The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device consists of a 6-French catheter terminating at a stainless steel housing in which a small diameter helical screw is attached to a drive shaft. A battery-operated motor rotates a flexible drive shaft connected to the helical screw at approximately 3,100 rpm. A central lumen within the device is provided for guidewire placement or infusion of fluids.

AI/ML Overview

The provided text is a 510(k) summary for the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment methods, MRMC study details).

Here's an attempt to answer your questions based only on the provided text, highlighting what is missing or cannot be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
*Not specified*	As safe and effective as the predicate device (MICROVENA Amplatz Thrombectomy Device (ATD)) for the removal of thrombus within synthetic dialysis access grafts.

Missing Information: The document states that clinical studies "demonstrated" the device is as safe and effective as the predicate, but it does not provide quantitative acceptance criteria (e.g., a specific percentage of thrombus removal, a certain patency rate, or a defined complication rate). It also does not present detailed performance metrics for the Baxter PMT Device.

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

Sample Size (Test Set): Not specified.
Data Provenance: The study is referred to as "clinical studies," implying human data, but no country of origin or whether it was retrospective or prospective is mentioned.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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 Comparative Effectiveness Study: Not mentioned. This device is a mechanical thrombectomy device, not an AI or imaging interpretation device, so an MRMC study is not relevant in this context.
Effect Size of AI: Not applicable.

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

Standalone Performance: Not applicable. This is a medical device for mechanical thrombus removal, not an algorithm.

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

Type of Ground Truth: Implied to be clinical outcomes related to "safety and effectiveness" in thrombus removal, but the specific metrics or "ground truth" used (e.g., successful removal confirmed by subsequent imaging, patency rates, complication rates) are not detailed.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This document describes a physical medical device, not an AI model requiring a training set.

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

Ground Truth for Training Set: Not applicable.

Summary of what the document does state about the study:

Study Type: "Clinical studies" were performed.
Purpose: To demonstrate that the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is "as safe and effective as the predicate device for the removal of thrombus within synthetic dialysis access grafts."
Predicate Device: MICROVENA Amplatz Thrombectomy Device (ATD).
Additional Testing: The device also underwent "design validation, as well as functional, animal and clinical testing."

The provided text serves as a regulatory summary indicating substantial equivalence, rather than a detailed scientific publication of study results. Therefore, many of the specific details requested about acceptance criteria and study methodology are not present.

Summary

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Baxter Healthcare Corporation 17221 Red Hill Avenue (Irvine)
PO Box 11150
Santa Ana, CA USA 92711-1150
Santa Ana, CA USA 92711-1150
949.250.2500

: :

: : .

MAY = 4 2000

raxter

510(k) Summary

Submitter:	Baxter Healthcare Corporation, CardioVascular Group
Contact Person:	Diane Peterson, Senior Regulatory Affairs Associāte
Date Prepared:	November 9, 1999
Trade Name:	Baxter Percutaneous Mechanical Thrombectomy (PMT)Device
Classification Name:	Peripheral Atherectomy Catheter
Predicate Devices:	MICROVENA Amplatz Thrombectomy Device (ATD)
Device Description:	The Baxter Percutaneous Mechanical Thrombectomy(PMT) Device consists of a 6-French catheterterminating at a stainless steel housing in which a smalldiameter helical screw is attached to a drive shaft. Abattery-operated motor rotates a flexible drive shaftconnected to the helical screw at approximately 3,100rpm. A central lumen within the device is provided forguidewire placement or infusion of fluids.
Intended Use:	The Baxter Percutaneous Mechanical Thrombectomy(PMT) Device is designed for percutaneous removal ofthrombus using aspiration and an internal helical screwto fragment and remove thrombus. The Baxter PMTdevice is indicated for removal of thrombus in syntheticdialysis access grafts.
ComparativeAnalysis	It has been demonstrated (through clinical studies) thatthe Baxter Percutaneous Mechanical Thrombectomy(PMT) Device is as safe and effective as the predicatedevice for the removal of thrombus within syntheticdialysis access grafts.
Functional/SafetyTesting:	The Baxter Percutaneous Mechanical Thrombectomy(PMT) Device has successfully undergone designvalidation, as well as functional, animal and clinicaltesting.
Conclusion:	The Baxter Percutaneous Mechanical Thrombectomy(PMT) Device is substantially equivalent to thepredicate device.

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MAY = 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diane Peterson Senior Regulatory Affairs Associate Baxter Healthcare Corporation Cardio Vascular Group 17221 Red Hill Avenue (Irvine) P.O. Box 11150 Santa Ana, CA 92711-1150

Re: K993816 Baxter Percutaneous Mechanical Thrombectomy Device Requlatory Class: II (two) Product Code: 74 MCW Dated: February 22, 2000 Received: February 23, 2000

Dear Ms. Peterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act

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Page 2 - Ms. Diane Peterson

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described This lected will afrow you co boying . The FDA finding of substantial In your 510(x) premained to a legally marketed predicate device equivalence of your device of a your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advanced additionally 809.10 for in vitro regulation (21 Crk fart over the addition of Compliance at (301)
diagnostic devices), please contact the Office promotion and diagnostic devisor), Iv, for questions on the promotion and 594-4640. Addicionariff 10- quise contact the Office of compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 394 1039. There to premarket notification" (21CR 807.97).
"Misbranding by reference to premarket notification the 7ct mi "Misbranding by reference to promation on your responsibilities under the Act may ocher general information of Small Manufacturers Assistance at its be obtained from the Brillers. I (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Christopher

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):

Kggz816

Device Name:

Baxter Percutaneous Mechanical Thrombectomy (PMT) Device

Indications for Use:

Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.

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

Concurrence of CDRH, Office Of Device Eva

Of Device Evaluation (QDE)
Chito M.V. Kinta

(Division Sign-Off) Division of Cardiovascular, Respira and Neurological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

CONFIDENTIAL

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).