The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Atrium Clearway™ PTFE Balloon Catheter." It is NOT a study report or clinical trial documentation, but rather a regulatory approval document.

Therefore, the input does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The FDA letter only states that the device is "substantially equivalent" to legally marketed predicate devices.

Here's why the requested information cannot be extracted from the provided text:

Acceptance Criteria and Device Performance Table: The document does not mention any specific acceptance criteria (e.g., minimum performance thresholds) or report any device performance metrics (e.g., efficacy rates, safety outcomes) from a study.
Sample Size and Data Provenance: No study is described, so there is no information about sample sizes or the origin of any data.
Number and Qualifications of Experts for Ground Truth: Since no study is described, there's no mention of ground truth establishment or experts involved.
Adjudication Method: No study, no adjudication method.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is only relevant for AI/imaging-based devices, and this letter is for a physical catheter. No such study is mentioned or implied.
Standalone Performance Study: No performance study is described. The clearance is based on substantial equivalence, not a standalone performance trial.
Type of Ground Truth: No ground truth is mentioned.
Training Set Sample Size: This is relevant for machine learning/AI models. This device is a catheter, not an AI model, and no training set is mentioned.
How Ground Truth for Training Set Was Established: Not applicable.

Conclusion:

The provided document is a regulatory approval letter and does not contain the details of a study or acceptance criteria as requested. To answer these questions, one would need access to the 510(k) summary or the full 510(k) submission, which might describe the testing performed to demonstrate substantial equivalence to a predicate device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 8 2002

Mr. Joseph P. De Paolo Director of Regulatory Affairs/Quality Assurance Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051

Re: K020634

Trade Name: Atrium Clearway™ PTFE Balloon Catheter Regulation Number: 21 CFR 870.5150 and 870.1210 Regulation Name: Embolectomy Catheter and Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: DXE and KRA Dated: April 10, 2002 Received: April 17, 2002

Dear Mr. De Paolo:

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. Joseph P. De Paolo

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 erth 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,

Da. Teek

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known) K626634

Device Name:

Atrium ClearWay™ PTFE Balloon Catheter

Indications for Use:

The Atrium ClearWay™ PTFE Balloon Catheter is intended for the removal of fresh, soft emboli and thrombi and for intraluminal irrigation of fluids.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use the text is:

Division of Cardiovascular & Respiratory Devices
510(k) Number K000634

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).