Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painfull vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

Spine-Fix is a self hardening and ready to use cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder

AI/ML Overview

Here's an analysis of the provided text regarding the Spine-Fix® Biomimetic Bone Cement, focusing on acceptance criteria and the supporting study:

This document is a 510(k) summary for a medical device (Spine-Fix® Biomimetic Bone Cement). It primarily discusses the device's substantial equivalence to predicate devices and presents a summary of non-clinical and clinical tests. It does not explicitly define specific "acceptance criteria" with numerical thresholds or metrics that the device needed to meet to be cleared. Instead, it describes general positive outcomes from a clinical study.

Therefore, the table below will reflect the "reported device performance" as described in the summary, and the "acceptance criteria" column will indicate what was assessed rather than explicit numerical targets.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was assessed)	Reported Device Performance (Outcome)
Improvement in neck pain and disability	100% of patients reported mild or no pain at the last follow-up visit.
Improvement in daily function	100% of patients were classified as normal function or mildly dysfunctional at the last follow-up visit.
Device safety (adverse events)	No patients reported any serious complications as a result of the surgery.
Patient survival	All patients were alive at the last follow-up.
Compliance with ISO 5833	Final properties are stable and in compliance with ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices.

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

Sample Size for Clinical Study (Test Set): 113 patients
Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address (Teknimed S.A., 11 rue Apollo, Z.I. Montredon, 31240 L'Union, France), it is likely the study was conducted, at least in part, in France or Europe.
Retrospective or Prospective: Not explicitly stated, but the mention of "24 months post-op" suggests a prospective follow-up of patients after surgery. However, the exact study design (e.g., randomized controlled trial) is not detailed.

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

There is no information provided about experts establishing ground truth for the clinical study. The "effectiveness" and "safety" assessments seem to be based on patient self-reports (pain, function) and clinical observation/reporting of adverse events, rather than an independent expert review establishing a ground truth for the test set itself.

4. Adjudication Method for the Test Set

There is no information provided about an adjudication method for the clinical study's assessments. The outcomes appear to be direct reports or classifications from the clinical team involved in the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for diagnostic imaging devices where different readers interpret cases. The Spine-Fix® cement is a therapeutic device, and the clinical study focuses on patient outcomes post-procedure.

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

N/A. This device is a bone cement, not an algorithm or AI. Standalone performance refers to the performance of an algorithm without human intervention, which is not applicable here.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for effectiveness appears to be:

Patient-reported outcomes: Mild/no pain, normal/mildly dysfunctional function.
Clinical observation/reporting: Absence of serious complications, patient survival.

For the non-clinical tests, the ground truth was:

Standard reference: ISO 5833 "implants for surgery - acrylic resin cements".

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The clinical study of 113 patients serves as the primary evidence for this device.

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

Since there is no training set, there is no information on how its ground truth was established.

Summary

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510(k) Summary Spine-Fix® Biomimetic Bone Cement December 16, 2005

Submitter	Teknimed S.A.11 rue ApolloZ.I. Montredon31240 L'UnionFrance
	MA
Contact person	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199
Trade Name	Spine-Fix® Biomimetic Bone Cement
Common name	Polymethylmethacrylate (PMMA) bone cement
Classification name	Filler, Bone Cement (for vertebroplasty)Class II per 21 CFR section 888.3027
Product Code	NDN
Equivalent Device	KYPHX HV-R Bone Cement, MODEL C01A (Kyphon, Inc. - K041584)Spineplex® (Stryker Corp. - K0032945)

Device Description

This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder

Intended Use

Summary Nonclinical Tests

Test data indicate that the final properties of Spine-Fix bone cement are stable and in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices.

Summary Clinical Tests

A study of 113 patients at 24 months post-op was conducted. Effectiveness was assessed whether there was improvement in neck pain and disability and whether or not the patient's ability to function in daily life was improved. Safety information was measured by the reporting of adverse events.

One hundred percent of the patients were classified as successful after this surgery. All patients reported mild or no pain at the last follow-up visit and all were classified as normal function or mildly dysfunctional. No patients reported any serious complications as a result of the surgery and all patients were alive at the last follow-up.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2006

Teknimed S.A.

c/o The OrthoMedix Group, Inc. ( Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K043593

Trade/Device Name: Spine-Fix® Biomimetic Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: December 16, 2005 Received: December 19, 2005

Dear Mr. Webb:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. J.D. Webb

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,

Hubert Lenoir

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological I calth

Enclosure

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Indications for Use

র

510(k) Number (if known): (Cy35) 3

Device Name: ___Spine-Fix® Biomimetic Bone Cement

Indications for Use:

Spine Fix cement is used for the fixation of pathological fractures of the vertebral Spine Fix cellient is used for the misules. Painful vertebral compression 000y using vertebrophasty of ityphopiasy prosis (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Prescription Use _ X -(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helent Lemmer

(Division Si: - Off) Division of Ceneral, Restorative, and Neurological Devices

510(k) Number K043593

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.”