(17 days)
The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.
The Modified 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. The Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.
This document describes a 510(k) premarket notification for a medical device and is not a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would. It's a regulatory submission asserting substantial equivalence to existing devices. Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable or available within this document.
However, I can extract the relevant information from the provided text based on the 510(k) process.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, "acceptance criteria" and "reported device performance" are primarily framed around substantial equivalence to predicate devices rather than a direct clinical performance study with numerical criteria. The acceptance criteria for the FDA in a 510(k) is whether the new device is "substantially equivalent" to a legally marketed predicate device.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use is identical or substantially equivalent | "The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters," which is equivalent to the predicate. |
| Technological Characteristics are identical or substantially equivalent (e.g., materials, design, method of operation) | Materials: "All materials used in the manufacture of the Modified Acumen Single-Lumen Delivery Sheath are identical to the predicate device." |
| Method of Operation: "identical or substantially equivalent to existing legally marketed predicate products." | |
| Construction: "methods of construction...are either identical or substantially equivalent to existing legally marketed predicate products." | |
| Design: The new device is "available in straight and multiple curved configurations" (an addition), but this is considered substantially equivalent to the predicate's overall design for its stated purpose. | |
| Performance Data (e.g., in-vitro testing) demonstrates substantial equivalence and safety/effectiveness | "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (Specific "specifications" are not detailed in this summary, but the general statement indicates compliance.) |
Study Proving Substantial Equivalence:
The "study" in this context is the 510(k) Premarket Notification itself, which argues for substantial equivalence based on a comparison to predicate devices and in-vitro testing.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable (N/A) in the context of a 510(k) summary relying on substantial equivalence and in-vitro testing. The document states "In-vitro testing has been performed," but does not provide the sample size of tested devices.
- Data provenance: N/A. The in-vitro testing was likely conducted by Acumen Medical, Inc. or a contracted lab. The document does not specify country of origin or whether it was retrospective/prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: N/A, as clinical "ground truth" establishment by experts is not described for a test set in this type of submission. The evaluation for substantial equivalence is primarily based on regulatory standards, engineering testing, and comparison to predicate devices by the manufacturer and the FDA.
- Qualifications of experts: N/A.
4. Adjudication method for the test set
- Adjudication method: N/A. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.
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. This device is a physical delivery sheath, not an AI or imaging diagnostic device.
- Effect size: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: N/A in the clinical sense. For the in-vitro testing, the "ground truth" would be the pre-defined engineering specifications and performance requirements for the device components and full assembly. The primary "ground truth" for the 510(k) submission is the documented characteristics and performance of the predicate devices to which it is being compared.
8. The sample size for the training set
- Sample size for training set: N/A. This term is relevant for machine learning algorithms, not for the development and testing of a physical medical device described here.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: N/A.
§ 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).