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The AcQGuide is intended for percutaneous catheter introduction into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

The AcQGuide Steerable Sheath is a sterile, single use device consisting of a composite structured single lumen shaft, an ergonomic handle to provide torque and active deflection, and a hemostasis valve with side flush port, to allow safe introduction of a catheter while simultaneously permitting saline to be flushed via the main shaft. The AcQGuide Steerable Sheath is designed for maneuverability of standard electrophysiology catheters that are advanced through the sheath and into the right or left chambers of the sheath is compatible with diagnostic and therapeutic devices. The AcQGuide Steerable Sheath includes a dilator. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart.

The provided text is a 510(k) premarket notification for the AcQGuide Steerable Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than strictly proving the device meets acceptance criteria in the way a new, novel AI algorithm might. Therefore, the information typically requested for AI/algorithm performance studies (like sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies) is not present here.

Instead, the document details nonclinical testing to ensure the device performs as intended and does not raise new questions of safety or effectiveness compared to its predicate.

Here's an attempt to answer your request based on the available information, with the understanding that it won't perfectly fit the structure for an AI performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format often seen for AI performance metrics. Instead, it states that "the collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQGuide Steerable Sheath meet the established specifications necessary for consistent performance during its intended use."

The comparison table on pages 4-5 indirectly serves as a form of acceptance criteria by showing how the proposed device is similar to the predicate. The "Analysis of Differences" column confirms that any differences "do not raise different questions of safety or effectiveness."

• Compatible with catheters up to 10.5F in diameter.
• Hemostasis valve prevents air incursion and minimizes blood loss.
• Flush port provides ability to administer saline flush.
• Usable length suitable for intended use (up to 75 cm).
• Radiopaque markers for visualization during fluoroscopy.
• Guidewire compatibility within acceptable range (e.g., .035").
• Mechanical integrity (e.g., handle torque, leak resistance, dimensional accuracy, visual defect absence). | - Maximum deflection: 180 degrees (with catheter inserted).
• Reach: 5.0cm at 90 degrees.
• Facilitates use with catheters up to 10.5F in diameter.
• Hemostasis valve to prevent air incursion and minimizes blood loss.
• Flush port provides ability to administer saline flush.
• Usable length of up to 75 cm.
• Distal sections are visible when using standard or low-level fluoroscopy.
• Guidewire compatibility: .035".
• Comprehensive nonclinical bench testing including Dimensional Inspection, Visual Inspection, Leak Testing, Functional and Compatibility Testing, Mechanical Testing, Handle Torque Testing. All tests "meet the established specifications necessary for consistent performance." |
  | Safety - Biocompatibility | - Device materials (shaft, dilator) must be biocompatible.
• No adverse biological reactions. | - Shaft: Biocompatible copolymer (Pebax®) with stainless steel, platinum/10% Iridium, PTFE.
• "Biocompatibility" testing was conducted and collectively demonstrates the device is safe. |
  | Safety - Sterility & Packaging/Shelf-Life | - Device must be sterile.
• Packaging maintains sterility and product integrity over shelf-life.
• Shelf-life stability confirmed. | - "Sterilization" testing was conducted.
• "Packaging and Shelf-Life" testing was conducted. (Implied successful results). |
  | Intended Use Equivalence | - Indications for Use are substantially equivalent to the predicate (e.g., "percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning"). | - "The AcQGuide is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning." This statement is identical to the predicate's stated intent. |
  | Overall Safety and Effectiveness Equivalence | - Device does not raise different questions of safety or effectiveness compared to the predicate device. | - "Extensive nonclinical testing has been performed... The collective results confirm that the AcQGuide Steerable Sheath is safe and effective, meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics for its intended use."
• "The AcQGuide does not raise different questions of safety or effectiveness when compared to the predicate devices." |

2. Sample Size Used for the Test Set and Data Provenance

• Test set sample size: Not explicitly stated in terms of a numerical count of devices tested for each individual test. The document refers to "extensive performance bench testing."
• Data Provenance: This was "nonclinical testing" and "bench testing" conducted by the manufacturer, Acutus Medical, Inc. It's a prospective testing program designed to evaluate the physical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This type of information is not applicable to this submission. The "ground truth" for a physical medical device's performance is typically established through engineering specifications, material science, and direct measurement/testing against those specifications, potentially with input from intended users (physicians).
• The document mentions "Physician simulated use in an animal model," which suggests expert input was involved in assessing practical functionality, though details on the number or qualifications of these physicians are not provided.

4. Adjudication Method for the Test Set

• Not applicable in the context of an AI ground truth. Device performance testing involves objective measurements and compliance with engineering specifications. Any subjective assessment during simulated use would likely follow standard protocols for observational evaluation by the participating physicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is a 510(k) for a physical medical device, not an AI algorithm. MRMC studies are specific to evaluating diagnostic performance, often of AI, against human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. There is no algorithm. The device itself is standalone in its function as a steerable sheath.

7. The Type of Ground Truth Used

• For the nonclinical testing, the "ground truth" would be the established engineering specifications, safety standards (e.g., biocompatibility standards), and the performance characteristics of the predicate device. For example, a leak test has a defined pass/fail criterion based on engineering principles. For "Physician simulated use," the ground truth would be the practical observation of the device's steerability, stability, and ease of use in a relevant anatomical model, assessed by a medical professional.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. No training set for an AI model.

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