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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The provided text describes the GE LOGIQ E9 Diagnostic Ultrasound System and its various transducers. It highlights the device's indications for use and a summary of non-clinical tests conducted to prove its safety and substantial equivalence to predicate devices. However, it explicitly states that no clinical studies were required or performed to support substantial equivalence.

Therefore, I cannot provide details on the acceptance criteria and a study that proves the device meets those criteria, as no such clinical study is reported in the provided document.

Here's a breakdown of the information that can be extracted or inferred based on your prompt and the document:

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed, there are no specific performance metrics derived from such studies to present in a table. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to recognized standards.

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

• Sample Size for Test Set: Not applicable, as no clinical studies were conducted that would involve a "test set" of patients for performance evaluation. Non-clinical tests typically involve phantom, bench, or ex-vivo testing.
• Data Provenance: Not applicable for patient data, as no clinical studies were conducted. The document details adherence to international and national standards (AAMI/ANSI, IEC, NEMA, ISO), indicating these standards and tests were likely performed according to established protocols in manufacturing or testing facilities.

3. 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 studies were conducted requiring ground truth established by experts for a patient test set.

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

Not applicable, as no clinical studies were conducted requiring adjudication for a patient test set.

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. The GE LOGIQ E9 is a diagnostic ultrasound system and the document does not suggest or describe any AI components or MRMC studies for improved human reader performance.

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

Not applicable. The device is a diagnostic ultrasound system, not an algorithm, and the document does not describe standalone algorithm performance.

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

Not applicable for clinical ground truth, as no clinical studies were described. For non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be defined by the specifications, standards, and established methodologies for each test (e.g., calibrated measurement devices for acoustic output).

8. The sample size for the training set:

Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.

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

Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ E9 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical studies against acceptance criteria.

Therefore, the document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Because no clinical studies were performed, it is not possible to extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document instead focuses on:

• Summary of Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety.
• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, and NEMA DICOM Set.
• Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Final Acceptance testing (Validation).
• Intended Use: A broad range of diagnostic ultrasound evaluations for various anatomical regions and clinical applications, with specific modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, and other features like 3D/4D imaging and needle guidance) listed for each supported transducer.

In summary, the provided text does not contain the information required to populate the table or answer the questions as it pertains to clinical acceptance criteria and a study demonstrating performance against those criteria. The device's clearance was based on demonstrating equivalence, not on de novo clinical performance studies with acceptance criteria.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user includes a computer keyboard. specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, additional software options (V Nav and Scan Assistant) leading to overall quality and image enhancement. The LOGIQ E9 Diagnostic Ultrasound System is initially released with the following 13 probes: S1-5, C1-5-D, 3CRF, 9L-D, 11L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D.

The GE LOGIQ E9 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system. Its acceptance criteria and proof of meeting those criteria are established through a predicate device comparison rather than specific performance metrics like sensitivity or specificity.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the GE LOGIQ E9 Diagnostic Ultrasound System is Substantial Equivalence to a legally marketed predicate device, specifically the GE LOGIQ BT08 Diagnostic Ultrasound System (K073408).

The reported device performance, which supports this acceptance criterion, is based on the claim that the GE LOGIQ E9:

• Has the same technological characteristics as the predicate device.
• Possesses key safety and effectiveness features similar to the predicate device.
• Is similar in physical design, construction, and materials to the predicate device.
• Has the same intended uses and basic operating modes as the predicate device.
• Conforms with applicable medical device safety standards (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety).
• Its design and development process conform to 21 CFR 820, ISO 9001, and ISO 13485 quality management systems.

The FDA's letter (Attachment {2}) confirms this determination of substantial equivalence.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Not Applicable. The document explicitly states: "Clinical Tests: None required" (Attachment {1}). The device's substantial equivalence is based on non-clinical tests and comparison to a predicate device, not on clinical performance metrics derived from a test set of patient data.

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

   • Not Applicable. As no clinical tests were required or performed to establish novel performance claims, there was no test set requiring ground truth established by experts for performance evaluation.

3. Adjudication Method for the Test Set:

   • Not Applicable. No clinical test set was utilized.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not Applicable. No MRMC study was conducted. The clearance is based on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with or without AI assistance.

5. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

   • Not Applicable. This device is an ultrasound system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, which are deemed substantially equivalent to a predicate.

6. Type of Ground Truth Used:

   • Not Applicable. No clinical ground truth (e.g., pathology, outcomes data) was used to assess the device's performance, as no clinical performance study was conducted. The ground truth for substantial equivalence is the safety and effectiveness profile of the predicate device, K073408.

7. Sample Size for the Training Set:

   • Not Applicable. This submission is for a diagnostic ultrasound system (hardware and associated software features), not a machine learning or AI model that requires a "training set" of data in the typical sense. The 'training' for this type of device would involve engineering design, component testing, and adherence to quality standards.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. As there is no "training set" for an AI model, this question does not apply. The development is based on established engineering principles, regulatory standards, and the performance characteristics of the predicate device.

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