(195 days)
The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.
This document describes a 510(k) premarket notification for a medical device called the "Acumen Single-Lumen Delivery Sheath". This type of submission is a declaration that a new device is "substantially equivalent" to one or more legally marketed predicate devices, rather than a study proving performance against acceptance criteria in the way one might for a novel AI device.
Therefore, many of the requested categories related to AI device studies (like sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone performance of an algorithm) are not applicable to this submission.
Here's a breakdown of the information provided in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable for intended use (introduction of pacing/defibrillator leads and catheters) | "In-vitro and animal testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." |
| Materials suitable for use in medical devices | "All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are suitable for this use and have been used in numerous previously cleared products." |
| Substantially equivalent to predicate devices (SafeSheath, Attain Access 6216, Attain Access 6218) in terms of intended use, method of operation, construction, and materials. | "Acumen Medical, Inc. believes the Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products." |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is not a clinical trial or AI performance study, but rather a premarket submission demonstrating substantial equivalence to existing devices through a combination of:
- In-vitro testing: Performed to ensure the device components, subassemblies, and the full device meet required specifications.
- Animal testing: Also performed to ensure the device components, subassemblies, and the full device meet required specifications.
- Material compatibility assessment: Confirming that all materials are suitable for medical use and have a history of use in previously cleared products.
- Comparison to Predicate Devices: A detailed comparison of the new device's intended use, method of operation, construction, and materials to those of the predicate devices.
2. Sample size used for the test set and the data provenance
- Not Applicable. This is not an AI device study requiring a traditional "test set" from a dataset of images or clinical cases. The testing involved in-vitro and animal studies, which are typically defined by the specific test protocols and models used, rather than a "sample size" of patient data.
- Data Provenance: The document does not specify the country of origin for the in-vitro or animal testing. It also doesn't explicitly state if the testing was retrospective or prospective, though in-vitro and animal studies for device clearance are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI device study involving expert human review for ground truth establishment. The "ground truth" here is compliance with engineering specifications and functional performance in in-vitro and animal models.
4. Adjudication method for the test set
- Not Applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for this type of device submission.
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 device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device. No standalone algorithm performance was assessed.
7. The type of ground truth used
- For the in-vitro and animal testing: The ground truth would be engineering specifications, functional performance metrics, and safety outcomes as defined by the test protocols.
- For the substantial equivalence claim: The "ground truth" is the characteristics and performance of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI device, so there is no training set mentioned or relevant.
9. How the ground truth for the training set was established
- Not Applicable. As no training set exists for an AI model, this question is not relevant.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).