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PriMatrix is intended for the management of wounds that include:

• Partial and full thickness wounds
• Pressure, diabetic, and venous ulcers
• Second-degree burns
• Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds abrasions, lacerations and skin tears
• Tunneled/undermined wounds
• Draining wounds

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surqeon to meet the individual patient's needs.

This document is a 510(k) premarket notification clearance letter for the PriMatrix Dermal Repair Scaffold. It is important to note that this document does not contain a study that proves the device meets specific acceptance criteria in the manner you've described.

The letter explicitly states: "No additional verification and validation test data were required as part of this submission. This 'traditional' 510(k) was submitted to clarify and correct the labeling, without changing the Intended Use of PriMatrix."

This 510(k) submission is for a device that is substantially equivalent to a previously cleared predicate device (PriMatrix Dermal Repair Scaffold, K131286). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate, or, if there are differences, those differences do not raise different questions of safety and effectiveness.

Therefore, your request for acceptance criteria and study details cannot be fulfilled from this document. This document confirms a regulatory clearance based on substantial equivalence, not a new study demonstrating performance against a specific set of acceptance criteria.

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PriMatrix is intended for the management of wounds that include:

• Partial and full thickness wounds
• Pressure, diabetic, and venous ulcers
• Second-degree burns
• Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds-abrasions, lacerations, and skin tears
• Tunneled/undermined wounds
• Draining wounds

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) premarket notification for a medical device called "PriMatrix Dermal Repair Scaffold." This document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets these criteria, or any details related to AI/algorithm performance. Therefore, I cannot extract the requested information regarding AI device evaluation.

The relevant sections of the input text for medical device regulation are highlighted below, but they do not pertain to the performance evaluation of an AI-powered device.

Device Information:

• Proprietary name: PriMatrix Dermal Repair Scaffold
• Common name: Animal-derived, dermal extracellular matrix wound care product
• Classification: Unclassified
• Intended Use: Management of various types of wounds (partial and full thickness, pressure, diabetic, and venous ulcers, second-degree burns, surgical wounds, trauma wounds, tunneled/undermined wounds, draining wounds).

Substantial Equivalence:

The device claims substantial equivalence to:

• PriMatrix (TEI Biosciences, K083440)
• DressSkin (TEI Biosciences, K023778)

Summary of Technological Characteristics and Biocompatibility:

• PriMatrix is an acellular dermal tissue matrix.
• It is described as substantially equivalent to other wound care products in design and application.
• Biocompatibility was assessed through tests including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
• Manufacturing methods were tested for viral inactivation.

The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on the performance evaluation of a new AI algorithm.

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PriMatrix is intended for the management of wounds that include:

• . Partial and full thickness wounds
• . Pressure, diabetic, and venous ulcers
• . Second-degree burns
• . Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• . Trauma wounds-abrasions, lacerations, and skin tears
• . Tunneled/undermined wounds
• Draining wounds .

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) Premarket Notification for the PriMatrix Dermal Repair Scaffold. This type of regulatory submission in the US is for devices that are demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific performance criteria against a disease state or condition.

Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance metrics, study designs (test sets, training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance), or statistical results like effect sizes.

Instead, the submission focuses on:

• Device Description: What the device is (acellular dermal tissue matrix).
• Intended Use: The types of wounds it's meant to manage.
• Substantial Equivalence: Claiming similarity in function and intended use to existing devices (PriMatrix K061407 and Oasis K061711).
• Biocompatibility Assessment: Mentioning tests performed (cytotoxicity, sensitization, etc.) to demonstrate safety.
• Manufacturing Methods: Stating that viral inactivation levels were assured.

Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the information provided in this 510(k) summary.

Ask a specific question about this device

PriMatrix is intended for the management of wounds that include:

• Partial and full thickness wounds .
• Pressure, diabetic, and venous ulcers .
• Second-degree burns .
• Surgical wounds-donor sites/grafts, post-moh's surgery, post-laser surgery, . podiatric, wound dehiscence
• Trauma wounds-abrasions, lacerations, and skin tears .
• Tunneled/undermined wounds .
• Draining wounds .

PriMatrix is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text describes a 510(k) premarket notification for the PriMatrix Dermal Repair Scaffold. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample size, ground truth, and expert involvement are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

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

• Not Applicable. This 510(k) submission does not present a table of acceptance criteria or specific device performance metrics from a new clinical study. The submission focuses on demonstrating substantial equivalence to a predicate device.

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

• Not Applicable. The submission does not describe a "test set" in the context of device performance evaluation against specific criteria. It relies on the known performance and characteristics of the predicate device and biocompatibility testing.

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. There is no "ground truth" establishment in the context of a clinical test set described for this 510(k) submission.

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

• Not Applicable. No adjudication method for a test set is described.

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 is a medical device (wound dressing), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device (wound dressing), not an algorithm.

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

• Not Applicable. As no clinical study against novel ground truth is presented, this is not relevant. The basis for approval is substantial equivalence to the predicate device.

8. The sample size for the training set

• Not Applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."

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

• Not Applicable. See point 8.

Summary of what was presented in the 510(k) submission:

The 510(k) Pre-market Notification for the PriMatrix Dermal Repair Scaffold focuses on demonstrating substantial equivalence to an already legally marketed predicate device, DressSkin (K023778), also manufactured by TEI Biosciences.

The evidence provided for this substantial equivalence includes:

• Summary of Technological Characteristics: PriMatrix is stated to be "substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds."
• Biocompatibility Assessment: A "rigorous biocompatibility assessment performed by an independent certified laboratory" demonstrated the biocompatibility of PriMatrix.
  • Tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
• Viral Inactivation: The manufacturing methods were tested by an independent laboratory to assure safe levels of viral inactivation.

The FDA reviewed this submission and determined that PriMatrix is substantially equivalent to the predicate device for the stated indications for use, thereby allowing the device to be marketed.

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