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510(k) Data Aggregation
(159 days)
The GORE® Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of selfexpanding endovascular prostheses (stent grafts).
The GORE® Molding and Occlusion Balloon Catheter is a sterile (EtO), single use, single-lobed polyurethane balloon catheter. The compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft (two inflation lumens and one quidewire lumen). Termination of the leading end of the catheter is an atraumatic catheter leading tip for smooth transition from the quidewire to catheter transition. Radiopaque markers (approximately 40 mm apart) indicate the proximal and distal end of the balloon which aid in proper balloon placement under fluoroscopy. Both of the (2) inflation lumens are in communication with each end of the balloon to facilitate balloon catheter preparation, inflation and deflation. At the trailing end of the balloon catheter is a dual port (balloon inflation and quidewire) yarm. The inflation port of the y-arm is in communication with both of the balloon inflation lumens and is affixed with a luer lock and three way stopcock via an extension tube. The quidewire lumen of the v-arm allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the quidewire lumen is affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. The balloon catheter proximal y-arm is provided within a housing which contains markings of the balloon length and inflation range diameter. The balloon can be inflated to diameters of 10 mm to a maximum inflation diameter of 37 mm. The balloon catheter profile is 10 Fr introducer sheath compatible.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE Molding and Occlusion Balloon Catheter:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes a series of "Design Verification Testing" activities as the performance data. While specific pass/fail criteria (e.g., a numerical range for "Inflation Time") are not explicitly listed in this summary, the document states that these tests "demonstrated the subject device performed as intended and was substantially equivalent to the predicate device." This implies that the device met internal specifications and expectations derived from the predicate device's performance.
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| Device Profile / Sheath Compatibility | Performed as intended, substantially equivalent to predicate device. |
| Guidewire Compatibility | Performed as intended, substantially equivalent to predicate device. |
| Repeat Inflation / Deflation | Performed as intended, substantially equivalent to predicate device. |
| Balloon & Marker Band Position & Length | Performed as intended, substantially equivalent to predicate device. |
| Inflation Time | Performed as intended, substantially equivalent to predicate device. |
| Catheter Effective Length | Performed as intended, substantially equivalent to predicate device. |
| Deflation Time | Performed as intended, substantially equivalent to predicate device. |
| Visual Inspection Mechanical Defects | Performed as intended, substantially equivalent to predicate device. |
| Occlusion | Performed as intended, substantially equivalent to predicate device. |
| Tip Durability | Performed as intended, substantially equivalent to predicate device. |
| Balloon Inflation Diameter | Performed as intended, substantially equivalent to predicate device. |
| Tensile Strength | Performed as intended, substantially equivalent to predicate device. |
| Burst Volume | Performed as intended, substantially equivalent to predicate device. |
| Shelf Life Testing | Performed as intended, substantially equivalent to predicate device. |
| Leakage | Performed as intended, substantially equivalent to predicate device. |
| Packaging Validation Testing | Performed as intended, substantially equivalent to predicate device. |
| Aspiration | Performed as intended, substantially equivalent to predicate device. |
| Sterilization Validation Testing | Performed as intended, substantially equivalent to predicate device. |
| Accessory Compatibility | Performed as intended, substantially equivalent to predicate device. |
| Biocompatibility | Performed as intended, substantially equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each of the "Design Verification Testing" activities. It only references "bench study" data.
- Sample Size: Not specified.
- Data Provenance: The studies were "bench studies," which are laboratory-based tests. The country of origin is not explicitly stated, but the company (W.L. Gore & Associates) is based in the U.S. (Flagstaff, Arizona), suggesting the studies were likely conducted in the U.S. These are retrospective tests performed to verify design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a physical medical device, and the "ground truth" for its performance is established through objective engineering and materials testing, not through expert human interpretation of data like in an AI/imaging device.
4. Adjudication Method for the Test Set:
Not applicable, as the tests are objective bench tests.
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:
Not applicable. This is a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used:
The ground truth used for this device's performance evaluation is based on objective engineering specifications, material properties, and functional requirements for a balloon catheter intended for occlusion and stent graft expansion. These are derived from established medical device standards and comparison to a predicate device. For example, "Burst Volume" would have a defined expected value, and the tested device's performance would be compared against that.
8. The Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for physical medical device bench testing in the same way there would be for an AI algorithm. The design and manufacturing processes are refined based on general engineering principles and iterative development, not a specific training dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of this device. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, scientific principles, and iterative design and testing.
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(88 days)
The GORE SYNECOR Biomaterial device is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material.
GORE® SYNECOR Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates three distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) a non-porous synthetic bioabsorbable PGA:TMC film layer, and 3) a porous synthetic bioabsorbable PGA:TMC web layer. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The non-porous bioabsorbable film layer is designed to limit cellular penetration which serves to minimize visceral adhesion formation to the material. The porous bioabsorbable web layer provides a scaffold for cellular infiltration and vascularization. The GORE® SYNECOR Biomaterial is for single use only.
This document describes the GORE® SYNECOR Biomaterial, a surgical mesh. The provided text is a 510(k) premarket notification summary and does not contain information about studies proving a device meets acceptance criteria using a test set that generates performance metrics for AI/ML algorithms. Instead, it focuses on the substantial equivalence of the GORE® SYNECOR Biomaterial to predicate devices based on pre-clinical (bench and animal) testing.
Therefore, many of the requested categories related to AI/ML device performance and testing (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and ground truth for training set) cannot be answered from the provided document.
However, I can extract information regarding preclinical performance testing.
Acceptance Criteria and Reported Device Performance (Bench Study)
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Acceptance Criteria for Strength | The GORE® SYNECOR Biomaterial device met the intended functional acceptance criteria necessary for providing strength when bridging a hernia or soft tissue defect for up to the stated shelf life. |
| Suture Retention | Suture retention testing was performed to compare the GORE® SYNECOR Biomaterial to the predicate devices. (Specific performance values or direct comparison results (e.g., "was comparable to" or "X N vs Y N") are not detailed in this summary.) |
| Burst Strength | Burst strength testing was performed to compare the GORE® SYNECOR Biomaterial to the predicate devices. (Specific performance values or direct comparison results are not detailed in this summary.) |
| Midsurface Adhesions (Animal Study) | The GORE® SYNECOR Biomaterial had no midsurface adhesions similar to the control (predicate) device. |
| Fibrous Tissue Ingrowth (Animal Study) | There was no statistical difference in the amount of fibrous tissue ingrowth for the GORE® SYNECOR Biomaterial relative to the predicate. |
| Overall Histopathology (Animal Study) | Histopathology was as expected for the type and construction of both devices (GORE® SYNECOR Biomaterial and predicate) with organized tissue ingrowth and vascularity filling the macropores. |
Study Details (Pre-clinical)
- 1. A table of acceptance criteria and the reported device performance: See table above.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Bench Study: Not specified.
- Animal Study: A rabbit model was used. The number of animals or specific details of their use are not provided. Data provenance is not specified beyond "Pre-Clinical."
- 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): Not applicable, as this is pre-clinical testing, not expert-based ground truth for interpretation. Histopathology would have been assessed by a pathologist, but specific numbers or qualifications are not mentioned in this summary.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to pre-clinical bench and animal studies in this context.
- 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: Not applicable. This document does not describe the use of AI/ML.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe the use of AI/ML.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Study: Engineering and material science measurements (e.g., strength, suture retention, burst strength).
- Animal Study: Histopathology and direct observation (for adhesions).
- 8. The sample size for the training set: Not applicable. This document does not describe the use of AI/ML.
- 9. How the ground truth for the training set was established: Not applicable. This document does not describe the use of AI/ML.
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