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MariGen Wound is indicated for the management of wounds including:

• . Partial and full-thickness wounds
• . Pressure ulcers
• . Venous ulcers
• . Chronic vascular ulcers
• . Diabetic ulcers
• . Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
• . Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).
• . Draining wounds

The Kerecis MariGen Wound Dressing is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in size from 3 x 3.5 cm (10.5 cm2), 3 x 7 cm (21 cm2) and 7 x 10 cm (70 cm2).
The device is intended for a single patient, one time use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MariGen Wound Dressing:

Key Takeaway: The provided document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report with specific acceptance criteria and performance metrics for a novel efficacy claim. It focuses on demonstrating equivalence to existing predicate devices through material composition, device characteristics, intended use, and non-clinical testing.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary focused on substantial equivalence, specific "acceptance criteria" in terms of precise numerical performance targets (e.g., sensitivity, specificity, wound healing rate) as one might find in a clinical trial for a new drug or a de novo device are not explicitly stated or reported with quantitative results.

Instead, the acceptance criteria are implicitly met by:

1. Biocompatibility: Showing the device is "usable and biocompatible" as per ISO 10993-12.
2. Safety (from animal and limited human use): Demonstrating that animal studies support safety and that "no serious adverse events have been noted in limited clinical use."
3. Substantial Equivalence: Concluding that the device is "substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use," and that "The differences between these devices are limited to the animal source of collagen. This difference is minor and does not raise new issues of safety or effectiveness."

Therefore, a table of precise numerical acceptance criteria and reported performance metrics cannot be constructed from the provided text in the way one would for a diagnostic or AI-driven decision support system. The "performance" is primarily safety and biocompatibility validated against ISO standards and existing predicate devices.

Study Details based on the provided text:

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

   Category	Acceptance Criteria (Implicit from text)	Reported Device Performance
   Biocompatibility	Meets requirements of ISO 10993-12 for biological evaluation.	"All biocompatibility tests that are required according to ISO 10993-12... were performed with favorable results." (Categories: cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). "The Kerecis MariGen Wound Dressing was shown to be usable and biocompatible."
   Safety (Animal)	Animal studies support the safety of the device.	"The results of the tests support the safety of the device."
   Safety (Clinical)	No serious adverse events in limited clinical use.	"No serious adverse events have been noted in limited clinical use."
   Functionality	Device functions to meet specified user requirements as per design validation.	"The design validation activities confirmed that the device as designed functions to meet specified user requirements."
   Substantial Equiv.	Same general intended use, principles of operation, and similar overall design to predicate devices. No new safety/effectiveness issues.	"The proposed and predicate devices have the same general intended use and principles of operation. The overall design... is similar... The differences... are minor and do not raise new issues of safety or effectiveness."

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

   • Test Set Sample Size:
     • Biocompatibility Tests: The specific number of samples for each test (cytotoxicity, sensitization, etc.) is not provided.
     • Animal Testing: "Several animal studies have been performed," but the number of animals or studies is not specified.
     • Clinical Testing: The product "has been studied on a limited number of subjects." The exact number is not provided.
   • Data Provenance: Not explicitly stated for any of the testing mentioned. The company is based in Iceland (Kerecis Itd., Isafjordur, Iceland), and the device is CE marked, suggesting European markets. The text does not specify where the limited clinical use took place.
   • Retrospective or Prospective: Not specified for any of the studies.

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/Not mentioned. The studies described are primarily non-clinical (biocompatibility, animal) and limited observational clinical experience, not studies requiring expert-adjudicated ground truth for a diagnostic performance evaluation.

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

   • Not applicable/Not mentioned. This type of adjudication is typically used for diagnostic performance studies involving human readers or AI algorithms for image interpretation, which is not the nature of the studies described here.

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 MRMC comparative effectiveness study was done. This device is a wound dressing, not an AI-powered diagnostic or decision support tool.

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

   • No standalone algorithm performance study was done. This device is a wound dressing, not an AI algorithm.

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

   • For biocompatibility, the "ground truth" would be the established safety profiles and pass/fail criteria defined by the ISO 10993-12 standards.
   • For animal studies, the ground truth would be observations of tissue response, healing, inflammation, etc., as assessed by veterinary pathologists or researchers.
   • For limited clinical use, the "ground truth" for safety would be the absence of serious adverse events, likely collected from patient records and observational follow-ups. The document hints at "supports the safety of the device" rather than efficacy outcomes.

8. The sample size for the training set

   • Not applicable. The device is a physical wound dressing, not a machine learning model, so there is no "training set."

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

   • Not applicable. No training set for an algorithm is involved.

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