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Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.

The provided document is a 510(k) summary for a medical device called "Standard Staple-Line Reinforcement (SSLR23)". It describes the device, its intended use, comparison to a predicate device, and a summary of performance testing. However, it does not include information about acceptance criteria and reported device performance in a table format, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested.

The document states: "Pre-determined performance specifications were evaluated, tested and verification/validation activities were completed to demonstrate that the subject device... met the defined criteria. Testing on the subject device included reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility per applicable parts of ISO 10993-1, Biological evaluation of medical devices. Sterilization and packaging validation activities were also completed to support this submission."

It also explicitly says: "No clinical studies were required to support this 510(k) submission."

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a detailed study with specific acceptance criteria and performance metrics for a standalone device or comparative effectiveness.

Here's a breakdown of why I cannot fulfill each requested point:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. While it mentions "pre-determined performance specifications were evaluated" and "met the defined criteria", it does not list these criteria or the specific performance results in detail.
2. Sample sized used for the test set and the data provenance: This is not specified. The document mentions "testing on the subject device" but gives no details about sample sizes or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-driven ground truth establishment for a test set is mentioned. The testing appears to be primarily engineering/laboratory-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no adjudication process involving human review of test set results is 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. The device is a "Staple-Line Reinforcement" which is a physical surgical mesh, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states that "No clinical studies were required to support this 510(k) submission," implying that the testing was primarily non-clinical (e.g., bench testing, biocompatibility). It doesn't detail standalone performance in a clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, as the testing described ("reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility, sterilization and packaging validation activities") would likely rely on physical measurements and standardized test methods rather than clinical ground truth sources like pathology or outcomes data.
8. The sample size for the training set: Not applicable. The device is a physical medical device, not an AI/machine learning algorithm requiring 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.

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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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NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

NEOVEIL® Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid (PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.

This document is a 510(k) summary for a medical device called NEOVEIL® Staple Line Reinforcement. It outlines a Special 510(k) submission, meaning the device is largely similar to a previously cleared predicate device with minor modifications. As such, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing rather than new extensive clinical studies.

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

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

The document does not explicitly provide a table of acceptance criteria with numerical targets. Instead, it states that "The performance testing validated that NEOVEIL® Staple Line Reinforcement meets its product specification and performs as intended. Results confirm that the specification requirements for the subject device have been met."

The performance tests conducted include:

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 does not specify the sample size used for each of the internal tests. The testing was described as "simulated usability testing on final finished versions of NEOVEIL®™ using a relevant mechanical stapler." The data provenance is "internal GUNZE test methods," implying the testing was conducted by Gunze Limited. The country of origin for the data is not explicitly stated, but Gunze Limited is based in Japan. The testing described is prospective, as it was conducted to validate the modified 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)

This section is not applicable as the evaluation involved non-clinical performance testing of a physical device, not an AI or diagnostic tool where expert ground truth would be established.

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

This section is not applicable as the evaluation involved non-clinical performance testing of a physical device.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a physical medical device (staple line reinforcement), not an AI diagnostic tool. The "usability" mentioned refers to the device's interaction with a stapler, not human interpretation.

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

A standalone performance study was not applicable. This device is a physical product, not an algorithm.

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

The "ground truth" for the non-clinical performance testing was the product specifications and intended performance as defined by Gunze's internal test methods. The tests verified if the device functioned correctly (e.g., stapler insertion, firing, and staple formation) under simulated conditions.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as above.

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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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GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It is also intended to be used for remforcement of suture lines and staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The subject of this 510(k) pre-market notification is a modification to the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Configured for Endoscopic Surgical Staplers (EBSG, also referred to as the predicate) to include altered bioabsorbable sheet geometries, tailored lattice stitching, and inner dimension geometry for both the cartridge and anvil devices. The cartridge and anvil devices were specifically designed to fit the geometry of the Intuitive SureForm 60™ mm staplers (K173721 cleared July 5, 2018) Black, Green and Blue cartridge reloads. GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers (EBSG-R, also referred to as the modified device) possesses the same fundamental scientific technology as the predicate. No other physical modifications were made to the predicate device, and the implantable materials of the modified device and predicate are the same synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer (PGA:TMC).

The provided text describes a 510(k) premarket notification for a medical device, the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement. However, it does not contain information about a study that assesses the performance of an AI-powered device against specific acceptance criteria, nor does it detail and of the requirements listed in points 2-9 of your prompt.

The document is a regulatory submission for a physical medical device (a staple line reinforcement material), not a software or AI device. Therefore, it focuses on demonstrating substantial equivalence to a predicate device through pre-clinical bench testing, and explicitly states that "No clinical evaluations were required to support this submission."

As such, it is not possible to extract the requested information (acceptance criteria for an AI device, sample sizes, expert qualifications, MRMC study details, ground truth methods, training set details) from this document.

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GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.

This document is a 510(k) premarket notification for a medical device (GORE® SEAMGUARD® Reinforcement), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample sizes, ground truth, expert opinions, MRMC studies, standalone performance, training sets), and adjudication methods for an AI/ML device is not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria using AI/ML methodology.

Here's what can be extracted from the document regarding the device's evaluation, framed in the context of the prompt's request, but clearly indicating the differences:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a list of specific, quantifiable acceptance criteria with corresponding numerical performance metrics as would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to a predicate device through various tests.

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

• Test Set Sample Size: Not explicitly stated with a numerical value. The document mentions "deployment reliability testing under simulated use conditions," which implies testing on a sample of devices, but the number of devices or trials is not provided.
• Data Provenance: The "Pre-Clinical: Bench study" implies testing performed in a laboratory setting, likely within the manufacturer's facilities. It is a prospective test specifically conducted for this submission.

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

• Not Applicable. This type of information is typically relevant for studies involving human interpretation (e.g., radiology images). The testing described here is a bench study evaluating mechanical/functional performance, which does not involve "ground truth" established by experts in the context of a diagnostic interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a bench test for mechanical/functional performance (deployment reliability), no adjudication method (like 2+1 or 3+1 for expert discrepancies) is described or relevant.

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

• No. An MRMC study is for evaluating human reader performance, often with AI assistance (e.g., radiologists interpreting images). This device is a surgical reinforcement material, and its evaluation did not involve human readers interpreting cases.

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

• Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The "bench study" is analogous to a standalone functional test for the physical device.

7. The Type of Ground Truth Used:

• For the "deployment reliability testing," the "ground truth" would be the successful or unsuccessful deployment of the device as per pre-defined functional specifications, measured by objective metrics in a simulated environment. It is based on engineering specifications and direct observation of device function rather than expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not Applicable. There is no training set for this device.

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NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with suture or staple line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

As packaged, NEOVEIL™ is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL TM are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL™ staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL™ is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m²).

The provided text describes a 510(k) submission for a medical device called NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against acceptance thresholds. Therefore, the concept of "acceptance criteria" as typically applied to performance claims (e.g., specific sensitivity/specificity targets for an AI algorithm) is not present. Instead, the "acceptance criteria" are implied by the comparison of technological characteristics and performance testing against a predicate device.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" in the context of substantial equivalence:

Table of Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a bench and in vivo animal testing to demonstrate substantial equivalence, not a study involving human subjects or AI performance. Therefore, many of your requested points related to AI algorithms, human readers, and ground truth in a clinical context are not applicable.

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

   • Test set size: Not explicitly stated in terms of number of samples for each test, but general in-vitro and in-vivo testing was performed.
   • Data provenance: Not explicitly stated, but it would be from internal lab testing (in vitro) and animal studies (in vivo). No information about country of origin of data is provided beyond the submitting company being from Japan. The studies are prospective in nature (designed to demonstrate equivalence).

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

   • Not applicable as this is a device based on material property testing and animal studies, not expert-adjudicated clinical data to establish diagnostic ground truth. The "ground truth" here is the performance of the predicate device and established engineering/biological benchmarks.

3. Adjudication method for the test set:

   • Not applicable for this type of device submission. Performance is measured against physical and biological parameters, not through expert adjudication of qualitative outcomes.

4. 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. This is not an AI device.

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

   • No. This is not an AI device.

6. The type of ground truth used:

   • For in vitro tests: Physical and mechanical property measurements (e.g., tensile strength, thickness, density, stiffness) are compared against the known properties of the predicate device and/or defined engineering standards.
   • For in vivo tests: Biological responses and functional performance in animal models (e.g., free bleed, air leak, burst, resorption rates) are compared against observations with the predicate device or accepted physiological norms for successful surgical repair.

7. The sample size for the training set:

   • Not applicable. There is no AI model to train.

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

   • Not applicable. There is no AI model to train.

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GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: GORE® SEAMGUARD® Reinforcement (K131658)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not explicitly state a numerical sample size for the "simulated use performance testing" (bench study) or the "in vivo safety studies" (animal study). It mentions "testing" and "studies" in plural, implying multiple tests/animals, but no specific numbers are given.
• Data Provenance:
  • Bench Study: Not specified, but generally performed in a laboratory setting.
  • Animal Study: Animal data (in vivo). The country of origin for the studies is not specified. Both studies are prospective as they were conducted specifically for this 510(k) submission.

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

• This information is not provided in the summary. The evaluations appear to be objective measurements (e.g., performance metrics in bench testing, histological analysis in animal studies) rather than interpretations requiring expert consensus on a subjective ground truth.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth establishment method (if any) is not specified as requiring adjudication.

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

• No. This device is a medical implant (staple line reinforcement material), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Not applicable. This device is a passive implant; it does not involve any algorithms or AI to be evaluated for standalone performance.

7. The Type of Ground Truth Used:

• Bench Study: The "ground truth" for the simulated use performance testing would be objective measurements and observations of the device's functional characteristics (e.g., successful loading, secure attachment, integrity after stapling, comparison to predicate device performance specifications).
• Animal Study: The "ground truth" for biocompatibility and in vivo safety studies would be:
  • Biocompatibility: Conformance to ISO 10993-1 standards, which involve specific tests for cytotoxicity, sensitization, irritation, etc.
  • In Vivo Safety: Histological analysis of tissue response (e.g., inflammation, foreign body reaction) and clinical observation of device-related complications in animal models. The comparison was made to the predicate device's expected tissue response.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set is involved for this type of medical device.

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