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Management of wounds including:

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

Kerecis "Parvus™ is a lyophilized, terminally sterilized, acellular, particulate fish skin medical device comprised of biocompatible, non-crosslinked, resorbable, acellular fish skin (North Atlantic Cod) for wound management. The device is intended for single use only.

The subject device is packaged in the following weights:
100mg (4 cm2) 200mg (8 cm2) 500mg (19 cm²) 1000mg (38 cm²) 2,500mg (95 cm2 ) 3,000mg (114 cm2)

This document is a 510(k) Premarket Notification summary for Kerecis® Parvus™, a wound dressing. It is not an AI/ML device, and therefore does not contain acceptance criteria for device performance related to AI/ML or a study proving those criteria are met. The document states that the Kerecis® Parvus™ is substantially equivalent to a predicate device, Kerecis MariGen Wound Extra (K190528), in terms of indications for use, intended use, raw material origin and composition, device performance, packaging material, and sterilization methods. The primary difference is an additional cutting and sieving step in the manufacturing process to convert the fish skin from intact sheets to fragmented pieces ≤2.0mm.

Here's a breakdown of the requested information based on the provided document, noting that many items are not applicable (N/A) due to the nature of the device:

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

   This document does not provide specific performance acceptance criteria or reported performance data in the traditional sense of a clinical or analytical study with defined metrics (e.g., accuracy, sensitivity, specificity). Instead, it asserts substantial equivalence to a predicate device based on material properties and manufacturing processes. The "Performance Characteristics" section for the subject device largely mirrors the predicate device, with differences primarily in the physical form (fragmented vs. sheets) and nominal sizes.

   Characteristic	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (as described)
   Source Origin	Wild Caught Atlantic Cod Fish	Wild Caught Atlantic Cod Fish (Same as predicate)
   Tissue source	Fish Skin	Fish Skin (Same as predicate)
   Nominal Sizes	Fragmented, size controlled to ≤2.00mm	Irregular shaped 3D fragmented fish skin, size controlled to ≤2.00mm and packaged in various weights (100mg to 3,000mg). (Differs from predicate's sheet sizes, but subject device is cut from predicate device sizes).
   Presentation	Lyophilized, sterilized, fragmented fish skin	Lyophilized, sterilized, Fragmented, fish skin in a Tyvek peel pouch. (Differs from predicate's sheet presentation due to cutting and sieving).
   Packaging	Tyvek Single and Double Peel Pouch	Tyvek Single and Double Peel Pouch (Same as predicate)
   Sterilization	Ethylene Oxide	Ethylene Oxide (Same as predicate)
   Sterility Assurance Level (SAL)	SAL 10^-6^	SAL 10^-6^ (Same as predicate)
   Endotoxin limit	≤20 EU/device	≤20 EU/device (Same as predicate)
   Shelf Life	At least 1 year (matching current reported)	1 year (Real-time shelf life testing in progress for the subject device; predicate has 3 years).
   Biocompatibility	Demonstrated	Additional testing for biocompatibility completed (for the subject device).
   Fragmented size characterization	Demonstrated	Additional testing for fragmented size characterization completed (for the subject device).
   Ethylene oxide residuals	Demonstrated	Additional testing for ethylene oxide residuals completed (for the subject device).
   Metal contamination	Demonstrated	Additional testing for metal contamination completed (for the subject device).
   Protein analysis	Demonstrated	Additional testing for protein analysis completed (for the subject device).
   Bioburden	Demonstrated	Additional testing for bioburden completed (for the subject device).
   Residual limits	Demonstrated	Additional testing for residual limits completed (for the subject device).

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

   N/A. This is a 510(k) submission for a non-AI/ML medical device establishing substantial equivalence through material and manufacturing process comparisons, not a clinical study involving a test set for performance evaluation. The "additional testing" mentioned is likely laboratory bench testing on the device materials.

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)

   N/A. Not an AI/ML device requiring expert-established ground truth.

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

   N/A. Not an AI/ML device requiring adjudication of a test set.

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

   N/A. This device is not an AI/ML product and does not involve human readers or AI assistance.

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

   N/A. This device is not an AI/ML product.

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

   N/A. Not an AI/ML device requiring ground truth for performance evaluation. The substantial equivalence argument relies on material characteristics and manufacturing processes.

8. The sample size for the training set

   N/A. This is not an AI/ML device with a training set.

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

   N/A. This is not an AI/ML device with a training set.

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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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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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