(26 days)
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease: including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- arthritis secondary to a variety of diseases and anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatments: have failed; and .
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offered in sizes ranging from 38-58mm and feature a female Morse-type taper that has been modified to accept taper sleeves that create a variety of neck length offsets. The taper sleeves feature a 12/14 female taper for attachment to the trunnion of a commercially-available Smith & Nephew femoral siem. The component is based upon the existing Smith & Nephew Modular Heads: and Uni-polar implants subject of K061243 and K896580, respectively.
The provided text is a 510(k) summary for a medical device (Smith & Nephew Modular Femoral (Hemi) Heads). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes a physical medical device, not a software or AI-based device that would typically undergo a study with acceptance criteria and performance metrics in the way your request outlines.
Therefore, most of the information requested (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this document. The 510(k) process for such a device primarily involves demonstrating that the new device is as safe and effective as a predicate device through:
- Comparison of design features: (e.g., materials, dimensions, manufacturing processes).
- Comparison of intended use/indications for use.
- Performance testing: This typically involves mechanical testing (e.g., fatigue, static strength, wear) to ensure the device meets engineering standards and is comparable to the predicate. It does not involve "performance" in the sense of diagnostic accuracy or reader improvement that would require test sets, ground truth from experts, or MRMC studies.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable in the typical AI/software sense. This document doesn't present a table of specific diagnostic accuracy criteria or performance metrics directly comparable to AI outputs.
- Instead, the "acceptance criteria" for a 510(k) for a physical implant relate to demonstrating substantial equivalence to a predicate device. This would involve meeting established material, mechanical, and dimensional standards. The "performance" is implicitly deemed acceptable if it passes these engineering tests and is equivalent to the predicate.
2. Sample Size used for the test set and the data provenance
- Not applicable. There is no "test set" in the context of image data or diagnostic performance for this physical implant. Performance testing for implants typically involves physical samples of the device undergoing mechanical stress tests. The document does not specify the number of samples used for such engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This concept relates to establishing a reference standard for diagnostic accuracy, which is not relevant for a physical hip implant.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication process as described is relevant for this device.
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. MRMC studies are for evaluating diagnostic systems (often AI-assisted) and human reader performance. This device is a physical hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI algorithm performance, which is not relevant for a physical implant.
7. The type of ground truth used
- Not applicable in the diagnostic sense. For a physical implant, "ground truth" might loosely refer to validated engineering specifications, material properties, and biomechanical principles used to design and test the device. However, it's not "pathology" or "outcomes data" in the typical sense of establishing diagnostic accuracy.
8. The sample size for the training set
- Not applicable. There is no "training set" for a physical implant device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for a physical implant device.
In summary, the provided 510(k) summary is for a physical medical implant, not an AI or software-based diagnostic device. Therefore, the questions related to clinical studies, diagnostic performance, expert review, sample sizes for test/training sets, and ground truth establishment (as typically applied to AI/software) are not relevant to this document. The "acceptance criteria" here are defined by demonstrating substantial equivalence to predicate devices through comparisons of design, materials, and intended use, along with standard engineering performance testing (which isn't detailed in this summary).
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K06 2408 (1 of 1)
510(K) Summary Smith & Nephew Modular Femoral (Hemi) Heads
1 2 2006
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | August 15, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Modular Femoral (Hemi) Heads |
| COMMON OR USUAL NAME: | Artificial Hip Replacement Prosthesis |
| CLASSIFICATION NAME: | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 2 CFR 888.3360 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | KWL - prosthesis, hip, hemi-, femoral, metalOrthopedics Panel/87 |
A. INTENDED USE:
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease: including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- arthritis secondary to a variety of diseases and anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatments: have failed; and .
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
DEVICE DESCRIPTION: B.
New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offered in sizes ranging from 38-58mm and feature a female Morse-type taper that has been modified to accept taper sleeves that create a variety of neck length offsets. The taper sleeves feature a 12/14 female taper for attachment to the trunnion of a commercially-available Smith & Nephew femoral siem. The component is based upon the existing Smith & Nephew Modular Heads: and Uni-polar implants subject of K061243 and K896580, respectively.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew Modular Femoral (Hemi) Heads are similar to the following commercially available devices regarding design features, overall indications, and materials:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2006
Smith & Nephew Orthopaedics c/o Mr. Gino J. Rouss Project Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116
Re: K062408
Trade/Device Name: Smith & Nephew Modular Femoral (Hemi) Heads Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: August 15, 2006 Received: August 17, 2006
Dear Mr. Rouss:
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.
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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" (21 CFR 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,
Barbara Buelow
Mark N. Melkerson 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): KO62408
Device Name: Smith & Nephew Modular Femorial Heads
Indications for Use:
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, . avascular necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- arthritis secondary to a variety of diseases and anomalies and correction of functional . deformity such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatments have failed; and .
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric . fractures of the proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemihip replacement system when articulating against the natural acetabulum.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchner
510(k) Number K062476
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.