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

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Certain cases of ankylosis.

Hemi-hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated 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 hemi-hip arthroplasty.

The ACTIS™ DUOFIX™ Hip Prosthesis - Collarless is indicated for cementless use only.

The DePuy Actis DuoFix Hip Prosthesis – Collarless is a forged titanium (Ti-6Al-4V) femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.
The Actis DuoFix Hip Prosthesis – Collarless implants have sintered commercially pure titanium bead porous coating (Porocoat®) and a thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient.
The Actis DuoFix Hip Prosthesis – Collarless is designed as a line extension to the primary predicate Actis DuoFix Hip Prosthesis (K160907) to meet the need of surgeons whose preference is to use a femoral stem without a collar for hip arthroplasty.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, especially in the context of an AI/ML-based medical device.

The document is a 510(k) premarket notification for a hip prosthesis (Actis DuoFix Hip Prosthesis - Collarless). It focuses on demonstrating substantial equivalence to predicate hip prostheses based on material, design, intended use, indications for use, and non-clinical testing (fatigue testing, biocompatibility, MRI safety, bacterial endotoxin testing, HA characterization).

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or how ground truth was established for a machine learning model, as this information is not present in the provided text.

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

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. 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.

The ACTISTM DUOFIX™ Hip Prosthesis is indicated for cementless use only.

The ACTIS Duofix™ Hip Prosthesis is identical to the previously cleared ACTIS Duofix™ Hip Prosthesis (K150862 & K160907). The ACTIS Duofix™ Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V), have a sintered commercially pure titanium bead porous coating (Porocoat ®), and thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-athroplasty and with modular metal or ceramic femoral heads intended for total hip arthroplasty.

The porous coating is applied over the proximal region of the stem. A thin coating of hydroxyapatite (HA) of uniform thickness is sprayed over the porous and distal stem areas via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process used to apply the HA coating to the ACTIS Duofix™ Stem is the same process used to coat the SUMMIT Duofix™ Stem which was cleared in K193398. The HA material used for the ACTIS Duofix™ Stem is the same as the HA material used on the SUMMIT Duofix™ Stem. Thirteen sizes of prostheses are provided to allow high resolution of fit within host femora. Each size is offered in standard and high offset neck options, desired recreation of patient biomechanics in combination with head and liner combinations.

This document describes a 510(k) premarket notification for the ACTIS Duofix Hip Prosthesis, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

• Manufacturing changes: Adding DePuy Ireland as an alternate manufacturing facility for the HA coating process and DePuy Orthopaedics Inc. Warsaw IN as an alternate site for grit-blasting.
• Non-clinical performance data:
  • Biological safety per ISO 10993-1.
  • Characterization testing of Hydroxyapatite Coating per FDA Guidance.
  • Performance Bench Testing - Body (Distal) Fatigue Testing per ISO 7206-4 2010.

No clinical tests were conducted as part of this submission, nor are there any indications of an AI/ML component in the device.

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