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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, cement restriction and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel® Trabecular Metal Reconstruction system may be used with bone graft.

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The devices in this line extension are wedge shaped and contoured so as to fit a variety of anatomical bone structures. The devices are available in small, medium and large sizes, with the cross-sectional dimensions being 0.52in x 0.88in for the small size; 0.58in x 0.96in for the medium size, and 0.62in x 1.06in for the large size. Each size consists of varying heights ranging from 2mm - 8mm in 2mm increments. There is a consistent inclination angle of 10 degrees along the length in all size ranges. A secondary inclination angle along the width ranges from 20-35 degrees in 5-degree increments. The resultant geometry is a bi-plane wedge. The devices have a 6mm central hole for optional bone graft placement. A tapered slot is provided for implantation instrumentation.

The provided document is a 510(k) summary for the Hedrocel Trabecular Metal Reconstructive System. It states that the device was deemed "substantially equivalent" to predicate devices without performing new testing on the subject device itself. Therefore, the information requested regarding acceptance criteria and performance studies in the prompt is not available for this specific device.

Instead, the summary refers to performance data for predicate devices (K023882 and K962468) as evidence of the subject device's anticipated performance. This means there are no specific acceptance criteria or a dedicated study described for the Hedrocel Trabecular Metal Reconstructive System in this document.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "The subject device of the Hedrocel Trabecular Metal Reconstructive System was not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K023882 and other mechanical testing reported in K962468." Therefore, no acceptance criteria or performance data for this specific device are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available for the subject device. The document explicitly states the subject device was not tested.

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 for the subject device was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for the subject device was used.

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 surgical mesh, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No specific ground truth was established for the subject device's performance through new testing.

8. The sample size for the training set: Not applicable. The device is a surgical mesh, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable. The device is a surgical mesh, not a machine learning model.

In summary, the 510(k) clearance for the Hedrocel Trabecular Metal Reconstructive System was based on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than new performance testing of the subject device itself.

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