(309 days)
InnovaBurn™ is indicated for the management of wounds including; partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds (donor sites/ grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), partial-thickness second degree burns, and draining wounds.
The device is intended for one-time use.
InnovaBurn™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaBurn" is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes greater than 5 x 5cm (25cm2) up to 20 x 20cm (400cm2). They are provided as single-use, sterile wound coverings.
The provided document is a 510(k) summary for the InnovaBurn™ device and does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or a formal statistical study with a specific sample size. Instead, it relies on substantial equivalence to a predicate device.
Here's a breakdown of the information available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for InnovaBurn™ that would typically be found in a clinical study report (e.g., sensitivity, specificity, accuracy).
Instead, it relies on the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Acceptable results for various tests. | All test results were acceptable. |
| Clinical Immunogenicity: Acceptable results for various tests. | All results were acceptable. |
| Viral Inactivation: Acceptable results. | Results were acceptable. |
| Compositional Testing: Acceptable results for various components. | All results were acceptable. |
| Heavy Metal Residual Testing: Acceptable results per FDA guidance. | All results were acceptable. |
| Other Tests (Implicit for a medical device): | Biological Risk Assessment, Toxicological Evaluation, Transportation Testing, Packaging Stability, Product Stability, Sterilization Validation Testing, Endotoxin, Physician Usability were conducted. (Specific "performance" results are not detailed for these beyond their completion). |
| Substantial Equivalence: To predicate device. | Achieved substantial equivalence based on indications for use, technological characteristics, and performance test results. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The document describes a bench testing and substantial equivalence comparison rather than a clinical study with a "test set" of patient data. Performance data from the predicate device (InnovaMatrix® K193552) was leveraged.
- Data Provenance: Not applicable in the context of a clinical test set. The data presented is from laboratory testing and analytical comparisons, primarily performed on the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This information is relevant for studies involving human interpretation or clinical data for ground truth establishment. This submission relies on analytical and bench testing performed in a laboratory setting.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with human adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on regulatory approval based on substantial equivalence, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. InnovaBurn™ is a physical medical device (collagen wound dressing), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is derived from analytical testing results against established biocompatibility, safety, and compositional standards, and the documented characteristics and performance of the predicate device. For instance, biocompatibility involves comparing test results to predetermined acceptable limits.
8. The Sample Size for the Training Set
Not applicable. InnovaBurn™ is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
N/A