(27 days)
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.