(45 days)
The Accolade™ C Femoral Component is indicated for cemented primary hip surgery in cases of non-inflammatory degenerative ioint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally; this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed. The Accolade™ C Femoral Component is intended for implantation with bone cement.
The Accolade™ C Femoral Component is a neutral, collared femoral stem and is available in a range of sizes to fit varying anatomical requirements. This device is available in two neck angle options, 127° and 132°, for each corresponding body geometry. A distal spacer is offered for use with this femoral component and is offered in various sizes. This femoral component is intended for the reconstruction of the head and neck of the femoral joint and is intended for implantation with bone cement. The Accolade™ C Femoral Component can be used in conjunction with any currently available Howmedica Osteonics acetabular components, unipolar and bipolar components and Howmedica Osteonics V40™ femoral heads that can be mated with a 5° 40′ BG taper. The Accolade™ C Femoral Component is fabricated from forged cobalt-chromium-molybdenum alloy which complies to ASTM standard F 799. The distal spacer is manufactured from polymethylmethacrylate (PMMA) with BaSO4.
The provided text describes the Accolade™ C Femoral Component, a medical device for hip replacement surgery. The information focuses on its design, materials, intended use, and substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets performance criteria in the way a diagnostic or AI-based device submission would.
The critical missing pieces of information that would be present for such a study are:
- Quantitative Performance Metrics: There are no metrics like sensitivity, specificity, accuracy, AUC, F1-score, etc.
- Test Set Description: No details on the size, source, or characteristics of a test set used to evaluate performance.
- Ground Truth Establishment: No mention of how the "correct" answers were determined for a test set.
- Human Expert Involvement: No mention of radiologists, pathologists, or other experts evaluating the device's output or establishing ground truth.
- AI/Algorithm Performance: This device is a physical prosthetic, not an AI or diagnostic algorithm, so standalone algorithm performance or human-in-the-loop studies are not applicable.
- Training Set Information: As it's not an AI device, there's no concept of a training set for an algorithm.
Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer the specific questions related to an AI/diagnostic device study.
The only performance-related statements are:
- "Finite element analysis of this femoral stem indicates the neck strength equals or exceeds the value proposed by Semlitsch, et. al."
- "Body strength of the smallest size stem meets the performance criteria outlined in ISO 7206-8."
These are engineering performance specifications, not clinical or diagnostic performance metrics.
Therefore, I will state that the requested information is not available in the provided text.
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SEP 1 4 2000
510(k) Summarv
Device: Accolade™ C Femoral Component
The Accolade™ C Femoral Component is a neutral, collared femoral stem and is available in a range of sizes to fit varying anatomical requirements. This device is available in two neck angle options, 127° and 132°, for each corresponding body geometry. A distal spacer is offered for use with this femoral component and is offered in various sizes.
This femoral component is intended for the reconstruction of the head and neck of the femoral joint and is intended for implantation with bone cement. The Accolade™ C Femoral Component can be used in conjunction with any currently available Howmedica Osteonics acetabular components, unipolar and bipolar components and Howmedica Osteonics V40™ femoral heads that can be mated with a 5° 40′ BG taper.
The Accolade™ C Femoral Component is indicated for cemented primary hip surgery in cases of noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed.
The Accolade™ C Femoral Component is fabricated from forged cobalt-chromium-molybdenum alloy which complies to ASTM standard F 799. The distal spacer is manufactured from polymethylmethacrylate (PMMA) with BaSO4.
Finite element analysis of this femoral stem indicates the neck strength equals or exceeds the value proposed by Semlitsch, et. al. Body strength of the smallest size stem meets the performance criteria outlined in ISO 7206-8.
The substantial equivalence of the Accolade™ C Femoral Component is based upon equivalence in intended use, materials, design, and operational principles to the Howmedica® DRG Femoral Component (Howmedica Osteonics Corp.; K936126), Howmedica® Premium Femoral Component (Howmedica Osteonics Corp.; K936127), Osteonics® Omnifit® EON™ Hip System (Howmedica Osteonics Corp.; K933561) and Ranawat/Burstein Total Hip Femoral Component (Biomet®; K911685).
For information contact:
Ms. Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584 Telephone: 201) 507-7956 Fax: (201) 507-6870 E-mail: NRieder@HowOst.com
Summary Date: July 28, 2000
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
SEP 1 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K002320
Trade Name: Accolade C Femoral Component Regulatory Class: II Product Code: LZO Dated: July 28, 2000 Received: July 31, 2000 Amended: September 11, 2000
Dear Ms. Rieder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 HI (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Nancy J. Rieder
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and if you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office additionally 809.10 for in vito diagnostions on the promotion and advertising of your device, (301) 594-4659. Additionally, for questions on are peaces on the regulation please contact the Office of Comphance at (301) 377 - Testion' (21) CFF 807.97). Other general entitled, "Misbranding by relective of pening the Act may be obtained from the Division of Small
information on your responsibilities under the 1000 (2000) 443, 6507, or at i information on your responsionnites under (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dune R. Lechner
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Accolade™ C Femoral Component
Indications for Use:
The Accolade™ C Femoral Component is indicated for cemented primary hip surgery in cases of non-inflammatory degenerative ioint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally; this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed.
The Accolade™ C Femoral Component is intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Duane P. Vochines
(Division Sign-Off) Civision of General Restorative Devices
510(k) Number LOOZ320
N/A