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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

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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Restrata® MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (e.g., donor site / grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Restrata MiniMatrix is a sterile, single use device intended for the local management of wounds. Restrata MiniMatrix is a form of Restrata Matrix that can be dispersed at the wound site during application. The device is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity similar to native extracellular matrix. Restrata MiniMatrix completely degrades via hydrolysis. The device does not contain any human or animal materials or tissues.

Restrata MiniMatrix is supplied in a nested pouch configuration, placed within a shelf-box. The product is terminally sterilized. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

The provided text describes data regarding the Restrata® MiniMatrix wound dressing, which is a medical device. However, it does not contain any information about an AI/ML-driven medical device, nor does it present acceptance criteria or a study proving performance for such a device.

The document is an FDA 510(k) clearance letter and its summary for a medical device (wound dressing). The studies mentioned (biocompatibility, sterilization, wound healing animal model) are typical for assessing the safety and efficacy of a medical device, especially when seeking substantial equivalence to a predicate device, but they are not related to AI/ML performance.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a non-AI medical device:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI device. The document discusses performance in terms of biocompatibility, sterilization, and wound healing in an animal model, not AI metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable in the AI context. The document mentions a "full thickness porcine wound model" but not a test set for an AI model.
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.
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: Not applicable in the AI context. The ground truth for this device's evaluation would be biological outcomes (e.g., wound healing progression in the animal model) and material properties.
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, the provided document details the FDA regulatory clearance for a wound dressing, not an AI/ML medical device. Therefore, the requested information pertaining to AI acceptance criteria and performance studies is not present.

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PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include:

• · Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• · Diabetic ulcers
• Chronic vascular ulcers
• · Tunneled/undermined wounds
• Surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, Podiatric wound, and wound dehiscence).
• · Trauma wounds (e.g., abrasions, lacerations, and skin tears)
• Partial thickness burns
• Draining wounds
  The device is intended for single patient use only.

PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of ≤ 1000μm. The device is sterile and packaged in a vial sealed in a single pouch.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a wound matrix device (PuraPly® Micronized Wound Matrix) and focuses on demonstrating substantial equivalence to predicate devices, not on specific performance acceptance criteria or a study designed to meet them.

The "Performance Data Non-Clinical Test" section mentions tests performed on the device (e.g., color, particle size, absorption capacity, endotoxin levels, pH) and biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, pyrogenicity, various systemic toxicities, genotoxicity, and a large animal wound healing study). However, it does not provide:

• A table of acceptance criteria with corresponding reported device performance values.
• Details on the study design, sample size, or data provenance for these tests.
• Information about experts, ground truth, adjudication methods, or MRMC studies.
• Specific details about the training set for any AI/ML model, as this device does not appear to be an AI-powered device.

Therefore, I cannot fulfill your request based on the provided input.

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Cytal® Wound 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 onetime use.

Cytal® Wound Particulate 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 sized

Here's a breakdown of the acceptance criteria and study information for the Cytal Wound Particulate, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete table of acceptance criteria with specific numerical targets. Instead, it describes "performance testing" to address a size change and demonstrate substantial equivalence to a predicate device. The general acceptance criterion implied is that the device "functioned as intended and the results observed were as expected" for each test.

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

The document does not specify the sample sizes used for the "Performance Data" tests (Particle Size Characterization, Dispensing, Sterilization Validation, Endotoxin).

Data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned. Given the nature of these tests (characterization, deployability, sterilization, endotoxin), they are typically conducted as part of the manufacturing and quality control process, likely at the manufacturer's facilities.

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

This information is not provided in the document. The tests described (e.g., particle size, endotoxin) are objective laboratory measurements, not typically requiring expert consensus for ground truth establishment in the same way clinical or diagnostic studies would.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective laboratory measurements rather than assessments that would require adjudication among experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes performance testing related to product characteristics and manufacturing, not a clinical study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device, Cytal Wound Particulate, is a medical device product (an animal-derived extracellular matrix scaffold for wound management), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the described "Performance Data" (Particle Size Characterization, Dispensing, Sterilization Validation, Endotoxin), the "ground truth" would be objective laboratory measurements against established specifications or industry standards for each test. For example, for endotoxin, the ground truth would be the quantitative endotoxin level measured against a defined acceptable limit.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/ML-based system requiring a training set.

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

This question is not applicable as the device is not an AI/ML-based system.

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