(12 days)
The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular device is miches. component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . Cententess primary inf varseular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .
The existing Accolade® TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on the body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy.
The provided text is a 510(k) Summary for a medical device (Accolade® RPS Femoral Stem) seeking market clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be seen for novel devices.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details cannot be extracted from the provided text because it describes a 510(k) submission, not a study designed to establish such criteria and performance.
A 510(k) relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or different technological characteristics that do not raise new questions of safety and effectiveness and are shown to be as safe and effective as the predicate device. This often involves non-clinical testing (e.g., mechanical, material characterization) and comparison to the predicate's performance, but not typically a clinical study with detailed acceptance criteria and expert reviews in the manner you've described for an AI/algorithm-based device.
Key points from the document that explain why the requested information is not present:
- "Substantial Equivalence" is the core principle: The document explicitly states, "The determination of the substantial equivalence of the Accolade® RPS hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000)."
- Device Description: The Accolade® RPS Hip Stem is a modification to an existing hip stem, featuring "a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on I body of the stem." This indicates a change to an already cleared device, not a completely new device requiring extensive de novo clinical validation against new acceptance criteria.
- Focus on intended use and material: The "Intended Use" and "Indications" sections describe common applications for hip stems, aligning with the predicate.
- FDA Letter: The FDA's letter (pages 2-3) confirms the "substantial equivalence determination" and that the device can proceed to market, which is the outcome of a successful 510(k).
In summary, your request describes the documentation typically found for AI/Diagnostic imaging devices or novel therapeutic devices undergoing rigorous clinical trials to establish performance against pre-defined acceptance criteria. The provided text is for a modified hip implant seeking 510(k) clearance, which follows a different regulatory pathway.
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SEP 2 7 2005
Image /page/0/Picture/2 description: The image contains the names of three companies: Stryker, Howmedica, and Osteonics. The text is black and the background is white. The names are stacked vertically, with Stryker at the top, Howmedica in the middle, and Osteonics at the bottom. The font is bold and easy to read.
325 Corporate Drive
Mahwah, NJ USA 07430
510(k) Summary of Safety and Effectiveness for the Accolade® RPS Femoral Stem
Proprietary Name:
Common Name:
Classification Name and Reference
Regulatory Class:
Device Product Code:
For Information contact:
Accolade® RPS Femoral Stem
Total Hip Joint Replacement Prosthesis
Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353
Class II
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate,
87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Phone: (201) 831-5412 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:
September 13, 2005
Device Description
The existing Accolade® TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on
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$\frac{1}{2}$
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I body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy.
ended Use:
The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is The subject imp stem is a = = =
intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This intended for primary
device is intended for use with any currently available Howmedica Osteonics acetabular device is miches.
component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . Cententess primary inf varseular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .
Substantial Equivalence:
The determination of the substantial equivalence of the Accolade® RPS hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). Predicate device information is located in Appendix E.
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SEP 27 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tiffani D. Rogers Regulatory Affairs Specialist Stryker Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K052542 Trade/Device Name: Accolade® RPS Hip Stem 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, MEH Dated: September 14, 2005 Received: September 15, 2005
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regions the Medical Device Amendments, or to commerce prior to May 20, 1976, in ecordance with the provisions of the Federal Food, Drug, devices mat have been reculise in assess as as a proval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to not request in the general controls provisions of the Act. The 1 ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of tractice, 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 If your device is classified (see aberty) als. Existing major regulations affecting your device can may be subject to saterial 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 r rease oe avrised has i termination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of uny I odelul states and we wents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF 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.
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Page 2- Ms. Tiffani D. Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin mantening of substantial equivalence of your device to a legally premarket nothleanon. The PDA maing of cacommand of 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 If you desire specific advice for Jour do 110-76-0120. Also, please note the regulation entitled, p Colliact the Office of Complance at (1) + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misoranting by release to premainters in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Millerson
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | Accolade® RPS Hip Stem |
Indications for Use
Indications
-
Cementless primary hip surgery in cases of non-inflammatory
-
Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including ostcoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
-
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
-
Revision procedures where other treatments or devices have failed. .
Prescription Use X
OR Over-the-Counter Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark D. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
N/A