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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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Foundation DRS+ Duo 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 degree 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+ Duo may be cut to size.

Foundation DRS+ Duo is a conformable, advanced wound care device comprising 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 Foundation DRS+ Duo has a semipermeable polyurethane backing layer (offered with or without perforations) providing a flexible covering for the wound surface.

This document is an FDA 510(k) clearance letter for a medical device called "Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo." It does not contain information about an AI/ML-driven medical device, hence it does not provide details on acceptance criteria or studies related to AI/ML performance.

The document discusses the substantial equivalence of the DRS+ Duo device to a predicate device based on:

1. Biocompatibility Testing: Conducted according to ISO 10093-1:2018, evaluating cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, bacterial reverse mutation, genotoxicity (Mouse Lymphoma Assay), systemic toxicity study, implantation studies (ISO 10993-6), and bacterial endotoxins.
2. Performance Testing: Assessed through additional endpoints within the Implantation (ISO 10993-6) model, functionality testing on aged devices (hydration, dimensional stability, handling characteristics) with saline and autologous body fluids.
3. Animal Testing: 14, 28, 42, and 91-day implantation studies in a porcine wound healing model on full thickness dermal wounds. These evaluated wound healing characteristics, dynamics, biological response, and residence time.
4. Sterilization and Packaging Validation: Leveraged from previous clearances (K210949 and K231937), performed per ISO 14937, ISO 10993-7, ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, and ASTM F88. Viral inactivation was also leveraged.

Conclusion stated: "Clinical testing was not necessary to demonstrate substantial equivalence." This means that the device's clearance was based on non-clinical data as described above, not on a study proving human reader improvement with AI assistance (MRMC) or standalone algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device per the prompt's outlined points (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment), as this document does not pertain to an AI/ML medical device.

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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
• · 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 highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan 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 text is a 510(k) summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo. This document describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document states, "Clinical testing was not required for the labeling update to include moistening of the device by autologous bodily fluids, in addition to saline." This immediately indicates that no clinical study was conducted to prove the device meets acceptance criteria related to its clinical performance for the specific change being submitted (the labeling update).

Therefore, I cannot provide information for all the requested points, as no clinical study was performed for this 510(k) submission. The provided information focuses on non-clinical testing performed to support the substantial equivalence claim.

Here's what can be extracted from the document regarding acceptance criteria and non-clinical testing, as well as the points that cannot be answered due to the absence of a clinical study:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The submission is for a labeling update to an existing device (Foundation DRS Solo, cleared under K210949). The primary focus of the provided document is to demonstrate that this labeling change (allowing moistening with autologous body fluids in addition to saline) does not raise new questions of safety or effectiveness. As such, no new clinical study was required or performed for this specific submission to prove clinical acceptance criteria are met. The document leverages existing data from the predicate device and conducts focused non-clinical tests to address the change.

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

Since no clinical study was performed for this submission, there are no clinical acceptance criteria or performance metrics reported in the typical sense for a clinical trial. The acceptance criteria and performance reported are for non-clinical tests and are aimed at demonstrating that the label change does not negatively impact the device's fundamental characteristics or safety.

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

• Non-Clinical Tests (Hydration, Dimensional Stability, Handling Characteristics): The document states these tests were performed but does not explicitly mention the sample size or exact provenance. These would be laboratory tests, typically conducted prospectively.
• Leveraged Tests (Biocompatibility, Sterilization, Packaging, Performance): These were leveraged from the primary predicate device (K210949). Specific sample sizes and provenance for these original tests are not detailed in this 510(k) summary. These would also be laboratory or animal studies, conducted prospectively.

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, as no clinical study with human readers/experts establishing ground truth was performed for this submission. The ground truth for non-clinical tests is based on established scientific methods and standards.

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

Not applicable, as no clinical study requiring human interpretation and adjudication was performed for this submission.

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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a medical product (dermal scaffold), not an algorithm.

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

• For the non-clinical tests (hydration, dimensional stability, handling), the ground truth is based on physical and chemical measurements against defined specifications and industry standards.
• For the leveraged biocompatibility, sterilization, and packaging tests, the ground truth is established through adherence to the specified ISO/ASTM standards and methods.
• For the leveraged performance tests (e.g., wound healing in porcine model), the ground truth would be based on physiological observations and measurements in the animal model.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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