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Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
  · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.

The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.

This is a medical device submission for the Insignia Hip Stem, which is a physical implant, not a software device or AI algorithm. Therefore, the questions regarding acceptance criteria and studies related to AI or algorithm performance are not applicable to the provided text.

The document discusses the mechanical and material performance of the hip stem rather than the diagnostic or predictive performance of an AI system. No information about AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI devices is 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.

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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