Search Results

The OMNI ARC Monoblock 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 (Coball 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; .
• י Revision procedures where other treatments or devices have failed;
• . Femoral neck and trochanteric fractures of the proximal femur.

The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty when used with the Apex Bipolar Head.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• · Femoral neck and trochanteric fractures of the proximal femur;
• · Osteonecrosis of the femoral head;
• · Revision procedures where other treatments or devices for these indications have failed.

The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock 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 ARC™ Monoblock Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

Femoral neck and trochanteric fractures of the proximal femur; Osteonecrosis of the femoral head; Revision procedures where other treatments or devices for these indications have failed.

The provided text focuses on the 510(k) summary for the OMNI ARC Monoblock Hip Stem, primarily establishing substantial equivalence to predicate devices through material similarity and performance testing. It does not contain the detailed setup and results of a clinical study or a study involving human readers and AI assistance for diagnostic accuracy. Therefore, many of the requested sections regarding acceptance criteria and study particulars cannot be filled using the provided information.

However, based on the provided text, we can infer some "acceptance criteria" related to mechanical performance and report the device's stated performance in those areas.

Here's an attempt to answer your questions based solely on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes mechanical testing of the device components, not a clinical test set with patient data. Therefore, this question is not applicable to the information provided. The study mentioned is primarily an engineering performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the document describes mechanical testing, not a study requiring expert clinical interpretation for ground truth.

4. Adjudication method for the test set

This question is not applicable as the document describes mechanical testing, not a study requiring adjudication of clinical findings.

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

No such MRMC study is mentioned in the provided 510(k) summary. The document describes mechanical performance testing of a hip stem, not a diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The device is a physical hip stem, not an algorithm.

7. The type of ground truth used

For the mechanical tests, the "ground truth" would be the specifications and requirements defined by the ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535). The device's performance was compared directly against these established engineering standards.

8. The sample size for the training set

This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

This question is not applicable.

Ask a specific question about this device