(142 days)
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to iniect into the vertebral body of a patient with pathological fractures within a vertebral body. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.
The provided text describes a medical device submission (K043518) for "Radiopaque Bone Cement". However, the document does not contain the specific information required to answer the requested questions about acceptance criteria, study details, and performance metrics.
The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria and specific outcomes for an AI/algorithm-based device.
Here's a breakdown of what can and cannot be answered from the provided text:
What can be inferred from the document:
- Device: Radiopaque Bone Cement
- Intended Use: Fixation of pathological fractures of the vertebral body.
- Predicate Device: Stryker Spineplex Radiopaque Bone Cement (K032945).
- Summary of Testing: "Performance testing demonstrated that the proposed Radiopaque Bone Cement is substantially equivalent to currently marketed Spineplex with regard to functional characteristics." This implies non-clinical tests were done, but no specific performance data or acceptance criteria are listed.
- Type of Study (General): Non-clinical performance testing for substantial equivalence.
What cannot be answered from the document:
The following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: The document states that performance testing was done to show substantial equivalence but does not provide any specific criteria (e.g., tensile strength, viscosity ranges, setting time, radiopacity levels) or the numerical results of those tests for either the new device or the predicate.
- Sample sizes used for the test set and the data provenance: No sample sizes are mentioned for any testing. Data provenance (country of origin, retrospective/prospective) is also not stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a bone cement as it's a physical material, not an interpretative AI/image analysis device. There's no ground truth in the sense of expert consensus on images.
- Adjudication method for the test set: Irrelevant, as above.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: This information is not relevant because the device is a physical bone cement, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm.
- The type of ground truth used: For a physical material like bone cement, "ground truth" typically refers to established physical properties (e.g., material standards, mechanical test results) rather than expert consensus, pathology, or outcomes data in the context of interpretation. The document only mentions "functional characteristics" for comparison.
- The sample size for the training set: Not applicable; this device is not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) documentation confirms the substantial equivalence of the Radiopaque Bone Cement based on "performance testing" related to "functional characteristics," but it does not detail the specific acceptance criteria, test results, or study methodologies that would be relevant for an AI/algorithm-based medical device performance description.
{0}------------------------------------------------
MAY I 1 2005
/
/
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.689.8410
Image /page/0/Picture/4 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of four curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Radiopaque Bone Cement
Cardinal Health Sponsor: 1430 Waukegan Road McGaw Park, IL 60085
Sharon Nichols Manager, Regulatory Affairs
(847) 578-6610 Telephone:
Date Prepared: December, 2004
Product Trade Name:
Polymethyl Methacrylate (PMMA) Common Name:
Classification: Predicate Device:
Intended Use:
Contact:
Substantial Equivalence:
Description:
Summary of testing:
Non-clinical Test Results:
McGaw Park, IL 60085
Sharon Nichols
Radiopaque Bone Cement
Class II per 21 CFR §882.5300
Stryker Spineplex Radiopaque Bone Cement
ger, Regulatory Affairs
(447) 578-6610
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
This device is substantially equivalent to Stryker Spineplex Radiopaque Bone Cement (K032945).
Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to iniect into the vertebral body of a patient with pathological fractures within a vertebral body. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.
Based on the product performance information provided to FDA, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.
Performance testing demonstrated that the proposed Radiopaque Bone Cement is substantially equivalent to currently marketed Spineplex with regard to functional characteristics.
00174
{1}------------------------------------------------
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 eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085
Re: K043518
Trade/Device Name: Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: April 25, 2005 Received: April 26, 2005
Dear Ms. Nichols:
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 Mav 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 docs 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.
{2}------------------------------------------------
Page 2- Ms. Sharon Nichols
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter with cation. The FDA finding of substantial equivalence of your device to a legally premaince notificate 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,
Hypt Clurdu
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085 847.689.8410 main 847,785,2506 fax
CardinalHealth
Indications for Use
ﯿﮯ
510(k) Number (if known):____K043518
Device Name:_Radiopaque Bone Cement
Indications For Use:
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K043518 |
§ 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.”