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The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F 10FG are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the SOUNDSTAR eco Catheter provides location information.

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F, 10FG are licensed for single use only. Models differ in shaft diameter (8F or 10F) and ultrasound system compatibility (Siemens [8F and 10F] or GE [8FG and 10FG]). The catheter consists of a CARTO connector, SwiftLink (ultrasound) connector, handle and shaft. In the distal tip of each catheter's shaft are a 64-element ultrasound transducer providing 2D imaging and a 3D location sensor providing location information to the compatible CARTO 3 Electrophysiology (EP) Navigation System. The deflection and tension knobs on the handle are used to articulate the distal tip and control the image plane orientation with four-directional (anterior-posterior, left-right) deflection.

The provided FDA 510(k) clearance letter pertains to the Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters. This document outlines the regulatory review and approval process for a reprocessed medical device, asserting its substantial equivalence to original predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria for AI/ML performance, nor does it describe a study involving AI assistance or standalone AI performance evaluation. The "Non-clinical Testing Summary" focuses on the physical, electrical, and reprocessing aspects of the reprocessed catheter itself (e.g., functional performance, electrical safety, cleaning validation, biocompatibility, sterilization validation, packaging and shelf life). It explicitly states: "The current submission does not include consoles or any other system components as part of this respective submissions." The device subject to clearance is an ultrasound catheter, not an AI-powered diagnostic system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for AI/ML device performance based on the provided document. The document pertains to a physical medical device (an ultrasound catheter) and its reprocessing, not an AI/ML-driven diagnostic or assistive technology.

If you have a document describing an AI/ML device and its performance study, I would be happy to analyze it according to your requested criteria.

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The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO® 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 EP Navigation Systems.

The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are both 90 cm 10F IntraCardiac Echo (ICE) Catheters with an acoustic arrav identical to the currently cleared SNDSTR10 and SNDSTR10G Catheters. The catheters have a magnetic location sensor (providing location information to the CARTO 3 Navigation System Version 2.2) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip. The modified SOUNDSTAR eco Catheters have a bifurcated 'tail' originating from their handle which is nearly identical to the bifurcated tail of the predicate devices. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via the appropriate SwiftLink cable to the corresponding Ultrasound system. For the SOUNDSTAR eco10F Catheter the SwiftLink cable connects to Acuson Cypress, Acuson Sequoia or Acuson X300 Ultrasound systems. For the SOUNDSTAR eco10FG Catheter the SwifLink cable connects to GE Vivid-i or Vivid-q Ultrasound systems. Both versions of SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are based on the existing SOUNDSTAR 3D 10F (SNDSTR10) and SOUNDSTAR 3D 10FG (SNDSTR10G) catheters and have the same intended use and clinical applications. The predicate and modified catheters share the majority of components and manufacturing process as explained previously. The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO 3 Version 2.2 electromagnetic acquired maps.

The provided text is a 510(k) summary for the SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing modifications.

Based on the provided document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of diagnostic performance metrics like sensitivity, specificity, or accuracy for the "device" as an AI/CAD system. Instead, the focus is on transducer surface temperature to ensure patient safety, as required by IEC 60601-2-37.

2. Sample size used for the test set and the data provenance

The document describes physical testing of the catheter's transducer surface temperature, not a clinical study involving human patients or a test set of data in the context of an AI/CAD system. Therefore, the concepts of "sample size for test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the way they would be for an AI/CAD diagnostic device. The testing was conducted in a lab environment using "tissue mimicking material" (TMM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an ultrasound catheter, not an AI/CAD system requiring expert ground truth for image interpretation. The "ground truth" here is the physical temperature measurement.

4. Adjudication method for the test set

Not applicable. The reported performance is a direct physical measurement (temperature), not an interpretation that requires adjudication.

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

Not applicable. This is not an AI/CAD device.

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

Not applicable. This is not an AI/CAD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance described is the measured surface temperature of the transducer in tissue mimicking material (TMM), conducted in accordance with IEC 60601-2-37 requirements. This is a physical, objective measurement of a safety-related parameter.

8. The sample size for the training set

Not applicable. This device is not an AI/CAD system and does not involve machine learning training data.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/CAD system and does not involve machine learning training data.

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