulated or liquefied sodium percarbonate is the samc compound as that found in common powdered oxygen bleaching products that are used for household, laundry, carpet, and deck cleaning chores. It should be rinsed down with water. The two catalysts are present in very small amounts and can be washed down along with the other chemicals without undue concern. If any of these chemicals come in contact with the skin or eves.

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rinse the affected area with cool water. If irritation persists medical advice should be sought.

The OX-GEN Rigid O2 Generation System, the Jet Research Center Model 415 and the Canogen Portable Oxygen Generator Model 615 use different pre-measured chemicals. The rcsults of combining these chemicals are all the same. They all gencrate emcrgency oxygen.

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SUBSTANTIAL EQUIVALENCE DATA SUMMARY

The OX-GEN Rigid O2 Generation System Model 5-OX-03, the Jet Research Center Model 415, and the Canogen Portable Oxygen Generator Model 615 are substantially equivalent in that they are designed to generate oxygen as a result of a chemical reaction. All three devices are provided in kit form with the necessary containers, chemicals, and accessories to provide oxygen for cmergency use. The Jet Research Center Model 415 and Canogen Model 615 use cartridges containing chemicals inserted into the reaction vessel which contains the reaction and ports the gas to the face mask tubing. While substantially equivalent, the OX-GEN Rigid O2 Generation System Model 5-OX-03 uses a three chamber container with valves that connect the chambers. The valves are opened enabling the chemicals to mix, react, and port the oxygen to the face mask tubing.

All devices are substantially cquivalent to one another in that they are intended to be emergency use devices. The targeted population is also equivalent by directing marketing to healthy individuals in emergency situations"

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Image /page/5/Picture/1 description: The image shows a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized caduceus-like symbol with a human figure in the center. The text "HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2005

Mr. Frank Fosella Ox-Gen Incorporated P.O. Box 5867 Boise, Idaho 83702

Re: K033863

Trade/Device Name: OX-GEN, Incorporated Regulation Number: 21 CFR 868.5440 Regulation Name: Portable oxygen generator Regulatory Class: II Product Code: CAW Dated: June 17, 2005 Received: June 20, 2005

Dear Mr. Fosella:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the enated in the 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, de rices that have been 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. Foscella

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dri 3 issualtes vith other requirements of the requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally I cacial statutes und registments, including, but not limited to: registration and listing (21 Comply with an the Hot 810 cart 801); good manufacturing practice requirements as set CITY art 607); adoming (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sell w (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neviolo (« seting your device as described in your Section 510(k) This letter will anow you to begin mailsoning of substantial equivalence of your device to a legally premaired 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 If you dom's operate as not any and (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Connerset notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

Intrem O. hot fer

Chiu Lin, Ph.D. 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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Indication for use

510(k) Number (if known): K033863

Device Name:

OX-GEN Rigid O2 Generation System Model 5-OX-03

Indication for use:

The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is intended to produce oxygen for emergency use.

Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

X Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oue Subon

(Division Sign-Off) Division of Anesthesiology, o Infection Control, Dental

510(k) Number:

Page 1 of __ 1

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Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).