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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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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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SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.

SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.

The provided text describes a 510(k) premarket notification for a medical device called SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction. It is a submission for a modified device, not an AI/ML powered device. Therefore, the information required to answer the prompt for acceptance criteria and study proving device meets acceptance criteria, in the context specified (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.), is not present in the document.

The document discusses substantial equivalence to a predicate device and includes information about performance testing, but not in the format or with the details requested for AI/ML device evaluation.

However, I can extract the available information related to the device's performance and testing:

Device Name: SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction

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

The document mentions that "All test results were acceptable," but does not explicitly list the acceptance criteria or specific numerical performance metrics for each test. It only states the types of tests performed.

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

The document mentions a "pre-clinical, acute/subacute animal model" but does not specify the sample size (number of animals or implants) used for this study. The provenance (country of origin or retrospective/prospective) is not specified.

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)

This information is not applicable and not provided since the study is a pre-clinical animal model evaluation of a surgical mesh, not an AI/ML device relying on expert-annotated ground truth.

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

Not applicable/provided for this type of device and study.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

For the animal study: "Gross, sub-gross and histological evaluation of explanted materials and surrounding tissues" were used to assess the biological response, revascularization, and resorption/remodeling. This is akin to pathological evaluation.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

The provided text is a 510(k) summary for the Miromatrix Biological Mesh, which is a surgical mesh. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It primarily focuses on a labeling change rather than a new medical AI device or diagnostic algorithm.

Therefore, the requested information regarding acceptance criteria and performance studies for an AI/diagnostic algorithm cannot be extracted from this document. The document describes a biological mesh and a change to its instructions for use (allowing quilting of multiple meshes). The "performance data" mentioned (Section 7) refers to a risk analysis and verification/validation activities related to the quilting of the mesh, not to the performance of an AI or algorithmic medical device in a clinical setting.

Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance for an AI/diagnostic algorithm.
• Sample sizes for test sets, data provenance, or training sets for an AI.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Standalone performance studies for an AI algorithm.
• Types of ground truth for an AI (pathology, outcomes data, etc.).

The "acceptance criteria" referred to in the document are about the quilted mesh meeting pre-determined acceptance criteria for the individual cleared mesh (a physical biological product), not for an AI.

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The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

The Miromatrix Biological Mesh RS is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

This document is a 510(k) premarket notification for the Miromatrix Biological Mesh RS, declaring its substantial equivalence to a previously cleared predicate device, the Miromatrix Biological Mesh (K134033). As such, it does not describe a study involving acceptance criteria and device performance in the typical sense of a rigorous clinical or standalone performance study for an AI/device algorithm.

Instead, the core of this submission is to demonstrate that the new device (Miromatrix Biological Mesh RS) is substantially equivalent to a legally marketed predicate device (Miromatrix Biological Mesh, K134033). This means that the acceptance criteria are implicitly met by demonstrating sameness or very similar characteristics and performance to the predicate device, which has already been deemed safe and effective.

Here's an breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present due to the nature of a 510(k) substantial equivalence submission for a physical medical device (not an AI algorithm):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds in this document for a "new" device performance study. Instead, the "acceptance criteria" are effectively that the new device (Miromatrix Biological Mesh RS) is identical in materials and design and has similar indications for use and the same intended use as the predicate device (Miromatrix Biological Mesh, K134033). The "reported device performance" is essentially the equivalence shown in the comparison table.

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

• Sample Size: Not applicable. This is not a study assessing performance on a test set of data. It's a regulatory submission demonstrating equivalence of a physical medical device to an existing one.
• Data Provenance: Not applicable.

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

• Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI algorithm.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable in the context of an AI algorithm. For this physical device, the "ground truth" for its safety and effectiveness is established by the prior clearance of the predicate device (K134033) and the demonstration that the subject device is essentially the same.

8. Sample Size for the Training Set

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

In summary: The provided text is a 510(k) premarket notification for a physical medical device (surgical mesh), not an AI algorithm. The core of such a submission is to argue that a new device is "substantially equivalent" to an already cleared predicate device. Therefore, the questions related to studies, test sets, training sets, ground truth, and expert adjudication, which are typical for AI/algorithm performance evaluations, are not addressed in this type of document. The "acceptance criteria" here are met by the demonstration of material, design, and functional similarity to the predicate device.

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