(28 days)
The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Arrial Appendage Occluder.
The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.
The provided text is a 510(k) summary for the Abbott Amulet™ Steerable Delivery Sheath (K232690). This document describes the device's characteristics, its comparison to a predicate device, and non-clinical performance testing conducted to demonstrate substantial equivalence.
It's crucial to understand that this document explicitly states the testing was non-clinical performance testing (Section VII). This means the study described is a benchtop simulated use model for design validation, and not a clinical study with human patients. Therefore, the questions related to human readers, experts, ground truth from pathology/outcomes, and typical clinical study elements like ROC curves, sample sizes for training/test sets based on patient data, and human adjudication methods are not applicable in the context of this specific regulatory submission.
The "study that proves the device meets the acceptance criteria" in this document refers to the Design Validation study which used a benchtop simulated use model.
Here's the information extracted from the provided text based on your request, focusing on the available non-clinical testing details:
1. A table of acceptance criteria and the reported device performance
The document states: "The protocol acceptance criteria were met." However, it does not provide a detailed table listing specific quantitative acceptance criteria or corresponding device performance results for the design validation study. It only lists the types of tests performed.
| Test Category | Acceptance Criteria (Not Detailed) | Reported Performance (Not Detailed) |
|---|---|---|
| Biocompatibility | Based on ISO 10993-1, ISO 14971, ASTM F2475 for limited (≤24 hour) contact with circulating blood. | Evaluation conducted in categories: Hemocompatibility, Cytotoxicity, Sensitization, Irritation, Materials-Mediated Pyrogenicity, Acute Systemic Toxicity. Results were presumably acceptable as acceptance criteria were met overall for substantial equivalence. |
| Design Verification | Performance specifications (e.g., tensile strength, torque, leak, dimensional, compatibility, visual, air introduction) | Met all performance specifications. |
| Sterilization | SAL of 10^-6 per ISO 11135, acceptable EO/ECH residuals per ANSI/AAMI/ISO 10993-7 | Achieved SAL, acceptable residuals. Device adopted into routine cycles. |
| Packaging | Requirements of ASTM F2825, ASTM D4332, ASTM F2096, F1886/F1886M, ASTM F88/F88M | All device packaging met acceptance criteria following 2X sterilization, environmental conditioning, and transport simulation. |
| Design Validation | Protocol acceptance criteria for delivery of Amplatzer Amulet Left Atrial Appendage Occluder in a benchtop simulated use model. | The protocol acceptance criteria were met. |
| Human Factors | No new user-device interactions or patterns of use errors compared to predicate device. | No patterns of use errors observed, no new user-device interactions identified. |
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 for Test Set: The document does not specify a numerical sample size for the benchtop simulated use model test set. It mentions "physicians who have experience with left atrial appendage devices" evaluated the performance.
- Data Provenance: This was a non-clinical benchtop simulation study, not involving human patient data. Therefore, country of origin or retrospective/prospective is not applicable in the traditional sense. The study was conducted as part of the regulatory submission by Abbott Medical, located in St. Paul, Minnesota, USA.
The sample sizes for training sets and the type of ground truth are not applicable for this type of non-clinical, benchtop study. The ground truth for this device's performance is against engineering specifications and functional objectives in a simulated environment, rather than clinical outcomes or diagnostic accuracy.
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)
- The document states "physicians who have experience with left atrial appendage devices evaluated the performance."
- Number of Experts: Not specified.
- Qualifications of Experts: "Physicians who have experience with left atrial appendage devices." No further detail (e.g., years of experience, specific specialty like interventional cardiologist etc.) is provided in this summary.
- Ground Truth Establishment: The "ground truth" for this benchtop study was the successful delivery of the Amplatzer Amulet Left Atrial Appendage Occluder within the simulated use model according to pre-defined protocol acceptance criteria related to the device's mechanical and functional performance, as evaluated by the experienced physicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. It only states that physicians evaluated the performance. Without a specified number of physicians or a detailed methodology, an adjudication method cannot be inferred.
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 comparative effectiveness study was not performed. This is a non-clinical benchtop study for a delivery sheath, not an AI-assisted diagnostic device for human readers. Therefore, questions regarding AI assistance and improvement for human readers are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Stand-alone Performance: This is a physical medical device (delivery sheath), not an algorithm or AI. Therefore, the concept of "standalone performance" of an AI algorithm is not applicable. The device's performance was evaluated in a simulated environment, with human interaction (physicians using it).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the Design Validation study, the "ground truth" was established by pre-defined protocol acceptance criteria for successful device function in a benchtop simulated use model, as assessed by physicians experienced with the procedure. This is distinct from ground truth derived from clinical outcomes, pathology, or expert consensus on diagnostic images.
8. The sample size for the training set
- Not applicable. This section describes non-clinical testing of a physical medical device, not the development or training of an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This section describes non-clinical testing of a physical medical device, not the development or training of an AI algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).