(38 days)
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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