(208 days)
The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Like its predicate, the modified MAYO Conservative Hip Prosthesis is a modular femoral stem intended to replace the hip joint in total hip arthroplasty. It is identical to its predicate in that it features a 12/14 Morse-type taper and uses the same variety of modular femoral heads. It differs only in overall size where the design is intended to address smaller patient anatomies. As with the predicate, the proposed stem is collarless, wedge-shaped, and is designed for use without bone cement. Fixation is achieved by mechanical press fit into the proximal femoral shaft and by biological ingrowth into the fiber metal pads. As with the predicate, the proposed device is available with and without Calcicoat Ceramic Coating (HA/TCP).
This device, the MAYO® Conservative Hip Prosthesis, is a traditional medical device, not an AI/ML-driven device. As such, the concept of "acceptance criteria" and performance metrics typical for AI/ML devices (like accuracy, precision, etc.) do not directly apply in the same way.
However, I can extract the relevant information from the provided text regarding the device and its evaluation as requested, adapting the AI/ML framework where possible to the context of a traditional medical device submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device is equivalent to its predicate device (MAYO Conservative Hip Prosthesis, K030733) in terms of intended use, fundamental scientific technology, and safety/effectiveness for its indications. | The modified MAYO Conservative Hip Prosthesis:Is a modular femoral stem intended to replace the hip joint in total hip arthroplasty, similar to its predicate.Features a 12/14 Morse-type taper and uses the same modular femoral heads as the predicate.Differs only in overall size to address smaller patient anatomies.Is collarless, wedge-shaped, and designed for cementless use with mechanical press fit and biological ingrowth into fiber metal pads, like the predicate.Is available with and without Calcicoat® Ceramic Coating (HA/TCP), like the predicate.Has the same intended use for cementless total hip replacement in skeletally mature individuals with diagnostic indications including various forms of arthritis and hip conditions.Changes neither the intended use nor the fundamental scientific technology compared to the predicate.Is packaged, manufactured, and sterilized using the same materials and processes as the predicate.Engineering evaluations demonstrated that the device is equivalent to the predicate. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised. | Non-Clinical Performance and Conclusions: "Engineering evaluations demonstrated that the device is equivalent to the predicate." This implies that the device maintained the safety and effectiveness profile of the predicate device. Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device." This statement, coupled with the substantial equivalence finding, indicates that the FDA considered the non-clinical data sufficient to demonstrate safety and effectiveness without requiring new human trials. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. This submission relies on "engineering evaluations" and comparison to a predicate device, rather than a "test set" of patient data or images in the AI/ML sense.
- Data Provenance: Not applicable for a "test set." The evaluation is based on engineering principles and comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. Ground truth for a test set is not relevant for this type of device submission based on engineering evaluations and predicate comparison. The "experts" involved would be the Zimmer Inc. engineers performing the evaluations and the FDA reviewers assessing the submission, but they are not establishing "ground truth" for a dataset.
4. Adjudication Method for the Test Set
- Not applicable, as there is no "test set" in the AI/ML sense.
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
- No. This is a traditional hip prosthesis, not an AI-driven medical imaging or diagnostic device. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implantable device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established safety and effectiveness of the predicate device (MAYO Conservative Hip Prosthesis, K030733) and the engineering principles applied to demonstrate that the modified device is equivalent. It's based on engineering evaluations and regulatory precedent, not pathology, expert consensus on patient data, or outcomes data specifically for this modified device.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" for this device.
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DEC 2 0 2006
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KO61461 Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Patricia JenksSpecialist, Regulatory AffairsTelephone: (574) 371-8354Fax: (574) 372-4605 |
| Date: | May 24, 2006 |
| Trade Name: | MAYO ® Conservative Hip Prosthesis |
| Common Name: | Total Hip Prosthesis |
| Classification Nameand Reference: | Prosthesis, Hip, Semi-constrained Metal/Polymer.Porous Uncemented,21 CFR § 888.3358 |
| Predicate Device: | MAYO Conservative Hip Prosthesis, manufacturedby Zimmer, Inc., K030733, cleared May 1, 2003 |
| Device Description: | Like its predicate, the modified MAYO ConservativeHip Prosthesis is a modular femoral stem intendedto replace the hip joint in total hip arthroplasty. It isidentical to its predicate in that it features a 12/14Morse-type taper and uses the same variety ofmodular femoral heads. It differs only in overallsize where the design is intended to address smallerpatient anatomies. As with the predicate, theproposed stem is collarless, wedge-shaped, and isdesigned for use without bone cement. Fixation isachieved by mechanical press fit into the proximalfemoral shaft and by biological ingrowth into thefiber metal pads. As with the predicate, theproposed device is available with and withoutCalcicoat ® Ceramic Coating (HA/TCP). |
| Intended Use: | The MAYO Conservative Hip Prosthesis is indicatedfor cementless use in skeletally mature individualsundergoing primary surgery for total hip |
*Trademark of Mayo Foundation
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| replacement. Diagnostic indications include severehip pain and disabilities due to rheumatoid arthritis.osteoarthritis, traumatic arthritis, polyarthritis,slipped capital femoral epiphysis, fused hip, fractureof the pelvis, and diastrophic variant. | |
|---|---|
| Comparison to Predicate Device: | The modifications to the MAYO hip change neitherthe intended use nor the fundamental scientifictechnology of the device. It is packaged,manufactured and sterilized using the samematerials and processes. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions: |
| Engineering evaluations demonstrated that thedevice is equivalent to the predicate. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for |
this device.
- Trademark of Mayo Foundation
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
DEC 2 0 2006
Re: K061461 Trade/Device Name: MAY0®* Conservative Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 7, 2006 Received: December 8, 2006
Dear Ms. Jenks:
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 - Ms. Patricia Jenks
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
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
K061461 510(k) Number (if known):
Device Name:
MAYO®* Conservative Hip Prosthesis
Indications for Use:
The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Prescription Use _X (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 if needed)
Concurrence of CDRH, Offic lice Evaluation (ODE)
, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
- Trademark of Mayo Foundation
510(k) Number K061461 Page 1 of 1
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.