(55 days)
The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The SPIRIT™ Navigable Lead Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), to aid in positioning of the device in the vasculature.
The provided 510(k) summary for the Acumen Medical, Inc. SPIRIT™ Navigable Lead Delivery Catheter (K083855) does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or information on AI/ML components.
This document describes a medical device that introduces pacing or defibrillator leads and catheters. It is a traditional medical device submission, primarily focused on establishing substantial equivalence to a predicate device (Acumen Lead Delivery Sheath with Stylet, K070197) based on similar intended use, method of operation, construction, materials, and biocompatibility testing. Performance is generally asserted through "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." without detailing specific performance metrics or study designs.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's what can be inferred or stated based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (No specific performance metrics are provided.) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified as no such test set or ground truth establishment is described for performance evaluation.
4. Adjudication method for the test set
- Not applicable/Not specified.
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
- No. This is a traditional medical device (catheter) and does not involve AI/ML or human readers/interpretation in the way an imaging AI diagnostic device would.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm.
7. The type of ground truth used
- Not applicable/Not specified, as performance testing details are very high-level. For a mechanical device like this, "ground truth" would typically refer to engineering specifications and performance capabilities (e.g., tensile strength, bending radius, flow rates) as tested in a lab setting, rather than clinical outcomes or expert labels.
8. The sample size for the training set
- Not applicable/Not specified, as this device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
§ 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).