(78 days)
Total hip components are indicated for 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 osteomyelitis 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 Oxinium DH femoral heads are for single use only.
The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:
The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.
Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:
- Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
- Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
- Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.
The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.
Given this context, here's the information extracted from the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Mechanical Performance | "A review of the mechanical testing results indicated that the Smith & Nephew Oxinium DH femoral heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." |
| Indications for Use | The stated Indications for Use are identical to the predicate devices, covering rehabilitation of hips damaged by trauma, inflammatory/degenerative joint disease, avascular necrosis, fractures, etc. |
| Design & Materials | "The Smith & Nephew Oxinium DH femoral heads are similar in overall design, indications, and materials to the Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners." |
| Biocompatibility | (Not explicitly detailed in the provided text, but implied through substantial equivalence to predicate devices likely already deemed biocompatible.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
- Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
- Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Ground Truth Type:
- For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
- For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.
In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.
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510(k) Summary of Safety and Effectiveness Smith & Nephew Oxinium DH Femoral Heads
AUG 2 1 2008
Contact Person and Address
Date of Summary: July 21, 2008
Jason Sells Project Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-5520
Name of Device: Smith & Nephew Oxinium DH Femoral Heads Common Name: Femoral Head
Device Classification Name and Reference: 21 CFR 888.3350 (Hip joint metal/polymer semiconstrained cemented prosthesis - Class II); and 21 CFR 888.3358 (Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis - Class II) Device Product Code: JDI, LPH
Device Description
The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.
| Description - - - | 510(k) | ClearanceDate |
|---|---|---|
| Echelon (Revision) Hip Stems - Porous and Non-porous | K963486 | 11/27/96 |
| Echelon Primary Hip Stems | K983834 | 2/24/99 |
| Echelon Hip Stems - HA Coated | KO23302 | 10/25/02 |
| Synergy (Tapered) Hip Stems - Porous and Non-porous | K963509 | 1/27/97 |
| Synergy (Tapered) Hip Stems - HA Press-fit | K970337 | 2/28/97 |
| Synergy Cemented Hip Stems | K990369 | 3/12/99 |
| Synergy Porous Size 8 Hip Stem | K991485 | 7/12/99 |
| Synergy HA Coated Porous Hip Stems | K002996 | 12/11/00 |
| Spectron Hip Stems | K970351 | 2/28/97 |
| Smith & Nephew Modular Hip (Emperion) | K042127 | 11/19/04 |
| Smith & Nephew Modular Hip (Emperion) - Line Additions | K052426 | 12/07/05 |
| Platform Hip Stem | K052275 | 12/07/05 |
| Anthology Hip Stems | K052792 | 10/07/05 |
| Smith & Nephew Patient Matched Hip Stem (PMHS) | K053246 | 7/12/06 |
| Smith & Nephew MIS Hip Stem | K072417 | 1/10/08 |
| Smith & Nephew MIS Hip Stem with StikTite | K080625 | 5/8/08 |
| SL-PLUS Standard and Lateral Hip Stems | K072852 | 6/9/08 |
Table 1: Previously cleared Smith & Nephew hip stems with a 12/14 taper
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$\qquad r^{2/2}$
| Description | 510(k) | ClearanceDate |
|---|---|---|
| Reflection Acetabular Cup System (formerly the Modular AcetabularCup System) (cemented use) | K920430 | 7/21/92 |
| Reflection Acetabular Components (uncemented use) | K932755 | 5/6/94 |
| Reflection Dual Dimension Shell (Interfit Shells) | K960094 | 3/27/96 |
| Hydroxyapatite Reflection Acetabular Shells (Interfit HA coated shell) | K990666 | 8/6/99 |
| Reflection Cross-linked UHMWPE Acetabular Liners: 5 MradIrradiation Dosage | K991026 | 10/28/99 |
| Reflection Cross-linked UHMWPE Acetabular Liners: 10 MradIrradiation Dosage | K002747 | 12/15/00 |
| Smith & Nephew Hip System - Reflection 36 mm XLPE Liners | K022902 | 10/2/02 |
| Reflection 3 Acetabular System | K061253 | 5/31/06 |
| Reflection 3-Hole Shell with Asymmetric Porous Coating | K060630 | 6/14/06 |
| Reflection 3 Acetabular System | K070756 | 6/6/07 |
Table 2: Previously cleared Smith & Nephew acetabular liners and shells
Mechanical Testing
A review of the mechanical testing results indicated that the Smith & Nephew Oxinium DH femoral heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Intended Use
Total hip components are indicated for 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 osteomyelitis 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 Oxinium DH femoral heads are for single use only.
Substantial Equivalence Information
The Smith & Nephew Oxinium DH femoral heads are similar in overall design, indications, and materials to the Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is simple and recognizable, representing the department's role in health and human services.
SEP 2-2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mr. Jason Sells Project Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116
Re: K081566 Trade Name: Oxinium DH Femoral Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDI Dated: July 21, 2008 Received: July 22, 2008
Dear Mr. Sells:
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. Jason Sells
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 Biometrics' (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 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.
Mark M Mulhausen
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: Oxinium DH Femoral Heads
Indications for Use:
Total hip components are indicated for 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 osteomyelitis 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 Oxinium DH femoral heads are for single use only.
Prescription Use X (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. C ice of Device Evaluation (ODE)
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Division of General, Restorative, and Neurological Devices
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510(k) Number K081566
Indications.doc
§ 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.