(98 days)
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:
| Protocol Feasibility/Performance Criteria | Acceptance Criteria (target) | Reported Device Performance |
|---|---|---|
| Placement of the device with ≥90% alignment of Magnets | Successfully placed in all subjects | 49 (100%) |
| Passage of the device without invasive re-intervention | Passage without re-intervention | 49 (100%) |
| Creation of a patent anastomosis confirmed radiologically | Confirmed radiologically | 49 (100%) |
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
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Sample Size: 49 subjects.
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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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