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The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).

The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.

FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology, and is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. The probe containing a mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.

This 510(k) submission (K173034) by Echosens for its FibroScan® Family of Products primarily focuses on a revision of the Indications for Use (IFU), changing "an aid to clinical management" to "an aid to diagnosis and monitoring" for adult patients. The submission explicitly states that no new hardware or software elements were included, and therefore, no new performance data were required in support of the submission.

This means that the document does not contain a new study proving the device meets new acceptance criteria related to its diagnostic and monitoring capabilities. Instead, it relies on the safety record and broad clinical use of the already cleared devices.

Therefore, many of the requested details regarding acceptance criteria and a new study are not present in the provided text. I will extract the information that is available based on the request and clearly state what is not found.

Acceptance Criteria and Device Performance

Since this submission is a revision of the Indications for Use and states "No new performance data were required," there are no new acceptance criteria or reported device performance metrics presented in this document specifically for the revised IFU. The document implicitly relies on the performance proven during the clearance of the predicate device (K160524) and prior versions of the FibroScan systems.

Study Details (for a new study validating the "aid to diagnosis and monitoring" claim)

No new study is presented in this 510(k) submission to demonstrate that the device meets new acceptance criteria for the revised "aid to diagnosis and monitoring" claim. The submission explicitly states: "No new hardware or software elements were included in the submission. Therefore, no new performance data were required in support of the submission."

Based on this, the following information is not applicable or not found in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as no new performance study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a standalone device, and no MRMC study for AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The FibroScan is inherently a "standalone" device in the sense that it provides measurements directly. However, the submission does not detail a new standalone performance study for the revised IFU. It relies on previously established performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study in this submission.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document regarding studies and performance:

The basis for the revised Indications for Use (from "aid to clinical management" to "aid to diagnosis and monitoring") is stated as:

• "Its perfect safety record and broad clinical use as an aid to the diagnosis and monitoring of adult patients with liver disease support the revision of its indications for use."
• This suggests reliance on post-market surveillance, existing clinical practice, and prior clearance data rather than a new, specific clinical performance study for this particular change.

The submission focuses heavily on non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electromagnetic, and mechanical safety, conforming to applicable standards (listed in the "Recognized Consensus Standards Used" section). This indicates that the device's fundamental physical and safety performance was established previously and confirmed to meet current standards.

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

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 520 mm wide (keyboard), 865 mm deep and 1760 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.

The provided text describes a 510(k) premarket notification for the GE LOGIQ S8 ultrasound system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new acceptance criteria through extensive clinical studies.

Therefore, the document does not provide specific acceptance criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a particular disease or measurement), nor does it detail a study performed to prove such metrics against acceptance criteria. Instead, it demonstrates substantial equivalence based on technological characteristics, intended use, and compliance with recognized safety and performance standards.

Here's an breakdown of the information that can be extracted based on your request, as well as indications of what is not present in this type of regulatory filing:

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

This information is not provided in the document as it is a 510(k) summary for showing substantial equivalence, not a clinical trial report establishing new performance criteria. The "performance" described relates primarily to equivalence with predicate devices and compliance with general safety and performance standards.

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

This information is not provided. The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." The testing mentioned is for acoustic output, biocompatibility, cleaning/disinfection, and safety standards.

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)

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided. The device is an ultrasound imaging system, and there's no mention of AI assistance or MRMC studies in this document.

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

This information is not provided. The device is a diagnostic ultrasound imaging system, not an AI algorithm for standalone interpretation.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission. The "ground truth" for the device's claims are the safety and performance characteristics of its predicate devices and compliance with recognized standards.

8. The sample size for the training set

This information is not provided as no machine learning or AI training is mentioned as being part of this submission's substantial equivalence argument.

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

This information is not provided as no machine learning or AI training is mentioned.

Summary of what the document does provide regarding device performance and compliance:

The document focuses on demonstrating that the GE LOGIQ S8 is substantially equivalent to legally marketed predicate devices. This is achieved by:

• Intended Use Equivalence: Stating that the LOGIQ S8 has the same clinical intended use as the predicate LOGIQ S8 (K152195).
• Technological Equivalence: Declaring that it employs the same fundamental scientific technology as its predicate device(s).
• Imaging Modes: Noting that it has the same imaging modes as the predicate LOGIQ S8, with additions of Fibroscan elastography and CAP (Controlled Attenuation Parameter), which are equivalent to features found on the reference predicate FibroScan (K160524).
• Safety and Standards Compliance:
  • Manufactured with materials evaluated and found safe.
  • Acoustic power levels are below applicable FDA limits.
  • Designed in compliance with approved electrical and physical safety standards.
  • Compliance with voluntary standards:
    • AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety)
    • IEC60601-1-2 (Electromagnetic Compatibility)
    • IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment Safety)
    • ISO10993-1 (Biological Evaluation of Medical Devices)
    • ISO14971 (Application of risk management to medical devices)
    • NEMA UD 2 (Acoustic Output Measurement Standard)
    • NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
    • NEMA, Digital Imaging and Communications in Medicine (DICOM) Set.
  • Quality assurance measures applied to development (Risk analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
  • Transducer and patient contact materials are biocompatible.

The document lists various transducers cleared with the system and for which clinical applications and modes of operation they are "previously cleared" (P), "new" (N), or "added under Appendix E" (E), primarily based on equivalence to other GE Ultrasound systems (e.g., LOGIQ E9, VIVID E90/E95).

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are compliance with established medical device safety and performance standards and demonstration of substantial equivalence to predicate devices, rather than predefined performance thresholds from new clinical trials.

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