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The DeepSight NeedleVue LC1 Ultrasound System is intended for use in Abdominal, Pediatric, Small Organ, Peripheral Vascular, Fetal, Urological, and Musculoskeletal Conventional and Superficial Imaging. This device is indicated for Prescription Use Only and by qualified healthcare professionals (HCPs). The DeepSight NeedleVue LC1 ultrasound system is intended to be used by qualified and trained physicians or sonographers with at least basic ultrasound knowledge. The operator must have read and understood the user manual. The DeepSight NeedleVue LC1 ultrasound system is intended to be used in medical practices and clinical environments including healthcare facilities, hospitals and clinics.

The DeepSight NeedleVue LC1 Ultrasound System is a general-purpose diagnostic ultrasound system that is mounted on a movable cart and has a mobile console that provides digital acquisition, processing, and display capabilities. The subject device has three major functional blocks that are consistent across ultrasound systems including the predicate:

• A front end, which includes a single curved (a.k.a. convex) array transducer and analog signal processing functions. This transducer transmits acoustic energy into the body and receives the resulting reflections, and performs the signal processing functions on them required to produce an ultrasound image (e.g., analog to digital conversion, noise filtering);
• A back end, which includes a user interface, memory, and export via USB. The user interfaces include a computer keyboard, standard ultrasound parameter controls, an LCD touch screen, acoustic output display and an LCD image display. The touch screen is divided into a display area and a user interaction area, and allows for patient data entry, transmit voltage adjustment, transducer/preset selection, depth and focus adjustment, annotation, freeze, image and clip capture, and measurements.
• Power systems which generate, regulate and supply the required voltages to the system parts.

The provided FDA 510(k) Clearance Letter for the DeepSight NeedleVue LC1 Ultrasound System does not contain acceptance criteria for device performance nor does it describe a study to prove the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Healthcare Logiq E9 Ultrasound System) based on:

• Intended Use and Indications for Use: Showing similarities in target patient populations and anatomical regions.
• Technological Characteristics: Comparing functional blocks, power sources, beamforming, controls, and display.
• Performance Testing (Non-clinical): Verifying compliance with relevant FDA guidance documents and recognized international standards for software, electromagnetic compatibility, thermal/mechanical/electrical safety, acoustic output, acoustic power, and reprocessing.

Therefore, it is not possible to provide the requested information based on the input document.

Here's why and what information is missing:

1. Acceptance Criteria and Reported Device Performance: The document lists various standards and guidance documents that the device's non-clinical performance testing complied with. However, it does not explicitly state specific acceptance criteria (e.g., image resolution in millimeters, signal-to-noise ratio in dB, penetration depth) for the DeepSight NeedleVue LC1 Ultrasound System and does not report quantitative data on how the device performed against any such criteria. It only states that the device was "found to have a safety and effectiveness profile that is similar to the predicate device."

2. Sample Size, Data Provenance, and Ground Truth for a Test Set (Clinical Study): The document explicitly states: "Clinical data was not required for this submission." This means there was no clinical study conducted to evaluate the device's performance in a real-world setting with patient data. Consequently, there is no information regarding:

   • Sample size used for a test set.
   • Data provenance (country, retrospective/prospective).
   • Number of experts or their qualifications.
   • Adjudication method.
   • Type of ground truth used.

3. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Since no clinical study was performed, an MRMC study comparing human readers with and without AI assistance was not conducted. The DeepSight NeedleVue LC1 is described as a general-purpose diagnostic ultrasound system, with no mention of AI features that would necessitate such a study.

4. Standalone Performance Study (Algorithm Only): The document describes the DeepSight NeedleVue LC1 as a general-purpose ultrasound system. While it mentions software testing, it does not describe an "algorithm only (standalone)" performance study in the context of diagnostic accuracy, as it's not an AI/CADe (Computer-Aided Detection) device in the sense that it provides an interpretation or analysis beyond standard imaging. The software testing mentioned relates to compliance with software life cycle processes, cybersecurity, and off-the-shelf software use.

5. Training Set Information: As no clinical study was reported and the device is a general-purpose ultrasound system (not an AI/ML-based diagnostic algorithm requiring a training set for diagnostic outcome prediction), there is no information about a training set, its sample size, or how its ground truth was established.

In summary, the provided document details a 510(k) clearance process based on substantial equivalence and compliance with non-clinical performance standards and guidance. It does not include information on clinical acceptance criteria or a study that specifically measures the device's performance against such criteria using patient data, as such a study was not required for this submission.

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