(210 days)
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:
| Acceptance Criteria (Inferred from "Special Controls Guidance Document" and "Consensus Standards") | Reported Device Performance |
|---|---|
| Mechanical constraints for 28mm and 32mm femoral heads (specific values not provided in document) | Designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. |
| Material properties (UHMWPE, Ti-6A1-4V) meeting ASTM F648 and ASTM F136 respectively | Polyethylene raw material meets all aspects of ASTM F648. All rings are machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. |
| Performance characteristics similar to predicate devices | "substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics." |
| Effective design for intended use | "It has been determined to be an effective design and when used according to instructions for use, is a useful and valuable device." |
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.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”