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MatriStem® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

MatriStem® Wound Matrix is a sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix sheet that maintains and supports a healing environment for wound management.

This document is a 510(k) summary for the MatriStem® Wound Matrix, which is a medical device for wound management. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not involve setting acceptance criteria or conducting a performance study in the way one would for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (for an AI/ML device) is not applicable to this 510(k) submission for the MatriStem® Wound Matrix.

Here's a breakdown of why and what information is available:

Rationale for Non-Applicability of AI/ML Study Criteria:

The MatriStem® Wound Matrix is described as a "sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix sheet." It is a biological/material-based medical device, not an AI/ML software device. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device based on characteristics like:

• Indications for Use: Are they the same or very similar?
• Technological Characteristics: Is the raw material, design, manufacturing process, packaging, sterilization, and shelf life similar?
• Performance Data: This typically involves biocompatibility testing, sterility testing, and sometimes bench testing or animal studies to show the device performs as intended, but not in the sense of predictive accuracy or diagnostic performance evaluated against ground truth established by experts, as is common for AI/ML.

Information Applicable to this 510(k) Summary:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: For a 510(k) of this nature, the primary "acceptance criteria" isn't a numerical performance metric like sensitivity/specificity, but rather that the device is substantially equivalent to the predicate device.

  • The document explicitly states: "No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act applicable to this device."

• Reported Device Performance: The document states:
  | Criteria for Substantial Equivalence | MatriStem® Wound Matrix Performance |
  |:-------------------------------------|:------------------------------------|
  | Indications for Use | Substantially equivalent to predicate device (MatriStem® Wound Sheet K092926) |
  | Raw Material | Substantially equivalent to predicate device |
  | Dimensions and Configuration | Substantially equivalent to predicate device |
  | Manufacturing Processes | Substantially equivalent to predicate device |
  | Packaging | Substantially equivalent to predicate device |
  | Sterilization | Substantially equivalent to predicate device |
  | Shelf Life | Substantially equivalent to predicate device |

  • The "performance" here refers to demonstrating that the new device shares fundamental characteristics and intended use with the predicate, rather than providing quantitative data on, for example, wound healing rates compared to a control.

The following points are NOT APPLICABLE to this 510(k) submission for a non-AI/ML device:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This device is not an AI/ML algorithm that uses a "test set" of data for performance evaluation in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No "ground truth" establishment by experts in this manner is described for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) 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.
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 (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (extracellular matrix for wound care) to a previously cleared predicate device. The framework for evaluating AI/ML algorithms, which involves acceptance criteria based on metrics like sensitivity/specificity, extensive testing with annotated datasets, and human-in-the-loop studies, simply does not apply to this type of device and submission.

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