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ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds. including venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled undermined wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), first and second-degree burns, draining wounds.

ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.

This document is a 510(k) premarket notification for the ABCcolla® Collagen ADM Scaffold, a medical device for wound management. The core of the submission is to demonstrate the substantial equivalence of the new device to a legally marketed predicate device, ABCcolla® Collagen Matrix (K162348), and a reference device, Cook® ECM Powder (K152033).

Based on the provided text, the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" are not related to an AI/ML-driven device's performance in terms of diagnostic accuracy or a clinical study in humans with a traditional statistical endpoint and acceptance criteria. Instead, the "acceptance criteria" for this specific device (a collagen scaffold for wound management) are primarily focused on benchmarking against a predicate device to demonstrate "substantial equivalence" as required by the FDA 510(k) pathway. The "study" here refers to the pre-clinical testing and characterization that demonstrates the new device has similar technological characteristics and performance to the predicate device, and any differences do not raise new questions of safety or effectiveness.

Here's an interpretation of the requested information based on the provided document:

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

For a 510(k) submission, "acceptance criteria" are not typically framed as specific performance metrics and thresholds like sensitivity/specificity for an AI device. Instead, the acceptance is based on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing various characteristics.

Here's a table based on the "Substantial Equivalence Comparison Table" in the document, interpreting "acceptance criteria" as demonstrating "sameness" or "differences that do not raise new questions of safety/effectiveness" compared to the predicate/reference devices:

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Myriad™ Particles is indicated for use in the management of the following wounds:

• · partial and full-thickness wounds
• · pressure ulcers
• venous ulcers .
• diabetic ulcers .
• chronic vascular ulcers .
• . tunneled/undermined wounds
• Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, . wound dehiscence)
• . trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
• · draining wounds

Myriad™ Particles is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.

The provided document is a 510(k) premarket notification for a medical device called "Myriad™ Particles." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies. The key points from the document that illustrate this are:

• No Clinical Performance Data Used for Substantial Equivalence: Section 5.6 explicitly states: "Substantial equivalence was not based on an assessment of clinical performance data." This means a human clinical study to prove performance was not conducted for this 510(k) submission.
• Focus on Substantial Equivalence through Technological Characteristics and Non-Clinical Data: The document relies on comparing the technological characteristics of Myriad™ Particles to its predicate device (Endoform™ Dermal Template) and presenting non-clinical (bench and biocompatibility) testing. The primary difference highlighted is the device presentation (powder vs. sheet format).
• No mention of AI/ML components: The device is a wound dressing, and there is no indication that it incorporates any artificial intelligence or machine learning components. Therefore, an MRMC comparative effectiveness study or standalone algorithm performance assessment would not be applicable.

In summary, the provided text does not describe a study designed to prove the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would. It focuses on demonstrating substantial equivalence to an existing device through non-clinical means.

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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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The Flowable Wound Matrix 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, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, 2nd degree burns, skin tears) and draining wounds.

The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

I am sorry, but the provided text only contains a 510(k) summary for the "Flowable Wound Matrix" device. It outlines the device description, its intended use, comparison to predicate/reference devices, and a summary of non-clinical tests conducted for substantial equivalence.

However, the document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets them. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance. It only lists performed tests (biocompatibility, rehydration and deployment, package integrity, shelf life, collagen characterization).
2. Sample sizes used for a test set, data provenance, or details about ground truth establishment.
3. Information on the number of experts or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. Sample size for a training set or how ground truth for a training set was established.

This document is focused on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and comparison of features, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.

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