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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 Device Reconstruction 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. This line extension adds new components to the Hedrocel Trabecular Metal Reconstruction System.

The provided text describes a 510(k) submission for "The Hedrocel Trabecular Metal Reconstructive System" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance criteria against predefined acceptance thresholds for a diagnostic AI device.

Therefore, many of the requested items related to acceptance criteria, ground truth establishment, expert review, and AI performance studies (MRMC, standalone) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

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

• Not applicable in the context of this 510(k) summary. This document is for a reconstructive surgical system, not a diagnostic AI device. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of material properties and mechanical performance to existing predicate devices, not diagnostic accuracy metrics.
• Reported Device Performance: The summary states: "The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378, as referenced in the predicate K023882, K032282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and calculations found herein indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use."
  • This indicates the device's performance was evaluated based on mechanical strength to ensure it can support weakened/deficient bony structures as intended. Specific quantitative results (e.g., tensile strength, fatigue life) are referenced in MAF #920 and K962468 but are not detailed in this summary.

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/Not specified. This pertains to clinical or diagnostic study data. The testing mentioned in the document refers to mechanical testing of the material and device components. Sample sizes for these types of engineering tests are typically determined by standards and are not described here in terms of "test sets" or data provenance.

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. There is no "ground truth" in the diagnostic sense for this type of surgical implant. The closest equivalent would be the engineering expertise used to design the tests and interpret the mechanical data, but this is not detailed.

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

• Not applicable. No adjudication method is mentioned as there's no diagnostic test set or expert disagreement to resolve.

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 reconstructive system, not an AI diagnostic tool. Therefore, MRMC studies are irrelevant.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable. As mentioned, there is no diagnostic "ground truth." The performance is measured against established engineering standards and material properties deemed suitable for the indicated orthopedic uses.

8. The sample size for the training set

• Not applicable. No machine learning or AI model is involved, so there's no training set.

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

• Not applicable. No machine learning or AI model is involved.

Summary of Relevant Information from the Document:

• Device Type: Surgical Mesh / Reconstructive System (Hedrocel Trabecular Metal Reconstructive System)
• Purpose: Reinforcing weak and/or deficient bony tissues in orthopedic surgical procedures.
• Performance Evaluation Method: "Mechanical test data... and calculations... indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use." This was done "per FDA guidance documents and applicable standards" and referenced previous 510(k) submissions (K010378, K023882, K032282, K032344) and specific mechanical test data (MAF #920 and K962468).
• Conclusion: The device is "substantially equivalent" to predicate devices, based on technological characteristics and performance data.

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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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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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