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LTM-Perforated Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/ or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM-Perforated Surgical Mesh is intended for single patient one-time use only.

LTM-Perforated Surgical Mesh is a surgical mesh that is derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration, and is sterilized via electron beam irradiation. The device is considered a single use device which is to be used in a healthcare facility or hospital.

The subject device shares the same underlying scientific design as a porcine derived acellular dermal matrix, and has the same Intended Use, Indications for Use, and principles of operation as the cleared predicate device, LTM-Surgical Mesh (K070560). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a pre-defined pattern of perforations throughout the tissue matrix.

The document is a 510(k) premarket notification for the LTM-Perforated Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device, LTM-Surgical Mesh (K070560), rather than providing acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic AI.

However, based on the provided text, I can extract information related to "acceptance criteria" (in this case, performance specifications for substantial equivalence) and the "study" (bench testing) used to support the claim.

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

1. Table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria or performance values for the LTM-Perforated Surgical Mesh. Instead, it states that the device "maintains similar mechanical properties and meets the established specifications as the predicate device." The "acceptance criteria" are implied by the listed bench tests and the goal to be "substantially equivalent" to the predicate.

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

• Sample Size: The document does not specify the sample size for the bench testing performed. It refers to "relevant elements" of the FDA guidance for test performance.
• Data Provenance: The bench testing was performed on the "subject LTM-Perforated Surgical Mesh device." It implies in-house testing by the manufacturer (LifeCell Corporation). The type of data is physical/mechanical test results.

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

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device where expert assessment of "ground truth" (e.g., image interpretation) would be relevant. The "ground truth" for this device's performance is established by objective physical and mechanical tests against defined standards and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device requiring expert 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

Not applicable. This is a medical device (surgical mesh) and not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (surgical mesh) and not an AI algorithm.

7. The type of ground truth used

For the bench testing, the "ground truth" is established by:

• Objective physical and mechanical measurements.
• Adherence to recognized industry standards (ASTM D5735-95 for Tear Resistance, ASTM D6797-07 for Burst Strength).
• Comparison to the established performance specifications and characteristics of the legally marketed predicate device (LTM-Surgical Mesh K070560).
• Prior biocompatibility and viral inactivation data from the predicate device, which is deemed applicable due to identical raw materials and manufacturing processes (except for the perforations).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

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The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien.

The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

This document describes a 510(k) premarket notification for the "Diaphragmatic Hernia Graft" manufactured by Cook Biotech Incorporated. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Diaphragmatic Hernia Graft are primarily demonstrated through substantial equivalence to predicate devices in terms of intended use, materials, and technological characteristics. The performance is assessed across several categories:

• Direct contact in vitro hemolysis
• Cytotoxicity
• Muscle implantation
• Acute intracutaneous reactivity
• Skin irritation
• ISO Sensitization
• Acute systemic toxicity
• Pyrogenicity
• LAL endotoxins
• Subchronic systemic toxicity | "The results of these tests provided evidence that the Diaphragmatic Hernia Graft meets biocompatibility requirements of the ISO standard." (ISO 10993-1 compliant) |
  | Mechanical Strength | - Suture retention strength
• Burst strength
• Tensile strength
• Stiffness | "The results of the mechanical testing provide evidence that the Diaphragmatic Hernia Graft possesses adequate mechanical strength for its application." |
  | Safety and Biocompatibility (Animal Studies) | Animal studies for diaphragmatic/hiatal hernia repair using SIS material. | "These animal studies provide evidence that the Diaphragmatic Hernia Graft is biocompatible and safe in its application." |
  | Clinical Performance (Human Studies) | Assessment of Surgisis (same base material) in several clinical studies. Further clinical evidence for rectangular flat sheet and U-shape configurations. | "The clinical outcomes of these studies show that the SIS material, which comprises the Diaphragmatic Hernia Graft, is safe and biocompatible."
  "Further clinical evidence was submitted showing that the rectangular flat sheet and U-shape configurations of the Diaphragmatic Hernia Graft performed adequately in patients." |
  | Substantial Equivalence | Comparison to predicate devices (SIS Hernia Repair Device, Surgisis Staple Line Reinforcement, Permacol Surgical Implant) in terms of intended use, material, dimensions, and thickness. | The document concludes: "The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Diaphragmatic Hernia Graft show that the device is substantially equivalent to its predicates." |

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

The document does not explicitly state the numerical sample sizes for the "test set" in the traditional sense of a randomized controlled trial comparing the new device against a control. Instead, it relies on:

• Biocompatibility Testing: Performed on "sterilized SIS devices," which are "identical in base material to the Diaphragmatic Hernia Graft." The specific number of samples for each test is not detailed.
• Mechanical Testing: Performed on "The Diaphragmatic Hernia Graft material." The specific number of samples for each test is not detailed.
• Animal Testing: The SIS material has been "tested in animal studies for diaphragmatic/hiatal hernia repair." No specific sample size (number of animals) or data provenance (country, retrospective/prospective) is provided.
• Clinical Testing: Refers to "several different clinical studies" for Surgisis (same base material) and "further clinical evidence" for the specific configurations of the Diaphragmatic Hernia Graft. No specific sample sizes, patient demographics, or data provenance (country, retrospective/prospective) are provided for these studies.

This submission focuses on demonstrating substantial equivalence by referring to existing data on the constituent material (SIS) and limited, non-comparative clinical data specific to the device's configurations, rather than a single, large-scale comparative test set for the new device.

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

This type of information (number and qualifications of experts for ground truth establishment) is not applicable or provided in this 510(k) submission. Medical device submissions for materials like surgical mesh typically rely on objective measurements (e.g., mechanical strength, biocompatibility assays) and clinical outcomes (e.g., healing, adverse events) rather than expert consensus on subjective interpretations like image analysis.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretations (e.g., radiology reads). This is not relevant to the types of tests (biocompatibility, mechanical, animal studies, general clinical outcomes) described for the Diaphragmatic Hernia Graft.

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

No MRMC comparative effectiveness study is mentioned or appears relevant to this type of medical device (surgical mesh). This study design is typically used for diagnostic or screening devices where human readers interpret medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Not applicable. The Diaphragmatic Hernia Graft is a physical surgical mesh, not an algorithm or AI system. Therefore, an algorithm-only standalone performance study was not conducted or mentioned.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Diaphragmatic Hernia Graft is established through a combination of:

• Objective Test Results: Biocompatibility test results (e.g., specific assay outcomes), mechanical strength measurements (e.g., numerical values for suture retention, burst strength).
• Histopathological & Biological Observations: Observations from animal studies and clinical studies regarding tissue integration, inflammatory response, and healing, though specific details are not provided.
• Clinical Outcomes Data: Safe and biocompatible performance, as evidenced in clinical studies, likely including absence of severe adverse events, successful repair, and tissue reinforcement. This is referenced as "clinical outcomes."

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The data supporting its safety and efficacy comes from prior biocompatibility, mechanical, animal, and clinical studies of the material (SIS) and the device configurations.

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

Not applicable, as there is no "training set" as understood in AI/ML. The "ground truth" for the underlying scientific understanding of SIS material and the performance of surgical meshes is established through standard scientific and regulatory practices, including:

• Peer-reviewed scientific literature: Supporting the properties and biological interaction of SIS.
• Industry standards: Such as ISO 10993 for biocompatibility.
• Pre-clinical research: Animal models for hernia repair.
• Prior clinical experience: With predicate devices and the SIS material, often documented in clinical registries or studies.

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The DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

The Restore Orthibiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a bionaterial desived from porcine small intestine. SIS is composed presionshately of water and collagen. This material to the material approved in IDF. G960196 for investigational use as an Anterior Cruciate Ligament (ACL) replacement device and submitted in K974540 for Hernia Repair. The device is intended to act as a resorbable scaffold which initially has sufficient mechanical strength to assist with a soft tissue repair, but then resorbs and is replaced by the patients own tissue.

The provided text is a 510(k) submission summary for the DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information, which is relevant to AI/ML device testing, is not applicable to this document.

However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

1. A table of acceptance criteria and the reported device performance
   This information is not explicitly provided in the context of specific quantitative acceptance criteria and device performance metrics, as is common for AI/ML device evaluations. The document focuses on showing "comparable" mechanical properties to predicate devices.

   Acceptance Criteria (Implied)	Reported Device Performance
   Comparable suture retention strength	Restore Orthobiologic Soft Tissue Implant and BioVascular Supple Periguard have comparable suture retention strength.
   Comparable mechanical strength (ball burst tests)	Restore Orthobiologic Soft Tissue Implant and BioVascular Supple Periguard have comparable mechanical strength as measured by ball burst tests.
   Biocompatibility (ISO 10993 and other standards)	Biocompatibility tests, performed according to ISO 10993, other accepted standards and other appropriate test methods indicate that the SIS material is biocompatible.
   Efficacy for soft tissue repair/replacement (animal studies)	Numerous animal efficacy studies indicate that SIS, in various configurations, is efficacious when used for soft tissue repair or soft tissue replacement.
   Absence of rejection	In all animal studies, the SIS implant served as a scaffold for new tissue formation and no evidence of rejection of the material was observed.

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

   • Sample Size for Test Set: Not applicable. The document refers to "numerous animal efficacy studies" but does not specify a sample size for an overall "test set."
   • Data Provenance: The studies are described as "animal efficacy studies." No country of origin is specified. The nature of these studies (e.g., retrospective or prospective) is not detailed.

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. The ground truth for this type of device (surgical mesh) is typically established through histopathological analysis in animal studies and clinical outcomes, not expert consensus reading of images or diagnoses. No information on experts establishing ground truth is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. Adjudication methods are typically relevant for human-read interpretations (e.g., medical image analysis) where multiple experts assess cases. This document describes material and animal studies.

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 is not an AI/ML device and therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Based on the description of "animal efficacy studies," the ground truth would inherently involve:

   • Pathology/Histology: Assessing new tissue formation, scaffold resorption, inflammation, and integration in animal models.
   • Outcomes Data (Animal Models): Functional outcomes related to the repair (e.g., strength of repair, recurrence of defect).

8. The sample size for the training set
   Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the sense of machine learning. The "numerous animal efficacy studies" that establish efficacy of SIS material generally pre-date this 510(k) submission, serving as foundational evidence for the material's properties and performance.

9. How the ground truth for the training set was established
   Not applicable. As above, there is no training set mentioned in the context of AI/ML. The evidence used to support the device's efficacy and substantial equivalence comes from scientific studies and established material characteristics of SIS.

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