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The implaFit® hip stems are indicated for use in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis:
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
• Revision of previously failed total hip arthroplasty.

The implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The implaFit® hip stems cementless are intented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.

The implaFit® hip stems are femoral stems for total or hemi hip arthroplasty. The implaFit® hip stems include cementless and cemented configurations (i.e., the implaFit® hip stems cementless and the implaFit® hip stems cemented).

The implaFit® hip stems cementless are monoblock, collarless tapered straight stems made from titanium alloy with a partial coating of commercially pure titanium (cpTi). They are fixed by press-fitting.

The implaFit® hip stems cemented are monoblock, collared, tapered straight stems made from cobalt chromium (CoCrMo). They are fixed using cement.

The provided text describes a 510(k) premarket notification for a medical device, the implaFit® hip stems, and primarily focuses on demonstrating its substantial equivalence to legally marketed predicate devices. This type of submission relies heavily on non-clinical performance testing rather than clinical study data involving AI.

Therefore, the information required to answer the prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm study (which would involve concepts like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training sets) is not present in the provided document.

The document describes performance testing for the physical device components (e.g., fatigue testing, impingement testing, coating testing). These tests have "predetermined acceptance criteria" related to the physical properties and performance of the hip stems, and the document states that "All performance testing conducted for the implaFit® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." However, this is not an AI-driven study.

In summary, this document does not contain the information needed to fill out the table or answer the questions related to an AI/algorithm study as requested.

If the request were about the acceptance criteria and study for a physical medical device, a different table and set of questions would be appropriate.

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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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