The KMC Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

KMC Kyphoplasty System consists of five components:

Balloon Catheter .
Tool Kit
. Puncture Needle
Balloon Catheter Syringe Pump .
Kyphoplasty Multifunctional Tool .
The Kyphoplasty Multifunctional Tool can be substituted for the Puncture Needle and Kyphoplasty Tool Kit.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

The KMC Kyphoplasty System is a medical device, and the information provided focuses on its 510(k) clearance process. For medical devices, "acceptance criteria" and "device performance" in the context of clinical studies often relate to the safety and effectiveness as defined by the "Indications for Use" and comparison to predicate devices, rather than specific numerical performance metrics like accuracy or sensitivity found in diagnostic AI. The primary goal of the studies for this type of device is to demonstrate that it performs as intended and is as safe and effective as legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device, the "acceptance criteria" are implied to be the successful demonstration of safety and effectiveness for its stated Indications for Use, and substantial equivalence to predicate devices, without unexpected adverse events or failures. Device performance is measured by its ability to achieve these goals in a clinical setting.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Biocompatibility, Sterility, Packaging Integrity	- Biocompatibility testing per ISO10993: All materials found to be biocompatible.
	- ETO gas sterilization process validated to SAL of 10⁻⁶; ETO residual testing met specification.
	- Packaging testing (accelerated and real-time aging) conducted; met specifications.
Functionality/Effectiveness: Performance per specifications (e.g., dimensional, inflation/deflation, balloon size, system compatibility)	- Product testing (dimensional, inflation/deflation, balloon size, system compatibility) completed on final sterilized devices: All testing met acceptance criteria.
Clinical Performance: System performs as specified when used according to IFU in human subjects.	- Clinical Evaluation: "The conclusions from the study show the system performed per specification when used according to the instructions for use."
Substantial Equivalence: Features, indications for use, overall function, manufacturing methods, and materials are equivalent to predicate devices.	- "The KMC Kyphoplasty System is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Evaluation): A total of 25 patients.
Data Provenance: The study was a "multicenter study" conducted at "two sites." The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in Shanghai, implying the study might have been international or conducted in the US (though the latter is less likely to be unnamed). The study is prospective, as it's a "clinical evaluation" of the system's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a clinical evaluation of a medical device like a kyphoplasty system, "ground truth" would typically be established based on clinical outcomes assessed by treating physicians and potentially radiologists, but the number and qualifications of experts involved in data collection or assessment are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for diagnostic imaging AI devices, where the "reader" is a human interpreting images. The KMC Kyphoplasty System is a surgical device, not an AI diagnostic tool.

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

No, this is not applicable. The KMC Kyphoplasty System is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant. The "performance" in this context refers to the device's physical and functional attributes, as well as its safety and effectiveness when used by a human surgeon.

7. The Type of Ground Truth Used

For the clinical evaluation, the "ground truth" would be the clinical outcomes observed in the 25 patients treated with the KMC Kyphoplasty System, as assessed by the treating clinicians in accordance with the study protocol. This includes the successful reduction and fixation of fractures, creation of a void in cancellous bone, and the device performing "per specification" when used according to instructions for use, without significant adverse events or complications that would indicate a failure of the device.

8. The Sample Size for the Training Set

This information is not applicable/provided. The KMC Kyphoplasty System is a physical medical device; it does not involve machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for the device would be its design, manufacturing, and preclinical testing phases.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided. As explained above, there is no AI training set for this device. The "ground truth" for its design and manufacturing would be established through engineering specifications, materials testing, and quality control processes.

Summary

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K113742:
PAGE 1 OF 3

SEP 1 7 2012

510(k) Summary

General Information

Classification

Regulation Number

21CFR 888.1100 21CFR 888.3027

Arthroscope

Class II

Regulation Name

Product Code

HRX NDN

Trade Name

Submitter

Submitted by

KMC Kyphoplasty System

Cement/Bone Vertebroplasty

Shanghai Kinetic Medical Co., Ltd

Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, MN 55612

Tel: (218) 387-1559

Gregory Mathison

Contact

Date Prepared

April 20, 2011

President

Indications for Use

Predicate Devices

K061222	Kyphx Inflatable Bone Tamp	Kyphon Inc.
K103231	Kyphon Inflation Syringe	Kyphon Inc

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Device Description

KMC Kyphoplasty System consists of five components:

Balloon Catheter .
Tool Kit
. Puncture Needle
Balloon Catheter Syringe Pump .
Kyphoplasty Multifunctional Tool .

The Kyphoplasty Multifunctional Tool can be substituted for the Puncture Needle and Kyphoplasty Tool Kit.

Sterilization

The system is provided sterile and is for single use only. The ETO gas sterilization process is validated with a resulting sterility assurance level (SAL) of 10°.

K13742

AGE 2 OF 3

ETO residual testing was also performed and the products met specification.

Packaging

The components are placed in a thermoformed PETG/PET tray with a heat sealed Tyvek lid. The sealed tray is placed in a Tyvek flexible peel pouch and heat sealed. The heat sealed pouches are placed in white shelf cartons and then packaged in a corrugated shipper box. Expiration dating testing was conducted using the industry standard ASTM method for accelerated aging and real-time aging was also performed.

Materials

All materials used in the manufacture of the KMC Kyphoplasty System are suitable for this use and have been used in s previously cleared products.

Testing

Product testing was performed on final sterilized devices. Testing was completed, including: dimensional, inflation/deflation, balloon size and system compatibility. All testing met the acceptance criteria.

Biocompatibility testing was performed per ISO10993 as required for a temporary bone/tissue contacting device. All materials were found to be biocompatible and suitable for this use.

Clinical Evaluation

The KMC Kyphoplasty system was evaluated in a multicenter study. A total of 25 patients were treated at two sites. The conclusions from the study show the system performed per specification when used according to the instructions for use.

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K113742
PAGE 3 OF 3

. ·

Summary of Substantial Equivalence

The KMC Kyphoplasty System is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

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

SEP 17 2012

Shanghai Kinetic Medical Company, Limited % Regulatory Strategies, Incorporated Mr. Gregory Mathison President 3924 Cascade Beach Road Lutsen, Minnesota 55612

Re: K113742

Trade/Device Name: KMC Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: August 20, 2012 Received: August 29, 2012

Dear Mr. Mathison:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Mr. Gregory Mathison

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
For
Deb Lin Din

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

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Indications for Use

510(k) Number (if known):

K113742

Device Name:

KMC Kyphoplasty System

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use (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)

thumor M. Taylor

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113742

Page 1 of 1

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”