(106 days)
Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.
Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.
The provided text describes a 510(k) premarket notification for the Sportmesh™ device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with defined endpoints and acceptance thresholds.
Therefore, the document does NOT contain information regarding:
- A table of acceptance criteria and reported device performance in the way typically found for novel device approvals.
- Sample sizes for a test set, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
- Standalone algorithm performance.
- Training set size or how ground truth for a training set was established.
Instead, the submission relies on:
Acceptance Criteria and Device Performance (as demonstrated for 510(k) pathway):
The "acceptance criteria" in this context are primarily demonstrating equivalence to already approved predicate devices concerning safety and effectiveness. The "performance" is shown through the successful completion of specific tests and comparisons.
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (as summarized in the 510(k)) |
|---|---|
| Similar Intended Use: The device should have the same intended use as a legally marketed predicate device. | Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, and for reinforcement of soft tissues repaired by suture or suture anchors (limited to the supraspinatus) during rotator cuff repair surgery. This use is stated to be equivalent to predicate devices such as Organogenesis, Inc's FortaFlex™ Surgical Mesh, DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant, Ethicon, Inc's ULTRAPRO™Mesh, and Davol's Marlex Mesh. |
| Similar Technological Characteristics: The device should have similar technological characteristics (e.g., material, design, operating principles) as a legally marketed predicate device, or differences in technological characteristics should not raise new questions of safety and effectiveness. | Sportmesh™ is a knitted fabric made from ARTELON fibers. The construction permits it to be cut without unraveling. It is supplied in sterile sheet form. The submission claims equivalence in technological characteristics to the same predicate devices as for intended use. The document doesn't provide a detailed comparison of all characteristics, but the FDA's clearance implies these were deemed sufficiently similar or that any differences did not raise new safety/effectiveness concerns. |
| Performance Testing: The device should demonstrate appropriate performance through testing, including biocompatibility and mechanical properties, consistent with its intended use and recognized standards, to support that any differences in technological characteristics do not raise new questions of safety and effectiveness. (This is where "testing" comes in for the 510(k)). | A collection of tests was conducted and successfully completed, including: |
- Biocompatibility safety studies: Conducted according to ISO 10993 standards.
- Mechanical testing: Conducted in accordance with the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance."
The results "demonstrate that Sportmesh™ provides appropriate mechanical properties for its use in soft tissue repair."
Based on these comparisons and performance tests, the conclusion is that Sportmesh™ is substantially equivalent and "presents no new concerns about safety and effectiveness." |
Study Details (as per the provided document):
-
Sample size used for the test set and data provenance:
- Not applicable/Not provided. The document describes premarket notification for a Class II medical device (Sportmesh™) via the 510(k) pathway. This pathway establishes substantial equivalence to predicate devices, and typically does not require a formal "test set" with a specified sample size in the context of clinical performance evaluation in the same way a PMA (Premarket Approval) submission would. Instead, testing focused on biocompatibility and mechanical properties. The data provenance is implied to be from Artimplant AB's internal testing as part of their submission process.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth in the sense of expert consensus on clinical outcomes for a "test set" is not detailed in this 510(k) summary. The "ground truth" for the performance tests would be the established ISO 10993 standards for biocompatibility and specific mechanical test parameters outlined in the FDA's guidance for surgical mesh, which are objectively measurable, rather than expert-derived clinical ground truth.
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Adjudication method for the test set:
- Not applicable/Not provided. No clinical adjudication method is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical mesh, not a software algorithm.
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The type of ground truth used:
- The "ground truth" for the performance evaluation primarily consisted of established regulatory standards and guidance documents. For biocompatibility, this was ISO 10993 standards. For mechanical properties, it was FDA guidance for surgical mesh. These are objective, measurable criteria, not expert consensus or pathology on a clinical dataset.
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The sample size for the training set:
- Not applicable/Not provided. The concept of a "training set" is not relevant for this type of device and submission, which involves physical material testing and comparison to predicates, not machine learning.
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How the ground truth for the training set was established:
- Not applicable/Not provided. See point 7.
§ 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.