Search Results

The CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed

The design features of the CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
• Porous coated with CoCrMo (ASTM F75) sintered beads with or without HA coating
• Available sizes: 36mm-56mm ID
• The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
• A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head
• Flange with screw holes on the rim of the shell to enhance fixation
• Cancellous flange screws available in 35-80 mm lengths

The provided text is a 510(k) summary for the CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a Class III PMA (Premarket Approval) submission would.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what information is missing:

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

Information Not Present: This document does not specify quantitative acceptance criteria or detailed performance metrics from a specific study. The basis for clearance is "substantial equivalence" to predicate devices, not performance against predefined clinical endpoints.

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

Information Not Present: There is no mention of a "test set" in the context of a performance study for this device. The submission relies on equivalence to predicate devices and analysis data (likely mechanical/material testing, not clinical human trials for performance).

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)

Information Not Present: No expert-established ground truth or clinical study data is described.

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

Information Not Present: No adjudication method is mentioned as there is no described test set or clinical study requiring such ground truth establishment.

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

Information Not Present: This device is an acetabular shell (a hip implant component), not an AI-driven diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

Information Not Present: As this is a medical implant, the concept of "standalone algorithm performance" does not apply.

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

Information Not Present: Ground truth, in the context of clinical performance, is not discussed. The "ground truth" for a 510(k) is typically the performance and safety of the predicate device, which is considered legally marketed and safe/effective.

8. The sample size for the training set

Information Not Present: No "training set" in the context of an algorithm or AI model is applicable or mentioned.

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

Information Not Present: Irrelevant, as no training set or AI model is involved.

Summary of Device Information and Substantial Equivalence (from the text):

The CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell is demonstrated to be substantially equivalent to predicate devices. This means that its safety and effectiveness are considered comparable to devices already legally on the market.

• Basis for Substantial Equivalence:
  • Identical Indications for Use to predicate devices.
  • Similar design features and materials to predicate devices.
  • Fundamental scientific technology has not changed relative to predicate devices.
  • Supported by material information and analysis data (likely mechanical, biocompatibility, etc., as per typical orthopedic implant testing, though specific tests/results are not detailed in this summary).

Key Takeaway: This document is a regulatory clearance through the 510(k) pathway, which fundamentally relies on demonstrating equivalence to existing devices. It does not typically involve the kind of detailed de novo clinical performance studies with acceptance criteria, ground truth, and reader studies that would be submitted for novel, high-risk devices or AI/imaging technologies.

Ask a specific question about this device