(301 days)
The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.
The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.
This 510(k) summary is for a medical device (SURGIMESH®XB surgical mesh) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.
Here's an attempt to address the points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:
Acceptance Criteria and Study for SURGIMESH®XB
The submission for SURGIMESH®XB is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) in the same way an AI diagnostic algorithm would, nor does it present a clinical trial with a test set, ground truth experts, or MRMC studies.
Therefore, the "acceptance criteria" for a device like SURGIMESH®XB are implicitly tied to demonstrating that its mechanical, material, and biocompatibility characteristics are "substantially equivalent" to predicate devices, which are themselves deemed safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and non-sensitizing | "The biocompatibility results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues when used as intended." |
| Mechanical/Material Characteristics: Substantially equivalent to predicate devices | "The SURGIMESH®XB mesh's mechanical and material characteristics are substantially equivalent to its predicate devices." |
| Intended Use: Reinforcement of tissues during surgical repair for hernias and soft tissue deficiencies; temporary bridging of fascial defects; silicone layer minimizes tissue attachment to viscera. | "The SURGIMESH®XB has the same intended uses and similar indications... as its predicate device." |
| Technological Characteristics: Non-absorbable synthetic mesh, non-knitted, non-woven polypropylene fibers, one surface coated with silicone, supplied sterile, available in anatomic forms. | "The SURGIMESH®XB has... similar technological characteristics, and principles of operation as its predicate device." |
| Safety and Effectiveness: As safe and effective as predicate devices. | "Performance data demonstrate that the SURGIMESH®XB is as safe and effective as [listing 6 predicate devices]." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not Applicable. This submission does not describe a clinical "test set" in the context of diagnostic performance. The evaluation is based on material testing and comparison to predicates.
- Data Provenance: Not Applicable. No patient data or clinical study dataset is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not Applicable. No ground truth establishment by experts is described for this type of device submission.
- Qualifications of Experts: Not Applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not Applicable. No test set requiring expert adjudication is described.
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: No. This is a surgical mesh, not an AI diagnostic device for human readers.
- Effect Size: Not Applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Applicable. The "ground truth" concept for a surgical mesh revolves around proven safety and effectiveness of similar devices and the demonstration of equivalent physical, mechanical, and biological properties. It's not based on case-level diagnoses or outcomes in a study, but rather on material science and biocompatibility testing.
8. The Sample Size for the Training Set
- Sample Size: Not Applicable. This is a surgical mesh, not an AI device that uses a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not Applicable.
§ 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.