(139 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.
The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemiarthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.
The modification consists of a change to the Instructions for Use for the devices listed above to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
This document is a 510(k) Premarket Notification from Encore Medical, L.P. to the FDA for a change to their "Encore Medical Hip System IFU" (Instructions For Use). It is not a study proving device performance against acceptance criteria for a new device.
The FDA letter (K070050) explicitly states: "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..." This indicates a substantial equivalence determination, not an assessment of a device's performance against specific acceptance criteria through a study.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as this type of documentation is typically associated with performance studies for new or significantly modified medical devices, especially those requiring clinical trials or rigorous testing.
Here's an explanation based on the provided text:
- This submission is for a change to the Instructions for Use (IFU), not for a new device or a significant modification requiring a new performance study. The core devices (various hip systems) were cleared previously under different 510(k) numbers (e.g., K910010, K934169, K962560, etc.).
- The criteria for clearance in this K070050 submission are primarily related to "substantial equivalence" to legally marketed predicate devices, meaning the modified IFU (and implicitly the affected devices) are as safe and effective as predicate devices. The comparable features highlighted are "same materials, design, indications, packaging, and sterilization."
In summary, there is no performance study described in this document against a set of acceptance criteria, as this is a filing for an IFU update based on substantial equivalence to previously cleared devices.
However, I can extract information related to the "Indications for Use" which serve as a type of acceptance criteria for patient suitability for the device, and the comparable features to predicate devices which form the basis of the substantial equivalence determination.
Analysis of Provided Document:
This document describes a 510(k) premarket notification regarding a modification to the Instructions for Use (IFU) for the Encore Medical Hip System. This is not a study demonstrating device performance against acceptance criteria in the way you've described (e.g., for a novel AI algorithm or a new physical device requiring a clinical performance study).
The FDA's clearance (K070050) is based on a determination of substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" here are largely implicit in the claim of substantial equivalence and relate to the device's design, materials, indications, packaging, and sterilization being comparable to existing devices. This document does not contain efficacy or performance data from a study designed to meet specific metrics.
1. A table of acceptance criteria and the reported device performance
Since this is an IFU update for existing, substantially equivalent devices, there are no new performance acceptance criteria or reported device performance results from a dedicated study in this document. The "criteria" are primarily the established indications for use, which define when the device should be used.
| Acceptance Criteria (Indications for Use) | Reported Device Performance (N/A - Substantial Equivalence Claim) |
|---|---|
| Joint replacement is indicated for patients suffering from disability due to: | Performance is considered substantially equivalent to predicate devices based on comparable features (materials, design, indications, packaging, sterilization). This document does not present new performance data. |
| - 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. | |
| The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemi-arthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications. Specific systems are indicated for Cementless, Cemented, or either Cemented/Cementless applications as listed in the document. (These define appropriate usage rather than performance metrics). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A): This document does not describe a performance study with a test set. The clearance is based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable (N/A): No test set or ground truth establishment is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A): No test set or adjudication method is described.
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 (N/A): This device relates to hip implants, not an AI software. No MRMC study was conducted or described in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable (N/A): This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable (N/A): No ground truth is described, as there is no performance study. The "truth" for this submission is that the updated IFU accurately reflects the device's intended use and that the device itself is substantially equivalent to predicates.
8. The sample size for the training set
- Not applicable (N/A): No training set is described.
9. How the ground truth for the training set was established
- Not applicable (N/A): No training set or ground truth establishment is described.
{0}------------------------------------------------
Summary of Safety and Effectiveness
Date: April 18, 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com
| Product | 510(k) Number, Clearance Date, Classification | Product Code |
|---|---|---|
| CLP I (Q System 28 Hip Stem) & CLP-R | K910010 – March 12, 1991Class II | LWJ |
| All Poly Acetabular Cup | K934169 – May 3, 1994K942611 – September 28, 1994Class II | JDI |
| Foundation Cemented Hip Stem | K935449 – March 30, 1995Class II | JDI |
| Bipolar | K953510 – August 9, 1995Class II | KWY |
| Vitality Hip Stem | K962560 – September 19, 1996Class II | JDI |
| Foundation Press-Fit Hip Stem & CoCr Femoral Heads | K973302 – December 2, 1997Class II | LPH, LZO |
| Unipolar with Modular Neck Length Sleeves | K973614 – December 18, 1997Class II | KWI |
| Revelation Hip Stem | K973685 – December 19, 1997Class II | LPH |
| Foundation Fracture Hip Stem | K973809 – January 2, 1998Class II | LWJ |
| FMP Acetabular Shells (Spiked, Hemispherical, and Flared) | K974093, K974095, and K973119 –January 28, 1998Class II | LPH |
| Lincar Hip Stem | K974294 – January 12, 1998Class II | LPH, LZO |
| Stamina Hip Stem | K980473 – April 16, 1998Class II | LZO, LWJ, KWY |
| Keystone Modular Hip Stem | K000521 – May 10, 2000Class II | LPH |
| ALFA II (Omega II Modular Total Hip System) & ModularFemoral Neck | K000817 – June 8, 2000Class II | JDI, LPH |
| R120 (R120 Modular Total Hip System) | K011774 – September 5, 2001Class II | JDI, LPH |
| R120 PC (R120 Modular Total Hip System) | K021822 – July 23, 2002Class II | JDI, LPH |
| FMP Constrained Acetabular Liners | K023794 – April 1, 2003Class II | KWZ |
| Product Code | Regulation and Classification Name |
|---|---|
| LWJ | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 |
| JDI | Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 |
| KWY | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis per 21 CFR 888.3390 |
| LPH | Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR 888.3358 |
| LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, per 21 CFR 888.3353 |
| KWL | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 |
| KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR 888.3310 |
{1}------------------------------------------------
Summary of Safety and Effectiveness - cont. Encore Medical - Hip System IFU
The modification consists of a change to the Instructions for Use for the devices Description: listed above to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
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.
The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemi-arthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.
The following Hip Systems are for Cementless application:
| Linear | Stamina |
|---|---|
| Foundation Press-Fit | CLP Offset |
| Keystone Modular | CLP I |
| Revelation | Foundation Fracture |
The following hip systems are for cemented application: Foundation Cemented Vitality
The following hip systems are for either cementless applications: CLP R Alpha II R120 PC R120
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2007
Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
Re: K070050
Trade/Device Name: Encore Medical Hip System IFU 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, LWJ, LZO, JDI, KWY, KWL, KWZ Dated: April 18, 2007 Received: May 9, 2007
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.
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 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.
{3}------------------------------------------------
Page 2 - Ms. Teffany Hutto
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.
barbare Rouchup
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): ___K070050
Device Name: Encore Medical Hip System IFU
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;
(Part 21 CFR 801 Subpart D)
- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts.
The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemiarthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.
| The following Hip Systems are for Cementless application: | |||
|---|---|---|---|
| Linear | Stamina | Keystone Modular | Revelation |
| Foundation Press-Fit | CLP Offset | CLP I | Foundation Fracture |
| The following hip systems are for cemented application: | |||
| Vitality | Foundation Cemented | ||
| The following hip systems are for either cemented or cementless applications: | |||
| Alpha II | CLP R | R120 | R120PC |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jubacebneupforma
Division Sign-Off
Restorative, and Neurological Devices
Page 1 of 1
(21 CFR 801 Subpart C)
(Posted November 13, 2003)
510(k) Number.
§ 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.