The POGS 65/130 is intended to generate and deliver USP 93% supplemental oxygen. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, military settings or where bottled oxygen is not readily available.

Device Description

The Portable Oxygen Generation System 65/130 (POGS 65) has been designed to accommodate medical personnel that require a portable, reliable source of supplemental oxygen in a setting where liquid oxygen may be unavailable. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through the oxygen boost and distribution system. The POGS 65/130 is a system that generates USP 93% oxygen at a flow rate of up to 65 LPM at a pressure of 50-60 PSI. Included with the generator are medical-grade oxygen hose for both low and high pressure, spare parts and tools that are required, but may be not be easily accessible to the user. The POGS 65/130 is compatible with commercial oxygen consuming equipment and accessories, including D. E, H, K, and M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. It also connects with the high pressure Hospital Oxygen Backup System and the low-pressure Patient Oxygen Distribution System. A complete POGS 65/130 system consists of two (2) feed air compressors, two (2) oxygen generators, one (1) boost and distribution center, and one (1) oxygen back-up system. Each feed air compressor and oxygen generator pair is designed to provide up to 65 LPM independently or can operate in parallel to achieve up to 130 LPM to provide the user flexibility in the deployment of their resources. The approach is modular and enables the user to add or subtract systems to meet the requirements of the situation. Each POGS 65 pair responds to the oxygen demand that is being used and when operated in parallel, will load share between the pair. The boost and distribution system receives the oxygen from up to two oxygen generators. The boost and distribution system can feed the oxygen to 1) the hospital distribution system, 2) fill the back-up system, 3) fill cylinders or 4) fill the hospital back-up system depending upon the requirements of the situation. To ensure patient care, the hospital distribution system has priority over all other options. One or more type of cylinder or back-up system may be filled in conjunction with supplying the hospital distribution system. The System includes the capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling.

AI/ML Overview

The provided text describes the POGS 65/130 Portable Oxygen Generation System and its 510(k) summary. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a study proving those criteria.

The document primarily focuses on:

The device's description, operation, and indications for use.
Comparisons with a predicate device (POGS 33C) and improvements.
The fact that non-clinical bench testing was performed.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study for POGS 65/130 Portable Oxygen Generation System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Generate USP 93% oxygen	Generates USP 93% oxygen
Flow rate up to 65 LPM	Up to 65 LPM
Pressure of 50-60 PSI	50-60 PSI
Compatibility with commercial oxygen consuming equipment and accessories (e.g., D, E, H, K, M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines, Impact Univent/Eagle 754/754M Ventilators, Hospital Oxygen Backup System, Patient Oxygen Distribution System)	Compatible as listed
Ability to operate with two (2) feed air compressors and two (2) oxygen generators	System consists of two (2) feed air compressors and two (2) oxygen generators.
Ability to provide up to 130 LPM (when two units operate in parallel)	Can operate in parallel to achieve up to 130 LPM.
Prioritization of hospital distribution system for oxygen supply	Hospital distribution system has priority over other options for oxygen supply.
Evacuation of high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling	Includes capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling.
Meet ASTM F-1464-93 performance standard	Performance Standard ASTM F-1464-93 was used.
Oxygen purity evaluations sufficient for substantial equivalence	Non-clinical bench testing, including oxygen purity evaluations, found sufficient for substantial equivalence.

Missing Information Regarding Acceptance Criteria:
The document states that "Requirements are based on the deployment oxygen system- medium (DOGS-M), operational requirements documents that have been issued by the United States Air Force and the United States Army." However, the exact quantitative acceptance criteria (e.g., specific thresholds for purity, flow rate stability, pressure consistency over time, or specific compatibility tests and their pass/fail criteria) from these military documents or the ASTM standard are not detailed in the provided text. The table above largely infers acceptance criteria from the reported performance claims.

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

Sample Size for Test Set: Not specified. The document only mentions "Non-clinical bench testing." The number of devices or test runs is not provided.
Data Provenance: The testing was "conducted by On-Site Gas Systems, Inc." The country of origin of the data is implicitly the USA, where On-Site Gas Systems, Inc. is located. It is a non-clinical bench test, not data from human subjects, so retrospective or prospective doesn't directly apply in the usual clinical sense.

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

Number of Experts: Not applicable. This was non-clinical bench testing of a device's physical output (oxygen purity, flow, pressure). There is no "ground truth" established by human experts in the context of diagnostic performance. The ground truth would be the direct measurement of the device's output parameters.
Qualifications of Experts: Not applicable for the reasons above.

4. Adjudication method for the test set

Adjudication Method: Not applicable. This was non-clinical bench testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of data where consensus is needed 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

MRMC Study: No. This device is an oxygen generator, not an AI-assisted diagnostic tool.

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

Standalone Performance: The non-clinical bench testing mentioned ("Performance Standard ASTM F-1464-93 was used," "Non-clinical bench testing conducted by On-Site Gas Systems, Inc. is sufficient in establishing substantial equivalence on the POGS 33C to the predicate device on which substantial equivalence is claimed, including oxygen purity evaluations.") could be considered "standalone" in the sense that they evaluated the device's inherent performance characteristics (oxygen output, purity, flow, pressure) without human intervention in the generation process itself. It's a test of the machine's output, not an algorithm's diagnostic performance.

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

Type of Ground Truth: The ground truth for this device's performance would be the direct, objective measurement of the oxygen's physical properties (purity, flow rate, pressure) using calibrated laboratory equipment and standard measurement techniques.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a physical oxygen generator, not an AI/machine learning algorithm that requires a "training set" in the computational sense.

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

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

Summary

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	O2N2 SITE
	On Site Gas Systems, Inc.
	Manufacturers / Designers of Oxygen & Nitrogen	Generating Equipment

5. 510(k) Summary	JAN - 7 2010
	POGS 65/130 Portable Oxygen Generation System

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:
	On-Site Gas Systems, Inc.
	35 Budney Road
	Newington, CT 06111
Contact Person:
	Guy T. Hatch, Chief Executive Officer
	Phone: 860-667-8888, extension 267
	Fax: 860-667-2222
	e-mail: ghatch@onsitegas.com
Date Prepared:	September 1, 2009
Trade Name:	POGS 65/130, Portable Oxygen Generation System
Common Name:	POGS 65
Classification Names:	Oxygen Concentrator
Device Classification:
Regulatory Class:	Class II
Product Code:	CAW
Classification Panel:	Anesthesiology
Regulation Number:	21 CFR 868.5440
Predicate Devices:
	POGS 33C, 510(k) K063454, On-Site Gas Systems, Inc.
Description of Device:

	On Site Gas Systems, Inc.
	35 Budney Road, Budney Industrial Park, Newington, CT 06111 U.S.A.
	Telephone: 860.667.8888 • Fax: 860.667.2222
	Website: www.onsitegas.com • Email: info@onsitegas.com
	A BUSINESS INCORPORATED IN THE STATE OF CONNECTICUT, U.S.A

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e Gas Systems. Inc.

Manufacturers / Designers of Oxygen & Nitrogen Generating Equipment

Requirements are based on the deployment oxygen system- medium (DOGS-M), operational requirements documents that have been issued by the United States Air Force and the United States Army. These two services are preparing a joint requirement document. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through the oxygen boost and distribution system.

The POGS 65/130 is a system that generates USP 93% oxygen at a flow rate of up to 65 LPM at a pressure of 50-60 PSI. Included with the generator are medical-grade oxygen hose for both low and high pressure, spare parts and tools that are required, but may be not be easily accessible to the user. The POGS 65/130 is compatible with commercial oxygen consuming equipment and accessories, including D. E, H, K, and M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. It also connects with the high pressure Hospital Oxygen Backup System and the low-pressure Patient Oxygen Distribution System.

A complete POGS 65/130 system consists of two (2) feed air compressors, two (2) oxygen generators, one (1) boost and distribution center, and one (1) oxygen back-up system. Each feed air compressor and oxygen generator pair is designed to provide up to 65 LPM independently or can operate in parallel to achieve up to 130 LPM to provide the user flexibility in the deployment of their resources. The approach is modular and enables the user to add or subtract systems to meet the requirements of the situation. Each POGS 65 pair responds to the oxygen demand that is being used and when operated in parallel, will load share between the pair.

The boost and distribution system receives the oxygen from up to two oxygen generators. The boost and distribution system can feed the oxygen to 1) the hospital distribution system, 2) fill the back-up system, 3) fill cylinders or 4) fill the hospital back-up system depending upon the requirements of the situation. To ensure patient care, the hospital distribution system has priority over all other options. One or more type of cylinder or back-up system may be filled in conjunction with supplying the hospital distribution system. The System includes the capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling.

Indications for Use:

Difference with Predicate Device:

The POGS 65/130 has included several improvements identified through the operation of the POGS 33C by the military around the world. To roughly double the oxygen output of the system in the same footprint, a new molecular sieve material, MDX made by UOP was used in place of the Oxysieve 5 made by UOP used in the POGS 33C. An input and exhaust valve block has replaced individual valves. The

On Site Gas Systems. Inc.

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e Gas Systems, Inc.

Manufacturers / Designers of Oxygen & Nitrogen Generating Equipment

valve block is designed by the same company, MAC, that produces the individual valves, thus we are confident of the lifetime, materials and quality of the components. The system control has been upgraded from a mechanical timer to a PLC. We utilize PLC's throughout the rest of our product line and the manufacturer, Allen-Bradley, is a well known manufacturer of PLC's. The functionality improvement is mainly in the areas of maintenance and troubleshooting and the ease of operation is improved as even those with limited experience with the system can quickly place it into operation and ensure continuous oxygen generation. The POGS 65/130 is not required to produce medical air, therefore there are no provisions for dew point or CO monitoring of the air.

Improvements from Previously Cleared Device:

Several improvements have been made to the predicate device. Improvements to the feed air compression packaging, increased oxygen production, enhanced user interface, and improved operator manuals are provided with the new device.

Non-Clinical Performance:

Performance Standard ASTM F-1464-93 was used.

Non-clinical bench testing conducted by On-Site Gas Systems, Inc. is sufficient in establishing substantial equivalence on the POGS 33C to the predicate device on which substantial equivalence is claimed, including oxygen purity evaluations.

On Site Gas Systems, Inc.

35 Budney Road, Budney Industrial Park, Newington, CT 06111 U.S.A. Telephone: 860.667.8888 · Fax: 860.667.2222 Website: www.onsitegas.com · Email: info@onsitegas.com A BUSINESS INCORPORATED IN THE STATE OF CONNECTICUT, U.S.A.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered horizontally. The text is likely part of a document or presentation from the U.S. Department of Health and Human Services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Guy Hatch Chief Executive Officer On-Site Gas Systems, Incorporated 35 Budney Road Newington, Connecticut 06111

JAN - 7 2010

Re: K092636

Trade/Device Name: POGS 65/130 Portable Oxygen Generation System Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 31, 2009 Received: January 4, 2010

Dear Mr. Hatch:

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 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. Hatch

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-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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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 4.

510(k) Number: K092636

Device Name: POGS 65/130 Portable Oxygen Generation System

Indications for Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092636

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).