(128 days)
For use with compatible, transvenous, left ventricular, pace/sense leads
The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).
The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.
This document describes the ACUITY™ Steerable Stylet Accessory, a Class II medical device, and its substantial equivalence to predicate devices. The information provided is for regulatory clearance and focuses on device characteristics and testing to meet acceptance criteria, rather than a detailed study comparing its performance against specific clinical metrics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. The information focuses on demonstrating substantial equivalence to existing predicate devices rather than proving specific clinical safety and effectiveness through quantified performance targets.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Testing Data" section broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria" without detailing the nature or scope of this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The document is concerned with the physical and functional characteristics of a medical device (a stylet) for regulatory clearance, not with image interpretation or diagnostic performance that would typically involve establishing ground truth by medical experts.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. As mentioned above, the evaluation does not involve diagnostic interpretation or human reader performance that would necessitate an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable and not provided. The device is a mechanical accessory (a stylet), not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of AI assistance for human readers is irrelevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This information is not applicable and not provided. The device is a physical stylet, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
This information is not provided. Given the nature of the device (a stylet), "ground truth" as typically understood in a diagnostic study (e.g., pathology, clinical outcomes) is not the primary focus. The focus is on physical and functional characteristics, and comparison to predicate devices, implying engineering and material testing rather than clinical outcome studies for establishing "ground truth."
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. The device is not an AI algorithm that requires a training set or ground truth for its development.
Summary of the Study and Acceptance Criteria (Based on the Provided Text):
The "study" described is a premarket notification (510(k)) submission to the FDA, not a clinical trial or performance study as might be conducted for an AI diagnostic device. The core assertion made is of "substantial equivalence" to legally marketed predicate devices.
- Acceptance Criteria (Implied): The implied acceptance criteria are that the ACUITY™ Steerable Stylet Accessory possesses "technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life" that are substantially equivalent to the predicate devices and that it meets unspecified internal "acceptance criteria" from internal testing. The ultimate acceptance criterion for the FDA is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
- Reported Device Performance: The document states, "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." It also lists the technological characteristics that were found to be substantially equivalent to the predicate devices. No specific quantitative performance metrics are provided.
- Study Type: This is a pre-market regulatory submission demonstrating substantial equivalence, not a clinical effectiveness study. It mentions internal "testing" but does not detail the methodology, sample sizes, or specific results of this testing. The focus is on comparing the new device's characteristics to those of established, legally marketed devices.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).