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Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners are components of the Exactech AcuMatch A-Series® or MCS® non-cemented acetabular cup system. 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 and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.

Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell.

The provided document is a 510(k) summary for the Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own meeting specific acceptance criteria and reporting on device performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The submission relies on performance testing according to an FDA guidance document and consensus standards, and a comparison to known predicate devices regarding materials, dimensions, and performance characteristics.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document refers to "Performance Testing" and "evaluation included a Risk Analysis and Comparison to Standards." This typically involves bench testing of a representative sample of devices, but the exact number of units tested is not provided.
• Data Provenance: Not specified, but generally, such performance testing is conducted in a laboratory setting by the manufacturer or a contracted testing facility. It is not clinical data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable as this is a device performance test, not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for material and mechanical properties would be established by validated testing methods and adherence to specified ASTM standards.

4. Adjudication Method for the Test Set:

• Not applicable. This is not a study involving expert adjudication. Performance testing against standards does not typically involve an adjudication method in the human-in-the-loop sense.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a mechanical medical device like an acetabular liner.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, in a sense, a "standalone" performance evaluation was done. The device itself was evaluated against established engineering standards and guidance documents. This is a standalone evaluation of the physical device's mechanical properties and material compliance, without human interpretation in a clinical context.

7. The Type of Ground Truth Used:

• Bench Test Results / Engineering Standards: The "ground truth" for this device's performance evaluation is adherence to the specifications outlined in ASTM F648 (for UHMWPE) and ASTM F136 (for Ti-6A1-4V), as well as compliance with the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." This involves objective measurements of material properties, mechanical strength, and other design characteristics.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this type of device.

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Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech AcuMatch A-Series® & MCS® Acetabular Shells and Liners are designed for use with appropriately sized Exactech femoral stems and heads.

The metal shells are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. They are porous coated with titanium beads, a blast finish, or with hydroxylapatite.

The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.

The provided document is a 510(k) Premarket Notification for medical devices, specifically for "Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical studies with detailed performance metrics and acceptance criteria as one would find for novel high-risk devices or software algorithms.

Therefore, the information requested in the prompt, which is typically found in studies for new or AI-based devices, is not present in this document. The document explicitly states:

• "Performance Testing: Testing for the Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners was performed for, and reviewed, in predicate device submissions. Design Control assessments did not indicate a need for additional testing for the line extensions which are the subject of this Special 510(k)."
• "The new sizes of Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are substantially equivalent to existing previously cleared devices in design, materials of construction, manufacturing, and other characteristics."

This indicates that no new performance studies were conducted for this specific 510(k) submission. Instead, the device's acceptable performance is inferred from its substantial equivalence to previously cleared predicate devices.

Given this, I cannot provide the requested table and study details as they are not available in the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a new test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used for this submission (as no new study was conducted).
8. Sample size for a training set (as this is not an AI/software device).
9. How ground truth for a training set was established.

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