Search Results
Found 2 results
510(k) Data Aggregation
(158 days)
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.
Ask a specific question about this device
(99 days)
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.
Ask a specific question about this device
Page 1 of 1