(63 days)
The Fixion® MH System is intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use 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® MH System is a modular hemi-hip system, which consist of the following main components:
- Implants (stainless steel), including the stem and head ball. The stem is the femoral diaphyseal component. It consists of an expandable stem body and a neck part. The unipolar head ball is the prosthesis hip component that articulates within the acetabulum.
- The Instrumentation Set is a set of accessories, including pre-operative tools, femoral canal preparation tools and accessories such as the stem insertion handle, inflation adapter, screwdriver for stem cap insertion and devices for implant removal.
- The Inflation Device is a pump, which rotation of its handle delivers saline into the stem. This action causes the expansion of the stem and its abutment to the bone medullary cavity. The pump pressure gauge indicates the inflation pressure.
The provided text describes the Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH) and its acceptance for market, primarily through establishing substantial equivalence to predicate devices and adherence to relevant performance standards. It does not contain information about a study with acceptance criteria in terms of device performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with AI/ML device evaluations. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided.
However, I can extract the acceptance criteria related to material and mechanical performance standards, which are a form of "acceptance criteria" for a medical device of this type.
Here's the information gleaned from the text as per your request, focusing on the available context:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Fixion® MH System are primarily met through adherence to established international and national standards for orthopedic implants, and demonstration of substantial equivalence to previously cleared devices. The "reported device performance" is implicitly that the device meets these standards and is substantially equivalent.
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| ISO 7206-1 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 1: Classification and Description of Dimensions. | The device's dimensions (10/16 mm stem body, 12 mm stem neck) are described. The submission implies compliance with this standard for classification and dimensional description. The dimensions are also stated to be "within the range of sizes of other cleared, marketed systems." |
| ISO 7206-4 (Draft, 1999): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties of Stemmed Femoral Components. | Implied to have met the endurance properties outlined in this standard. The "Substantial Equivalence" section states the added components are made of the same materials and have the same basic design and operating principles as previously cleared devices, suggesting similar endurance performance. |
| 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. | Implied to have met the endurance performance under torsion as per this standard. Similar to ISO 7206-4, substantial equivalence to predicate devices (with same materials, design, operating principles) supports this. |
| Guidance Document for Femoral Stem Prostheses (Draft), ORDB/DGRD/CDRH/FDA, August 1, 1995. | Compliance with relevant FDA guidance for femoral stem prostheses. |
| Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995. | Compliance with relevant FDA guidance for modular implant components. The Fixion MH is described as a modular system with components like the stem and head ball. |
| ASTM F138-2000: Standard Specification for Stainless Steel Bar and Wire for Surgical Implants. | The implants (stem and head ball) are made of 316L stainless steel. This indicates compliance with material specifications for surgical implants. |
| ASTM F565-2000: Standard Practice for Care and Handling of Orthopedic Implants and Instruments. | Implied compliance with standard practices for care and handling, which would be part of the product's instructions for use and manufacturing processes. |
| Substantial Equivalence to Predicate Devices (K014072 and K010988, K012967): Same intended use, indications, basic design, operating principles, fixation method, packaging, sterilization, and materials. | The Fixion® MH 10/16 stem and 316L stainless steel head balls are explicitly stated to be substantially equivalent to cleared components of the Fixion® MH System (K014072) due to sharing these characteristics. This is the core "performance" assessment presented for this 510(k) submission. |
2. Sample size used for the test set and the data provenance
Not applicable. This submission relies on "substantial equivalence" to predicate devices and compliance with engineering standards, not on a clinical or performance study with a test set of data in the AI/ML sense. Data for engineering tests (e.g., endurance) would be laboratory-generated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's acceptance is its physical and mechanical properties as defined by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This device is a physical hip implant, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this device's acceptance includes:
- Engineering Standards: Defined mechanical properties, material composition, and performance under specific test conditions (e.g., fatigue, torsion) as outlined in ISO and ASTM standards.
- Predicate Device Performance: The established safety and effectiveness record of the legally marketed predicate devices, to which this device is deemed substantially equivalent.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.