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ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel and colorectal procedures.

Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line.

The Subject Device is to be used Echelon Endopath GST 60 mm reloads in conjunction with the Echelon family of 60 mm endoscopic linear cutters. The Echelon 60 mm Stapler in conjunction with the Echelon Endopath GST60 mm reload places staggered rows of titanium staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple line reinforcement material which is secured to the stapler anvil and reload with a synthetic attachment material. The Subject Device contains an applicator and the implantable device which consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process.

Echelon Endopath Staple Line Reinforcement is composed of undyed multifilament fibers identical to those used in Vicryl surgical sutures. The polyglactin 910 implant is knitted by a process which interlocks each fiber juncture to prevent unraveling. The implanted material consists of a Vicryl layer laminated with a PDO film on each side, and a Buttress Attachment Material which is a synthetic material applied to the top outer surface of each implant. The staple line reinforcement is used as a buttress to provide support during the healing process. Both Subject and Predicate materials are hydrolyzed by body fluids and absorbed after serving the intended function. The subject Device absorption is essentially complete at 120 days.

The primary difference between the Subject and Predicate Devices is the feature for loading and delivery of the device to the implantation site. A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device and is composed of a synthetic polymer/poloxamer blend to attach the Subject Device to the stapler. Whereas the Predicate Device utilized a sleeve construction and suture pullcord to secure the reinforcement material on the stapler.

The provided text pertains to a 510(k) premarket notification for a medical device, the Echelon Endopath Staple Line Reinforcement. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than clinical studies involving human patients. Therefore, information typically associated with AI/ML device evaluations (such as sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for training sets) is not present.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance tests conducted to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't present acceptance criteria in a quantitative table with specific pass/fail values. Instead, it describes various performance tests conducted to demonstrate equivalence to the predicate device. The "reported device performance" is the successful completion of these tests, confirming the device functions as intended and is comparable to the predicate.

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

• Sample Sizes: The document does not specify the exact sample sizes (number of devices, number of animal subjects) used for each ex-vivo and in-vivo test. It generally refers to "studies with animal models" and various "evaluations."
• Data Provenance: The data is generated from preclinical (ex-vivo and in-vivo animal studies) conducted by the manufacturer, Ethicon Endo-Surgery, LLC. No country of origin is explicitly stated for the testing, but it's presumed to be within the manufacturer's operational locations or accredited testing facilities. The data is prospective in the sense that these tests were specifically designed and executed to support this 510(k) submission. There is no mention of retrospective human data.

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

This information is not applicable to this 510(k) submission. The "ground truth" in this context is established by physical measurements for ex-vivo tests and observable physiological responses/outcomes in animal models for in-vivo tests. There are no human experts "adjudicating" a test set for diagnostic accuracy as would be the case for an AI/ML device. The experts involved would be the engineers, scientists, and veterinarians conducting and interpreting the non-clinical studies.

4. Adjudication Method for the Test Set

This is not applicable in the context of an AI/ML device's human reader adjudication. For non-clinical studies, "adjudication" typically refers to the rigorous interpretation of test results by qualified personnel (e.g., pathologists reviewing tissue samples from animal studies, engineers analyzing mechanical test data) according to established protocols and scientific principles.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive devices where human readers' performance is augmented by AI. The Echelon Endopath Staple Line Reinforcement is a surgical implant, not an AI/ML diagnostic or assistive tool.

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

No, a standalone performance evaluation in the context of an AI/ML algorithm was not done. The device is a physical surgical implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation comprises:

• Quantitative measurements and physical properties: For ex-vivo tests (e.g., thickness, porosity, tensile strength, staple height, burst strength).
• Physiological and histological observations in animal models: For in-vivo tests (e.g., assessment of hemostasis, tissue healing response, absence of adverse tissue reactions, degradation profile).
• Adherence to established biocompatibility standards: ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" for an AI/ML algorithm. For the non-clinical studies, the "ground truth" (i.e., expected performance and characteristics) is derived from scientific principles, engineering specifications, and comparison to the predicate device's established performance.

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SeriScaffold™ surgical mesh is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.

SeriScaffold surgical mesh is a knitted, multi-filament, bioengineered, silk mesh. It is mechanically strong, biocompatible, and long-term bioresorbable. SeriScaffold surgical mesh is a sterile, single use only mesh and is supplied in a variety of shapes and sizes ready for use in open or laparoscopic procedures. The device is flexible and well suited for delivery through a laparoscopic trocar due to its strength, tear resistance, suture retention, and ability to be cut in any direction. SeriScaffold surgical mesh provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold-like) construction of its mesh.

The provided text is a 510(k) summary for a medical device called "SeriScaffold™ surgical mesh." It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing, biocompatibility testing, and an in vivo rabbit study.

However, the provided document does not contain the specific type of information requested regarding acceptance criteria, reported device performance in those terms, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies.

The document instead focuses on demonstrating substantial equivalence through:

• Bench testing: "Results from performance testing based on 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh', March 2, 1999 demonstrates substantial equivalence of SeriScaffold surgical mesh to predicate surgical mesh products." These likely cover properties like tensile strength, suture retention, and tear resistance, which are typical for surgical mesh.
• In vitro bioresorption study: "Results from an in vitro bioresorption study characterize the bioresorption properties of SeriScaffold surgical mesh versus Vicryl Mesh which support the long-term bioresorption property of SeriScaffold surgical mesh."
• Biocompatibility testing: "Biocompatibility was conducted according to internationally recognized standards and all results indicate the device is biocompatible."
• In vivo rabbit study: "Data from an in vivo rabbit study further support the bioresorption and biocompatibility properties of the device."

Since the request is specific to an AI/ML device evaluation structure (e.g., acceptance criteria for a diagnostic performance, MRMC study effect sizes), and this document is for a physical surgical mesh, the requested information categories are not directly applicable or present in the provided text.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device evaluation as the document describes a traditional medical device submission (surgical mesh) that does not involve artificial intelligence, machine learning, or diagnostic performance metrics with human readers.

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PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.

PREVADH™ Mesh is sterile and can be anchored. It has three component layers: one porous side made of lyophilized porcine collagen; one non-porous smooth side made of porcine collagen, polyethylene glycol and glycerol; and a multifilament polylactic acid mesh inserted between the two collagen layers. The porous side is soft and hydrophilic, and combined with the highly porous mesh, allows for fast tissue in-growth. The nonporous smooth side minimizes visceral attachment. The entire PREVADH™ Mesh device resorbs. The porous side is resorbed in less than 1 week and the non-porous smooth side is resorbed in approximately 3 weeks. The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period.

This submission describes the PREVADH™ Mesh, a resorbable surgical mesh indicated for temporary wound support in abdominopelvic surgery. The device consists of three layers: a porous porcine collagen side, a non-porous layer of porcine collagen, polyethylene glycol, and glycerol, and a multifilament polylactic acid mesh inserted between the collagen layers.

Here's an analysis of the provided information regarding acceptance criteria and supportive studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Bench and animal testing has been conducted to evaluate the performance characteristics of PREVADH™ Mesh."

• Sample Size for Test Set: Not specified. The document only mentions "Bench and animal testing."
• Data Provenance: Not specified. It's common for animal studies for device clearance to be conducted in-house or by contract research organizations, but the specific origins are not detailed. These studies are typically prospective.

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

No mention of human experts establishing ground truth for the "Bench and animal testing." The evaluations appear to be objective measurements (e.g., mechanical properties, resorption rates, tissue response in animals).

4. Adjudication Method for the Test Set:

Not applicable, as there's no mention of human-involved assessment in the "Bench and animal testing" that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, and its evaluation focuses on material properties, biocompatibility, and animal efficacy, not interpretation of medical images by multiple readers.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

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

7. Type of Ground Truth Used:

The ground truth for the performance claims appears to be based on:

• Objective Measurements: Mechanical property tests, resorption rate measurements.
• Animal Observations: Assessment of tissue in-growth, visceral attachment minimization, and overall biological response in animal models.
• Material Standards: Compliance with ISO 10993-1 and/or USP standards for biocompatibility.

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable, as this is not an AI/ML device requiring a training set.

Summary of Study and Justification for Equivalence:

The 510(k) submission for PREVADH™ Mesh relies on demonstrating substantial equivalence to legally marketed predicate devices: PARIETEX™ COMPOSITE (PCO) Mesh (K040998), Ethicon, Inc. VICRYL Mesh (K810428), and UGYTEX™ Mesh (K033376).

The studies conducted to support this claim include:

• Bench Testing: To evaluate mechanical properties and similarity to predicate VICRYL Mesh.
• Animal Testing: To assess performance characteristics such as tissue in-growth and minimization of visceral attachment, which are key functions of the device, particularly the hydrophilic film (similar to the PCO Mesh predicate).
• Biocompatibility Testing: Materials shown to be in compliance with ISO 10993-1 and/or USP standards.

The acceptance criteria are implied by the desired functional characteristics of a surgical mesh (biocompatibility, appropriate mechanical strength, desirable resorption profile, and minimization of adhesions), and the performance data presented aims to show that the PREVADH™ Mesh meets these characteristics and performs similarly to its predicate devices. The submission concludes that the technological characteristics are similar to the predicate devices, thereby supporting substantial equivalence for its intended use.

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