(36 days)
The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
The CPT® 12/14, like its predicate, is a one-piece straight, collarless and highly polished femoral stem that is intended to be used for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum
The provided document is a 510(k) summary for a medical device, the CPT® 12/14 Hip Prostheses. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for device performance in the way an AI/ML device submission would.
Therefore, many of the requested elements for an AI/ML device study are not applicable to this document. The document describes a traditional medical device (hip prosthesis) and its regulatory clearance process, which relies on demonstrating equivalence to an already marketed device rather than a de novo performance study against specific acceptance criteria for an AI algorithm.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). The acceptance criterion for regulatory clearance is "substantial equivalence" to the predicate device.
- Reported Device Performance:
"Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate."
This statement is the core "performance" reported, indicating that the new device performs comparably to the previously cleared predicate device in non-clinical settings.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Non-clinical) |
|---|---|
| Substantial equivalence to predicate device Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses (K960658) in non-clinical performance. | "Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes non-clinical performance testing, which often involves bench testing (e.g., mechanical tests, fatigue tests) rather than a "test set" of patient data as understood in AI/ML studies. The data provenance would typically refer to the testing conditions and methodologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of a hip prosthesis typically refers to its mechanical properties, biocompatibility, and surgical outcomes, not to an expert-labeled dataset for an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for expert consensus on AI ground truth, which is not part of this submission.
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 a physical medical device, not an AI/ML diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a hip prosthesis involves demonstrating that its materials, design, and manufacturing meet established standards for safety and effectiveness, typically through bench testing and material characterization to verify mechanical strength, fatigue life, wear resistance, and biocompatibility. Clinical outcomes data or expert consensus for diagnosis are not the primary ground truth for this device type in a 510(k) submission.
8. The sample size for the training set
- Not Applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for an AI model.
Summary of the Study (as described in the document):
The "study" described in this document is a non-clinical performance testing to demonstrate the substantial equivalence of the CPT® 12/14 Hip Prostheses to its predicate device, the Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses (K960658).
- Objective of the study: To show that modifications to the predicate device do not change its intended use or fundamental scientific technology and that its performance is equivalent.
- Methodology: "Non-clinical performance testing" was performed. While the details of these tests are not provided in this summary, they would typically include:
- Mechanical testing (e.g., fatigue strength, static strength)
- Material characterization
- Biocompatibility assessments
- Design comparison to the predicate
- Conclusion: The non-clinical performance testing "demonstrated that the modified devices are equivalent to the predicate." This established the basis for the FDA's "substantial equivalence" determination, allowing the device to be marketed.
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Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 | MAR 0 4 2003 |
|---|---|---|
| Contact Person: | Dalene T. Binkley, RACAssociate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605 | |
| Date: | January 21, 2003 | |
| Trade Name: | CPT® 12/14 Hip Prostheses | |
| Common Name: | Total hip prosthesis | |
| Classification Name and Reference: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,Cemented | |
| 21 CFR § 888.3350 | ||
| Predicate Device: | Collarless Polished Taper and Collarless PolishedTaper LS Hip Prostheses, manufactured by Zimmer,K960658, cleared July 16, 1996. | |
| Device Description: | The CPT® 12/14, like its predicate, is a one-piecestraight, collarless and highly polished femoral stemthat is intended to be used for cemented fixationinto the intramedullary canal for pathological ordegenerative conditions involving the femur and/oracetabulum | |
| Intended Use: | The CPT® 12/14 Hip Prostheses are indicated foruse with patients suffering from severe hip pain anddisability due to rheumatoid arthritis, osteoarthritis.traumatic arthritis, polyarthritis, collagen disorders,avascular necrosis of the femoral head, andnonunion of previous fractures of the femur and inthe presence of proximal femoral bone defects;patients with congenital hip dysplasia, protrusioacetabuli, or slipped capital femoral epiphysis;patients suffering from disability due to previous |
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Image /page/1/Picture/0 description: The image shows the Zimmer logo. The logo consists of a large, stylized letter "Z" inside of a circle on the left, followed by the word "zimmer" in a smaller, sans-serif font on the right. The letter "Z" is bold and black, contrasting with the white background of the circle.
fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
Comparison to Predicate Device: The modifications to the Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses change neither the intended use nor the fundamental scientific technology of the device. It is packaged and sterilized using the same materials and processes. The modified device was created to offer a line extension to provide the surgeon with more options. Performance Data: Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, possibly representing the concept of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Ms. Dalene T. Binkley Regulatory Affairs Associate Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K030265
Trade/Device Name: CPT 12/14 Hip Prostheses Regulation Numbers: 21 CFR 888.3350 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: February 18, 2003 Received: February 19, 2003
Dear Ms. Binkley:
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. Dalene T. Binkley
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 N. Milkersen
Celia M. Witten, Ph.D., M.D. 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
Page 1 of 1
510(k) Number (if known):
Device Name:
CPT® 12/14 Hip Prosthesis
Indications for Use:
The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark H. Millkeun
Division Sign-Off
Division of Cere
and Neurologics
| 510(k) Num | K030265 |
|---|---|
| ------------ | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.