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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 also be used with bone graft.

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The Hedrocel Trabecular Metal Reconstructive System has oval cross-sectional geometries of 11mm by 14mm and 21mm by 32mm and is available in height options ranging from 8mm to 62mm. The superior and inferior faces of the implant are canted (included angle of 7 degrees) to provide for initial stability and to facilitate implantation.

The provided text describes a 510(k) summary for "The Hedrocel Trabecular Metal Reconstructive System," a surgical mesh device. Based on the document, here's an analysis of the acceptance criteria and study information:

This document does not provide specific acceptance criteria in terms of numerical thresholds for device performance. Instead, it relies on substantial equivalence to predicate devices and general performance testing. Therefore, I cannot generate a table comparing acceptance criteria to reported device performance as that detailed information is not present.

However, I can extract information related to the device performance study as described:

Study Information for The Hedrocel Trabecular Metal Reconstructive System:

• 1. A table of acceptance criteria and the reported device performance:
  As stated above, no explicit numerical or quantitative acceptance criteria are provided in the document. The general acceptance is implied through the "substantially equivalent" determination to predicate devices and performance testing indicating the device "will perform as indicated."

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
  The document does not specify a distinct "test set" sample size or data provenance. It mentions "Performance Data: The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement." This suggests performance testing was conducted, but details on sample size, origin, or study design (retrospective/prospective) are absent.

• 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):
  This information is not applicable and not provided in the document. This device is a physical implant, not an AI or diagnostic device that requires expert ground truth for a test set.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
  This information is not applicable and not provided.

• 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:
  This is not an AI-assisted device. Therefore, no MRMC comparative effectiveness study involving AI or human readers was conducted or reported.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
  This is not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  For this physical medical device, "ground truth" would typically refer to the successful mechanical or biological performance of the implant in its intended use, usually assessed through in-vitro mechanical testing, pre-clinical animal studies, or clinical outcomes (though no clinical trials are explicitly mentioned for this 510(k) submission beyond "performance testing"). The document indicates that testing was done "per FDA guidance documents and applicable standards." However, the specific type of ground truth (e.g., specific pathology results, long-term outcomes) is not detailed.

• 8. The sample size for the training set:
  This is not an AI algorithm and thus does not have a "training set."

• 9. How the ground truth for the training set was established:
  This is not an AI algorithm and thus does not have a "training set."

Summary of Acceptance related to Substantial Equivalence:

The primary "acceptance" for this device is based on substantial equivalence to predicate devices. The document states:

• "A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices."
• "The Hedrocel Trabecular Metal Reconstructive System is substantially equivalent to the cited predicate devices identified in this premarket notification."

The study that "proves" the device meets acceptance criteria (i.e., is substantially equivalent and performs as indicated) is summarized as:

• "The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement. These results indicate that the subject device will perform as indicated for use in support of weakened bony structures."

This indicates that mechanical and/or material performance testing was conducted according to regulatory standards to support its intended use and similarity to previously cleared devices, forming the basis for its 510(k) clearance.

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