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The Flowable Wound Matrix is intended 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, 2nd degree burns, skin tears) and draining wounds.

The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

I am sorry, but the provided text only contains a 510(k) summary for the "Flowable Wound Matrix" device. It outlines the device description, its intended use, comparison to predicate/reference devices, and a summary of non-clinical tests conducted for substantial equivalence.

However, the document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets them. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance. It only lists performed tests (biocompatibility, rehydration and deployment, package integrity, shelf life, collagen characterization).
2. Sample sizes used for a test set, data provenance, or details about ground truth establishment.
3. Information on the number of experts or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. Sample size for a training set or how ground truth for a training set was established.

This document is focused on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and comparison of features, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.

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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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