Mendec Spine HV / Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

Mendec Spine HV and Mendec Spine HV System are highly viscous, radioopaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. These devices are made with the same raw material, but are supplied in different ways: . Mendec Spine HV is a traditional bone cement product: the liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary PVC-blister with Tyvek lid, which is placed in an aluminum bag. . Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device haa serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The devices are sold disposable and sterile.

AI/ML Overview

The provided text describes a 510(k) summary for the Tecres Mendec Spine HV and Mendec Spine HV System, which are polymethylmethacrylate (PMMA) bone cements for vertebroplasty/kyphoplasty. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than a novel study proving a device meets specific clinical acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of device submission.

Here's how the available information maps to your request:

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

For a PMMA bone cement, acceptance criteria are typically defined by demonstrating that the device has comparable material and mechanical properties to legally marketed predicate devices.

Acceptance Criteria Category	Reported Device Performance
Mechanical Properties	Tested (static and fatigue properties, viscosity) and found substantially equivalent to predicate devices.
Chemical-Physical Properties	Tested (setting-time, MMA release) and found substantially equivalent to predicate devices.
Intended Use Equivalence	The intended use is the same as the predicate devices: treatment of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty.
Material Equivalence	Composed of the same raw material as predicate devices.

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

Not applicable for this type of device. The "test set" here refers to the actual physical devices undergoing laboratory testing for their material and mechanical properties, not a clinical data set. The provenance of the data is from Tecres S.P.A.'s own performance testing.

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

Not applicable. Ground truth, in the context of device performance, relates to laboratory measurements and conformity to recognized standards or comparison to predicate device specifications, not expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human readers or interpretations needing adjudication.

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 is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is a medical device (bone cement), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on established material science and engineering principles, and comparison to the specifications and performance of legally marketed predicate devices. This includes:

Physical measurements of mechanical properties (e.g., strength, viscosity).
Chemical analysis of material composition and properties (e.g., setting time, monomer release).
Verification that the device meets safety and performance standards equivalent to the predicates.

8. The sample size for the training set

Not applicable. There is no AI/ML model, hence no training set.

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

Not applicable. There is no AI/ML model, hence no training set or ground truth establishment method for it.

Summary

{0}------------------------------------------------

1-02. 510k Summarv

MAR 2 8 2013

Official Correspondent: CHRISTINE L. BRAUER, PH.D. US AGENT Manufacturer/Submitter: TECRES S.P.A. VIA A. DORIA 6 37066 SOMMACAMPAGNA VERONA – ITALY FDA OWNER/OPERATOR ID: 9033624 Date: JULY 20, 2012 Trade/Proprietary Names: MENDEC SPINE HV MENDEC SPINE HV SYSTEM Common Name: ACRYLIC RESIN FOR VERTEBROPLASTY/KYPHOPLASTY ACRYLIC RESIN FOR VERTEBROPLASTY/KYPHOPLASTY WITHIN A MIXING SYSTEM Device Classification Name: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT Classification Regulation: 21 CFR § 888.3027 Regulatory class: CLASS II Classification panel: ORTHOPAEDIC Classification Product Code: NDN - CEMENT, BONE, VERTEBROPLASTY Device Description: Mendec Spine HV and Mendec Spine HV System are highly viscous, radioopaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. These devices are made with the same raw material, but are supplied in different ways: . Mendec Spine HV is a traditional bone cement product: the liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary PVC-blister with Tyvek lid, which is placed in an aluminum bag. . Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device haa serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The devices are sold disposable and sterile. Mendec Spine HV / Mendec Spine HV System is indicated for the treatment Indication for Use: of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant Jesions (metastatic cancers, myeloma). Substantial Equivalence: This 510(k) submission demonstrates that the Tecres Mendec Spine HV and Mendec Spine HV System devices are substantially equivalent. The following predicate device:

{1}------------------------------------------------

1-02. 510k Summary

. Kyphx HV-R Bone Cement (Kyphon Inc.), cleared in the 510(k) submission #K033801 and #K093828; and,
. Mendec Spine (Tecres), cleared in the 510(k) submission #K042415.

The intended use of Mendec Spine HV / Mendec Spine HV System is the same as the predicate devices, i.e. the treatment of pathological fractures of the vertebral body.

Mendec Spine HV and Mendec Spine HV System are equivalent in materials, mechanical and chemical-physical performances to the predicate devices. Mendec Spine HV System differs only for the configuration of the powder and liquid components that are enclosed within a ready to mix container.

Performance testing was conducted to verify the substantial equivalence to the predicate devices and their suitability to the intended use.

Tecres Mendec Spine HV devices were characterized through the following testing:

mechanical: static and fatigue properties, viscosity; and, י
chemical-physical properties: setting-time, MMA release.

The safety and effectiveness of Mendec Spine HV / Mendec Spine HV System is adequately supported by the data and testing results.

Based on the same fundamental scientific technology and on the results of the verification activities, it is concluded that Tecres Mendec Spine HV / Mendec Spine HV System is substantially equivalent to legally marketed Kyphon Inc. Kyphx HV-R and Tecres Mendec Spine.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

March 28, 2013

Tecres SpA % Brauer Device Consultants Christine Brauer, Ph.D. Regulatory Affairs Consultant 7 Trail House Court Rockville, Maryland 20850

Re: K122175

Trade/Device Name: Mendec Spine HV/Mendec Spine HV System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, LOD Dated: February 25, 2013 Received: February 26, 2013

Dear Dr. Brauer:

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

{3}------------------------------------------------

Page 2 - Christine Brauer, Ph.D.

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/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,

Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters are bold and black, with some of the letters having a decorative, outlined design. The name appears to be a logo or signature.

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

Enclosure

{4}------------------------------------------------

Section 1 - Attachments

1-01. Indications for Use Statement

510(k) Number:
----------------	--

Device Name:

Mendec Spine HV / Mendec Spine HV System

INDICATIONS FOR USE STATEMENT

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

and/or Over the Counter Use (21 CFR 801 Subpart C)

Laurence D: Goyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122175

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.”