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Foundation DRS+ Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• · First dearee burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrasions, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS+ Solo may be cut to size.

Foundation DRS+ Solo is a conformable, advanced wound care device that consists of a porous matrix of chitosan derived from shellfish, sodium chondroitin sulfate, a glycosaminoglycan, and hyaluronic acid. The chitosan- glycosaminoglycan- hyaluronic acid biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

The provided document is a 510(k) summary for the Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo. It details that this device is substantially equivalent to a previously cleared predicate device, Foundation DRS+ Duo (K240298), with the primary difference being the absence of a backing layer. It also leverages information from a secondary predicate, Foundation Dermal Regeneration Scaffold (DRS) Solo (K231937), which also lacks a backing layer but has a different matrix formulation.

The document states that clinical testing was not necessary to demonstrate substantial equivalence. This means there was no multi-reader multi-case (MRMC) comparative effectiveness study, nor a standalone performance study in the traditional sense of evaluating an algorithm's performance against a clinical ground truth.

Therefore, the acceptance criteria and study that proves the device meets them are focused on non-clinical performance characteristics rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical submission, the "acceptance criteria" are related to physical and biological properties. The document mentions that the tests performed "indicate that the Foundation DRS+ Solo is substantially equivalent to the predicate devices." This implies that the results of the performed tests met pre-defined internal acceptance criteria for substantial equivalence to the predicates.

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

• The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for hydration or dimensional stability). Regulatory submissions often state compliance with standards, which implicitly defines aspects of sample sizes.
• Data Provenance: The data is generated from laboratory testing of the device itself and leveraged from previous FDA clearances (K240298 and K231937). The country of origin for the data is not explicitly stated, but it's likely linked to the manufacturer's R&D/testing facilities. The testing is prospective in the sense that it was performed specifically for this 510(k) submission, or leveraged from previous submissions.

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

• This question is not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to the defined acceptable ranges and standards for material properties and biological responses, which are established by industry standards (e.g., ISO, ASTM, USP) and regulatory guidance, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

• This is not applicable as there is no human interpretation of data requiring adjudication for clinical endpoints. The "adjudication" is essentially confirming that the test results meet the specified acceptance criteria of the relevant standards.

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

• No. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence." Therefore, no MRMC study was performed.

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

• No. This device is a medical product (dermal scaffold), not a software or AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The closest equivalent is the standalone performance of the physical device in meeting its non-clinical specifications.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is established by validated test methods, industry standards (e.g., ISO, ASTM), and predetermined specifications for material properties, sterility, packaging integrity, and biocompatibility. It's not based on expert consensus, pathology, or outcomes data related to human clinical performance.

8. The Sample Size for the Training Set:

• This question is not applicable as this is not an AI/ML device requiring a training set.

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

• This question is not applicable as this is not an AI/ML device requiring a training set.

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