(49 days)
VersaCoat Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used to manage and protect surrounding tissues such as ligament and skeletal muscle. In these procedures, the device may encounter implanted structures such as anchors, grafts, staples, or sutures.
VersaCoat Tendon Protector is an absorbable implant (device) designed to function as a gelatinous interface between an injured tendon and surrounding tissues, providing a non-constricting, protective encasement for injured tendons. VersaCoat Tendon Protector consists of a Hydrogel Pellet and Wetting Solution. The Pellet is a hollow, cylindrical hydrogel of alginate and hyaluronic acid. The Pellet is easy to handle and is designed for quick hydration with the Wetting Solution. The Pellet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The Wetting Solution hydrates the Pellet, rendering a viscous, flowable, tissue-adherent gel. The Wetting Solution is aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Wetting Solution is sterile, non-pyrogenic, and is intended for single use only. A sterile container (dual syringe system) is offered and may be used to facilitate hydration of the Pellet with Wetting Solution.
The provided FDA 510(k) Clearance Letter for the VersaCoat Tendon Protector (K251655) does not describe a study involving an AI/Machine Learning device. Instead, it concerns a physical medical device (surgical mesh) and its performance, safety, and equivalence to a predicate device.
Therefore, I cannot provide information on acceptance criteria and study details related to an AI/Machine Learning device based on this document. The document details non-clinical laboratory tests for the physical properties and biocompatibility of the surgical mesh.
Specifically, the document implies that "studies" refer to bench testing and biocompatibility assessments of the physical device, not an AI model.
Summary of Information that CANNOT be Extracted for an AI/ML Device:
- A table of acceptance criteria and the reported device performance for an AI/ML model: The document outlines functional and safety testing for a surgical mesh, including visual inspection, dimensional/weight measurements, gel integrity, handling, tissue adherence, conformance, and biocompatibility. These are not performance metrics for an AI/ML algorithm.
- Sample sizes used for the test set and data provenance: Not applicable to a physical device.
- Number of experts used to establish ground truth & qualifications: Not applicable to a physical device.
- Adjudication method: Not applicable to a physical device.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The device is a surgical mesh, not an AI tool assisting human readers.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in the context of an AI model, refers to the definitive correct answer against which the AI's predictions are compared. For a physical device like surgical mesh, "ground truth" relates to measurable physical and biological properties.
- Sample size for the training set: Not applicable to a physical device.
- How ground truth for the training set was established: Not applicable to a physical device.
The document focuses on demonstrating substantial equivalence based on:
- Intended Use/Indications for Use: Managing and protecting tendon injuries.
- Materials of Construction: Alginate and hyaluronic acid hydrogel.
- Operating Principle: Providing a gliding surface and physical separation of damaged tissues.
- Fundamental Scientific Technology: Bioabsorbable hydrogel.
- Performance: Assessed through bench testing (visual inspection, dimensions, gel integrity, handling, tissue adherence/conformance) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, subchronic toxicity, muscle implantation toxicity).
In conclusion, this FDA clearance letter is for a physical medical device (surgical mesh) and does not contain the information requested about an AI/Machine Learning device's acceptance criteria or study methodologies.
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