(30 days)
Indications for use as a Bipolar or Hemi-Hip Replacement:
- Femoral head/neck fractures or non-unions .
- Aseptic necrosis of the femoral head; .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion;
- Pathological conditions or age considerations which indicate a more conservative . I amongiour conditions of up voidance of the use of bone cement in the acetabulum;
- Salvage of failed total hip arthroplasty. .
Indications for use as part of a Total Hip Replacement include:
OR
- 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;
- Procedury, . are less likely to achieve satisfactory results.
This Special 510(k) submission is intended to address a design modification to the Omnifit EON Femoral Stems. This modification will create the new subject device, hereby referred to as the Super EON Plus femoral stems to expand the product line. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The subject device is fabricated from forged cobalt chromium alloy conforming to ASTM F 799. The Super EON Plus femoral stems are available in 127 degree and 132 degree neck angles and range in size from size #4 through size #10.
The provided text describes a design modification to the Omnifit EON Femoral Stems, creating the new Super EON Plus Femoral Stems. The core of the information addresses the substantial equivalence determination for this new device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical (Fatigue) Strength Comparable to Predicate | Fatigue testing of the subject Super EON Plus femoral stems demonstrated that the body and neck strength are comparable to the body and neck strength of the predicate Omnifit EON Femoral Stems. |
| Intended Use Identical to Predicate | Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications. |
| Manufacturing Methods Identical to Predicate | The manufacturing methods of the subject device are identical to those of predicate devices. |
| Materials Identical to Predicate | The materials of the subject device are identical to those of predicate devices. (Subject device fabricated from forged cobalt chromium alloy conforming to ASTM F 799). |
| Packaging Identical to Predicate | The packaging of the subject device is identical to those of predicate devices. |
| Sterilization Identical to Predicate | The sterilization of the subject device is identical to those of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the fatigue testing. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). However, given it's a 510(k) submission to the FDA, the testing would have been conducted to US regulatory standards. The testing appears to be prospective as it's specifically for the new device and its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in this context. The study described is a mechanical fatigue test of a medical device (femoral stem). It does not involve human subjects, image interpretation, or diagnostic decision-making, where "ground truth" would typically be established by human experts. The "ground truth" here is the physical performance of the device against established engineering standards and comparison with the predicate device.
4. Adjudication Method for the Test Set
This question is not applicable. As stated in point 3, this is a mechanical test, not one involving human decision-making or disagreement that would require an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This study is a mechanical performance comparison of a medical implant, not an AI or diagnostic imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not applicable. The device is an artificial hip component, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" used for this study is physical measurement and engineering standards conformance. The performance of the Super EON Plus femoral stems was compared to that of the predicate Omnifit EON Femoral Stems and likely against relevant ASTM standards for fatigue strength of implants.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI or machine learning study. It is a physical device safety and performance study.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.