Search Results

The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial 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 distal tip. 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.

This document is a 510(k) clearance letter for a medical device called the "Amulet™ Steerable Delivery Sheath." The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve comprehensive clinical studies or complex AI performance evaluations.

Based on the provided text, the changes to the device are primarily related to manufacturing processes:

• "The difference between the subject device and predicate is the in-process solvent used to prepare the surface of the distal tip PEBAX extrusions."
• "Additionally, a tip bond tensile specification and in-process tensile test method are being implemented."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing designed to show that these manufacturing changes do not negatively impact the device's function or safety, and that the new device remains substantially equivalent to the predicate. There is no mention of AI, human-in-the-loop studies, multi-reader multi-case studies, or complex ground truth establishment in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text, presented in the requested format, while acknowledging the severe limitations of this specific document for an "AI" type of study.

Acceptance Criteria and Device Performance for Amulet™ Steerable Delivery Sheath

Summary of Device Modification: The primary difference between the subject device and the predicate device is the "in-process solvent used to prepare the surface of the distal tip PEBAX extrusions." Additionally, a new "tip bond tensile specification and in-process tensile test method are being implemented." The submitted 510(k) is a "Special 510(k)," which is used for modifications to a manufacturer's own legally marketed device where the modified device does not raise new questions of safety and effectiveness.

Study Type: Non-clinical (benchtop) performance testing, process qualifications, and re-evaluation of biocompatibility and sterilization profiles for substantial equivalence demonstration. This is not a clinical study involving human patients, nor an AI performance study.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Important Note: The provided document is for a medical device modification, not an AI or diagnostic device. Therefore, many of the requested bullet points regarding AI-specific evaluation are not applicable. I will address them by stating their non-applicability.

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical value (N) for each test. For "Process Qualification," it refers to "Product performance qualification (PPQ) testing." This typically involves a defined number of units tested per batch or according to a statistical sampling plan (e.g., AQL tables), but the specific numbers are not disclosed in this summary.
   • Data Provenance: This is non-clinical benchtop testing conducted by the manufacturer, Abbott Medical, in a laboratory setting. It is not patient data; therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in their clinical sense. The testing is essentially "prospective" in that it's performed on newly manufactured samples of the modified device prior to marketing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is non-clinical benchtop testing of a physical medical device. "Ground truth" in the context of expert review (e.g., for AI image analysis) is not relevant here. Performance is measured against engineering specifications and industry standards by qualified engineers and technicians.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. As this is non-clinical engineering testing, there are no human "readers" or clinical "adjudication" in the sense of consensus on medical findings. Test results are compared against predefined acceptance criteria from engineering specifications.

4. 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 describes the clearance of a physical medical delivery sheath, not an AI-powered diagnostic device or a device intended for clinical interpretation improvement. No human reader studies or AI assistance are mentioned or relevant to this 510(k).

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by predefined engineering specifications (e.g., tensile strength values, deflection angles, number of cycles) and adherence to recognized industry standards (e.g., ISO, ASTM). For biocompatibility, it's based on ISO 10993 standards and the assessment of material properties. For sterilization, it's based on ISO 11135 and a Sterility Assurance Level (SAL).

7. The sample size for the training set:

   • Not Applicable. This device is not an AI model requiring a training set. The "training" for the device's performance is its design and manufacturing process, and its "experience" is validated through the non-clinical tests described.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no AI training set, this question is not relevant. The device's foundational "ground truth" (its design and intended performance) is established through extensive engineering design, development, and risk assessment processes preceding this specific 510(k) modification.

Ask a specific question about this device

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.

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.

Ask a specific question about this device