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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.

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Total Hip Arthroplasty and Hemi Hip Arthroplasty

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

HA coated stems of the Corail Hip System are indicated for cementless use only.

The Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.

The provided document describes the Corail AMTTM Hip Prosthesis, an orthopaedic device. The submission is a 510(k) to expand the cleared indication for use to include hip hemi-arthroplasty surgical application.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Non-clinical (Performance) Tests: The document does not specify the exact sample sizes (number of devices tested) for the "Validation of the taper/heads dimensional compatibility" or the "Fatigue Resistance tests." It only states that these tests were performed. Given the nature of these tests, they would typically involve a defined number of test articles to meet industry standards (e.g., ISO or ASTM standards for implant testing).
• Clinical Evaluation: No new clinical tests were conducted. The clinical evaluation utilized a "systematic literature review of Corail Hip System for the treatment of femoral neck fractures." The provenance of the data in this systematic review would depend on the included studies, but the document does not provide details on country of origin or whether these studies were retrospective or prospective. It is a compilation of retrospective existing scientific literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies on non-clinical performance testing and a literature review for clinical evaluation, not on a test set requiring expert ground truth for interpretation of images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

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 medical device for hip arthroplasty, not an AI-based diagnostic or imaging device that would typically involve MRMC studies or AI assistance for human readers.

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

Not applicable. This is a hip prosthesis, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Non-clinical (Performance) Tests: Ground truth for these tests is based on engineering specifications, material properties, and established test standards (e.g., demonstrating mechanical compatibility and fatigue life under simulated physiological conditions).
• Clinical Evaluation: The "ground truth" for the clinical evaluation is based on the outcomes data and findings reported in the systematic scientific literature review regarding the safety and effectiveness of the Corail Hip System for femoral neck fractures, by extension supporting the expanded indications for hemi-arthroplasty.

8. The sample size for the training set

Not applicable. This is a medical device for hip arthroplasty, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this type of device submission.

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