(222 days)
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is intended for cementless use only
A highly cross linked polyethylene acetabular liner infused with pure liquid phamnaceutical grade alpha-tocopheral. The liners are the same dimensions and size offerings as the currently cleared Highly Cross Linked Poly liners (K072154) (28mm, 32mm, 36mm, 40mm, and 44mm 1D, with neutral, 10° and 20° hooded configurations available in each ID).
The provided text describes a 510(k) summary for the X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI algorithm might.
Therefore, many of the requested categories related to clinical study design (sample size for test set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this regulatory document.
However, I can extract the relevant information regarding the device's performance based on non-clinical testing.
Acceptance Criteria and Device Performance for X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device's ability to perform under expected conditions was demonstrated through various mechanical tests, and that "All testing has determined that the device is substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating equivalence to the predicate devices' performance in these tests. Specific numerical acceptance criteria are not explicitly detailed in the summary.
| Test Category | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Characterization | Performance equivalent to predicate devices regarding mechanical properties. | Demonstrated ability to perform under expected conditions. |
| Push Out Strength | Performance equivalent to predicate devices for resistance to dislodgement. | Demonstrated ability to perform under expected conditions. |
| Lever Out Strength | Performance equivalent to predicate devices for resistance to lever-out forces. | Demonstrated ability to perform under expected conditions. |
| Torsion Strength | Performance equivalent to predicate devices for resistance to rotational forces. | Demonstrated ability to perform under expected conditions. |
| Rim Impingement Resistance | Performance equivalent to predicate devices for resistance to damage from impingement. | Demonstrated ability to perform under expected conditions. |
| Fatigue Crack Propagation Resistance | Performance equivalent to predicate devices for resistance to crack growth under cyclic loading. | Demonstrated ability to perform under expected conditions. |
| Izod Impact Strength | Performance equivalent to predicate devices for resistance to impact. | Demonstrated ability to perform under expected conditions. |
| Small Punch Strength | Performance equivalent to predicate devices for localized resistance to puncture/deformation. | Demonstrated ability to perform under expected conditions. |
| Tensile Properties | Performance equivalent to predicate devices for resistance to stretching/breaking. | Demonstrated ability to perform under expected conditions. |
| FTIR Analysis (Material Composition) | Material composition equivalent to predicate devices' materials. | (Implied to be comparable) |
| Wear Performance | Wear rates and characteristics equivalent to predicate devices. | Demonstrated ability to perform under expected conditions. |
| Optical and SEM Analysis (Surface/Structure) | Microstructural and surface characteristics equivalent to predicate devices. | (Implied to be comparable) |
| Wear Particle Analysis | Wear particle characteristics (size, morphology) equivalent to predicate devices. | (Implied to be comparable) |
| Extraction Testing (Chemical Leaching) | Levels of extractables equivalent to predicate devices and deemed safe. | (Implied to be comparable) |
| Animal Implant for Toxicological Response | Non-toxicological response equivalent to predicate devices. | (Implied to be acceptable) |
| Cytotoxicity | Non-cytotoxic response equivalent to predicate devices. | (Implied to be acceptable) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The non-clinical testing refers to various mechanical and material characterization tests. These typically involve testing multiple samples per test, but a cumulative "sample size" is not provided in the context of a typical clinical test set with human subjects.
- Data Provenance: Not specified, but the testing was likely conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This was a non-clinical, mechanical testing study, not a study requiring expert readers or ground truth establishment in the diagnostic sense.
4. Adjudication Method:
Not applicable. This was a non-clinical, mechanical testing study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This was a non-clinical, mechanical testing study.
6. Standalone Performance Study:
Yes, in the sense that the device's performance was evaluated independently through a battery of non-clinical tests. However, it's not "standalone" in the context of an AI algorithm performing without human intervention. The performance refers to the physical and material properties of the device itself.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be established by:
- Standardized test methods: Adherence to established mechanical testing standards (e.g., ISO, ASTM).
- Material specifications: Conformance to the physical and chemical properties expected for the materials used.
- Predicate device performance: The performance of the legally marketed predicate devices served as a benchmark for comparison to establish "substantial equivalence."
8. Sample Size for the Training Set:
Not applicable. There is no AI algorithm being trained in this context. The manufacturing and design process of the physical device serves as its "development" or "training."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no AI algorithm and thus no training set in the conventional sense. The "ground truth" for the device's design and manufacturing would be based on engineering principles, material science, and the performance characteristics of successful predicate devices.
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510(k) Summary
Date: February 11, 2013
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| Product | Classification | Product Code |
|---|---|---|
| X-altTM Highly Cross Linked AcetabularLiner with Vitamin E | Class II | LPH - Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis per 21 CFR 888.3358OQG - Hip prosthesis, semi-constrained, cemented.metal/polymer, + additive, porous, uncemented per 21 CFR888.3358 |
Description: A highly cross linked polyethylene acetabular liner infused with pure liquid phamnaceutical grade alpha-tocopheral. The liners are the same dimensions and size offerings as the currently cleared Highly Cross Linked Poly liners (K072154) (28mm, 32mm, 36mm, 40mm, and 44mm 1D, with neutral, 10° and 20° hooded configurations available in each ID).
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- noninflanımatory degenerative joint disease including osteoarthritis and avascular necrosis of the . natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity: ●
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only
Predicate Device:
SEP 2 3 2013
- DJO Surgical X-alt™ Highly Cross Linked Acetabular Liner K072154 .
DJO Surgical 3DKnee Tibial Insert with Vitamin E - K091956 .
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications, sterilization, packaging and intended use.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, rim impingement, fatigue crack propagation, Izod impact, small punch, tensile, FTIR, wear, optical and SEM analysis, wear particle analysis, extraction testing, animal implant for toxilogical response, and cviotoxicity. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
September 23, 2013
Encore Medical, L.P. Ms. Teffant Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K130365
Trade/Device Name: X-alt" Highly Cross Linked Acctabular Liner with Vitamin E 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: OQG, LPH Dated: July 15, 2013
Received: July 16, 2013
Dear Ms. Hutto:
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
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Page 2 - Ms. Teffany Hutto
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 of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Reportal?roblem/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.
Eriñ I. Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E
Indications for Use:
X-alt™ Highly Cross Linked Acetabular Liner with Vitamia E Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity; .
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is intended for cementless use only
Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page I of I
§ 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.