(28 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.
Hedrocel Trabecular Metal Reconstruction The 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 components with a variety of cross-sections and heights to the Hedrocel Trabecular Metal Reconstruction System.
Here's an analysis of the provided text regarding the Hedrocel Trabecular Metal Reconstructive System:
Summary of Acceptance Criteria and Study Details:
Based on the provided 510(k) summary, the device is a surgical mesh (The Hedrocel Trabecular Metal Reconstructive System) made of Hedrocel porous tantalum. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific performance acceptance criteria for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Same as predicate device (Tantalum/Hedrocel porous Tantalum) | Manufactured wholly of Hedrocel porous tantalum. |
| Indications for Use: Same as predicate device (Reinforcing weak/deficient bony tissues in orthopaedic procedures) | Indicated for: pelvic, acetabular, femoral, humeral reconstruction, cement restriction, and use with bone graft. |
| Technological Characteristics: Similar to predicate device | Addition of components with a variety of cross-sections and heights to the existing system. |
| Performance (Mechanical Strength): Sufficient strength for indicated use. | Tested per FDA guidance for K010378 and 023882. Mechanical test data in MAF #920 indicates "sufficient strength." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or algorithm validation. The "testing" refers to mechanical performance tests of the material itself. The document mentions "mechanical test data found in MAF #920," implying laboratory-based material characterization, not patient data.
- Data Provenance: Not applicable in the context of clinical data. The mechanical test data would be lab-generated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This submission focuses on demonstrating substantial equivalence through material properties and mechanical testing, not through expert-verified clinical outcomes or diagnostic accuracy.
4. Adjudication Method for the Test Set:
- Not Applicable. There is no mention of adjudication, as this wasn't a clinical performance study requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not mentioned. The submission is for a medical device (surgical mesh) and its mechanical performance, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the material's performance is derived from laboratory mechanical testing that quantifies properties like strength, and comparison to existing standards and predicate device performance. It is not based on expert consensus, pathology, or outcomes data in a clinical trial setting.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The material properties are inherent to the manufacturing process and material composition.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.