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The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be pressfit.

The Keystone® Hip System is available in a variety of proximal bodies and distal stem diameter and length configurations. The proximal body and stem are attached via a Morse type taper junction with an axially loading screw providing secondary attachment. The bodies, stems, and fixation screws were cleared on 510(k) K000521. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136 with a porous coating that conforms to ASTM 1854-98 applied to the proximal body.

The additional components that are the subject of this Special 510(k) submission are the calcar replacement bodies and calcar build-ups.

The calcar replacement bodies are to be used either with or without a calcar build-up. During revision surgery or treatment of intertrochanteric fractures, the medial calcar bone is often deficient. This implant allows the surgeon to rest the calcar platform of the stem on the remaining medial bone. The modular build-up is available in a +15 and +30mm height for each size stem. The build-up is attached to the stem using an attachment screw. The modular buildups are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The attachment screw is used to attach the calcar build-up to the calcar replacement bodies. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

This document is a 510(k) premarket notification for the Keystone® Hip System Calcar Replacement Body and Build-up. It states that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating equivalence rather than conducting new clinical trials to prove efficacy and safety. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a de novo or PMA submission might.

Specifically, for the Keystone® Hip System Calcar Replacement Body and Build-up, the FDA determined substantial equivalence based on comparable features to predicate devices, including "same materials, design and indications." This implies that the acceptance criteria for this 510(k) were primarily satisfied by demonstrating that the new components perform similarly to previously cleared devices under similar conditions and for similar intended uses.

Given this context, I cannot provide the specific details for many of your requested points because they are not typically part of a 510(k) summary demonstrating substantial equivalence for an orthopedic implant of this nature.

Here's an attempt to answer based on the provided text, recognizing the limitations:

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

Based on the 510(k) summary, the acceptance criteria implicitly relate to demonstrating substantial equivalence to predicate devices. This means the new components must:

• Use the same materials (Titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a porous coating conforming to ASTM 1854-98).
• Have a similar design as the predicate and the existing Keystone® Hip System.
• Be intended for the same indications as the predicate (total hip arthroplasty for specific conditions like osteoarthritis, avascular necrosis, rheumatoid arthritis, etc., and revision arthroplasty).
• The mechanical properties of the attachment mechanism (Morse type taper junction with an axially loading screw) are implied to be robust and already cleared with the K000521 submission.

The "reported device performance" in this context is the FDA's determination that these new components do meet these implicit criteria for substantial equivalence. No numerical performance metrics are stated.

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

Not applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of data.

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 for a 510(k) substantial equivalence submission for this type of device. There was no "test set" requiring expert ground truth in the context of efficacy for the new components.

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

Not applicable. See point 3.

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 device is a hip implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

Not applicable. See point 5.

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

For a 510(k) substantial equivalence determination for an implant, the "ground truth" is typically established by:

• Regulatory Precedent: The FDA has previously cleared similar devices (predicates) based on their safety and effectiveness.
• Material Standards: Adherence to recognized national and international standards (e.g., ASTM F136, ASTM 1854-98) for materials.
• Bench Testing: Mechanical testing (which is not detailed in this summary but is typically part of a 510(k) submission for implants) to demonstrate that the new components meet performance specifications similar to the predicate.
• Clinical Experience: The established clinical history and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This device is a hip implant, not an AI or machine learning system that requires a "training set."

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

Not applicable. See point 8.

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