The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug. The safety and effectiveness of this device for use in the spine have not been established.

Device Description

The KMI Cement Restrictor Implant is a flexible, bio-resorbable restrictor designed to provide a quick and effective method of plugging the intramedullary canal with an easy-to-place absorbable bone plug. Based on the size of the canal and reamer used to form the channel, the appropriate size cement restrictor is selected and is guided into the canal to the desired depth. The KMI Cement Restrictors are malleable to take on the irregular shape of the canal, effectively sealing them at the desired friction-fit position. There are a variety of sizes and shapes offered, including cylindrical and cube versions. Each device can be custom shaped either by manual manipulation, by using a scalpel at the time of surgery, or by press-fitting into the canal.

AI/ML Overview

This prompt describes a 510(k) premarket notification for a medical device and not a study that proves the device meets specific acceptance criteria via performance data. Therefore, many of the requested fields cannot be filled as they pertain to clinical trial design and results.

However, I can extract the information relevant to the device and its intended use, as well as the FDA's acceptance of its substantial equivalence.

Here's a breakdown of the provided information, noting what can (and cannot) be answered based on the input:

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

This document does not provide a table of acceptance criteria or reported device performance for the KMI Cement Restrictor. It is a 510(k) summary, which demonstrates substantial equivalence to a predicate device rather than providing performance data against predefined criteria. The FDA's letter states they have "reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent." This implies the device met the regulatory requirements for showing substantial equivalence, which is the "acceptance criteria" in this context, but no specific performance data is provided in the document.

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

Not applicable. This is a 510(k) submission, not a study report with a test set of data. Substantial equivalence is typically demonstrated through comparison of design, materials, and intended use to a predicate device, sometimes supported by non-clinical testing (e.g., biocompatibility, mechanical testing) but not necessarily a "test set" of clinical data for performance metrics.

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)

Not applicable. No ground truth establishment for a test set is described in this 510(k) summary.

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

Not applicable. No test set or adjudication method is described.

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 applicable. This document pertains to a cement restrictor, not an AI or imaging device that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No ground truth is described in the context of device performance testing. The "ground truth" for a 510(k) itself is the existing legal market status and safety/effectiveness profile of the predicate device.

8. The sample size for the training set

Not applicable. This is not a study involving a training set.

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

Not applicable. No training set is described.

Summary of Device Information (from the provided text):

Device Name: KMI Cement Restrictor
Common Name: Bone Plug
Classification Name: Cement Obturator
Product Code: LZN (initially), later determined to be JDK (Surgical mesh) by FDA.
Submitter: Kinetikos Medical, Inc.
Predicate Device: Improve Absorabale Cement Flow Restrictor (K011943)
Description: Flexible, bio-resorbable restrictor designed to plug the intramedullary canal as an absorbable bone plug. Malleable, can be custom shaped.
Materials: L,D-L Lactic Acid Polymer
Shelf Life: Two (2) years
Intended Use: Implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug.
Contraindications: Active local infection, allergic reaction to foreign bodies, poor/insufficient bone stock, clinical/functional abnormalities precluding good results, other patient risks, and spinal applications.

Key FDA Determination/Acceptance:

Determination: The device is "substantially equivalent" to legally marketed predicate devices.
Limitations/Warnings:
- "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS."
- "WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
- These warnings must be prominently displayed in all labeling and promotional materials.

In conclusion, this document serves as a regulatory approval notice based on substantial equivalence to a predicate device, not a performance study detailing acceptance criteria and their fulfillment through specific test results.

Summary

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APPENDIX I SUMMARY OF SAFETY AND EFFECTIVENESS For OCT 5- 2006

KMI Cement Restrictor

Submitter: Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Suite 180 Carlsbad, CA 92011

Contact Person:

John G. Spampinato, V. P., Q.A Kinetikos Medical, Inc. 6005 Hidden Valley Road Suite 180 Carlsbad, CA 92011 FAX (760) 448 1739 (760) 448 1706

Date Prepared: May 25, 2006

2. Trade Name:	KMI Cement Restrictor
Common Name:	Bone Plug
Classification Name:	Cement Obturator
Device Product Code:	LZN (878.3300)

Predicate or legally marketed devices which are substantially equivalent 3. -ImproVise Absorabale Cement Flow Restrictor (K011943)

4. Description of Device

The KMI Cement Restrictor Implant is a flexible, bio-resorbable restrictor designed to provide a quick and effective method of plugging the intramedulalry canal with an easy-to-place absorbable bone plug. Based on the size of the canal and reamer used to form the channel, the appropriate size cement restrictor is selected and is guided into the canal to the desired depth. The KMI Cement Restrictors are malleable to take on the irregular shape of the canal, effectively sealing them at the desired friction-fit position. There are a variety of sizes and shapes offered, including cylindrical and cube versions. Each device can be custom shaped either by manual manipulation, by using a scalpel at the time of surgery, or by press-fitting into the canal.

Materials: L,D-L Lactic Acid Polymer Shelf Life: This product will be labeled with a shelf life of two (2) years

1. Intended Use The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug. The safety and effectiveness of this device for use in the spine have not been established.
  Use of this implant is contraindicated for use in patients with the following conditions:
. Active local infection / any evidence of infection
. Allergic reaction to foreign bodies
. Poor or insufficient bone stock
The presence of any clinical or functional abnormalities that would . preclude the potential of achieving a good result for the patient
- Other conditions that may place the patient at risk (physiologically)
Or for spinal applications .

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA". The eagle is positioned to the right of the text.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kinetikos Medical Incorporated c/o Mr. John Spampinato 6005 Hidden Valley Road Carlsbad, California 92011

OCT 5 - 2006

Re: K061465 KMI Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: August 29, 2006 Received: September 13, 2006

Dear Mr. Spampinato:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING:

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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Page 2 - Mr. John Spampinato

These warnings must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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.

If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices an Radiological Health

Enclosure

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APPENDIX IX

Indications for Use

510(k) Number (if known):

Device Name: KMI Cement Restrictor Implant

Indications For Use:

The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug.

The safety and effectiveness of this device for use in the spine have not been established.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,

and Neurological Devic

510(k) Number K061465

Page 1 of

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.