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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 of this 510(k) is the same as the Predicate Device with a modification to the labeling to include the addition of the Intuitive Surgical SureForm™ 60 mm Blue, Green and Black Reloads and SureForm™ 60 mm Stapler 510(k) Cleared K173721 as compatible devices. The Predicate Device is compatible with the Echelon Flex™ 60 mm Powered Plus Articulating Endoscopic Linear Cutters with Echelon Endopath 60 mm Endoscopic Linear Cutter Reloads with Gripping Surface Technology, (510k cleared K202665, K183435). There are no design or manufacturing changes associated with this submission.

The Subject Device is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of 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 both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive 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. There are no modifications to the predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch.

The provided information is for the ECHELON ENDOPATH Staple Line Reinforcement device. This submission is a 510(k) premarket notification, indicating that the device is claiming substantial equivalence to a predicate device, rather than presenting novel clinical study data for a new device. The "study" mentioned mainly refers to bench testing for compatibility.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All bench studies passed the criteria for success," but it does not explicitly list the specific numerical acceptance criteria (e.g., a minimum force in Newtons for shear force) for each test. Instead, it confirms that the device met whatever criteria were predefined for these tests.

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

The document only mentions "bench testing." It does not specify sample sizes for individual tests. The data provenance is laboratory/bench testing, not human or animal data. Therefore, details like country of origin for data or retrospective/prospective do not apply in the context of this bench study.

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

Not applicable. This was a bench study, not an expert-driven clinical evaluation. The "ground truth" would be the engineering specifications and performance thresholds set for the device's mechanical properties, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This was a bench study with objective measurements, not a test involving human interpretation 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

No a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a mechanical staple line reinforcement, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a passive mechanical component, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench testing would be established by the engineering and design specifications for the device's mechanical properties and compatibility requirements with the staplers. This typically involves objective physical measurements and established test methods, not expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.

8. The Sample Size for the Training Set

Not applicable. There is no information in the document about a "training set" as this is a mechanical device, not an AI or machine learning model.

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

Not applicable, as there is no training set.

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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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