Search Results

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.

Ask a specific question about this device

LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, GynecologyPelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor. The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.

The provided FDA submission for the GE LOGIQ E10 does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML component or performance metrics for diagnostic accuracy beyond general equivalence claims.

The document primarily focuses on establishing substantial equivalence of the LOGIQ E10 ultrasound system to predicate devices based on:

• Intended Use: Similar clinical applications.
• Technology: Same fundamental scientific technology (ultrasound imaging).
• Components: Similar transducers and system capabilities (measurements, digital imaging, reporting).
• Safety Standards: Compliance with electrical, thermal, electromagnetic safety, and biocompatibility.
• Software Features: Identical software features with some migrations from other GE systems (Voluson E10, LOGIQ E9, LOGIQ S8) and a new feature (UGAP) similar to one on another predicate.

The document explicitly states: "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." This means no specific performance metrics comparing the LOGIQ E10 to a gold standard or human readers were presented for this submission.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any details about MRMC or standalone AI studies, as this information is not present in the provided text.

The information provided only demonstrates that the device is an ultrasound system with various imaging capabilities, and its submission for FDA clearance relies on substantial equivalence to existing predicate devices, rather than a de novo clinical performance study showcasing specific diagnostic accuracy metrics.

Ask a specific question about this device

The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatic; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers. which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

This is a 510(k) premarket notification for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 ultrasound systems. The document states that clinical studies were not required to support substantial equivalence. Therefore, there is no information about specific acceptance criteria related to a study proving device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC comparative effectiveness studies.

The document focuses on demonstrating substantial equivalence to predicate devices (K162269 Voluson E6_E8_E10 Diagnostic Ultrasound System and K150087 Vivid E80/E90/E95 Diagnostic Ultrasound System) through technological characteristics, intended use, imaging capabilities, safety, and compliance with recognized standards.

Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no specific performance metrics reported for the device against acceptance criteria in the traditional sense of a clinical trial. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards.

Specific Information Regarding Studies:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • No clinical test set was used, as clinical studies were not required for this 510(k) submission. Non-clinical tests were performed to ensure compliance with standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable, as no clinical test set requiring expert ground truth was utilized.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable due to the absence of a clinical test set.

4. 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:

   • No MRMC comparative effectiveness study was conducted or reported. The submission focuses on substantial equivalence of the ultrasound system itself, not on specific AI assistance features that would require such a study for performance evaluation. While new software features like "IOTA Simple Rules," "Fetal Heart Analysis," and "SonoMetrium" are mentioned, their specific performance metrics requiring MRMC studies are not detailed or were not deemed necessary for this 510(k) due to claimed substantial equivalence.

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

   • Not applicable, as the device is a diagnostic ultrasound system, not a standalone algorithm. The mentioned software features are integrated into the system.

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

   • Not applicable, as no clinical studies with ground truth were conducted. Compliance with safety and performance standards was demonstrated through non-clinical testing.

7. The sample size for the training set:

   • Not applicable, as no clinical studies were conducted, and therefore no training set was explicitly mentioned. The development of software features would involve internal datasets, but details are not provided in this regulatory document.

8. How the ground truth for the training set was established:

   • Not applicable, for the reasons stated above.

Ask a specific question about this device

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/ML device.

Instead, the document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ P9 and LOGIQ P7) and its various transducers. The "study" described is a non-clinical comparison to predicate devices to establish substantial equivalence, rather than a clinical trial demonstrating performance against specific metrics.

Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria or reported performance metrics in terms of accuracy, sensitivity, specificity, or other performance measures typically associated with AI/ML devices.

Instead, the "acceptance criteria" are implied by the comparison to legally marketed predicate devices and compliance with voluntary safety and performance standards. The "reported device performance" is framed as its "substantial equivalence" to these predicates.

Implied Acceptance Criteria (based on comparison to predicate and standards):

• Intended Use Equivalence: Same clinical intended uses as predicate devices.
• Imaging Capabilities Equivalence: Same imaging modes and similar capabilities (measurements, digital image capture, reviewing/reporting).
• Technological Equivalence: Employs the same fundamental scientific technology as predicate devices.
• Safety Standards Compliance: Acoustic output below FDA limits, compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, NEMA UD 2, ISO10993-1, ISO14971, and NEMA PS 3.1 3.20 (DICOM).
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.
• Quality Assurance: Adherence to risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, and safety testing.

Reported Device Performance (as stated in the document):

The LOGIQ P9 and P7 systems are "substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness."

Specific new features or transducers are noted to be "previously cleared by FDA" on other GE Healthcare devices, implicitly demonstrating their performance was already deemed acceptable.

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

The document explicitly states: "The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data of a specific sample size used for performance evaluation in the context of an AI/ML study, nor is there information on data provenance (country of origin, retrospective/prospective). The substantiation is primarily based on engineering and performance testing against standards, and comparison to already cleared predicate devices.

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

Since no clinical studies or test sets with patient data were required for this submission, there is no mention of experts used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

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

No MRMC comparative effectiveness study was done or reported in this document. The device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and the submission focuses on substantial equivalence to existing ultrasound devices.

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

Not applicable. This submission is for an ultrasound imaging system. While it includes "software features" like STIC and OmniView, and a "general measurement tool" called Cardiac AFI, these are presented as capabilities of the ultrasound system itself, not as standalone AI algorithms whose performance is evaluated independently. The primary focus is the imaging hardware and its integrated software relative to predicate ultrasound devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the new features or specific transducers mentioned as "previously cleared," their original submissions would have involved appropriate ground truth methods relevant to specific clinical applications (e.g., phantom studies for image quality, clinical data for specific measurements). However, for this specific 510(k) submission, since no new clinical studies were required, there is no ground truth established using patient data for the purpose of demonstrating performance of the LOGIQ P9/P7 as a complete system. The ground truth for proving safety and effectiveness here relies on compliance with engineering standards and demonstrated performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a diagnostic ultrasound system, not an AI/ML algorithm that would undergo specific training on a data set.

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

Not applicable. As there is no AI/ML training set explicitly discussed, the establishment of ground truth for such a set is not detailed.

Ask a specific question about this device