(118 days)
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.
| Acceptance Criteria (Inferred from Predicate & Clinical Outcomes) | Reported Device Performance (FLEX SFM) |
|---|---|
| Biocompatibility (per ISO 10993) | Passed all specified ISO 10993 tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subchronic Toxicity/Implantation, Genotoxicity, Chemical Characterization). |
| Sterilization Validation (SAL of 1 x 10^-6) | Validated to an SAL of 1 x 10^-6 per ISO 11137-1. |
| Transportation Validation | Performed per ASTM D 4169: 2022. (Result: Met requirements, implied by clearance). |
| Packaging Validation | Performed. (Result: Met requirements, implied by clearance). |
| Shelf-life Testing | Performed. (Result: Met requirements, implied by clearance). |
| Device Performance (magnetic clamping force, pressure & tensile strength, magnetic interference, corrosion resistance) | Performed, design meets functional and performance requirements. (Results: Met requirements, implied by clearance). |
| Clinical placement of device with ≥90% alignment of magnets (from predicate) | N=70 (100%) successful placement with alignment. |
| Creation of a patent anastomosis confirmed radiologically (from predicate) | N=70 (100%) successful creation of a patent anastomosis. |
| Safety: Low incidence of serious adverse events (SAEs) and resolution without sequelae. No anastomotic bleeding, leakage, or deaths. | Most adverse events were low grade (Clavien-Dindo Classification I-II). SAEs resolved without sequelae. No cases of anastomotic bleeding, leakage, and no deaths. |
| Effectiveness: Creation of durable small bowel to small bowel anastomosis (from animal study) | Performed as well as or better than control devices (60mm linear staple and sutures) with respect to tissue burst pressure and histological architecture. |
| Device Expulsion: Magnets pass naturally or with minimal non-surgical intervention. | For all subjects, the device passed as a pair of connected magnets naturally or with minimal non-surgical intervention. |
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."
N/A