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Kerecis® Marigen Wound Extra Autologous Hydration, Kerecis Silicone Autologous Hydration and Kerecis Parvus Autologous Hydration

Management of wounds including:

• Partial thickness wounds
• 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

All three subject devices of this bundled submission are part of a family of devices manufactured by Kerecis Limited. The subject devices can be seen in Table 1. They are lyophilized, terminally sterilized, fish skin medical devices comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod) for wound management. The devices are intended for single use only. The devices are applied to the wound bed to maintain a moist wound environment. The primary predicate device is Marigen Wound Extra (K190528) and the additional predicate devices are Kerecis Silicone (K213231), and Kerecis Parvus (K241080). Marigen Wound Extra is commercially available under the names Kerecis MariGen, Kerecis GraftGuide, and Kerecis SurgiClose. Kerecis Silicone is commercially available under the names Kerecis Shield and Kerecis SurgiClose Silicone. For clarity, this submission will refer to the devices under their commercially available names, except when specifically referring to the primary predicate device. This information is also shown in Table 1.
Although the subject devices differ from each other in terms of device indications and dimensional specifications, each one remains physically identical to its primary predicate device, both in design and packaging, as well as for indications for use. The only difference between each subject device and its respective primary predicate device is in the device labeling, with the subject devices having additional rehydration fluid options included in their instructions for use (IFUs).

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a study to prove the device meets these criteria. However, it's important to note that this submission is for a modification to an existing device (Kerecis Marigen Wound Extra, Kerecis Silicone, Kerecis Parvus) and not for an entirely novel device. The modification specifically addresses the inclusion of additional rehydration fluids. Therefore, the "study" is focused on verifying the device's performance with these new rehydration fluids, rather than establishing initial clinical effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's performance with the original rehydration fluid (saline) and the need for the device to perform comparably with the new rehydration fluids. The performance is assessed through specific bench tests.

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

The document does not explicitly state the sample size for the rehydration and suture retention tests. It mentions "bench testing" was performed.

Data provenance: Not explicitly stated, but bench testing typically involves laboratory-controlled conditions. It is not patient data from a specific country, nor is it referred to as retrospective or prospective in a clinical trial sense.

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

This type of information (expert consensus for ground truth) is typically associated with clinical studies or diagnostic device clearances where a "truth" is established through expert review of patient data (e.g., radiologist opinions on images). Since this submission focuses on bench testing for a modification to rehydration fluids, this information is not relevant or provided. The "ground truth" here is the prior established performance of the predicate device under saline rehydration.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints. As this submission describes bench testing for material and process compatibility, an adjudication method is not applicable and therefore not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices where multiple readers evaluate cases to assess performance with and without AI assistance. This submission is for wound dressings and focuses on physical and biological compatibility with different rehydration fluids.

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

This question is not applicable. The device is a wound dressing, not a software algorithm or an AI-based system. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

For the specific tests conducted for this modification (rehydration and suture retention with new fluids), the ground truth is implicitly the established performance characteristics of the predicate device when rehydrated with saline. The goal of the new tests was to show that these characteristics are maintained or are comparable when using lactated Ringer's solution and autologous body fluids.

8. The Sample Size for the Training Set

This concept is not applicable as this is not a machine learning or AI device. The "training set" for a traditional medical device would refer to the data used to design and develop the device prior to its initial submission. The summary doesn't provide this detail for the original device development, only that performance testing was "leveraged from the Kerecis primary predicate devices."

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

Again, "training set" and its "ground truth" are terms typically used in AI/ML contexts. For a medical device like a wound dressing, the "ground truth" during initial development (analogous to a training phase) would involve extensive material testing, biocompatibility studies, mechanical property evaluations, and potentially pre-clinical and clinical studies to establish its safety and effectiveness for wound management. The summary indicates that for this modification, the ground truth is based on the previously established performance of the predicate devices.

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For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Kerecis SurgiBind (50241) is a part of a family of devices manufactured by Kerecis® Limited. The device is lyophilized, terminally sterilized, fish skin medical device comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod). The device is intended for single use only.

Analysis of Kerecis SurgiBind (K251844) Acceptance Criteria and Study

This FDA 510(k) clearance letter details the Kerecis SurgiBind device, which is essentially a re-submission of the Kerecis Reconstruct (K202430) with an updated label to include additional rehydration fluid options. Due to this, the performance testing for this submission primarily focuses on demonstrating that the change (new rehydration fluids) does not negatively impact the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for this 510(k) submission, as it largely leverages prior testing of the predicate device. Instead, the focus is on demonstrating that the new rehydration fluids do not compromise the device's existing performance characteristics. The implicit acceptance criterion is that performance using the expanded rehydration fluids (including autologous body fluids) is comparable to performance using the previously cleared rehydration fluids (saline and Ringer's solution).

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

The document states: "Performance testing... was largely leveraged from the Kerecis predicate device... As a result, performance testing is not required, except for rehydration and suture retention tests using autologous body fluid."

• Sample Size for this submission's additional tests: Not explicitly stated. The nature of these tests (bench testing) suggests a relatively small, controlled sample size, but the exact number is not provided.
• Data Provenance: The new tests (rehydration and suture retention with autologous body fluids) are presumed to be prospective bench testing conducted specifically for this submission. The origin of the "autologous body fluids (such as blood)" used for testing is not detailed (e.g., human, animal, synthetic proxy).

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

• Experts: Not applicable for this type of bench testing. The "ground truth" for these tests would be the established scientific and engineering principles for material properties and device function.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance testing for this submission involves objective physical measurements (e.g., rehydration rate, suture pull-out force) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device is a biological surgical mesh (fish skin), not an AI/software device. Therefore, MRMC studies are not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the specific tests conducted for this submission (rehydration and suture retention with autologous body fluids), the ground truth is based on bench testing measurements against established parameters or comparison to the predicate device's performance. For the broader substantial equivalence claim, the ground truth is the performance and safety profile of the legally marketed predicate device (K202430).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set." The manufacturing process for the fish skin material itself has an inherent "training" through its development and validation, but this is not typically referred to as a "training set" in this context.

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

• Ground Truth for Training Set: Not applicable. See point 8.

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Kerecis® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Kerecis® Tendon Protect is a medical device made from solid fish skin (North Atlantic Cod) sheets of thickness no less than 0.4 mm. The product is intended to provide a covering around the newly repaired tendon for the management and protection of tendon injuries in which there has been no substantial loss of tissue. The device with natural structure and proteins from fish skin is applied around the newly repaired tendon. The structure of the fish skin provides a supportive environment for new host tissue deposition as part of wound healing while still providing an initial barrier facilitating the sliding of the repaired tendon within the surrounding tissue during tendon use. The biomechanical strength for the tendon itself is provided separately by sutures used to repair the tendon tear and/or by sutures or bone anchors used to attach the tendon tissue to the bone.

The fish skin is fully integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The device is biocompatible, non-crosslinked, bioresorbable, strong, and pliable. Its tensile strength supports fixation by sutures customary for tendon protection surgical procedures. The device is intended for one-time use and supplied sterile in labelled Tyvek® pouch packaging.

The subject device is available in following sizes:

• 3x5 cm size
• 6x9 cm size

Kerecis® Tendon Protect is a standalone, single use medical device made from fish skin that is technologically similar to the predicate device Tendon Wrap Tendon Protector (K053655) (Substantial Equivalence) and identical to the Kerecis® Reconstruct™ (K202430).

The provided text is a 510(k) clearance letter and summary for a medical device called "Tendon Protect." It details the device's characteristics, indications for use, and a summary of the non-clinical performance testing conducted to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. However, it does not contain the specific detailed information typically found in acceptance criteria tables or a comprehensive study report, particularly regarding a multi-reader multi-case (MRMC) study, standalone algorithm performance, or the detailed methodology for ground truth establishment that would be associated with AI/ML-based medical devices.

The document describes a physical medical device (surgical mesh made from fish skin) rather than an AI/ML-based diagnostic or assistive software. Therefore, many of the questions related to AI/ML specific criteria (such as sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable to this particular device submission.

Here's a breakdown of the applicable information found in the document:

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

The document mentions that the device "met all the pre-defined acceptance criteria" for various tests, but it does not provide a table detailing the specific numerical or quantitative acceptance criteria and the corresponding reported performance values. It only states that the tests were "conducted and passed successfully according to the test specifications."

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

• Test Set Sample Size: Not explicitly stated for most tests (e.g., biocompatibility bench tests). For the Tendon GLP Chicken Study, it is a chronic model evaluating early, mid-term, and late time points, comparing the subject device to a control and a negative control. The specific number of animals or tendons tested is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal testing), not human clinical data, and are likely prospective given they are part of a regulatory submission.

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

This is not applicable as the device is a physical surgical mesh, not a diagnostic or AI-based device requiring expert interpretation of images or signals for ground truth. Ground truth for the animal study would be based on objective scientific measurements and observations (e.g., histology, biomechanics).

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

This is not applicable for the reasons stated above.

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:

This is not applicable as the device is a physical surgical mesh, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical surgical mesh, not an AI algorithm.

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

For the animal study:

• Histopathology evaluation
• Macroscopic evaluations
• Tendon biomechanical function assessment
• Overall animal health

For bench testing, ground truth would be established by the physical and mechanical properties of the material itself, measured against predefined specifications.

8. The sample size for the training set:

This is not applicable as the device is a physical surgical mesh, not an AI/ML system requiring a training set.

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

This is not applicable for the reasons stated above.

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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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Kerecis Silicone 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, partial-thickness burns, skin tears)
• Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
• Draining Wounds

The subject device is a bilayer of processed resorbable acellular fish dermal matrix adhered to a thin, transparent, porous, soft silicone layer.
The subject device is obtained from fish skin via standardized controlled GMP manufacturing process. The fish dermal matrix layer is approximately 1 mm in thickness and is porous.
The silicone layer is a transparent polyurethane film single-coated with soft, medical grade silicone that is attached to the scaly side of the fish dermal matrix. The silicone layer is porous, soft and conformable to the wound surface.
The subject device is supplied as a sterile intact sheet offered in two configurations: a) with the silicone layer extending beyond the borders of the fish dermal matrix and b) the silicone layer having the same dimension as the fish dermal matrix with no silicone layer extending beyond the fish dermal matrix.
The silicone acts as: protection for the fish dermal matrix layer, as additional wound coverage, and in configuration (a), as an adhesive contact layer to the skin surrounding the wound.
The silicone layer can be peeled off as the fish dermal matrix is resorbed.
The device is intended for single use only.

The provided document is a 510(k) summary for a medical device (Kerecis Silicone) and does not describe a study involving an AI/Machine Learning device or a human-in-the-loop study.

This document describes a medical device, Kerecis Silicone, which is a bilayer wound dressing. The substantial equivalence determination is based on the technological characteristics and performance testing of the device itself (biocompatibility, physical properties, etc.), not on the performance of a software algorithm or AI.

Therefore, most of the requested information regarding AI/ML acceptance criteria, ground truth establishment, sample sizes for AI training/testing, expert adjudication, or MRMC studies for AI assistance is not applicable to this document.

However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance testing) and the study proving it meets these criteria based on the provided text.

Device: Kerecis Silicone (a bilayer wound dressing)
Regulatory Status: 510(k) clearance (K213231)

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating biocompatibility and physical/chemical characteristics that are comparable to or safe for its intended use, typically by meeting the requirements of established ISO and ASTM standards. The reported device performance is indicated by a "Pass" for each test.

Study Proving Device Meets Acceptance Criteria

The study proving the device meets the acceptance criteria is detailed under "7. PERFORMANCE TESTING" in the 510(k) summary. These are pre-clinical (biocompatibility, physical, and chemical) tests.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample sizes for each specific biological or physical test. These tests generally use a small number of samples (e.g., typically n=3 or n=5 for physical tests, or a defined number of animals for in-vivo biocompatibility tests) as per the specific ISO/ASTM standards referenced.
   • The data provenance is not specified in terms of country of origin, but it is implied to be from laboratory testing supporting the device's manufacturing and regulatory submission. The tests are retrospective to the submission date.

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

   • This question is not applicable as this document does not describe a study involving image interpretation by experts or a clinical diagnostic AI. The "ground truth" here is established by validated laboratory testing methods governed by the cited ISO/ASTM standards, and the results are interpreted by qualified laboratory personnel.

3. Adjudication method for the test set:

   • Not applicable. There is no "adjudication" in the sense of expert consensus for laboratory tests. The results are typically quantitative or qualitative (e.g., cytotoxic/non-cytotoxic) based on direct measurement and predefined criteria within the respective standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

   • Not applicable. This is a physical medical device, not a software algorithm.

6. The type of ground truth used:

   • The ground truth for this device's performance is established through adherence to recognized international standards (ISO, ASTM, ANSI/AAMI) for biological safety and physical properties. This involves direct laboratory measurements and observations under controlled conditions to determine if the device elicits specific biological responses or possesses particular physical characteristics as defined by these standards.

7. The sample size for the training set:

   • Not applicable. This concept applies to machine learning models, not to the pre-clinical performance testing of a physical medical device. The "training" for such a device involves product development and manufacturing process controls, not data-driven algorithm training.

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

   • Not applicable. As above, this pertains to AI/ML context.

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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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Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.

Kerecis SecureMesh can be used for reinforcement of staple lines during:

• Bariatric surgical procedures
• Colorectal and Colon surgical procedures
• Gastric, small bowels and mesentery procedures
• Lung and bronchus resections

Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.

The provided text is a 510(k) summary for the Kerecis SecureMesh, a surgical mesh. This document describes the device, its intended use, comparison with predicate devices, and performance testing to demonstrate substantial equivalence for regulatory clearance.

However, the questions you've asked are typically relevant to the development and validation of an AI/Machine Learning medical device, particularly concerning diagnostic or interpretative capabilities. The Kerecis SecureMesh is a physical surgical implant, not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets) do not apply to this medical device.

The document describes performance testing for a surgical mesh, which includes:

1. Bench Testing:

   • Biocompatibility (by leveraging prior testing on a similar product).
   • Viral-inactivation evaluation (also leveraged from similar product).
   • Tensile strength comparison with predicate.
   • Usability (loading time, transfer to stapler, ease of use, force to fire, slippage).
   • Performance (leak at staple line, leak pressure, seal burst).

2. Animal Studies:

   • An acute porcine ex-vivo study comparing the Subject Device to a predicate device and un-buttressed stapling (negative control). The conclusion was "no significant difference."

3. Clinical Studies:

   • "No clinical testing was included in this submission." This means no human clinical trials were performed for the 510(k) clearance based on substantial equivalence to predicate devices and the non-clinical testing.

Given the nature of the device and the provided text, I cannot answer the questions about AI/ML device validation. The "acceptance criteria" for this device would be established engineering and performance specifications, and the "proof" is the bench and animal testing demonstrating equivalence to a legally marketed predicate device.

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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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