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Premvia is indicated for the management of wounds including: partial thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, postlaser surgery, podiatric wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.

Premvia™ is a wound matrix supplied in a package containing sterile 3 lyophilized vials and 1 vial of sterile reconstitution solution. Premvia™ is a resorbable, viscoelastic hydrogel matrix that consists of modified glycosaminoglycan and collagen molecules that crosslink upon reconstitution and combination of the three sterile, lyophilized components: thiolmodified hyaluronan, thiol-modified gelatin, and polyethylene glycol diacrylate (Extralink). To create the hydrogel, each component is reconstituted with sterile saline solution (pH 6.8-7.2) and then mixed together.

The provided text describes the BioTime Premvia, a wound matrix device (K134037) and its substantial equivalence to a predicate device, INTEGRATM Flowable Wound Matrix (K072113). However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in terms of numerical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence based on:

• Identical Indications for Use
• Similar Class of materials (collagen and glycosaminoglycan)
• Similar Delivery method (syringe)
• Biocompatibility and similar physical properties (dispersion, absorbance, hydrating properties)
• Capability of providing a matrix for cells and vascular integration

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, ground truth establishment for test/training sets, adjudication methods, or MRMC studies, as this information is not present in the document.

The document states that "Product testing has been done to assess the following characteristics," and then lists types of tests like ISO 10993 Biocompatibility, EN 13726-1 for primary wound dressings (e.g., Free Swell Absorptive Capacity, Fluid Affinity of Amorphous Hydrogel Dressings, Dispersion/Solubility of Hydrogel Dressings), and Cytocompatibility with human skin cells. These are categories of tests, not specific acceptance criteria with numerical targets or results.

Summary of available information:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document lists types of tests performed (e.g., ISO 10993 Biocompatibility, EN 13726-1) but does not state specific acceptance criteria or performance metrics for these tests.
• 2. Sample sized used for the test set and the data provenance: Not provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set with ground truth is described.
• 4. Adjudication method for the test set: Not applicable.
• 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: Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable (no algorithm training described).
• 9. How the ground truth for the training set was established: Not applicable.

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