The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.

Device Description

The Invacare Venture Home Fill II with oxygen conserver is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. It consists primarily of a 5 liter per minute (1pm) oxygen concentrator, a compressor module, and a portable oxygen cylinder with specially adapted cylinder fitting that includes an oxygen conserver. The oxygen conserver delivers oxygen to the user at the beginning of each breath instead of on a continuous basis.

The concentrator provides continuous flow of oxygen at concentrations of 87% to 96%, at flow rates of 0 to 51pm. The compressor fills the cylinder with oxygen concentrations of 90% to 96%. and the cylinder regulator allows flow rates of 0 to 6 lpm. The oxygen supplied by the oxygen concentrator is supplemental and is not considered to be life susporting or life sustaining. The system is not sold or labeled as sterile.

AI/ML Overview

The provided text is a 510(k) summary for Invacare Corporation's Model Venture HomeFill II with Oxygen Conserver. This document is a premarket notification to the FDA for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain the specific information requested about acceptance criteria for device performance or a detailed study proving the device meets those criteria, especially in the context of an AI-powered device or human-in-the-loop studies.

The section "Performance Data" states: "A number of mechanical and electrical tests were conducted on the Invacare Model HomeFill II with oxygen conserver and the oxygen conserver to demonstrate that the device performs as intended." However, it does not provide details of what those tests were, what the acceptance criteria were, or what the reported performance was against those criteria. It also does not mention any studies involving AI, human readers, or image analysis, as assumed in many of the questions.

Therefore, I cannot populate the requested table and answer many of the questions based on the provided text.

Here's what I can infer or definitively state from the provided text, addressing the questions as much as possible:

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

Based on the provided text, this information is not available. The document states "A number of mechanical and electrical tests were conducted... to demonstrate that the device performs as intended," but it does not specify what those tests were, what the acceptance criteria were, or the performance results.

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

Based on the provided text, this information is not available. The document mentions "mechanical and electrical tests" but gives no details about sample sizes or data provenance.

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)

Based on the provided text, this information is not applicable and not available. This device is an oxygen concentrator, not an AI diagnostic device that would typically involve expert-established ground truth for a test set in the way a medical imaging AI would.

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

Based on the provided text, this information is not applicable and not available. See point 3.

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

No MRMC study was done, and this information is not applicable. The device described is an oxygen concentrator, not an AI system intended to assist human readers in interpretation.

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

This is not an AI algorithm, so this concept is not applicable. The device is an electro-mechanical oxygen concentrator.

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

Based on the provided text, this information is not applicable in the typical sense for AI/diagnostic devices. For an oxygen concentrator, "ground truth" would likely relate to objective measurements of oxygen concentration, flow rates, and other physical parameters, validated against established scientific standards for medical gases and equipment, rather than expert consensus on a diagnostic image. The document does state the concentrator provides "oxygen at concentrations of 87% to 96%" and "fills the cylinder with oxygen concentrations of 90% to 96%", suggesting these are measured performance characteristics.

8. The sample size for the training set

Based on the provided text, this information is not applicable and not available. This device does not involve a "training set" in the context of machine learning or AI.

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

Based on the provided text, this information is not applicable and not available. See point 8.

Summary

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K02)685

510(k) SUMMARY

Invacare Corporation's Model Venture HomeFill II With Oxygen Conserver

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Contact Person:

Edward A. Kroll Director, Regulatory Affairs

Date Prepared: May 21, 2002

Name of Device and Name/Address of Sponsor

Invacare Model Venture HomeFill II with Oxygen Conserver

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Common or Usual Name

Oxygen Concentrator

Classification Name

Portable Oxygen Generator

Predicate Devices

Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939),

Intended Use

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Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

The Invacare Model Venture HomeFill II with oxygen conserver is substantially equivalent to the Invacare Model HomeFill II Complete home Oxygen System (K003939)

Performance Data

A number of mechanical and electrical tests were conducted on the Invacare Model HomeFill II with oxygen conserver and the oxygen conserver to demonstrate that the device performs as intended.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2002

Mr. Edward A. Kroll Director, Regulatory Affairs Invacare Corporation One Invacare Way Elyria, Ohio 44036-2125

Re: K021685

Trade/Device Name: Invacare Model Venture HomeFill II with Oxygen Conserver Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 21, 2002 Received: May 22, 2002

Dear Mr. Kroll:

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.

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.

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Page 2 - Mr. Kroll

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639, Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours

Timothy A. Ulatowski

Timo A. Ulatowski 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 (if known): fBB K021685

Device Name: Invacare Model Venture HomeFill II with Oxygen Conserver

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 √
(Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number __

(Optional Format 1-2-96)

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).