(205 days)
The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of:
- Femoral head and/or neck fractures or non-unions.
- Aseptic necrosis of the femoral head and/or neck.
- Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with minimal acetabular involvement.
The Fixion® Hip System is indicated as a total hip replacement in cases of:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
The Fixion® Hip Stem is intended for cemented or non-cemented use.
The Fixion® Hip System is composed of an implant, inflation device (pump) and an instrumentation set.
- Implant comprises femoral stem and head ball, and for total hip replacement - acetabular cup and liner and cancellous bone screws, as detailed below:
- A stainless steel Stem, including stem body and neck, which is inserted into the femoral medullary canal and expanded following insertion.
- A Head Ball, assembled on the stem neck and articulates within the acetabulum (in hemi-hip replacement) or acetabular cup and liner (in total hip replacement). A unipolar stainless steel head (for hemi- hip replacement), and a cobalt chromium head (for total hip replacement) are available.
- A porous coated, cobalt chromium Acetabular Cup, inserted and fixated within the acetabulum.
- A UHMWPE Acetabular Cup Liner, which is seated inside the acetabular cup.
- Cobalt chromium Cancellous Bone Screws, intended to fixate the acetabular cup to the acetabulum, in cases additional stabilization of the cup is required.
- Instrumentation Set - a set of accessories to be used with the Fixion® Hip implants.
- Inflation Device (Pump) - a manual pump used to expand the Fixion® stem.
The provided text describes the 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. Fixion® Hip System, which is a medical device application. Medical device regulatory submissions like 510(k) summaries do not typically include the detailed study design elements you are asking for, such as specific acceptance criteria and detailed performance reporting from a clinical study, sample sizes for test and training sets, ground truth establishment methods, or multi-reader multi-case (MRMC) study results with effect sizes.
Instead, 510(k) submissions demonstrate "substantial equivalence" to legally marketed predicate devices. This is typically achieved through:
- Comparison of technological characteristics: Showing that the new device has the same intended use, design features, materials, and operating principles as one or more predicate devices.
- Performance testing (benchtop/mechanical): Ensuring the device meets relevant industry consensus standards (e.g., ISO, ASTM) to demonstrate safety and effectiveness for its intended use, often through engineering tests rather than clinical trials with human subjects.
- Biocompatibility testing: As required.
The document states: "The Fixion® Hip System intended use, design, materials, technological characteristics and principles of operation are substantially equivalent to those of Disc-O-Tech's Fixion® Unipolar Modular Hemi-Hip System (K014072, K030972), Fixion® Interlocking PF Intramedullary Nailing System (K010988, K012967, K023437), United Orthopedic Corporation' U1 Hip System (K994078 Orthopaedics' Elite® Modular Hip System (K871867) and S-ROM® Total Hip System (K851422, K913231, K954935, K961939 and others), and the Link America Inc.' Link® MP® Hip System (K955296)."
It also lists several Performance Standards (ISO and ASTM) that were referred to. These standards define the mechanical and material properties that such an implant should meet. Meeting these standards comprises the "acceptance criteria" for the mechanical performance of the device.
Therefore, I cannot provide the specific details you requested because they are not typically part of a 510(k) summary for a hip implant system, which focuses on substantial equivalence rather than a clinical study demonstrating performance against a detailed set of acceptance criteria with human subjects or AI algorithms.
However, I can extract the closest analogous information from the document regarding acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Referred) | Reported Device Performance |
|---|---|
| ISO 7206-1 (Draft, 1995): Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1: Classification and Description of Dimensions. | The device's dimensions and classification conform to this standard, implying its design and size ranges are within accepted specifications for hip prostheses. |
| ISO 7206-4 (Draft, 1999): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties of Stemmed Femoral Components. | The device's stemmed femoral components meet the endurance properties defined by this standard, indicating sufficient fatigue strength under cyclic loading conditions experienced in the body. |
| ISO 7206-8 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion. | The device's stemmed femoral components demonstrate adequate endurance performance under torsional loads, ensuring stability and integrity during hip movement. |
| Guidance Document for Femoral Stem Prostheses (Draft), ORDB/DGRD/CDRH/FDA, August 1, 1995. | The device's femoral stem components comply with the recommendations outlined in this FDA guidance, ensuring its design and performance address specific regulatory concerns for safety and effectiveness. |
| Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995. | The modular components of the device (e.g., head-neck junction, cup/liner assembly) meet the testing requirements for mechanical locking mechanisms, assuring their secure and stable assembly. |
| ASTM F 138-2000: Standard Specification for Stainless Steel Bar and Wire for Surgical Implants. | The stainless steel components (e.g., stem, unipolar head) are made from materials conforming to this standard, ensuring appropriate mechanical properties and biocompatibility for surgical implants. |
| ASTM F 565-2000: Standard Practice for Care and Handling of Implants and Instruments. | The labeling and instructions for the device align with this standard, providing proper guidance for its care and handling to maintain sterility and integrity prior to and during implantation. |
| ASTM F 1586-95: Wrought Nitrogen Strengthened 21 Chromium 10 Nickel - 3 Manganese - 2.5. Molybdenum Stainless Steel Bar for Surgical Implants. | Where applicable, stainless steel components are fabricated from materials meeting this specific standard, indicating use of high-strength, corrosion-resistant steel. |
| ISO 5832-1 (1997): Implants for Surgery Metallic Materials Part 1: Wrought High Nitrogen Stainless Steel. | Where applicable, metallic components are made from materials conforming to this standard. |
| ISO 5832-9 (1995): Implants for Surgery Metallic Materials Part 9: Wrought High Nitrogen Stainless Steel. | Where applicable, metallic components are made from materials conforming to this standard. |
| BS EN 12563: 1999: Non-active surgical implant Joint replacement implants - Specific requirements for hip joint replacement implants. | The device meets the specific requirements outlined in this European standard for hip joint replacement implants, covering various aspects of design, materials, and performance. |
Note: The "reported device performance" is inferred from the statement of "substantial equivalence" and the reference to these standards. Regulatory bodies accept that if a device design, materials, and mechanical properties meet these established standards, it is inherently performing acceptably for its intended use, similar to predicate devices that have also met these standards.
The following information cannot be extracted from the provided text for the reasons explained above, as this document is a 510(k) summary focused on substantial equivalence rather than a clinical trial report:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.