The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.

Device Description

The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.

AI/ML Overview

The provided document is a 510(k) summary for the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit. It does not contain the detailed performance study information typically associated with AI/ML-based medical devices or diagnostic tools that would have "acceptance criteria" and "reported device performance" in the way an AI model would be evaluated.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Precision Medical 2200 liquid oxygen system K041122) and the results of general performance and mechanical/climatic testing.

Therefore, I cannot directly provide answers to all the requested categories, as they are not applicable to the type of device and submission described. However, I can extract the relevant information from the document as it pertains to the device's validation.

Here's a breakdown of what can be extracted and what cannot:

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

The document states: "The Precision Medical, Inc. Easy Mate 6+6 has successfully passed tests in the following areas; Mechanical / Climatic, Device Performance."
It does not provide a table with specific quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy, duration of oxygen delivery under certain conditions) or corresponding measured performance values. This type of detail is usually found in the full 510(k) submission, not the summary.
Acceptance Criteria (General): The device functions as intended to deliver supplemental oxygen at set rates.
Reported Device Performance (General): The device successfully passed mechanical/climatic and device performance tests.
Specifics of Acceptance Criteria/Performance: Not provided in this summary.

Applicability of other questions for this type of device:

The remaining questions (2-9) are typical for the evaluation of AI/ML algorithms or diagnostic devices where "ground truth" establishment, expert review, and statistical analysis of performance against a reference standard are critical. For a purely mechanical device like a portable liquid oxygen unit, these concepts are not directly applicable in the same way.

No "test set" in the context of images or patient data for AI.
No "experts" establishing ground truth for disease presence.
No "adjudication method."
No "multi-reader multi-case (MRMC) comparative effectiveness study" as there's no human interpretation component to be assisted by AI.
No "standalone" algorithm performance study.
No "ground truth" in the diagnostic sense (pathology, outcomes data). The "ground truth" for this device would be its ability to physically deliver oxygen accurately and safely, validated through engineering and functional tests.
No "training set" as this is a mechanical device, not an AI model.

Summary based on the provided text for a general medical device, not an AI/ML device:

The document describes the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit.

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

Acceptance Criteria (General)	Reported Device Performance (General)
Mechanical / Climatic integrity and function	Successfully passed tests in Mechanical / Climatic areas.
Device Performance (e.g., oxygen delivery)	Successfully passed tests in Device Performance areas, indicating it is "safe and effective."
Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to the Precision Medical 2200 liquid oxygen system (K041122).

(Note: Specific quantitative values for criteria and performance are not included in this 510(k) summary.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. This device undergoes engineering and functional testing, not a clinical "test set" in the diagnostic data sense. Details on the number of units tested are not in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this mechanical device is established through engineering specifications and verified by technical testing, not through expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is described for this type of device validation.

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 is a mechanical device, not an AI-assisted diagnostic tool for human interpretation.

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

Not applicable. There is no algorithm or AI component in this mechanical device.

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

Engineering/Functional Specifications: The "ground truth" for this device would be its adherence to established engineering specifications for oxygen production, flow rates, pressure regulation, and mechanical durability. This is verified through direct measurement and physical testing.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set."

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

Not applicable. See point 8.

Summary

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Liquid system 510K 6+6

APR 2 1 2011 510(k) Summary Precision Medical, Inc. Easymate 6+6

103324

Submitter Information

Submitter

Precision Medical, Inc. 300 Held Drive Northampton, Pa. 18067

FDA registration number:

Contact

2523148

James Parker Quality Assurance Manager

Tel: Fax: (610)-262-6090 Extensions 228 (610)-262-6080

Preparation Date: April 6, 2011

Device Name

Easy Mate 6+6

Proprietary Name: Common Name: Classification Name: Precision Liquid Oxygen System Portable Liquid Oxygen Unit Portable Liquid Oxygen Unit (73 BYJ) as per CFR 868.5655

Class II Device

Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to the Precision Medical 2200 liquid oxygen system K041122

Intended Use

The Precision Medical, Inc. Easy Mate 6+6 is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The Easy Mate 6+6 deliver 100% oxygen at 5 Conserved settings or 6 continuous flow settings. The device is intended to be used as ambulatory source of oxygen both inside and outside of the patient's home.

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Device Description

Comparison of Technological Characteristics

and the Easy Mate 6+6 include a vacuum insulated cryogenic The Easy Mate container heat exchange system, and a pneumatic conserver Both devices are intended only as sources of supplemental oxygen and are not intended to be lifesupporting devices.

Summary of Performance Testing

The Precision Medical, Inc. Easy Mate 6+6 has successfully passed tests in the following areas;

Mechanical / Climatic

Device Performance

Conclusions

In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. Easy Mate 6+6 is safe and effective. The combined testing and analysis of results provides assurance that the device meet the specifications and is safe and effective for the intended use.

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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 stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067

APR 2 1 2011

Re: K103324

Trade/Device Name: Precision Medical, Inc. Easy Mate 6+6 Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: April 7, 2011 Received: April 8, 2011

Dear Mr. Parker:

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.

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Page 2- Mr. Parker

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 (OS) 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh 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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510 (k) number 103324

Device Name: Precision Medical, Inc. Easy Mate 6+6 Indications for use:

(Please do not write below this line- continue on another page if needed) Concurrence of CDRH, office of device Evaluation (ODE)

Prescription Use: X (Per 21 CFR 801.109) Or

Over the counter use (Optional Format 1-2-9)

signature

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

510(k) Number: K183324

Regulation Number and Section

§ 868.5655 Portable liquid oxygen unit.

(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).