(122 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 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.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in doc) | Reported Device Performance (as described in the document) |
|---|---|---|
| Biocompatibility | Device materials are biocompatible. | "Biocompatibility testing demonstrated the device is biocompatible according to ISO 10993-1." |
| Magnetic Field Safety | Distances from magnets are safe for patients and users with ferromagnetic implants/devices. | "Magnet field strength testing characterized the distances from the magnets are safe for patients and users with ferromagnetic implants, devices, or objects." |
| Separation Force | Magnets maintain adequate separation forces over the use life. | "The Magnets maintain adequate separation forces over the use life." |
| Delivery System Function | Magnets connect and disconnect to the Delivery System over the use life. | "The Magnets connect and disconnect to the Delivery System over the use life." |
| Sterility | Device has a Sterility Assurance Level (SAL) of $10^{-6}$ and maintains sterility through labeled shelf life. | "The MagDI System demonstrates a SAL of $10^{-6}$, a continued sterility through the labeled shelf life of the device, and conforms to ISO 11137-1, ISO 11137-2, and ISO 11137-3." |
| Anastomosis Creation | Successful placement with alignment and creation of patent anastomoses. | "The Magnets were successfully placed in all cases with alignment and created patent anastomoses confirmed by imaging." |
| Device Expulsion | Natural expulsion of the device. | "The device was expelled naturally in most of the subjects reaching the one-month study visit." (One case removed via colonoscopy due to low bowel motility, but after creating a patent anastomosis and natural progression through the small bowel.) |
| Adverse Events | Low incidence/severity of adverse events, particularly serious adverse events (SAE), and no specific anastomotic complications (bleeding, leakage, obstruction). | "Most adverse events were of low grade, Clavien-Dindo Classification I-II and only one serious adverse event (SAE). No cases of internal hernia or bowel obstruction were reported. There were no cases of anastomotic bleeding, leakage, infection, or obstruction and no deaths." (The device performed "as least as safe as the predicate compression anastomosis device.") |
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.
N/A