(246 days)
Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Stryker Spineplex™ Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Stryker Simplex® P.
The provided text is a 510(k) summary for the Stryker Spineplex™ Radiopaque Bone Cement. It focuses on demonstrating substantial equivalence to a predicate device (Stryker Simplex® P) rather than presenting a detailed study with acceptance criteria and performance metrics in the way one might expect for a diagnostic AI device.
Therefore, many of the requested points regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as it describes a medical device (bone cement) and its regulatory approval based on equivalence.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the context of a study demonstrating numerical performance against specific acceptance criteria. The submission is a 510(k) summary for a PMMA bone cement, claiming substantial equivalence to a predicate device. The "performance" assessment is based on the chemical similarity and modified ratios for improved working time and visualization, rather than quantitative clinical performance metrics with predefined acceptance thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not mentioned. This document does not describe a "test set" in the context of evaluating a device's performance through a study involving patient data or specimens. The evaluation is based on the device's composition and comparison to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not mentioned. There is no "ground truth" establishment described, as this is not a diagnostic device evaluation requiring interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned.
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/Not mentioned. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not mentioned. This is not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a bone cement would relate to its material properties, biocompatibility, and clinical outcomes for fracture fixation, which are assessed through different types of studies (e.g., mechanical testing, biocompatibility studies, implant registries for long-term outcomes), but these details are not provided in this 510(k) summary. The summary focuses on the inherent properties and modifications of the substance itself.
8. The sample size for the training set
Not applicable/Not mentioned. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable/Not mentioned.
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striker INSTRUMENTS 2007 წლებში 2005 წლის 2001 წლის 2001 წლის 2001 წლის 2002 წლის 2002 წლის 2002 წლებში 2000 წელს 2000 წლებში 2000 წელს 2000 წლების 20
4100 Cast Milham Avenue
Kalamazoo. MI 49001
Phone (269) 323-7700 (800) 253 3210
510(k) Summary
| Trade Name: | Stryker Spineplex™ Radiopaque Bone Cement |
|---|---|
| Common Name: | PMMA bone cement |
| Classification: | Bone Cement, 888.3027 |
| Equivalent to: | Stryker Simplex® P |
| Device Description: | Stryker Spineplex™ Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Stryker Simplex® P. |
| Intended Use: | Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). |
| Technological Comparison: | Stryker Spineplex™ Radiopaque Bone Cement is made of the exact components a Simplex™ P. The ratio of the ingredients has been modified to increase the working time and enhance visualization of the cement to meet customer needs in the fixation of vertebral compression fractures. |
| Submitted by: | Dannielle C. WheelerSr. Regulatory Affairs RepresentativeStryker Instruments |
| Signature | |
| Date | |
| Date Submitted: | Sept. 19, 2003 |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing health and medical services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 25 2004
Ms. Dannielle Wheeler Senior Regulatory Affairs Representative Stryker Corporation Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K032945
Trade/Device Name: Spineplex™ Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Codes: LOD, NDN Dated: February 27, 2004 Received: March 1, 2004
Dear Ms. Wheeler:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Dannielle Wheeler
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retect notification. The FDA finding of substantial equivalence of your device to a legally premailed 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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkeess
Celia M. Witten, PhD, MD 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
510(k) Number (if known): K032945
Device Name: Spineplex™ Radiopaque Bone Cement
Indications for Use:
Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use (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)
R. Mark N. Millican
Division of General, Restorative, and Neurological Devices
KO32995 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.”