The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Device Description

The Modified Concentric Retriever consists of a flexible, tapered core wire with five The Nically-shaped helical loops at the distal end. Polymer filaments are fastened to the helix to aid in the entrapment and retrieval of foreign bodies. A radiopaque coil is attached over the distal end to facilitate fluoroscopic visualization. The device is covered with a hydrophilic coating to reduce friction during use. A visible marker on the Retriever wroximal end aids the physician in determining when the Retriever tip is about to exit the Microcatheter tip. The device is provided with an insertion tool to facilitate introduction into a Microcatheter and a torque device to facilitate manipulation. The Modified Coocentric Retriever is delivered to the treatment site using a compatible Microcatheter as specified in the Instructions for Use.

AI/ML Overview

The provided text is a 510(k) summary for the Concentric Medical, Inc. Modified Concentric Retriever. It is a premarket notification to the FDA for a medical device. This type of document focuses on establishing substantial equivalence to a predicate device and demonstrating safety and effectiveness based on non-clinical performance and functional testing, not typically on extensive clinical studies as would be required for a novel device or a higher-risk classification.

Therefore, the information requested in your query, particularly regarding clinical study details like acceptance criteria measured against patient outcomes, sample sizes for test and training sets, expert adjudication, and MRMC studies, is not present in this 510(k) summary. These summaries generally do not include such detailed clinical study information because they rely on performance data and a comparison to an already-approved device.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Specific performance criteria for the device are not detailed in this summary. It generally states that the device passed all tests.	The Modified Concentric Retriever has successfully passed all performance and functional testing performed, demonstrating that the device performs in accordance with the requirements of the Product Specification. (Detailed results are not provided.)

Missing: Specific quantitative performance criteria (e.g., tensile strength, retrieval efficiency, etc.) and their measured values.

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

Missing: This 510(k) summary mentions "performance and functional testing" but does not specify a "test set" in the context of clinical data or patient samples. The testing described appears to be benchtop or non-clinical. Therefore, there is no information on sample size, country of origin, or whether it was retrospective or prospective in a clinical sense.

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)

Missing: No information regarding experts or ground truth establishment in a clinical context is provided. The testing described is non-clinical.

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

Missing: No information on adjudication is provided as the summary does not detail clinical study results or expert interpretation.

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

Missing: No MRMC or AI-assisted studies are mentioned. This device is a mechanical retriever, not an AI diagnostic tool.

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

Missing: This is not an algorithm-based device.

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

Missing: As the testing appears to be non-clinical, there is no mention of clinical ground truth types like expert consensus, pathology, or outcomes data. The "ground truth" for the non-clinical testing would be the predefined product specifications.

8. The sample size for the training set

Missing: No training set information is provided. This type of device does not typically involve training sets in the machine learning sense.

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

Missing: Not applicable.

Summary of Device and Study Information Present in the Document:

Device Name: Modified Concentric Retriever
Intended Use: To remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
Predicate Device: K040745 Concentric Retriever LX
Testing Summary: The device "successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification."
Regulatory Compliance: Designed, developed, and manufactured in accordance with Concentric Quality System which complies with 21 CFR §820.30.
Substantial Equivalence: Concludes that the Modified Concentric Retriever is substantially equivalent to the legally marketed predicate device.

To obtain the detailed information requested in your prompt, one would typically need to refer to the full 510(k) submission, including specific test reports and protocols, which are usually more extensive than the publicly available 510(k) Summary.

Summary

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Concentric Medical, Inc. Modified Concentric Retriever

SEP - 1 2005

510(k) Summary

General InformationClassification	Class II, Percutaneous Catheter per 21 CFR § 870.1250
Trade Name	Modified Concentric Retriever
Submitter	Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043tel: 650-938-2100
Contact	Jean M. Caillouette, RACManager, Regulatory Affairs

Intended Use

The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Predicate Device K040745 Concentric Retriever LX Manufactured by Concentric Medical, Inc.

Device Description

Materials

All materials used in the manufacture of the Modified Concentric Retriever are suitable for the intended use of the device and have been used in numerous previously-cleared products.

Testing Summary

The Modified Concentric Retriever has successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification. The Modified Concentric Retriever has

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Concentric Medical, Inc. Modified Concentric Retriever

been designed, developed and manufactured in accordance with the Concentric Quality System which complies with the requirements of Title 21, CFR$820.30.

Summary of Substantial Equivalence

Dulminal y of Bubbannal the Modified Concentric Retriever are either identical or substantially equivalent to the existing, legally marketed predicate device identified in this application. As such, Concentric Medical, Inc. believes the Modified Concentric Retriever is substantially equivalent to the legally marketed predicate device.

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Public Health Service

SEP - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical, Inc. c/o Ms. Jean M. Caillouette Manager, Regulatory Affairs 1380 Shorebird Way Mountain View, CA 94043

Re: K051838

Modified Concentric Retriever, Model 90039 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY · Dated: August 11, 2005 Received: August 12, 2005

Dear Ms. Caillouette:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave uctchined the acrese to actives marketed in interstate for use stated in the encrosule, to regary manological Device Amendments, or to commerce prior to May 28, 1970, the characterial as a securitions of the Federal Food, Drug, devices that nave been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. and Cosmetic Act (Act) that do not require upprovite of the general controls provisions of the Act. The Y ou may, merelore, market the device, saloject to the gentration, listing of
general controls provisions of the Act include requirements for annual registration, includes a general controls provisions of the free here.................................................................................................................................. adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) this effective major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller. Entrological on 898. In addition, FDA may be found in the Code of Peastal Registering your device in the Federal Register.

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Page 2 - Ms. Jean M. Caillouette

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 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Durna R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Concentric Medical, Inc. Modified Concentric Retriever

Indications for Use

510(k) Number (if known):	This application K051838
Device Name:	Modified Concentric Retriever
Indications for Use:	The Modified Concentric Retriever is intended toremove foreign bodies misplaced during interventionalradiological procedures in the neuro, peripheral andcoronary vascular systems.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R. Jochner

Division Sign-Off) Tivision of Cardiovascular Devices

: 10(k) Number_k 051838

Confidential

Page

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).