Search Results

The Miro3D Fibers 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 Miro3D Fibers 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 into fibers. The device is packaged dry and terminally sterilized in its packaging by e-beam irradiation. The Miro3D Fibers Wound Matrix may be used dry or rehydrated and is provided in four sizes by weight.

The provided text is a 510(k) summary for the Miro3D Fibers Wound Matrix. It describes the device, its intended use, a comparison to a predicate device, and the performance data submitted to the FDA to demonstrate substantial equivalence.

However, there is no information within this document about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/software performance.

The document solely focuses on the physical and biological characteristics of a wound matrix, which is a physical medical device (a collagen matrix derived from porcine liver). It is not an AI or software-driven device.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to AI/software performance, ground truth, expert adjudication, and MRMC studies, none of which are relevant to a physical wound matrix device in this context.

To answer your request, I would need a document describing the regulatory submission for an AI/software medical device.

Ask a specific question about this device

The MiroDry 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 MiroDry 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 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 MiroDry Wound Matrix is provided in six sizes that may be cut to fit a wound size prior to application.

This document is a 510(k) Premarket Notification from the FDA regarding the "MiroDry Wound Matrix." It indicates that the device is substantially equivalent to a previously marketed predicate device ("Miro3D Wound Matrix").

The request asks for information about the acceptance criteria and the study proving the device meets these criteria. However, the provided text explicitly states:

"No performance testing was completed as prior testing of Miro3D was leveraged for MiroDry based on identical material and processing equivalence."

This means that Reprise Biomedical, Inc. did not conduct new performance studies or establish new acceptance criteria for the MiroDry Wound Matrix because they are claiming "substantial equivalence" to their predicate device, Miro3D Wound Matrix (K223257), due to "identical material and processing equivalence." The FDA's 510(k) clearance process often allows for this, especially for devices that are very similar to already cleared ones.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided document, as no new performance studies with their own acceptance criteria were performed for the MiroDry Wound Matrix. The substantial equivalence argument relies on the prior performance data and acceptance criteria met by the predicate device, Miro3D Wound Matrix.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable. No new performance testing was conducted for MiroDry. Its equivalence is based on the predicate.
2. Sample size used for the test set and the data provenance: Not applicable. No new test set data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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. The device is a wound matrix, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a wound matrix, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. The device is not based on a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence by comparing the technological characteristics of the MiroDry Wound Matrix to its predicate, Miro3D Wound Matrix. The critical points for substantial equivalence are highlighted in "Table 1: Subject vs. Predicate Wound Matrix Comparison":

• Identical Intended Use and Indications for Use: Both are for wound management, including various types of wounds.
• Identical Material: Both are perfusion-decellularized porcine liver.
• Identical Manufacturing Process: Perfusion decellularize, dry, cut to size.
• Identical Preparation: Rehydration with sterile saline or Lactated Ringer's solution.
• Identical Sterilization Method and SAL: Electron beam irradiation at 10^-6.
• Identical Packaging, MR Compatibility, Shelf Life (initial), and Storage Conditions.

The only stated difference is the "Wound Matrix Configuration and Sizes," where the MiroDry is a "collagen sheet scaffold...0.6cm thick" with six sizes, and the Miro3D is a "Three-dimensional collagen scaffold...2cm thick" with four sizes. The document argues that this change "does not change the Intended Use or fundamental scientific technology of the collagen matrix for wound management."

Ask a specific question about this device

The MiroTract 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 Biomedical MiroTract device consists of the MiroTract Wound Matrix and disposable delivery system. The MiroTract Wound Matrix is a sterile, single use, noncrosslinked acellular wound dressing that is derived from porcine liver tissue. The porcine liver is perfusion decellularized resulting in a collagen matrix that is dried, cut to size, and radially compressed onto the guidewire of the MiroTract delivery system. The delivery system includes a guidewire and tamp tube to manually push the MiroTract Wound Matrix off the guidewire into a wound. The MiroTract Wound Matrix porous scaffold provides a protective environment for wound healing. The MiroTract Wound Matrix is provided in two diameters (3 mm and 5 mm) and two lengths (5 cm and 9 cm). The MiroTract device is packaged dry in a plastic tray placed inside a foil pouch. The device is terminally sterilized in its packaging by e-beam irradiation. An optional Introducer Set accessory consisting of a tearaway sheath and dilator is provided in a separately packaged sterile pouch that is placed in a shelf box along with a MiroTract packaged device.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

The document describes a 510(k) submission for a medical device called "MiroTract Wound Matrix". A 510(k) submission is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets new acceptance criteria through a clinical study.

The "Performance Data" section (VIII) lists several types of testing performed:

1. Biocompatibility Testing: This ensures the device is safe for biological contact.
2. Bench Testing: This includes:
   • Package integrity
   • Package and product stability
   • Collagen denaturation (a material property)
   • Dimensional testing (ensuring it's within specified size tolerances)
   • MR testing (for MRI compatibility)
   • Deliverability assessment (how well the device can be delivered)

These tests are primarily focused on the safety, material properties, and physical performance characteristics of the device, and ensuring it performs as intended from an engineering and safety perspective. They are not designed to determine clinical efficacy or diagnostic accuracy, which would typically involve human subject studies with specific clinical acceptance criteria.

Therefore, I cannot provide the requested information for the following reasons:

• No acceptance criteria for clinical performance: The document does not specify clinical acceptance criteria (e.g., wound healing rates, infection reduction percentages, diagnostic sensitivity/specificity).
• No study proving clinical acceptance criteria met: The listed "performance data" is bench and biocompatibility testing, not a clinical study designed to measure effectiveness in human patients against predefined clinical endpoints.
• No information on sample size for a test set (clinical): Since no clinical test set for efficacy is described, there's no sample size, data provenance, or details on expert adjudication for ground truth.
• No MRMC study: A multi-reader multi-case study is not applicable as this is a wound matrix, not an imaging diagnostic device.
• No standalone algorithm performance: This is a physical wound matrix, not a software algorithm.
• No ground truth type for clinical efficacy: As above, no clinical efficacy study is detailed.
• No sample size for training set (clinical/AI): Given it's not an AI/diagnostic device, this is not applicable.
• No ground truth establishment for training set: As above, not applicable.

In summary, the provided text describes the technical and material safety testing of a wound matrix device to demonstrate substantial equivalence, not its clinical efficacy against specific performance criteria derived from a human study.

Ask a specific question about this device

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.

Ask a specific question about this device