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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 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. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Hemi hip replacement 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 SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices.
The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.

This is a 510(k) summary for the Summit Hip System, which is a medical device. This document does not describe acceptance criteria for an AI/ML device, nor does it contain information about a study proving such a device meets acceptance criteria. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence of the Summit Hip System to predicate devices.

Therefore, I cannot answer your request based on the provided text as it does not contain the information you are looking for.

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