Search Results

The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

Trabecular Metal Acetabular Augments provide an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Buttress and Column-Buttress Augments possess a truncated hemispherical geometry with integral flanges. The Shim Augments are space / void filler and bridge gaps between bone and other acetabular reconstructive hardware. These devices are available in several sizes and geometries to accommodate the wide range and location of bone deficiencies often encountered in revision acetabular surgery.

The provided text describes a 510(k) premarket notification for Zimmer Trabecular Metal Technology, Inc.'s Trabecular Metal Acetabular Augments. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information for acceptance criteria and a study proving their fulfillment cannot be extracted from this document, as such a study is not part of a 510(k) submission that relies on substantial equivalence. This type of submission aims to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily that it meets novel performance criteria.

However, I can provide a summary based on the information that is present concerning the device and its regulatory pathway:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. The underlying acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices. This implies that the device is as safe and effective as the predicate based on material properties, design, indications for use, and technological characteristics.
• Reported Device Performance: Not reported in terms of specific performance data (e.g., mechanical strength, wear rates, biological response). The performance is inferred to be similar to the predicate devices through the substantial equivalence argument.

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. The document does not describe a clinical or performance study with a test set. The submission relies on a comparison to predicate devices, not de novo testing against a patient or cadaveric test set.

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. No test set or ground truth establishment by experts is described in this 510(k) summary.

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

• Not applicable. No test set or adjudication process is described.

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 is a medical implant, not an AI-assisted diagnostic device.

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

• Not applicable. This is a medical implant, not a software algorithm.

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

• Not applicable. No ground truth is established or used, as no specific performance study is detailed for this 510(k) submission.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not a study involving machine learning or statistical model training.

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

• Not applicable. No training set or ground truth establishment is mentioned.

Summary of 510(k) Process as it Relates to "Acceptance Criteria"

In the context of this 510(k) notification, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The listed predicate devices are:

• K042871 Trabecular Metal Acetabular Augments (12/31/04, Zimmer TMT)
• K012507 The Trabecular Metal Technology Acetabular Augment System (8/30/01, Implex Corp.)
• K001471 The Implex Hedrocel Acetabular Augment System (8/7/00, Implex Corp.)

The basis for this "acceptance" by the FDA is the determination that the new device has the same intended use and the same technological characteristics as the predicate devices, or, if there are differences in technological characteristics, that those differences do not raise different questions of safety and effectiveness. This is a comparative assessment rather than a direct measurement against predefined performance thresholds for a standalone claim.

Ask a specific question about this device

The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The Trabecular Metal Acetabular Augments provides an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Acetabular Augments possesses a truncated hemispherical geometry. The device is available in OD sizes 50 to 74 mm in 4 mm increments, and each size is offered in thicknesses from 5mm to 30mm in 5mm increments, aside from the 74mm implant which is available only in thicknesses of 10mm, 20mm and 30mm.

The provided text is a 510(k) summary for the Trabecular Metal Acetabular Augment System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

This document is a regulatory filing asserting substantial equivalence, which typically relies on comparisons to existing devices and performance data that may have been generated for those predicate devices, or through design verification and validation activities (e.g., mechanical testing, biocompatibility testing) that are not detailed in this summary.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, and expert review based on the provided input. The document focuses on the regulatory submission process and the determination of substantial equivalence, not the detailed technical performance data or clinical study results.

Ask a specific question about this device