(51 days)
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available in 22, 28, 32 and 36mm articulation diameters.
Here's a breakdown of the acceptance criteria and the study information for the Longevity® IT Highly Crosslinked Polyethylene Elevated Liners based on the provided text:
Lack of Specific Acceptance Criteria and Detailed Study Information:
It's important to note that the provided document is a "Summary of Safety and Effectiveness" (510(k) Premarket Notification) for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report with statistical performance metrics like sensitivity, specificity, or AUC. The document states that "Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate." This general statement is the core finding presented without delving into specific numerical acceptance criteria or granular study results.
Therefore, many of the requested details, especially those related to AI algorithm performance (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, or MRMC studies), are not applicable to this type of device and document. This is a traditional medical device (hip prosthesis liner), not an AI-powered diagnostic or predictive algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance requirements, safety, and effectiveness equivalent to predicate device for Total Hip Arthroplasty. | Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "Non-Clinical testing" which would typically involve mechanical testing, material characterization, and wear studies, not clinical patient data in the typical sense of a "test set" for an AI algorithm.
- Data Provenance: Not explicitly stated, as it pertains to non-clinical laboratory testing rather than patient data from a specific country. The device sponsor is Zimmer, Inc. from Warsaw, IN, USA.
- Retrospective or Prospective: Not applicable for non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This device is a physical implant. "Ground truth" would be established through engineering specifications, material science standards, and performance benchmarks in non-clinical testing settings, not via expert interpretation of patient data.
4. Adjudication Method for the Test Set
- Not applicable. This is a physical device, not an AI model requiring adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This is not an AI-assisted diagnostic or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- The implicit "ground truth" for this device's performance would be established through engineering specifications, material testing standards (e.g., ISO standards for orthopaedic implants), and performance benchmarks set by the predicate device. These would typically involve measures like wear rate, mechanical strength, fatigue resistance, and biocompatibility.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI model that undergoes a "training set" process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below the circle. The logo is black and white.
093846
P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131
ﺷ ﺑﮯ
FEB - 4 2010
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Benjamin Curson, CQE RAC Associate Project Manager, Regulatory Affairs Telephone: (574) 372-4119 Fax: (574) 372-4605
December 14, 2009
Longevity® IT Highly Crosslinked Polyethylene Elevated Liners
Total Hip Prosthesis
LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented; 21 CFR § 888.3358.
JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented; 21 CFR § 888.3350.
LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented; 21 CFR § 888.3353.
Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer Inc., K091508, cleared September 11, 2009.
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Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available in 22, 28, 32 and 36mm articulation diameters.
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are packaged, manufactured, and sterilized using the same materials and processes as their predicates. The subject device also has the same intended use as the predicate.
Non-Clinical Performance and Conclusions:
Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate.
p. 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Zimmer. Inc. % Mr. Benjamin Curson Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
FEB - 4 2010
Re: K093846
Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene Elevated Liners 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: LZO, JDI, LPH Dated: January 19, 2010 Received: January 21, 2010
Dear Mr. Curson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. 1
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Page 2 - Mr. Benjamin Curson'
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Aabaue Breenm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K093846 Indications for Use
510(k) Number (if known):
Device Name:
Longevity® IT Highly Crosslinked Polyethylene Elevated Liners
Indications for Use:
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
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, Office of Device Evaluation (ODE)
Omita for mkn
(Devision Sign-Off) Division of Surgical, Orthopedic and Restorative Devices
510(k) Number K093846
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§ 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.