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• Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
• Covering of implants placed in immediate extraction sockets;
• Covering of implants placed in delayed extraction sockets;
• Covering of bone defects after root resection and removal of retained teeth; and
• Guided tissue regeneration procedures in periodontal and recession defects.

The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:

• 15mm x 20mm
• 20mm x 30mm
• . 30mm x 40mm
  It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.

This document is a 510(k) Premarket Notification from the FDA regarding the Kerecis® Oral device. It details the device's characteristics, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence.

Based on the provided text, the device itself (Kerecis® Oral) is a biological material (acellular resorbable fish dermal matrix) used for various oral surgical procedures to aid in soft tissue and bone regeneration. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing and animal studies performed to demonstrate that the Kerecis® Oral device is substantially equivalent to existing predicate devices, thereby clearing it for market.

Here's an analysis of the provided information to answer your questions:

1. Table of acceptance criteria and the reported device performance

The document doesn't present a single, explicit "acceptance criteria" table with pass/fail thresholds for the entire device in the way a software or AI model might have. Instead, it outlines a series of tests performed on the material properties and functional characteristics of the Kerecis® Oral device and compares them to predicate devices. The "acceptance" is implied by demonstrating substantial equivalence.

Here's a table summarizing the comparison and performance points, where "acceptance" means demonstrating substantial equivalence or meeting/exceeding predicate device performance:

2. Sample sizes used for the test set and the data provenance

• Bench Testing: The specific sample sizes for each bench test (e.g., number of samples for tensile strength, compression, dimensional validation) are not explicitly stated in the provided text. It mentions "representative product samples" and "three lots" for dimensional validation. The provenance is implied to be laboratory testing of the manufactured Kerecis® Oral device.
• Animal Testing: The sample size for the animal study is a "canine (beagle bilateral mandibular bony defect model)." This implies multiple beagle dogs, but the exact number is not specified. The study was conducted in AAALC accredited facilities in compliance with GLP (Good Laboratory Practices) 21 CFR §58, suggesting a controlled, prospective study. The location (country) is not specified, but GLP compliance implies a rigorous study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the animal study, the evaluation involved "gross pathology and histological, and quantitative micro-CT volumetric analysis." This type of analysis would typically be performed by veterinary pathologists and possibly radiologists/imaging specialists. However, the number and specific qualifications of these experts are not mentioned in the text.
• For the user evaluation of cutting and shaping, it was done "using a questionnaire." This implies that "ground truth" was established by user feedback, not by experts in the context of diagnostic accuracy. The number and qualifications of these users are not stated.

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

• None explicitly mentioned. For the animal studies, "no qualitative or significant differences was observed" suggests direct comparison by the evaluators rather than an explicit adjudication process among multiple independent reviewers, though this is not definitively stated. For the bench tests, the data itself (e.g., tensile strength, dimensional measurements) would be objective, not typically requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This product is a biological medical device (a tissue graft), not a diagnostic AI device that assists human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

• Not applicable. This is a physical medical device, not an algorithm. The "performance" assessment is based on its material properties and biological interaction in an in vitro and in vivo (animal) setting, not an algorithm's output.

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

• For Bench Testing: The "ground truth" is defined by objective material property measurements (e.g., tensile strength in MPa, dimensional measurements in mm, pH and conductivity values) and established international standards (e.g., ISO, ASTM, ICH).
• For Animal Testing: The "ground truth" was established through histologic and micro-CT volumetric analysis of animal tissues collected at different time points post-surgery. This involves pathological assessment (histology) and quantitative imaging analysis (micro-CT) to assess bone formation, xenograft resorption, and soft tissue infiltration. While the specific experts aren't named, this is a form of expert assessment of biological outcomes.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of an AI/ML algorithm.

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

• Not applicable. As a physical device, there is no "training set" or "ground truth for the training set."

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The subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness. The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes: 4x7 cm, 7x10 cm, 7x20 cm. The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.

The provided document is a 510(k) summary for a medical device called "Kerecis Reconstruct," which is a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical effectiveness studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, the information requested in the prompt, which is typical for AI/ML-based diagnostic devices, is not directly available in this document for the Kerecis Reconstruct device.

However, I can extract the information that is present, particularly regarding the studies and comparisons performed to demonstrate substantial equivalence, which serves a similar purpose to meeting "acceptance criteria" in the context of a 510(k) submission for this type of device.

Here's an analysis based on the provided text, structured to address your points where possible, and noting where the information is not applicable or not provided.

Device: Kerecis Reconstruct (Surgical Mesh)

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical mesh, the "acceptance criteria" for 510(k) clearance are primarily focused on demonstrating that the new device is as safe and effective as a predicate device, based on similar technological characteristics and performance. Formal quantitative performance metrics (like sensitivity/specificity for AI, or specific effect sizes for human reader improvement) are not typically applicable or reported for this type of device in a 510(k) summary in the same way they would be for an AI diagnostic algorithm.

Instead, the "acceptance criteria" implicitly relate to meeting similar material properties, functional performance (e.g., tensile strength, suturability), and biocompatibility as the predicate device. The "reported device performance" is demonstrated through bench testing and animal studies, showing equivalence.

• Veterinarian's assessment of animal health (safety) was equivalent.
• Pathologist's assessment of tissue response (safety and efficacy) was equivalent. |
  | Material Properties: Similar physical and mechanical properties to predicate (e.g., non-crosslinked, resorbable, strong, flexible). | Described as biocompatible, non-crosslinked, resorbable, strong, and flexible. Derived from cod fish skin (similar to predicate being porcine). |
  | Mechanical Performance: Equivalent functional characteristics (e.g., tensile strength, suturability, stiffness, hydration). | Bench testing (tensile strength, suturability, hydration time, thickness, weight, stiffness/bend test, microscopic structure) performed on hydrated, sterile, ready-for-market devices confirmed performance as expected.
• Specific quantitative values for these tests are not provided in the summary.
• In-vitro performance data tensile strength testing of the test and control explants side-by-side (efficacy) showed equivalence. |
  | Intended Use Compatibility: Works for reinforcing soft tissue in plastic/reconstructive surgery. | Predicate device's intended use is identical: "to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery." Subject device claims identical intended use. |
  | Sterility & Shelf Life: Meets established standards. | Sterilization Method: Ethylene Oxide (identical to predicate/references).
  Shelf-Life: 3 years. Predicate was 1.5 years, but reference devices were 3 years. This seems to be accepted. |

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

• Test Set Sample Size: Not explicitly stated numerically for the bench testing. The animal study involved at least one "test device" (Kerecis Reconstruct) and a "control device," but the number of animals/samples is not specified in this summary.
• Data Provenance:
  • Bench testing: Performed internally or by a testing laboratory as part of the submission per FDA guidance.
  • Animal testing: Performed in a "GLP laboratory" (Good Laboratory Practice). The origin (country/retrospective/prospective) is not specified, but GLP implies a prospective, controlled study.

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

This information is not applicable in the context of this 510(k) submission for a non-diagnostic medical device. "Ground truth" in this case is established through objective physical measurements (bench testing) and histological/veterinary assessments in the animal model. The animal study mentions a "veterinarian's assessment" and a "pathologist's assessment," but the number and specific qualifications (beyond "veterinarian" and "pathologist") are not provided.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers/interpreters needing adjudication. The evaluation relies on objective physical/mechanical tests and expert animal health and pathology assessments.

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 a surgical mesh, not an AI diagnostic tool or an imaging product that would involve human readers or AI assistance.

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

Not applicable. This device is a surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For bench testing: Established by validated testing methods against industry standards or direct comparison to the predicate device. This is essentially objective physical and mechanical property measurement.
• For animal study: Established by GLP-compliant veterinary examination and histopathological analysis. This can be considered a form of "pathology" ground truth for tissue response and "outcomes data" for animal health.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding the "study that proves the device meets the acceptance criteria" (i.e., demonstrates substantial equivalence):

The submission for Kerecis Reconstruct justifies substantial equivalence to the predicate device (Biodesign Plastic Surgery Matrix, K191696) and reference devices (Kerecis SecureMesh K153364, Biodesign Hernia Graft K133306) through:

• Analysis of 510(k) Substantial Equivalence Decision-Making Process: Following FDA's guidance document.
• Bench Testing: Performed according to FDA guidance "Preparation of a Premarket Notification Application for a Surgical Mesh" (1999). Tests included: tensile strength, suturability, hydration time, thickness, weight, stiffness (bend test), and microscopic structure analysis. These tests were performed on hydrated, sterile, ready-for-market devices. The summary states these tests "confirmed that the devices perform as expected under clinical conditions, and there were no negative effects on the mechanical properties."
• Animal Testing: Performed in a GLP laboratory using the subject device and a control device. The results demonstrated "equivalence in safety and efficacy" to the control device, based on:
  • Veterinarian's assessment of animal health (safety).
  • Pathologist's assessment of the tissue response to the device (safety and efficacy).
  • Histology.
  • In-vitro performance data (tensile strength testing of the test and control explants side-by-side) (efficacy).

The document concludes that the "data provided within this submission support substantial equivalence of the subject device to the predicate device with regards to intended use, technological characteristics including principles of operation, performance characteristics, and device safety."

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Kerecis Gingiva Graft is indicated for:

• Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.

The subject device is fish skin medical device indicated gingiva augmentation.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes:

• 15mm x 20mm
• 20mm x 30mm
• 30mm x 40mm
  The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue.
  The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.

The provided text describes the Kerecis Gingiva Graft device, a collagen membrane intended for localized gingival augmentation. This is a 510(k) submission, meaning the device seeks clearance based on its substantial equivalence to a legally marketed predicate device, not necessarily on meeting quantitative acceptance criteria established by the FDA for novel devices.

Therefore, the information typically requested in questions 1 through 9 (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) is not applicable in the context of this 510(k) summary, as it describes a different type of regulatory submission process. The study presented here aims to demonstrate equivalence, not to quantify the device's performance against pre-defined thresholds.

However, I can extract information related to the "study that proves the device meets the acceptance criteria" in the context of proving substantial equivalence to the predicate device.

Here's the relevant information based on the provided text, reinterpreting "acceptance criteria" as "criteria for demonstrating substantial equivalence" for this 510(k) submission:

1. A table of (Substantial Equivalence) Criteria and the Reported Device Performance:

The document establishes substantial equivalence by comparing the Kerecis Gingiva Graft (subject device) to the MUCOGRAFT® Collagen Matrix (predicate device) and other reference devices across various characteristics and performance tests. Rather than explicit "acceptance criteria" with numerical thresholds, the "performance" is the demonstration of comparability or superiority to the predicate device.

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MariGen Wound Extra is indicated for the management of wounds, including:

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

The subject device is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in sizes up to 20 x 30 cm. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process and supplied in terminally sterile packaging. The subject device is biocompatible, pliable, and non-cross linked.
The device is intended for single use only.

This document is a 510(k) Premarket Notification from the FDA, evaluating Kerecis Limited's MariGen Wound Extra device. The core of this document is to establish "substantial equivalence" to a predicate device, rather than to prove new performance criteria through a study involving AI. Therefore, the information requested about acceptance criteria and a study proving device performance, especially related to AI, is not present in the provided text.

The document states that "The subject device is identical to the predicate device apart from being offered in sizes up to 600cm²." This is a key statement explaining why extensive new performance studies (like those typically associated with AI devices) were not required. The approval is based on the device being a larger version of an already approved product made of the same material.

Here's how the requested information relates to the provided text:

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

   • Not Applicable. This document does not describe acceptance criteria for a new performance study like an AI model. Instead, it aims to show substantial equivalence to an existing cleared device. The "performance data" mentioned (elemental impurities and chemical residual analysis) are for basic safety and material characterization, not for clinical performance demonstration as would be expected for an AI device. The table provided is a "Summary Table of Substantial Equivalence," comparing features like product codes, intended use, indications, resource origin, tissue resource/scaffold base, nominal sizes, presentation, sterilization, and shelf life between the subject and predicate devices. The acceptance criteria for each of these features is "Equivalent," meaning the subject device needs to be essentially the same or functionally similar to the predicate.

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

   • Not Applicable. No test set or data provenance for a performance study (as would be done for an AI device) is described. The rationale for approval is similarity to an existing device.

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. Ground truth establishment by experts for a test set is not described as part of this submission, as it is not an AI device or a device requiring a de novo clinical performance study against expert reads.

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

   • Not Applicable. No adjudication method is mentioned as there is no clinical performance test set 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 device is a wound dressing, not an AI-assisted diagnostic or treatment device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

   • Not Applicable. This is a physical wound dressing, not a software algorithm.

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

   • Not Applicable. The "ground truth" here is the established safety and efficacy of the predicate device, which the subject device is deemed substantially equivalent to due to material and functional similarity. There's no new "ground truth" established for clinical performance via a new study.

8. The sample size for the training set:

   • Not Applicable. There is no AI model or training set described.

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

   • Not Applicable. There is no AI model or training set described.

In summary, the provided FDA 510(k) document for K190528, MariGen Wound Extra, is for a physical wound dressing and does not involve AI or new clinical performance studies to prove its efficacy. Its clearance is based on its substantial equivalence to a previously cleared predicate device (MariGen Wound) and a reference device (SecureMesh), primarily due to sharing the same material and functional design, with the only significant difference being larger available sizes.

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