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510(k) Data Aggregation
(122 days)
MagDI System (MAG-02, DS-01)
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.
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(99 days)
MagDI System (MAG-01, DS-01)
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.
| Acceptance Criteria (Implied from Text) | Reported Device Performance |
|---|---|
| Biocompatibility ISO 10993-1 | Device demonstrated biocompatibility |
| Magnet field strength safety (ferromagnetic implants/devices) | Magnet field strength characterized, distances safe for patients/users |
| Magnets maintain adequate separation forces | Magnets maintain adequate separation forces over use life |
| Magnets connect and disconnect to Delivery System | Magnets connect and disconnect to Delivery System over use life |
| Patient-contacting materials conform to ISO 10993-1 / FDA Guidance | Patient-contacting materials conform to ISO 10993-1 and FDA Guidance |
| Sterility Assurance Level (SAL) of 10^-6 | MagDI System demonstrates a SAL of 10^-6, continued sterility through shelf life |
| Chronic porcine animal testing | Conducted over 6-week period (details not provided) |
| Clinical performance (anastomosis creation, passage, AEs) | Magnets successfully placed, alignment achieved, device passed naturally. Most adverse events (AEs) low grade (Clavien-Dindo Classification I-II), SAEs resolved without sequelae. No internal hernia, bowel obstruction, anastomotic bleeding, leakage, infection, or deaths. Performed safely and as intended. |
| Compliance with 21 CFR 801 and ISO 15223 | Labeling conforms to 21 CFR 801 and ISO 15223 |
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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(98 days)
MagDI System
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
-
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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