Search Results

Corplex P/Theracor P/Allacor P 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

Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.

The provided text describes a 510(k) premarket notification for a medical device called Corplex P/Theracor P/Allacor P. It states that the device is identical to its predicate device (K231325) in most aspects, with a minor modification being the addition of an 8 cc configuration. The document explicitly states that this modification does not raise new questions of safety or effectiveness and therefore, no new clinical testing, biocompatibility testing, or extensive performance studies were required to demonstrate substantial equivalence.

Instead, the submission relies on the established performance of the predicate device and verification testing related to the minor design change.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typically associated with performance studies, are not explicitly present in this summary document because such extensive studies were deemed unnecessary for this 510(k) submission.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available due to the nature of this submission:

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

The document does not explicitly state acceptance criteria in a quantitative format for all characteristics. Instead, it relies on the device being "identical" or having "same" or "does not raise new questions of safety and effectiveness" compared to the predicate device. For the one specific test mentioned (Bioburden Testing), the outcome is a simple "PASS".

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 primarily relies on the substantial equivalence to a predicate device (K231325). For the specific modification (8 cc configuration), verification testing was performed.

• Test Set Sample Size: Not specified for the bioburden testing or other verification tests mentioned. The document states "Testing was performed based on the risk assessment for the proposed change using the same methods used to support the clearance of the predicate device."
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the US FDA by a US-based company (StimLabs, LLC, Roswell, Georgia), the data is most likely from the US, and refers to prior data from the predicate device. It is not a clinical study, so terms like "retrospective" or "prospective" are not applicable to the verification testing conducted for this submission. The predicate device's data would have been part of its original 510(k) submission.

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. This submission is for a material device, not an AI or diagnostic device that requires expert ground truth for image interpretation or similar tasks. The "ground truth" for the characteristics listed would be defined by standard laboratory testing methodologies and specifications.

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

Not applicable. The verification testing mentioned (e.g., bioburden) involves laboratory results rather than expert adjudication of interpretations.

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

No. This is a wound dressing made from human umbilical cord extracellular matrix, not an AI or diagnostic device.

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

No. This is a physical medical device, not an algorithm.

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

For the verification testing related to the new device, the ground truth would be defined by standard laboratory test results and established acceptance criteria for physical and chemical properties (e.g., bioburden levels, particle size distribution, moisture content, collagen content, endotoxin levels). For the predicate substantial equivalence, the "ground truth" refers to the established safety and effectiveness of the existing legally marketed device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Ask a specific question about this device