(70 days)
INTEGRA™ Flowable Wound Matrix 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, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.
INTEGRA™ Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagen-glycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and capillary growth. INTEGRA™ Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.
The provided text is a 510(k) Summary for the INTEGRA™ Flowable Wound Matrix. It does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria beyond a general statement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with predefined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the given document.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states, "Results of physical testing, biocompatibility studies and clinician evaluation have demonstrated the collagen-glycosaminoglycan matrix in INTEGRA Flowable Wound Matrix to be safe and effective for the management of wounds." However, it does not specify what the acceptance criteria were for "safe and effective" or present quantitative performance data against those criteria.
2. Sample sized used for the test set and the data provenance:
- Cannot be provided. The document mentions "physical testing, biocompatibility studies and clinician evaluation" but does not detail the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. The document does not describe the establishment of a "ground truth" using experts for a test set. The evaluation seems to be related to general clinician feedback, not a formal expert-adjudicated performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No information on an adjudication method is present.
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:
- Cannot be provided. This device is a wound matrix, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a physical wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The document refers to "biocompatibility studies and clinician evaluation" for demonstrating safety and effectiveness, but it doesn't define a specific 'ground truth' as would be done in a diagnostic device study (e.g., using pathology as ground truth for a cancer detection device). In the context of a wound dressing, "safety and effectiveness" would likely be based on observations of wound healing, absence of adverse reactions, and clinician satisfaction, but no specific methodology for establishing ground truth is detailed.
8. The sample size for the training set:
- Cannot be provided. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable as there is no training set for an AI algorithm.
Summary based on the provided text:
The document focuses on demonstrating substantial equivalence to predicate devices (INTEGRAIM Matrix Wound Dressing K022127 and Medifi® Particles K910944) for the INTEGRA™ Flowable Wound Matrix. The testing mentioned ("physical testing, biocompatibility studies and clinician evaluation") is cited as the basis for concluding the device is "safe and effective," but not as a study designed to meet specific, quantitatively defined acceptance criteria for performance as typically seen for diagnostic devices or more complex medical technologies. The 510(k) process often relies on demonstrating that a new device is as safe and effective as an already legally marketed one, rather than requiring extensive de novo performance studies against pre-defined metrics.
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