(29 days)
The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).
The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using well-established standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Meshare incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
This FDA 510(k) summary does not describe a study involving a medical device with acceptance criteria and performance results in the way one would typically expect for a diagnostic or AI-driven device. Instead, it concerns a surgical mesh (T-Line Hernia Mesh) and its substantial equivalence to previously cleared versions of the same product.
The primary goal of this submission (K232924) was to add a smaller size of the T-Line Hernia Mesh to its product line, based on customer feedback. Therefore, the "study" described is a performance evaluation to demonstrate that this new size meets the same safety and effectiveness standards as the existing, cleared mesh products.
Here's the breakdown based on your request, with an emphasis on how it applies to this specific submission:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on prior clearances) | Reported Device Performance (for the new, smaller size) |
|---|---|---|
| Safety | No new risks associated with the modified (smaller) T-Line Hernia Mesh. Biocompatibility, sterility, mechanical properties (e.g., tensile strength, tear strength, burst strength), and material characteristics (e.g., pore size, density) comparable to predicate. | A risk analysis was conducted, confirming no new risks. The modified T-Line Hernia Mesh continues to meet pre-determined functional and performance requirements and external standard requirements. |
| Effectiveness/Function | Maintenance of intended function for reinforcement of soft tissue for ventral hernia repair. Performance comparable to predicate devices in surgical use. | The modified T-Line Hernia Mesh continues to meet pre-determined functional and performance requirements and external standard requirements. |
| Technological Characteristics | Material (polypropylene monofilament yarn), manufacturing process (knitting and heat pressing), design (continuous, uninterrupted, seamless extensions with swaged needles) remain consistent with predicate, differing only in physical dimensions. | The device's technological characteristics are identical to the predicate in terms of intended use, indications for use, function, technology, safety, performance, and procedural steps, with the only change being the addition of a smaller size. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a distinct "test set" in the context of clinical data for the new, smaller mesh size. The performance evaluation likely involved bench testing of the new mesh size. The "sample size" for such tests would refer to the number of physical mesh samples subjected to various mechanical and material property tests. This information is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical trial data. The device is manufactured by Deep Blue Medical Advances, Inc. in Durham, NC, USA. The performance data would originate from their internal testing.
- Retrospective or Prospective: Not applicable for a device modification of this nature, which primarily relies on bench testing and comparison to previously cleared devices.
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. This is not a diagnostic device where expert ground truth on medical images or patient conditions is required. The assessment is based on engineering and material science principles, and comparison to existing, cleared products.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert interpretations. The evaluation focuses on physical and material properties and risk analysis.
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
- No. This is not an AI-driven or diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is implied by the established performance specifications and material properties of the previously cleared predicate T-Line Hernia Mesh devices (K230227, K221556, K193144), as well as relevant external standards for surgical mesh. The new, smaller mesh size must demonstrate that it meets these same pre-determined physical, chemical, and mechanical requirements.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device submission.
In summary: K232924 is a submission for a minor modification (addition of a smaller size) to an already cleared surgical mesh. The "study" involves performance testing and risk analysis to confirm that the new size maintains the same safety and effectiveness profile as the predicate devices, rather than a clinical study establishing new efficacy or diagnostic performance. The acceptance criteria are essentially that the modified device's performance, material characteristics, and risk profile are equivalent to its previously cleared versions and comply with relevant standards.
§ 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.