(86 days)
The Securian™ Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. Securian™ Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. Securian™ Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Securian™ Tissue Reinforcement Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. Securian™ Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. Securian™ Tissue Reinforcement Matrix is intended for one-time use.
Securian™ Tissue Reinforcement Matrix is a sterile product composed of microbial-derived cellulose. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery. The non-resorbable surgical mesh is used for trauma and reconstructive surgical procedures involving tendons or other soft tissues. Securian™ Tissue Reinforcement Matrix maintains the relative position and stability of soft tissues during the healing period.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Securian™ Tissue Reinforcement Matrix:
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter for a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a novel clinical study with new acceptance criteria for a first-of-its-kind device. Therefore, many of the requested categories for a new AI/software device study (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
The "study" in this context refers to the demonstration of substantial equivalence through a comparison to predicate devices and performance testing.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K081882 XYLOS Surgical Mesh, K023237 Ortho-Wrap® Bioresorbable Sheet, K072190 Ortho-Wrap® Bioresorbable Sheet, K021056 Permacol™ Biological Implant): The device must demonstrate identical or similar technological characteristics, principles of operation, and achieve comparable performance and safety as the legally marketed predicate devices. | "Securian™ Tissue Reinforcement Matrix is identical to previously cleared K081882 XYLOS Surgical Mesh. Therefore Securian™ Tissue Reinforcement Matrix has the same biocompatibility and performance characteristics to those cited in K081882." |
"The Securian™ Tissue Reinforcement Matrix is substantially equivalent to legally marketed predicate devices and has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as the predicate devices."
"Performance data demonstrate that Securian™ Tissue Reinforcement Matrix functions equivalently to the predicate devices. Thus, Securian™ Tissue Reinforcement Matrix is substantially equivalent to the predicate devices."
"Securian™ Tissue Reinforcement Matrix met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." |
| Biocompatibility: Must be biocompatible for its intended use. | "Securian™ Tissue Reinforcement Matrix has the same biocompatibility... to those cited in K081882 [XYLOS Surgical Mesh]." (Implied acceptance based on predicate) |
| Performance for Modified Indications for Use: The device must meet test requirements supporting its modified 'Indications for Use' statement without posing new questions of safety and effectiveness. | "Additional performance testing was performed to support the modified 'Indications for Use' statement."
"Securian™ Tissue Reinforcement Matrix met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence."
"The modified 'Indications for Use' in this submission do not pose new questions of safety and effectiveness." |
Study Details (Based on the provided 510(k) Summary)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate clinical test set of patients. The "performance data" refers to comparative testing against predicate devices. The study doesn't involve human clinical trials with a patient test set in the traditional sense for demonstrating primary safety and efficacy, but rather bench testing and comparison to existing data from predicate devices.
- Data Provenance: Not applicable in the context of a de novo clinical data collection from a test set. The data provenance would be from internal performance testing and data cited in the predicate device clearances.
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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. This submission relies on demonstrating similarity to already approved devices. There is no mention of "ground truth" established by experts for a novel test set in the provided document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no independent clinical test set requiring expert adjudication.
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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:
- Not applicable. This device is a physical surgical mesh, not an AI/software device used by human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/software context. For a physical device, "ground truth" would relate to established scientific and engineering principles, biocompatibility standards, and the performance characteristics (e.g., tensile strength, pore size, degradation rate) of the predicate devices. The "truth" is established by the successful prior clearance of the predicate devices.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not use machine learning or a training set.
§ 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.