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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.

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The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

The Steerable Stylet is a sterile, single-use, disposable implantation tool which assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation.

The provided text describes a medical device, the "Steerable Stylet," and its submission for FDA approval (K040001). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through quantitative metrics.

Instead, the document focuses on the regulatory submission process, stating that the device is "substantially equivalent" to a legally marketed predicate device (The Locator Steerable Stylet, Model 4036, K972814). This substantial equivalence is based on "similar performance, technological characteristics, and indication for use." The "Testing" section broadly mentions that "Test results are included in submission" without detailing those results or the defined acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the specific questions as the necessary information is not present in the provided text.

Here's what can be inferred and what is missing:

• Acceptance Criteria and Reported Device Performance: This information is not provided. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific quantitative acceptance criteria and the device's performance against them.
• Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): No details are provided regarding any specific studies conducted to establish performance metrics. The submission relies on demonstrating equivalence to a predicate device.
• Adjudication Method: Not applicable as no specific study with ground truth establishment is described.
• MRMC Comparative Effectiveness Study: Not mentioned or implied.
• Standalone Performance Study: Not explicitly described with quantitative results. The "substantial equivalence" claim suggests performance is in line with the predicate, but specific standalone metrics are absent.
• Type of Ground Truth Used: Not applicable, as no study with ground truth established is detailed.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device in the sense that would require a training set.
• How Ground Truth for Training Set was Established: Not applicable.

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Ask a specific question about this device