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The Miro3D Wound Matrix is intended for the management of wounds including:

• Partial and full thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Tunneled, undermined wounds
• Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• Draining wounds
• Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.

This document describes the regulatory submission for the Miro3D Wound Matrix, a medical device. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device.

The provided text does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.

Instead, this document is a 510(k) summary for a biomedical device (wound matrix) that is based on animal-derived tissue. The key points from the provided text are:

• Device: Miro3D Wound Matrix (a sterile, single-use, non-crosslinked acellular wound dressing derived from porcine liver tissue).
• Purpose of Submission (K223257): To add MR Safe information and symbols to the labeling of the existing Miro3D Wound Matrix.
• Predicate Device: Miro3D Wound Matrix (K221520), which is explicitly stated to be the identical product to the subject device, with the only difference being the labeling for MR Safe information.
• Performance Data: The performance data provided are specifically related to MR (Magnetic Resonance) testing to support the "MR Safe" claim. This includes adherence to ASTM standards for MR image artifacts, magnetically induced displacement force, magnetically induced torque, radio frequency induced heating, and marking for safety in the MR environment.
• No AI/ML Component: There is no mention of any AI or machine learning component in the device or its intended use. The performance data and acceptance criteria relate solely to the physical and material properties of the wound matrix, particularly its compatibility with MRI.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the input document is not about an AI/ML device.

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The Miro3D Wound Matrix is intended for the management of wounds including:

• Partial and full thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Tunneled, undermined wounds
• Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
• Draining wounds
• Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.

The provided FDA 510(k) summary for the Miro3D Wound Matrix does not describe a study that uses AI/ML or involves human readers interpreting diagnostic images. Instead, it describes a medical device, a wound matrix, and its non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them as related to AI/ML or human interpretation of images. The document exclusively details the bench testing and animal study for a physical wound care device, not a diagnostic or AI-driven system.

However, I can extract the acceptance criteria and study findings related to the Miro3D Wound Matrix's physical and biological performance, as described in the provided text.

Acceptance Criteria and Study for Miro3D Wound Matrix (Non-AI/ML Device)

Based on the provided 510(k) summary for the Miro3D Wound Matrix, the acceptance criteria and supporting studies are focused on demonstrating the device's physical properties, biocompatibility, and performance in wound healing, compared to a predicate device. This is not an AI/ML diagnostic or image interpretation study.

1. Table of Acceptance Criteria and Reported Device Performance

• Collagen denaturation temperature
• Mechanical properties
• Dimensions
• Rehydration properties
• Residual detergent
• Residual DNA
• Bacterial endotoxin
• Viral inactivation | The listed bench tests were conducted. The implication is that the results demonstrated the device's conformance to its specifications and comparability to the predicate. |
  | Wound Healing Performance (Animal Study) | Comparable performance to predicate device (MiroDerm) in a porcine full-thickness wound healing model. | "The study results indicated that Miro3D performed comparably to MiroDerm in all aspects evaluated." |
  | Shelf Life | Ability to support 18 months shelf life (initial), with real-time aging supporting 3 years. | "18 months (as of this submission date; real-time aging will continue to support 3 year shelf life)" |

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set (Animal Study): A "GLP compliant animal study to evaluate Miro3D compared to MiroDerm on healing of porcine full thickness wounds" was conducted. The specific sample size (number of animals or wounds) is not explicitly stated in the provided text.
• Data Provenance: The animal study was "GLP compliant," implying a controlled laboratory setting. The country of origin is not specified but given the FDA submission, it would typically be conducted in a country adhering to GLP standards (e.g., U.S. or equivalent). The study was prospective in nature, as it intentionally compared the subject device to the predicate in a living model.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable and not provided. The "ground truth" for this device's performance was established through objective laboratory testing (bench tests) and direct biological observation/measurement in an animal model, not through expert radiological or diagnostic image interpretation.

4. Adjudication Method for the Test Set

• Not applicable as there were no human readers interpreting data that required adjudication. The animal study would have involved histological, photographic, and perhaps gross morphological assessments, likely by qualified veterinary pathologists or researchers, but no "adjudication method" in the sense of reconciling human reader disagreements on diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human interpretation of diagnostic images. The Miro3D Wound Matrix is a physical medical device, not a diagnostic AI system.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. There is no algorithm or AI model being evaluated for standalone performance.

7. The Type of Ground Truth Used

• For Bench Testing: The ground truth was based on objective measurement against predefined specifications (e.g., specific values for residual DNA, collagen analysis, dimensions, endotoxin levels) and adherence to industry standards (e.g., ISO, ASTM).
• For Animal Study (Proxy for in vivo performance): The ground truth was established through direct observation and measurement of wound healing parameters in the porcine model, comparing the subject device (Miro3D) against the predicate (MiroDerm). This would involve histological analysis, macroscopic assessment of wound closure, and potentially other biomarkers, confirmed by veterinary professionals.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical wound matrix, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no AI/ML algorithm, there is no training set or associated ground truth establishment process in this context.

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