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510(k) Data Aggregation
(231 days)
OVINE TISSUE MATRIX(OTM)
Ovine Tissue Matrix is intended for use as a surgical mesh to repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The OTM family is comprised of ovine derived extracellular matrix devices combined with polypropylene. The device is individually packaged and supplied sterile in various sizes and thicknesses to address the complexity of the soft tissue repair. The device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device is supplied "ready to use" in a peel pouch, and does not require rehydration or soaking prior to implant.
The provided documentation (K141053) describes the TELA Bio Incorporated Ovine Tissue Matrix (OTM), a surgical mesh. This document is a 510(k) summary, which establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not explicitly present in the provided text, as they are typically found in detailed study reports.
However, based on the information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit, quantitative acceptance criteria for each performance metric, nor does it report specific numerical performance results against such criteria. Instead, it states that the device's performance is "acceptable" or "equivalent" to the predicate.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable per ISO 10993-1:2009 | "acceptable" |
| Cytotoxicity | Passed | Conducted |
| Sensitization | Passed | Conducted |
| Irritation | Passed | Conducted |
| Acute Systemic Toxicity | Passed | Conducted |
| Implantation | Passed | Conducted |
| Chronic Toxicity | Passed | Conducted |
| Pyrogenicity | Passed | Conducted |
| Viral Inactivation | Acceptable levels | "safety testing included a viral inactivation study" |
| Residual Chemical Assessment | Acceptable levels | "safety testing included ... residual chemical assessment" |
| Biomechanical Bench Testing | Equivalent to predicate and meets requirements for intended use | "equivalent to the predicate device and meet the requirements for their intended use." |
| Uniaxial Tensile Strength | Equivalent to predicate | Conducted |
| Ball Burst Strength | Equivalent to predicate | Conducted |
| Suture Retention | Equivalent to predicate | Conducted |
| In Vivo Performance (Safety & Effectiveness) | Safety and effectiveness demonstrated in a model | "demonstrated the safety and effectiveness" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Biomechanical bench, and in vivo performance testing have been conducted," but does not specify the sample sizes for these tests. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.
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)
This information is not provided in the document. The document refers to "in vivo study" and "biomechanical bench testing" but does not detail how "ground truth" or performance assessment was established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable. The device is a surgical mesh, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as it's a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility, the ground truth was established by adherence to ISO 10993-1:2009 standards and testing protocols.
For biomechanical testing, the ground truth was defined by comparison to the predicate device and meeting the "requirements for their intended use".
For the "in vivo study," the ground truth for "safety and effectiveness" would likely be based on histopathological evaluation, clinical observations, and potentially macroscopic assessment in the animal model, but this is not explicitly detailed.
8. The sample size for the training set
This is not applicable as the device is a physical product and not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason mentioned above.
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