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510(k) Data Aggregation
(109 days)
The WATCHMAN™ TruSeal™ Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
The Boston Scientific WATCHMAN™ TruSeal™ Access System is composed of an Access Sheath and Dilator. The TruSeal Access System is used to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
The document is a 510(k) premarket notification for the WATCHMAN™ TruSeal™ Access System. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Instead, it details the performance and biocompatibility testing of a medical catheter system. Therefore, I cannot provide information on acceptance criteria, reader studies, ground truth, or training set relevant to an AI/ML device based on this document.
However, I can extract the acceptance criteria and study information related to the physical device's performance testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted. While specific quantitative acceptance criteria values are not provided in this summary, the document states: "The results of the tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implies that the device met pre-defined acceptance criteria for each test.
| Test Category | Specific Performance Test | Reported Device Performance |
|---|---|---|
| Device Performance | Dimensional Characterization | Conformed to requirements |
| Distal and Proximal Marker Location | Conformed to requirements | |
| Curve Shape | Conformed to requirements | |
| TruSeal Access System Guidance / Crossing | Conformed to requirements | |
| Contrast Flow Rate | Conformed to requirements | |
| Leak-Free Conduits | Conformed to requirements | |
| Pressure Retention | Conformed to requirements | |
| Corrosion Resistance | Conformed to requirements | |
| Sheath Force Transmission | Conformed to requirements | |
| Kink Resistance | Conformed to requirements | |
| Tip Deflection | Conformed to requirements | |
| Torqueability | Conformed to requirements | |
| Snap Fit Attachment Force | Conformed to requirements | |
| Access Sheath Compression Force | Conformed to requirements | |
| Dilator Stiffness | Conformed to requirements | |
| Tensile | Conformed to requirements | |
| Radiopacity | Conformed to requirements | |
| Luer Lock Testing | Conformed to requirements | |
| Particulates | Conformed to requirements | |
| Surface | Conformed to requirements | |
| Package Performance | Master Shipper Carton Integrity | Conformed to requirements |
| Shelf Carton Condition | Conformed to requirements | |
| Sterile Barrier Integrity | Conformed to requirements | |
| Sterile Barrier Seal Strength | Conformed to requirements | |
| Ease of Opening Pouch | Conformed to requirements | |
| TruSeal Access System Containment | Conformed to requirements | |
| Tray Condition | Conformed to requirements | |
| Removal From Packaging | Conformed to requirements | |
| DFU and eDFU Card Print Quality | Conformed to requirements | |
| Label Adhesion and Print Quality | Conformed to requirements | |
| Biocompatibility | Cytotoxicity | Conformed to requirements (biocompatible) |
| Sensitization | Conformed to requirements (biocompatible) | |
| Intracutaneous Reactivity | Conformed to requirements (biocompatible) | |
| Acute Systemic Toxicity | Conformed to requirements (biocompatible) | |
| Complement Activation | Conformed to requirements (biocompatible) | |
| Materials Mediated Pyrogenicity | Conformed to requirements (biocompatible) | |
| Hemolysis Direct Contact | Conformed to requirements (biocompatible) | |
| Hemolysis Extract Method | Conformed to requirements (biocompatible) | |
| In Vitro Platelet and Leukocyte Count | Conformed to requirements (biocompatible) | |
| Partial Thromboplastin Time | Conformed to requirements (biocompatible) |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes physical, chemical, and biological testing of a medical device, not a data-driven test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for device performance testing. Ground truth in this context refers to established standards and test methodologies (e.g., ISO standards, internal Boston Scientific specifications).
4. Adjudication method for the test set: Not applicable for device performance testing. Performance was determined by meeting pre-defined physical, mechanical, and biological specifications.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For device performance and biocompatibility, the "ground truth" is defined by established engineering specifications, relevant industry standards (e.g., EN ISO 10555-1: 2013), and regulatory guidance documents (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 2010).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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