(168 days)
The Versafit Cup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: - Severely painful and/or disabled joint as a result of osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis, - Congenital hip dysplasia . - Ankylosing spondylitis . - Avascular necrosis of the femoral head - Acute traumatic fracture of the femoral head or neck . - Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Dislocation risks
The Versafit Cup Double Mobility Acetabular Component is a two piece modular designed device consisting of the metal acetabular shell and a mating polyethylene liner. The metal component is machined from stainless steel M30NW conforming to ISO 5832-9. The outer surface of the metallic cup has two types of coatings: Ti plasma spray and HA/Ti plasma spray. The polyethylene liner is a double mobility liner made of standard UHMWPE conforming to ISO 5834. The liner has a minimum thickness of 5 mm. The acetabular component is available in 10 sizes which accept both CoCrMo and MectaCer BIOLOX forte Ceramic ball heads with diameters of 22 and 28 mm. The polvethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafit cup Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. The Versafit Cup Double Mobility Family is designed to be used with the Medacta Total Hip Prosthesis' Quadra S Stems and ball heads (K072857, K073337, K080885, K082792).
The provided text describes the 510(k) summary for the Versafit Cup Double Mobility Family, a medical device for total hip arthroplasty. The document focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested elements about acceptance criteria, study details, human reader performance, sample sizes, and ground truth establishment are not explicitly available in the provided text. The document refers to "performance testing" but does not provide the results of these tests in a quantifiable manner as described in a scientific study.
Here's a breakdown of what can be extracted and what information is missing based on the prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-defined acceptance criteria (specifics not provided) | "The testing met all acceptance criteria" and "verifies that the performance of the Versafit Cup Double Mobility family is substantially equivalent to the predicate devices." (Specific performance metrics are not given.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states testing was "conducted on the worst case component size and option/design," but no number of samples is given.
- Data Provenance: Not specified. The study is described as "Performance Testing" for design verification, implying it's data generated during the development and testing phase by the manufacturer. It does not state if human data was used, but given the device is mechanical, it's likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this type of device (mechanical hip implant) would be based on engineering specifications, material science standards, and established biomechanical performance requirements, not expert clinical interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. As this is likely bench testing against predefined engineering specifications, "adjudication" in the sense of reconciling expert opinions on medical imaging or clinical outcomes is not relevant.
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
- MRMC Study: No. This is a medical device (hip implant), not an AI-powered diagnostic tool. Therefore, an MRMC study and effects on human readers are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Based on the context of a 510(k) submission for a mechanical implant, the ground truth would be based on international standards (e.g., ISO 5832-9, ISO 5834) and FDA guidance documents for mechanical and material performance (e.g., strength, wear, biocompatibility). These standards define acceptable material properties and performance characteristics. The document mentions "written protocols with pre-defined acceptance criteria."
8. The sample size for the training set
- Sample Size: Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable for a training set. The "ground truth" for evaluating the device's conformity to standards is established by the specifications in the relevant international standards and FDA guidance documents.
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11083116 (pg 1/3)
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a bold, sans-serif font, with a stylized graphic above the first letter. Below the word "Medacta" is the word "International" in a smaller font, and to the right of that is a symbol that looks like a plus sign.
510(k) Summary
APR - 7 2009
Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66
Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
Date Prepared: February 20, 2009
DEVICE INFORMATION
Trade/Proprietary Name: Versafit Cup Double Mobility Family
Common Name: Total Joint Replacement /Classification Name: Hip Joint, metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis
21 CFR 888.3353 Class II Device Product Code: MEH
Predicate Devices:
K070278 POLARCUP® Dual Mobility System K072020 Restoration ™ ADM System
Product Description:
The Versafit Cup Double Mobility Acetabular Component is a two piece modular designed device consisting of the metal acetabular shell and a
Versafit Cup Double Mobility 510(k)
Section 5 - Page 2 of 4
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mating polyethylene liner. The metal component is machined from stainless steel M30NW conforming to ISO 5832-9. The outer surface of the metallic cup has two types of coatings: Ti plasma spray and HA/Ti plasma spray. The polyethylene liner is a double mobility liner made of standard UHMWPE conforming to ISO 5834. The liner has a minimum thickness of 5 mm. The acetabular component is available in 10 sizes which accept both CoCrMo and MectaCer BIOLOX forte Ceramic ball heads with diameters of 22 and 28 mm.
The polvethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafit cup Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation.
The Versafit Cup Double Mobility Family is designed to be used with the Medacta Total Hip Prosthesis' Quadra S Stems and ball heads (K072857, K073337, K080885, K082792).
Indications for Use:
The Versafit Cup Double Mobility Acetabular Component Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- . Severely painful and/or disabled joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- Avascular necrosis of the femoral head .
- Acute traumatic fracture of the femoral head or neck .
- Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
- Dislocation risks .
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the Versafit Cup Double Mobility Family was conducted in accordance with various international standards and FDA guidance documents.
The Versafit Cup Double Mobility family was tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performance of
Versafit Cup Double Mobility 510(k)
Section 5 - Page 3 of 4
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the Versafit Cup Double Mobility family is substantially equivalent to the predicate devices.
Conclusion:
The data and information provided in this submission support the conclusion that the Versafit Cup Double Mobility Family are substantially equivalent to its predicate devices, POLARCUP® Dual Mobility System and Restoration™ ADM System with respect to intended use, design, materials, and operational principles.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medacta International, SA % NJK & Associates, Inc. Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, CA 92129
APR - 7 2009
Re: K083116
Trade/Device Name: Versafit Cup Double Mobility Family Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: March 30, 2009 Received: April 3, 2009
Dear Ms. Kennel:
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. Natalie J. Kennel
forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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 Statement
510(k) Number (if known): K083116
Device Name: Versafit Cup Double Mobility Family
Indications for Use:
The Versafit Cup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.
The patient should be skeletally mature. The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint as a result of osteoarthritis, post ● traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- Avascular necrosis of the femoral head ●
- Acute traumatic fracture of the femoral head or neck .
- Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Dislocation risks �
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carlae Busein Dor
Page · of
Division of General, Restorative. and Neurological Devices
510(k) Number K083116
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.