(119 days)
The OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Congenital dislocation;
- Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fractures of the proximal femur.
The OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.
The OMNI Anseris Stem is a "fit and fill" femoral stem with a tapered conical design and is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System.
This document is a 510(k) premarket notification for a medical device called the "OMNI Anseris Hip Stem." It details the manufacturer's claim of substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a standalone study of its performance in a clinical setting.
Therefore, the information typically found in a study proving acceptance criteria for an AI/algorithm-based device (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment) is not present in this document because it describes a physical implantable device, not a software algorithm.
However, I can extract the information related to the device's non-clinical testing which serves as the "study" proving it meets specific engineering/physical acceptance criteria.
Here's the information parsed from the provided text, focusing on the nearest equivalent to your request:
Acceptance Criteria and Device Performance for OMNI Anseris Hip Stem (Non-Clinical Testing)
This document describes the non-clinical testing performed to demonstrate substantial equivalence of the OMNI Anseris Hip Stem to predicate devices. The "acceptance criteria" here refer to meeting specific engineering and performance standards for a hip implant, rather than clinical performance metrics of an AI algorithm.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test Standard / Requirement | Reported Device Performance (as stated in the document) |
|---|---|---|
| Fatigue Strength | ISO 7206-6 (Fatigue testing of hip joint prostheses – Part 6: Endurance performance of stemmed femoral components with application of torsion) | Met the requirements for fatigue strength per ISO 7206-6 |
| Fatigue Strength | ISO 7206-4 (Fatigue testing of hip joint prostheses – Part 4: Endurance performance of stemmed femoral components with application of a force) | Met the requirements for fatigue strength per ISO 7206-4 |
| Range-of-Motion (ROM) | ISO 21535 (Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacements) | Met the range-of-motion requirement per ISO 21535 |
| Biocompatibility | Ethylene Oxide (EO) Sterilization | Devices undergo the same validated sterilization process, using EO, to a sterility assurance level (SAL) of 10-6. All ethylene oxide residuals are monitored and well below standard limits. |
| Biocompatibility | Endotoxin Levels | Plan to test endotoxins on all OMNIlife science device groups through Limulus amebocyte lysate (LAL) testing. Products segregated into 8 product groups (based on manufacturing process/material type) tested quarterly on a yearly rotation. Product not released if 20 EU/device limit is exceeded. |
| Design/Mechanical | Conical Stem FEA per ASTM F2996-13 | Testing performed. |
| Design/Mechanical | Solidworks Simulation Verification | Verification performed. |
| Design/Mechanical | Conical Stem Bipolar Head Impingement Risk | Testing performed. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of individual units tested, but the document refers to "the results of testing of the proposed Anseris Hip Stems." For mechanical testing, this typically refers to a specific number of samples required by the standard (e.g., n=6 or more for fatigue testing). The document does not specify the exact number of physical stems tested.
- Data Provenance: The testing was carried out by the manufacturer, OMNIlife Science. The data is internal to the company's testing processes as part of their 510(k) submission. There is no mention of country of origin of data in a clinical sense, nor is it retrospective or prospective as it's mechanical testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device being cleared through substantial equivalence to existing predicate devices based on non-clinical (mechanical and material) testing. There is no "ground truth" derived from expert consensus like in an AI/imaging study. The "ground truth" here is the pass/fail criteria of established international and industry standards (ISO, ASTM).
4. Adjudication method for the test set
- Not Applicable. As there are no human readers or interpretations of data akin to an AI study, there's no adjudication method. The tests are designed to provide objective, quantifiable results against predefined engineering specifications.
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 is a physical hip implant, not an AI software or diagnostic imaging tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm. The "standalone performance" is the performance of the hip stem in a mechanical testing environment.
7. The type of ground truth used
- For the non-clinical testing, the "ground truth" refers to compliance with established international and industry standards for hip implants, such as ISO 7206-6, ISO 7206-4, ISO 21535, and ASTM F2996-13, as well as biocompatibility standards (e.g., SAL of 10-6 for sterility, endotoxin limits).
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an algorithm undergoing machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth for it.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.