(135 days)
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as theumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.
The Smith & Nephew MIS Stem is a straight, tapered, proximally loading stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 1 through 9 and have modular neck options to address patient anatomy. The stems are manufactured from titanium alloy (Ti-6Al-4V) and the necks are manufactured from Cobalt Chrome. Each femoral stem is proximally coated with Smith & Nephew's Roughcoat porous coating.
The provided text is a 510(k) summary for the Smith & Nephew MIS Hip Stem. This submission establishes substantial equivalence to already-marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in the way a novel therapeutic or diagnostic device might.
In the context of a 510(k) for a medical implant like a hip stem, "acceptance criteria" are typically related to mechanical and biocompatibility testing, demonstrating that the new device performs as safely and effectively as previously cleared, substantially equivalent devices. There isn't usually a clinical study with patients and AI models as described in your prompt for this type of device.
Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, training ground truth) is not applicable to this 510(k) submission. These details are generally relevant for diagnostic devices, AI/ML-driven analyses, or novel therapeutic approaches where clinical performance metrics (sensitivity, specificity, accuracy, etc.) are directly evaluated against a ground truth.
However, I can extract information regarding the device's characteristics and the basis for its substantial equivalence, which serves as its "proof" of meeting regulatory requirements.
Here's the breakdown of what can be derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
For a 510(k) of a conventional implantable device, "acceptance criteria" are not reported as clinical performance metrics (like sensitivity/specificity) but rather as compliance with design, material, and performance standards demonstrated through bench testing and comparison to predicate devices. The "reported device performance" is essentially that it meets these standards and is substantially equivalent to existing devices.
| Acceptance Criteria (Implied by 510(k) Submission) | Reported Device Performance (Summary) |
|---|---|
| Material Composition: Use of established biocompatible materials. | Manufactured from titanium alloy (Ti-6Al-4V) for the stem, Cobalt Chrome for the necks. Proximal porous coating (Roughcoat). |
| Design Characteristics: Match geometry of femur, proportional sizing, modular neck options. | Straight, tapered, proximally loading stem designed to match femoral geometry. Sizes 1-9. Modular neck options. |
| Intended Use: For uncemented total hip arthroplasty in specified conditions. | Indicated for uncemented primary and revision surgery for various orthopedic conditions (trauma, inflammatory/degenerative joint disease, avascular necrosis, fractures, etc.). |
| Mechanical Performance: Implied by substantial equivalence to predicate devices which have undergone appropriate mechanical testing (e.g., fatigue strength, torsional stability, push-out strength for porous coatings, etc. - though not explicitly detailed in this summary). | Overall design is substantially equivalent to other cleared devices (Anthology Hip Stem, Profemur TL Hip Stem, Mayo Conservative Hip, Lateralized Taperloc Microplasty). |
| Biocompatibility: Implied by substantial equivalence to predicate devices and use of well-established medical-grade materials. | Uses Ti-6Al-4V and Cobalt Chrome, common materials in hip implants. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This 510(k) is for a medical implant where testing is primarily bench-top and comparison to predicate devices, not clinical studies in the way a diagnostic device would be evaluated. The "test set" would typically refer to the physical devices tested in a lab, but no sample sizes for such testing are mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in this context, would be established through engineering specifications, material standards, and clinical experience with predicate devices, rather than expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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:
- No. This is a medical implant, not an AI-driven diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Ground Truth: The "ground truth" for this device's approval is its substantial equivalence to legally marketed predicate devices. This means that the device's design, materials, manufacturing processes, and intended use are sufficiently similar to those of devices that have already been proven safe and effective. The safety and effectiveness of the predicate devices would have been established through a combination of engineering analysis, biocompatibility testing, mechanical testing, and clinical experience/outcomes data.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/ML device.
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Smith & Nephew, Inc. Summary of Safety and Effectiveness MIS Hip Stem
Contact Person and Address
Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054
Date of Summary: 08/17/2007
JAN 10 2008
Name of Device: Smith & Nephew MIS Hip Stem Common Name: MIS Hip Stem
Device Description
The Smith & Nephew MIS Stem is a straight, tapered, proximally loading stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 1 through 9 and have modular neck options to address patient anatomy. The stems are manufactured from titanium alloy (Ti-6Al-4V) and the necks are manufactured from Cobalt Chrome. Each femoral stem is proximally coated with Smith & Nephew's Roughcoat porous coating.
Device Classification
21 CFR 888.3358 Hip joint metal semi-constrained porous-coated Uncemented prosthesis -Class II
Indications for Use
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as theumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.
Substantial Equivalence Information
The overall design of the Smith & Nephew MIS Hip Stem is substantially equivalent to previously cleared devices listed below.
| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---|---|---|---|
| Smith & Nephew, Inc. | Anthology Hip Stem | K052792 | 10/07/2005 |
| Wright Medical Technology, Inc. | Profemur TL Hip Stem | K060358 | 5/10/2006 |
| Zimmer Inc. | Mayo Conservative Hip | K030733 | 5/1/2003 |
| Biomet Manufacturing Corp. | Lateralized Taperloc Microplasty | K062994 | 5/9/2007 |
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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 consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the eagle. The eagle symbol is composed of three curved lines that resemble the shape of an eagle's head and neck. The text is written in a simple, sans-serif font.
JAN 10 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mr. Rishi Sinha Regulatory Affairs Specialist 1450 Brooks Road Memphis, TN 38116
Re: K072417 Trade/Device Name: MIS Hip Stem 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 Dated: January 4, 2008 Received: January 7, 2008
Dear Mr. Sinha:
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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Page 2 - Mr. Rishi Sinha
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Millman
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):
Device Name: MIS Hip Stem
Indications for Use:
Total hip components are indicated for Uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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)
Valerie Owen
Page 1 of and Ne
510(k) Number K072417
§ 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.