(293 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 pharmaceutical grade alpha-tocopheral. This application is for the addition of size 32 ID, with neutral, 10° and 20° hooded configurations available.
This document is a 510(k) premarket notification for a medical device called the "X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E". This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials. As such, the information you're looking for regarding acceptance criteria and studies proving the device meets them, in the context of a diagnostic or AI-driven device, is largely not applicable to this document.
Here's why and what information can be extracted:
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This is a hip implant component, not a diagnostic device. The concepts of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, and studies involving ground truth from experts, sample sizes for test/training sets, or MRMC studies, are primarily relevant to diagnostic algorithms or AI-driven systems. This document describes a physical medical implant.
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Substantial Equivalence, not novel performance claims. The 510(k) pathway focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate device. It's not about proving superior or novel performance against acceptance criteria in the way an AI diagnostic would.
Therefore, many of your requested points are not present or applicable. However, I can still parse the document for the information that is there, even if it highlights its absence in other areas:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the sense of predictive performance metrics (e.g., sensitivity, specificity, AUC). For a physical implant like this, "performance" relates to mechanical properties, material biocompatibility, and meeting certain design specifications, all compared to predicate devices. The document states:
| Criterion Type | Acceptance Criteria (Implied by 510(k) - Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Device must demonstrate mechanical properties comparable to or better than predicate devices, and demonstrate safety for its intended use, typically through bench testing (e.g., wear testing, fatigue testing, compression strength). The introduction of a new size (32 ID) or material (Vitamin E infusion) must not create a "new worst-case" scenario for mechanical performance compared to the predicate devices. This implies that the performance must be within acceptable limits for hip implants, as established by standards and predicate device performance. | "The 32 mm liner does not create a new worst-case for mechanical testing compared to the predicate devices." (This implies that existing mechanical testing results from predicate devices, or new testing proving equivalence/non-inferiority for the 32mm size, were sufficient to meet the substantial equivalence standard as it relates to mechanical performance.) |
| Biocompatibility | Materials (highly cross-linked polyethylene with vitamin E) must be biocompatible and safe for implantation, typically demonstrated by referencing existing materials in predicate devices or by standard biocompatibility testing. | Implied by "Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials..." (The Vitamin E infusion itself likely had its biocompatibility assessed during K130365, the predicate for the Vitamin E infused liner). |
| Sterilization | The sterilization method must be validated to ensure sterility and material integrity. | Implied by "Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications, sterilization, packaging, and intended use." |
| Indications for Use | The device's indications for use must be substantially equivalent to the predicate device, or any differences must not raise new questions of safety or effectiveness. | The listed indications for use are typical for hip joint replacements and align with standard practice for such devices. The document directly lists them, implying their alignment with predicate devices: "noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis... rheumatoid arthritis; correction of functional deformity; femoral fracture. Salvage of previously failed surgical attempts." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. There is no "test set" in the context of diagnostic performance. Mechanical testing for implants typically involves a specified number of samples (e.g., n=3 or n=5 for various types of tests according to standards), but these details are not provided in this summary.
- Data Provenance: Not applicable for clinical data. For non-clinical (mechanical) testing, the data would be generated in a lab setting, presumably by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" established by experts is a concept for diagnostic performance evaluation.
4. Adjudication Method for the Test Set
Not applicable.
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. The device is a physical hip implant component, not an AI diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The Type of Ground Truth Used
Not applicable in the sense of expert consensus, pathology, or outcomes data for diagnosis. For an implant, "ground truth" would relate to accepted engineering standards for material properties, mechanical integrity, and biocompatibility, as confirmed by laboratory testing.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for an implant of this nature.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary based on the document:
This 510(k) premarket notification describes a hip implant component. The concept of "acceptance criteria" and "study" in the context of diagnostic performance (as implied by your questions, e.g., sensitivity, expert ground truth) does not apply to this type of device.
The study referenced is "Non-Clinical Testing", which states: "The 32 mm liner does not create a new worst-case for mechanical testing compared to the predicate devices." This is the core "proof" presented in this summary for the specific change (addition of 32mm size) in relation to the predicate devices. This implies that the device's mechanical performance (e.g., wear, strength) is considered equivalent or acceptable based on comparisons to known predicate devices and presumably relevant engineering standards, without explicit performance numerical targets provided in this summary. No clinical testing was provided as it was deemed unnecessary for this 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6. 2014
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K140130
Trade/Device Name: X-alt™ Highly Cross Linked Acetabular 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: September 12, 204 Received: September 15, 2014
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 – Ms. Teffany Hutto
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lori A. Wiggins -S
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): _ K140130
Device Name: X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E
Indications for Use:
X-alt™ Highly Cross Linked Acetabular Liner with Vitamin 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
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
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510(k) Summary
Date: November 4, 2014
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-alt™ Highly Cross LinkedAcetabular Liner with Vitamin E | Class II | LPH - Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis per 21 CFR888.3358OQG - Hip prosthesis, semi-constrained, cemented,metal/polymer, + additive, porous, uncemented per 21CFR 888.3358 |
Description: A highly cross linked polyethylene acetabular liner infused with pure liquid pharmaceutical grade alpha-tocopheral. This application is for the addition of size 32 ID, with neutral, 10° and 20° hooded configurations available.
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
Predicate Device:
- K973119, K974093, K974095 DJO Surgical FMP Acetabular Shells with Standard Poly Liner ● (Spiked, Hemispherical, Flared Shells)
- K130365 DJO Surgical X-alt Highly Cross Linked Acetabular Liners with Vitamin E ●
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 The 32 mm liner does not create a new worst-case for mechanical testing compared to the predicate devices.
Clinical Testing: None provided.
§ 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.