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The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of side-to-side jejunum-jejunum and ileum-ileum anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows Flexagon SFM Plus OTOLoc is intended for use in adult patients > 21 years.

The Flexagon SFM Plus OTOLoc device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of self-forming magnets and includes the delivery system. The OTOLoc component provides enterotomy preservation for immediate fluidic flow upon implant, while the alternating dipoles of the Flexagon magnet drives magnetic self-alignment to prevent apposition. The anastomosis formation occurs over time once the remodeling of the targeted tissues is complete. The Flexagon magnets compress the opposing tissues which allows the body to dictate the time required for re-epithelialization. Compression and necrosis of tissue is achieved between magnet devices and is created by the polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed, the magnet device is expelled naturally in approximately 3-6 weeks.

The provided text does not contain acceptance criteria or study details for an AI/software device. The document is an FDA 510(k) clearance letter for a physical medical device, the "Flexagon Plus OTOLoc System," which is a magnetic compression anastomosis system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI device meets them, as the input document is not about an AI device.

The document discusses:

• Acceptance criteria (implicitly met through "Pass" results) for various non-clinical performance tests (biocompatibility, sterilization, packaging, shelf-life, magnetic properties, etc.) and animal studies.
• Clinical performance data for the physical device based on patient outcomes, but not related to an AI's diagnostic or assistive capabilities.

To answer your request, I would need a document detailing the clearance of an AI-powered medical device.

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The GI Windows FLEXAGON System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEXAGON is intended for use in adult patients > 21 years.

The FLEXAGON device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of magnets and includes the delivery systems. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed the magnet device is expelled naturally in approximately 3-6 weeks.

I am sorry, but the provided text is an FDA 510(k) clearance letter for a medical device (Self-Forming Magnet - Flexagon). While it discusses device performance and testing, it does not contain the specific details required to answer your full request about acceptance criteria and a study proving the device meets them, especially in the context of an AI/algorithm-based device.

The information you are asking for, such as:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample size and data provenance for a test set.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

These are all critical components of a regulatory submission for AI/Machine Learning-enabled medical devices. The provided document describes a physical medical device (magnetic compression anastomosis system) and its non-clinical and clinical testing, which focuses on aspects like biocompatibility, sterilization, mechanical properties, and animal/cadaver/human clinical use for a surgical procedure.

The document explicitly states on page 10:
"Software
The Flexagon System does not contain software"

Therefore, there is no AI/algorithm component to this device, and thus no data on AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI performance will be found in this document.

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The GT Metabolic MagDI™ System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.

The GT Metabolic MagDI System is intended for use in adult patients > 21 years.

The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis.

After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.

The provided FDA 510(k) summary (K243359) describes the GT Metabolic MagDI System, a magnetic compression anastomosis system. However, it does not explicitly detail acceptance criteria in a structured table or provide information about a study proving the device meets specific acceptance criteria in the way a clinical trial endpoint analysis would. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K242086) through a summary of performance testing and clinical outcomes.

Here's an attempt to extract the requested information based on the provided text, with explicit notes where information is not available:

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

The document does not present explicit acceptance criteria in a table format with corresponding reported device performance values. It discusses performance testing in a narrative form to demonstrate substantial equivalence.

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: The document states, "Clinical testing was conducted in obese patients with or without type 2 diabetes mellitus using the MagDI System for creation of a side-to-side duodeno-ileal anastomosis." It mentions "most of the subjects" for device expulsion but does not provide an explicit numerical sample size for the clinical study. It implies a single study for the clinical data.
• Data Provenance: Not explicitly stated, but the submission is to the U.S. FDA, and a post-market surveillance study is planned for "U.S. patients, representative of the U.S. intended use population." This suggests the clinical data presented might be from the U.S. or a similar regulatory jurisdiction, but it's not confirmed. The study was prospective in nature, as it involved patients using the 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 information is not provided in the document. The "ground truth" (e.g., successful anastomosis, patency, adverse events) was likely established by the treating clinicians and study staff based on clinical observation, imaging, and patient outcomes, but the specific number and qualifications of independent experts for ground truth establishment are not mentioned.

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

This information is not provided in the document.

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

• MRMC Study: No, an MRMC study was not conducted and is not mentioned.
• Effect Size of AI assistance: Not applicable, as this device is a physical medical device (magnetic compression anastomosis system), 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, as this is a physical medical device, not a software algorithm.

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

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

• Outcomes data: Successful placement, alignment, patent anastomoses confirmed by imaging, natural device expulsion, absence of specific adverse events (internal hernia, bowel obstruction, bleeding, leakage, infection, obstruction), and overall safety profile (Clavien-Dindo Classification for AEs).
• Clinical observation and imaging: To confirm anastomoses patency and device expulsion.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The clinical study described in the document served as performance verification for the device in humans.

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

Not applicable, as this is a physical device and there is no "training set" in the context of AI/ML required.

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The GI Windows FLEX SFM System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEX SFM is intended for use in adult patients > 21 years.

The FLEX SFM device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The systems are comprised of magnet devices and include delivery systems. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally (within 3-6 weeks).

Here is an analysis of the acceptance criteria and study information for the FLEX SFM device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document mostly outlines performance tests undertaken rather than explicitly stating pre-defined numerical acceptance criteria for each test and then reporting precise numerical results against those. However, some clinical performance metrics are provided and can be inferred as acceptance criteria for successful anastomosis creation.

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

• Test Set (Clinical Study): N=70 patients.
• Data Provenance: Clinical studies were conducted in Argentina, Canada, Spain, and the United States. This indicates a prospective, multi-country clinical study.
• Test Set (GLP Animal Studies): Porcine model. The exact number of animals is not specified, but it was a "chronic swine anastomosis model" comparing FLEX SFM to controls (60mm linear staple and sutures).

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

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical test set. It mentions "patent anastomosis confirmed radiologically," implying radiologists were involved, but details on their number or experience are absent. For the animal study, histological evaluation and tissue burst pressure tests would typically be assessed by pathologists, but their specific qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for the clinical or animal study data. Outcomes like "successful placement with alignment" and "patent anastomosis confirmed radiologically" imply assessments were made, but the process for resolving disagreements or establishing a definitive ground truth by multiple experts is not detailed.

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, the FLEX SFM is a physical magnetic compression anastomosis system, not an AI software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

This question is not applicable as the device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Clinical Study: Inferred ground truth includes:
  • Radiological Confirmation: For patent anastomoses.
  • Clinical Observation: For magnet alignment, expulsion, and occurrence/severity of adverse events.
  • Surgical Observation/Reporting: For successful placement.
• GLP Animal Studies:
  • Histology: For architecture of healed tissue.
  • Mechanical Testing: Tissue burst pressure.
  • Direct Observation: For usability, safety, and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable as the FLEX SFM device is a physical medical device and does not involve AI/machine learning models that require a "training set."

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

This question is not applicable as the FLEX SFM device is a physical medical device and does not involve AI/machine learning models that require a "training set."

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The GT Metabolic MagDI System is intended for use in the creation of side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.

The GT Metabolic MagDI System is intended for use in adult patients > 21years.

The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis.

After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.

The provided text is a 510(k) Summary for the GT Metabolic MagDI System. It describes the device, its intended use, and summarizes performance testing to support its substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria or a detailed study proving the device meets specific acceptance criteria with reported performance metrics in a readily extractable format.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:

• Same intended use and indications for use.
• Same or similar technological characteristics (with specified changes).
• Performance testing (pre-clinical and clinical summaries).

Here's an attempt to answer your questions based on the available information, noting where information is not present in the document:

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

The document does not explicitly state acceptance criteria in a quantitative table format. It describes the findings of tests performed, which imply successful outcomes but don't define the pre-established thresholds for those successes.

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: The clinical testing summary states, "The Magnets were successfully placed in all cases... and for all subjects reaching the one-month study visit, the device passed naturally as a set of connected Magnets..." This phrasing implies that "all cases" or "all subjects" were monitored, but the exact number of subjects for the clinical test set is not provided in this document.
• Data Provenance:
  • Country of Origin: Not specified in the given text.
  • Retrospective or Prospective: "Clinical testing was conducted in obese patients with or without type 2 diabetes mellitus using the MagDI System for creation of a side-to-side duodeno-ileal anastomosis." This describes an active study (prospective).

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 provided in the document. The document summarizes clinical outcomes without detailing the mechanism or personnel involved in establishing "ground truth" for those outcomes beyond standard clinical observation and reporting.

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

This information is not provided in the document.

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

• MRMC Study: No, the device is a physical medical device (Magnetic Compression Anastomosis System), not an AI/software device that involves "human readers" interpreting data. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this device's evaluation and was not performed.

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

• No, this is a physical medical device, not a standalone algorithm.

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

For the clinical testing, the "ground truth" seems to be based on:

• Clinical observation/outcomes data: Successful placement, alignment, natural passage of the device, incidence of adverse events (SAEs, internal hernia, bowel obstruction, anastomotic bleeding, leakage, infection, obstruction, deaths), and assessment of patent anastomoses.
• Imaging/surgical observation (implied): To confirm placement and alignment.

8. The sample size for the training set

This information is not provided in the document. The document details a clinical test (performance evaluation) but does not mention a "training set" in the context of device development, which is typically relevant for machine learning algorithms.

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

Not applicable, as no training set (for an algorithm) is mentioned in the document.

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The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.

The GT Metabolic MagDI System is intended for use in adult patients > 21 vears.

The MagDI System is comprised of two (2) GT Metabolic DI Magnet ("Magnet") devices delivered sequentially with a minimally invasive GT Metabolic Delivery System ("Delivery System"). Class I magnetic surgical instruments (GT Metabolic Laparoscopic Positioning Device: FDA Listing #D512834) are used to position the Magnets to the target anastomosis locations in the duodenum and ileum and connect the two Magnets. The device provides a method for the creation of a round (oval/circular) compression anastomosis.

After a period of approximately 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.

The MagDI System components (Magnets and Delivery System), as shown in Figures 1 and 2 below, are provided sterile and are for single use.

Acceptance Criteria and Device Performance Study for MagDI System

1. Table of Acceptance Criteria and Reported Device Performance

The clinical study's primary endpoint focused on feasibility and performance. The acceptance criteria were:

Note: The document also details extensive pre-clinical (bench and animal) testing with their own acceptance criteria, all of which were reported as "Pass." For brevity, only the clinical performance acceptance criteria are included in this table.

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

• Sample Size: 49 subjects.

• Data Provenance: The data was collected from a multi-center, open-label, two-stage clinical study (MAGNET Study, GTM-001 / NCT05322122). The study was conducted retrospectively (based on the date of data closure) across four centers in:

  • Belgium
  • Canada
  • Republic of Georgia
  • Spain

  The study involved follow-up durations of 3, 6, 9, and 12 months, indicating a prospective data collection approach from the start of the study, even though the report itself is a summary of already collected data.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish all aspects of clinical ground truth for the test set. However, for radiological confirmation of patent anastomoses, it can be inferred that qualified radiologists were involved. For surgical assessments and adverse event adjudication, surgeons and other medical professionals at the study sites were involved.

4. Adjudication Method for the Test Set

The document does not explicitly describe a specific adjudication method like "2+1" or "3+1" for establishing ground truth for the test set outcomes. However, safety outcomes, specifically the relationship of adverse events to the study device and procedure, were classified as "Possible, Probable, Definite, or Indeterminate" by clinicians. Events assessed as "probable or definite" were categorized as "Related" for causality in the report. This implies an internal adjudication process based on clinical assessment at the study sites.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned for the MagDI System. The device's primary clinical study did not compare its performance against human readers with or without AI assistance. The study design focused on the feasibility and safety of the device itself.

6. Standalone (Algorithm Only) Performance Study

The MagDI System does not contain software, as explicitly stated in the document. Therefore, a standalone (algorithm only) performance study was not applicable and not performed. The device is a mechanical system.

7. Type of Ground Truth Used

The ground truth for the clinical effectiveness endpoints was primarily based on:

• Radiological confirmation: To confirm the creation of a patent anastomosis.
• Direct observation/Clinical assessment: For device placement, alignment, and natural passage.
• Clinical assessment/Medical records: For the incidence and severity of adverse events, hospital stay, and device expulsion time.

8. Sample Size for the Training Set

The clinical study (MAGNET Study) served as the primary data for evaluating the device's performance related to its indications for use. There is no mention of a separate "training set" in the context of machine learning, as the device does not employ AI/machine learning. The 49 subjects in the clinical study are effectively the "test set" for regulatory evaluation.

9. How Ground Truth for the Training Set Was Established

As the device does not use AI/machine learning and thus has no "training set" in that context, this question is not applicable. The clinical study data was collected and evaluated as described in point 7.

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