(112 days)
The 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 Trabecular Metal Reconstruction System may also be used with bone graft
The Trabecular Metal Reconstructive System is manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Trabecular Metal porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter.
The components of this line extension are wedge-shaped components, similar to the cleared wedge-shapes (K032344). The smallest size wedge is 19mm height with a 5° angle and the largest size wedge is 28mm height with a 30° angle. The angles run in increments of 5 degrees and there are 6 heights for each range of angles. One 'arm' is longer than the other, with the shorter 'arm' contoured along its length and slightly wider than the longer 'arm'. The base of the wedge is contoured. The relief allows biological fixation to occur along both the outer and inner segments of the device.
The provided text is a 510(k) summary for the Hedrocel Trabecular Metal Reconstructive System. It does not describe a study to prove a device meets acceptance criteria. Instead, it states that the device was not tested directly for performance.
Here's a breakdown based on your request, highlighting the lack of a new study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Reasoning: The document explicitly states: "The subject devices of the Trabecular Metal Reconstructive System were not tested." Therefore, there are no specific acceptance criteria or direct performance data for this particular device in this submission.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable. No new test set was used for this device.
- Data Provenance: Not applicable. No new data was generated for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: Not applicable. No new test set or ground truth was established for this device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
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:
- MRMC Study Done? No. This device is a surgical mesh, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its evaluation.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study Done? No. This device is a surgical mesh; it does not involve an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. No new ground truth was established for this device.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a surgical mesh; it does not involve a training set.
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth Established: Not applicable.
Summary of the Document's Approach to Performance:
Instead of conducting new studies, the submission relies on the concept of substantial equivalence to predicate devices. It states:
"The subject devices of the Trabecular Metal Reconstructive System were not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K02388, Master File MAF #920, and other mechanical testing reported in K962468. These results indicate that the subject device will perform as indicated for use in support of weakened and/or deficient bony structures."
This means that the manufacturer asserts that because their new device is technologically similar to previously cleared devices (predicates) that did undergo testing and meet performance standards, the new device will also perform as intended. They are not presenting a new study for this specific device.
§ 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.