(143 days)
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
The Stryker® Patient Specific Polymer Implant is made from PMMA, specifically Surgical Simplex P Radiopaque Bone Cement. Surgical Simplex P Radiopaque Bone Cement is a biocompatible nonresorbable material that will maintain its shape after implantation and provide protection to the skull. Surgical Simplex P Radiopaque Bone Cement is a porous composite material comprised of polymethylmethacrylate (PMMA). The implant will be designed and molded for a specific patient to correct trauma and/or defects in mandibulsa, maxilloficial, or craniofacial bone. A Patient Specific Polymer Implant provides for replacemant of an amorphous shaped implant not contained within standard product offerings.
The provided text describes a 510(k) premarket notification for the Stryker® Patient Specific Polymer Implant. However, it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical performance study would.
Instead, the submission focuses on substantial equivalence to previously approved predicate devices, a common pathway for medical device approval under 510(k). The safety and effectiveness are established by referencing the long-standing use and biocompatibility of the material (PMMA, specifically Surgical Simplex P Radiopaque Bone Cement) and its predicate devices.
Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable in this type of submission. The device is not cleared based on novel clinical performance data demonstrating specific metrics, but rather on its similarity to already approved devices and materials with established safety profiles.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission does not provide a table of acceptance criteria with corresponding performance metrics from a dedicated clinical study for the Stryker® Patient Specific Polymer Implant. The basis for approval is substantial equivalence to predicate devices and the established safety and efficacy of the PMMA material.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific "test set" in the context of a clinical performance study is described for this device. The submission relies on the historical use and safety profile of the PMMA material and its predicate devices. The text mentions "Clinical use of Surgical Simplex P Radiopaque Bone Cement has been used in thousands of cases proving to be safe and effective," but this refers to the historical aggregated experience with the material, not a specific, controlled test set for this particular patient-specific implant.
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. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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/software device. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/software device. No standalone performance study was conducted or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this submission is historical clinical evidence and regulatory acceptance of the PMMA material (Surgical Simplex P Radiopaque Bone Cement) and its predicate devices. The safety and effectiveness are inferred from decades of clinical use of the material and similar devices.
8. The sample size for the training set
- Not Applicable. No "training set" in the context of machine learning or a clinical trial is described. The device's design is patient-specific and its material properties are well-established.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, there is no description of how ground truth for it was established.
Summary of the "Study" Proving Acceptance:
The "study" or evidence proving the device meets acceptance criteria in this 510(k) application is primarily based on:
- Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices (Hard Tissue Replacement - Patient Match Implant K924935, Hard Tissue Replacement --Malleable Facial Implant, Hard Tissue Replacement--MX K904111, Surgical Simplex P Radiopaque Bone Cement N-17-004). This implies that its safety and effectiveness are comparable to these established devices.
- Material Biocompatibility and Historical Use: The implant is made from PMMA (Surgical Simplex P Radiopaque Bone Cement), a "biocompatible nonresorbable material" that "has been used for decades in various applications from clinical orthopaedics to oral surgery since the 1900's." The document states, "Clinical use of Surgical Simplex P Radiopaque Bone Cement has been used in thousands of cases proving to be safe and effective." This long history of safe and effective use of the core material is a key proof point.
In essence, the device is cleared because its material and intended use are demonstrably similar to products already on the market with a proven track record of safety and effectiveness, rather than through a new, dedicated clinical performance study with defined acceptance criteria.
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K043250 page 1/2
APR 1 5 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVEN
Stryker® Patient Specific Polymer Implant
General Information
| Proprietary Name: | Stryker® Patient Specific Polymer Implant |
|---|---|
| Common Name: | PMMA |
| Proposed Regulatory Class: | Class II |
| Device Classification: | KKY (882.3500) |
| Submitter: | Stryker Leibinger4100 East Milham AvenueKalamazoo, MI 49001269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 1226001 |
| Contact Person: | Wade T. RutkoskieAssociate Manager RA QAPhone: 269-323-4226Fax:269-323-4215 |
| Summary Preparation Date: | November 20, 2004 |
Intended Use
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Substantial Equivalency Information
The Stryker® Patient Specific Polymer Implant is substantially equivalent to the Hard Tissue Replacement - Patient Match Implant K924935, Hard Tissue Replacement --Malleable Facial Implant, Hard Tissue Replacement--MX K904111, Surgical Simplex P Radiopaque Bone Cement (Howmedica Osteonics N-17-004).
The Stryker® Patient Specific Polymer Implant is manufactured by Doctor's Research The Stryker® Patient Specific Polymer Implant is made from PMMA, Group. specifically Surgical Simplex P Radiopaque Bone Cement.
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K043250 page 2/2
Surgical Simplex P Radiopaque Bone Cement is a biocompatible nonresorbable material that will maintain its shape after implantation and provide protection to the skull. Surgical Simplex P Radiopaque Bone Cement is a porous composite material comprised of polymethylmethacrylate (PMMA). PMMA has been used for decades in various applications from clinical orthopaedics to oral surgery since the 10000's. Clinical use of Surgical Simplex P Radiopaque Bone Cement has been used in thousands of cases proving to be safe and effective.
The safety and effictiveness of Surgical Simplex P Radiopaque Bone Cement has been established over several decades. The implant will be designed and molded for a specific patient to correct trauma and/or defects in mandibulsa, maxilloficial, or craniofacial bone. A Patient Specific Polymer Implant provides for replacemant of an amorphous shaped implant not contained within standard product offerings.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing or feather shapes.
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Nathan M, Miersma Regulatory Affairs Representative Stryker 4280 Commercial Avenue, Suite A Portage Commerce Park Portage, Michigan 49002
Re: K043250
Trade/Device Name: Stryker Leibinger Patient Specific Polymer Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: March 13, 2005 Received: March 15, 2005
Dear Mr. Miersma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Nathan M, Miersma
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/cdrl/industry/support/index.html.
Sincerely yours,
Ru. U. Ru
_Miriam C. Provost, Ph.D. Acting 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): K043250
Device Name: Stryker Leibinger Patient Specific Polymer
Indications For Use:
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in madibular, maxillofacial, or craniofacial bone.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
E. K.
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K04 32.50
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§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.