(150 days)
The Opacity + Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Opacity + is a self-hardening and ready to use bone 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 polymerization is included in the polymer powder.
This document is a 510(k) summary for a medical device called "Opacity + Cement." It describes the device, its intended use, and its equivalence to a predicate device. This type of regulatory document typically focuses on demonstrating substantial equivalence to pre-existing devices based on established non-clinical performance standards rather than detailed clinical studies with specific acceptance criteria that would assess improvement over human readers or standalone AI performance.
Therefore, many of the requested categories are not applicable or not explicitly stated in this 510(k) summary. I will fill in what can be inferred or stated directly from the text and mark the rest as "Not Applicable (N/A)" or "Not Stated (NS)".
Acceptance Criteria and Study Details for Opacity + Cement (K080873)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Nonclinical Performance (Stability/Compliance) | Compliance with ISO 5833 "Implants for surgery - acrylic resin cements" | Final properties of Opacity + Bone Cement are stable and in compliance with ISO 5833. |
| Nonclinical Performance (Similarity to Predicate) | Similar to predicate devices | Final properties are similar to predicate devices. |
| Substantial Equivalence | Modifications do not change intended use or fundamental scientific technology. | Modifications do not change the intended use or fundamental scientific technology. |
| Substantial Equivalence | Modifications do not raise new issues of safety or effectiveness. | Modifications do not raise any new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not Stated (NS) – The document refers to "test data," but a specific sample size for a test set (e.g., number of cement samples tested) is not provided.
- Data Provenance: Not Stated (NS) – The country of origin of the data or whether it was retrospective or prospective is not specified. It is implied to be laboratory-based nonclinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not Applicable (N/A) – Ground truth in this context typically refers to clinical diagnosis or outcome, which is not the focus of this nonclinical performance evaluation. The "ground truth" for the nonclinical tests would be the established chemical and mechanical properties as defined by ISO 5833, not expert consensus.
- Qualifications of experts: Not Applicable (N/A)
4. Adjudication method for the test set
- Adjudication method: Not Applicable (N/A) – Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance studies, not for nonclinical material property testing.
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
- MRMC study: No – This document pertains to bone cement, not an AI or imaging device that would involve human readers.
- Effect size: Not Applicable (N/A)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not Applicable (N/A) – This device is a bone cement, not an algorithm.
7. The type of ground truth used
- Type of ground truth: Nonclinical performance standards (e.g., ISO 5833). The "ground truth" for the device's properties (e.g., strength, setting time) would be defined by the specifications laid out in the ISO standard.
8. The sample size for the training set
- Sample size for training set: Not Applicable (N/A) – This is not an AI/machine learning device, so the concept of a "training set" is not relevant. The cement formulation is developed through research and development, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established
- How ground truth was established: Not Applicable (N/A) – As above, the concept of a training set and its ground truth does not apply to this device. The properties of the cement are established through material science principles and manufacturing specifications to meet the requirements of the ISO standard.
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510(k) Summary Opacity + Cement K080873 Teknimed SA Submitter l 1 rue Apollo AUG 2 8 2008 Z.I. Montredon 31240 L'Union France J.D. Webb Contact person 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Trade Name Opacity + Bone Cement Polymethylmethacrylate (PMMA) bone cement Common name Classification name Cement, Bone, Vertebroplasty Class II per 21 CFR section 888.3027 Product Code NDN Spine-Fix Biomimetic Cement, K043593 Equivalent Device Opacity + is a self-hardening and ready to use bone cement with a high amount of Device Description 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 polymerization is included in the polymer powder. The Opacity + Bone Cement is used for the fixation of pathological fractures of the Intended Use vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma). Test data indicate that the final properties of Opacity + Bone Cement are stable and Nonclinical in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices The modified Opacity + cement is substantially equivalent to commercially Conclusion marketed device, Spine-Fix Biomimetic Cement, K043593.
The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
Teknimed SA % The Orthomedix Group, Inc. J.D Webb Authorized Contact Person 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K080873
Trade/Device Name: Opacity + Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement. Regulatory Class: II Product Code: NDN Dated: July 25, 2008 Received: July 30, 2008
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
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Page 2 - Mr. J.D. Webb
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. product raunil 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K080873 510(k) Number (if known):
Device Name: Opacity + Bone Cement
Indications For Use:
The Opacity + Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangiom), or malignant. lesions (metastatic cancers, myeloma).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millers
ion=( )f Division of General, Restorative, and Neurological Devices
K080873 510(k) Number_
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§ 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.”