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MicroMatrix® UBM Particulate 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.

The subject device is composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, specifically known as urinary bladder matrix (UBM). MicroMatrix devices are supplied as a dry, absorbent, white to off-white particulate with two particle size distributions, specifically <500um and <1000um. The particulate is packaged in an amber glass vial with butyl stopper and crimp sealed, which is then packaged in a peel-open outer pouch. The device is terminally sterilized using electron beam irradiation and is intended for one-time use. MicroMatrix can be applied to a wound either in the dry state or pre-hydrated with sterile saline and can be used in conjunction with other extracellular matrix derived sheets indicated for wound management.

The provided text is related to an FDA 510(k) premarket notification for a medical device called MicroMatrix® UBM Particulate. This notification is for a device (a medical product), not an AI algorithm.

Therefore, many of the requested categories related to acceptance criteria and studies for AI algorithms (such as sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on nonclinical testing (bench tests) and that no animal or clinical studies were required.

Here's a breakdown of what can be extracted from the document:

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

The document lists "Performance Bench Test Results" and states that for each test, the device "Meets Acceptance Criteria." It does not provide the specific numerical acceptance criteria themselves, only the conclusion that they were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the bench tests. The document only states "All testing was performed on production equivalent devices."
• Data Provenance: Not applicable/not specified. These are laboratory bench tests on physical devices, not clinical data.

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. Ground truth for AI algorithms is not relevant for physical device bench testing. The "ground truth" here is the established test methodology and the specifications the device is designed to meet, verified by laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI studies.

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. This device is not an AI algorithm. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of AI. For the bench tests, the "ground truth" relates to the predetermined specifications and standards that the device must meet, verified through objective measurements and observations in a laboratory setting. For example, particle size analysis would have a specified acceptable range, and the "ground truth" is whether the measured particle size falls within that range. Similarly, package integrity tests have defined parameters for success.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This is not an AI algorithm.

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MicroMatrix® Flex 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 (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use.

The MicroMatrix® Flex device is a dual-syringe system for the mixing and delivery of a paste for the management of wounds. The particulate component of the device is composed of porcine-derived extracellular matrix known as urinary bladder matrix. The particulate component is identical to that particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of <1000 um. The device is packaged in a nested tray system with peel-open lids. The device is terminally sterilized using electron beam irradiation.

The provided FDA 510(k) summary for the MicroMatrix® Flex device does not describe specific acceptance criteria in the typical sense of a diagnostic device (e.g., sensitivity, specificity, AUC). Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MicroMatrix® UBM Particulate) by showing that the new device has identical intended use, similar technological characteristics, and similar principles of operation, with minor differences not raising new safety or effectiveness issues.

The "acceptance criteria" here are therefore related to demonstrating that the new device performs equivalently to the predicate in various aspects.

Acceptance Criteria and Reported Device Performance

Study Information for Device Performance

This 510(k) submission does not describe a clinical study comparing device effectiveness in patients, as is common for many AI/diagnostic devices. Instead, it relies on bench (design verification) testing and biocompatibility studies to demonstrate equivalence to a previously cleared device. Therefore, many of the typical questions for AI/diagnostic device studies are not applicable.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of clinical cases. The "test set" here refers to samples of the device and its components used for biocompatibility and bench testing. Specific sample sizes for each bench test (e.g., number of devices tested for tip bending, number of samples for particle size analysis) are not disclosed in this summary.
   • Data Provenance: Not applicable for a clinical study. The data provenance would be from laboratory testing conducted by or for ACell, Inc.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. Ground truth, in the sense of expert consensus on patient cases, is not relevant for this type of submission focused on material and functional equivalence. The "ground truth" for bench tests would be established by validated measurement methods and equipment.

3. Adjudication Method for the Test Set: Not applicable. There is no expert adjudication process described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. This device is a wound care product, not an imaging or diagnostic AI device that would typically involve human readers.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance): Not applicable. This is not an algorithm-based device. Performance tests involve bench testing of the physical properties and functional aspects of the device itself.

6. Type of Ground Truth Used:

   • Biocompatibility: Established by reference to and compliance with ISO 10993-1 standards and associated test methods, which define acceptable thresholds for biological responses.
   • Bench Testing (Design Verification): Established by engineering specifications and validated measurement techniques (e.g., particle size analysis, temperature measurements, force measurements for tip bending).

7. Sample Size for the Training Set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the Ground Truth for the Training Set Was Established: Not applicable.

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MicroMatrix® 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 (donor sites/grafts, post-Mohs 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.

MicroMatrix® is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix ("UBM"). The devices are supplied as a dry, absorbent, white to off-white particulate with two particle distributions, specifically <500um and <1000µm. The particulate is packaged in an amber glass vial with butyl stopper and crimp sealed. The device vial is then packaged in a peel-open outer pouch that is terminally sterilized using electron beam irradiation. MicroMatrix® can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other sheet based extracellular matrix derived scaffolds indicated for wound management. MicroMatrix is composed of resorbable extracellular matrix particles comprised of UBM. Submitted in vitro and in vivo studies suggest that the product will be sloughed from the skin during the normal wound healing process or will be incorporated (remodeled) into the wound bed via enzymatic degradation, cellular infiltration, capillary growth, and/or integration by the surrounding host tissue. The device is intended for one time use.

The provided document is a 510(k) premarket notification for a medical device called MicroMatrix®. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert details for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes and ground truth methods.

This document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with detailed acceptance criteria and results. The "PERFORMANCE DATA" section states: "Packaging validation, LAL endotoxin, and shelf life studies were submitted in support of the modifications to MicroMatrix® described in this 510(k)." This indicates that performance data related to these specific aspects were provided, but the document does not elaborate on their acceptance criteria or detailed results in a format that would fulfill the request.

Therefore, I cannot provide the requested information from the given text.

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MicroMatrix® is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined 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.

MicroMatrix® is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied as a dry, absorbant, white to off-white particulate with two particle distributions, specifically <500um and <1000um. The particulate is packaged in an amber glass vial with butyl stopper and crimp sealed. The device is packaged in a peel-open pouch. The devices are terminally sterilized using electron beam irradiation. The device is intended for one time use. MicroMatrix® can be applied to a wound either in the dry state or pre-hydrated, and can be used in conjunction with other sheet based extracellular matrix derived scaffolds indicated for wound management.

This document is a 510(k) Pre-Market Notification from the FDA regarding the device MicroMatrix®. It outlines the device's indications for use and states its substantial equivalence to a predicate device.

Here's the breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a table format with specific performance metrics such as sensitivity, specificity, accuracy, or other quantifiable measures typically associated with device performance in diagnostic or screening contexts. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The "performance data" section primarily discusses biocompatibility testing and the support for labeling changes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for a "test set" in the context of clinical performance data for the MicroMatrix® itself. The "performance data" section mentions biocompatibility testing and a retrospective review of published literature.

• Test set sample size: Not specified as a distinct clinical test set for performance metrics. Biocompatibility testing involved various in-vitro and in-vivo tests, but the specific number of samples or subjects is not provided.
• Data provenance:
  • Biocompatibility testing: Conducted according to ISO-10993-1. The location of these tests or the source of any in-vivo subjects is not specified.
  • Literature review: Retrospective, for "published literature describing the clinical use of urinary bladder matrix devices in wound management." No country of origin is specified for this literature.

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)

This information is not provided. The document focuses on demonstrating substantial equivalence through biocompatibility testing and a literature review, not on a study involving expert-adjudicated ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a clinical test set requiring adjudication in the context of expert consensus or interpretation.

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. This document pertains to a medical device (wound dressing) and its regulatory clearance based on substantial equivalence, not an AI/CADe or CADx system that would typically involve human readers and MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "performance data" mentioned:

• Biocompatibility: Ground truth is established by standardized testing protocols (ISO-10993-1) against defined endpoints (e.g., absence of cytotoxicity, sensitization, etc.).
• Hydration uptake: Ground truth is established by physical measurements of hydration.
• Clinical use with other scaffolds: Ground truth is derived from the "published literature describing the clinical use of urinary bladder matrix devices in wound management," which would encompass various types of clinical evidence including outcomes data, expert observations, etc., as documented in scientific publications.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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