KMD-Markl Tissue Marker is a sterile, single patient use, polymeric discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). KMD-Mark1 Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the KMD-Mark1 Tissue Marker. It details the device's indications for use, description, and predicate devices. Here's an analysis of the acceptance criteria and the study as requested, based solely on the provided text:

No specific acceptance criteria or an explicit "study" proving the device meets those criteria are detailed in the provided input. The document primarily outlines the regulatory submission process and the general types of preclinical testing performed.

However, based on the information provided, we can infer the broad categories of "acceptance criteria" through the performance standards and the nature of the device.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not provided in the text, this table will be based on the general "Performance Standards" mentioned. The "reported device performance" is also generalized as specific results are not detailed.

Acceptance Criteria Category (Inferred)	Reported Device Performance (Summary from text)
Sterilization Validation	Verified and validated per ISO 11135.
Biocompatibility	Tested per ISO 10993-1.
MRI Safety	Tested per F119, F2182, and F2034.
Radiographic Visualization	Verified and validated for visibility on standard radiographs (x-ray, mammography), ultrasound, and MRI.

The following information (points 2-9) cannot be extracted from the provided text, as the document focuses on regulatory submission details and general testing categories, not the specifics of individual study designs or results.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 mentioned. This device is a passive tissue marker, not an AI-assisted diagnostic tool, so such a study would not be applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and not applicable for this device type.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a tissue marker, "ground truth" would likely relate to its physical properties and visibility, rather than a diagnostic accuracy.

8. The sample size for the training set: Not mentioned. (Not applicable for this type of device as it's not a machine learning model).

9. How the ground truth for the training set was established: Not mentioned. (Not applicable for this type of device as it's not a machine learning model).

Summary

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Kent Medical Devices, Inc.

Confidential

K 093473

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510(k) Summary

Date Submitted:	November 5, 2009JUL - 2 2010
Manufacturer:	Kent Medical Devices, Inc.4169 Reservoir BoulevardMinneapolis, MN 55421
Device Trade Name:	KMD-Mark1 Tissue Marker
Contact:	Mr. Justin EggletonDirector, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Classification:	21 CFR §878.4300
Class:	II
Product Code:	NEU

Indications For Use:

The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Device Description:

Predicate Device(s) Reference:

The KMD-Markl Tissue Marker was shown to be substantially equivalent to the following previously cleared devices and has the same indications for use, design, and function:

K072219 Cytophil Tissue Marker

K070436 BiomarC Tissue Marker

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Confidential

U093473
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Performance Standards:

In Vitro and In vivo preclinical testing were performed to verify and validate the safety and effectiveness of the product. These tests included sterilization validation to ISO 11135; biocompatibility testing per ISO 10993-1; MRI safety testing per F119, F2182, and F2034; and radiographic visualization.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

JUL - 2 2010

Kent Medical Devices, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H. Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K093473

Trade/Device Name: KMD-Mark1 Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: July 1, 2010 Received: July 2, 2010

Dear Mr. Eggleton:

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.

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

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Page 2 - Mr. Justin Eggleton

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 (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.

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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Wilkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health

Enclosure

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Indications for Use 4.

510(k) Number (if known): K093473

Device Name: KMD-Mark1 Tissue Marker

The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093473

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.