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The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

The provided text is a 510(k) Summary and related Indications for Use forms for the GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound systems. It describes the device, its intended uses, and claims substantial equivalence to a predicate device.

Key takeaway: This documentation explicitly states, "Clinical Tests: None required." Therefore, there are no specific acceptance criteria or a study provided to prove the device meets performance criteria beyond safety and effectiveness compared to a predicate device. The information requested regarding performance metrics, sample sizes, expert qualifications, ground truth, and MRMC studies is not available in these documents because clinical studies were not performed for this 510(k) submission.

However, I can extract the information that is present concerning the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

As per the "Non-clinical Tests" section (Section b.1), the device was evaluated for its conformity with applicable medical device safety standards.
The core acceptance criterion for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K091374).

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

• No clinical test set was used. The submission explicitly states: "Clinical Tests: None required." This is a regulatory filing asserting substantial equivalence based on technical characteristics and safety standards, not a performance study using patient data.

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

• Not applicable. As no clinical test set was used, no experts were required to establish ground truth for a test set.

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

• Not applicable. No clinical test set and thus no adjudication method were used.

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 study was done. This device is an ultrasound imaging system, and the submission does not mention any AI components or features that would warrant an MRMC study comparing human reader performance with and without AI assistance.

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

• Not applicable. This device is an ultrasound imaging system, not an algorithm being tested in a standalone fashion.

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

• Not applicable. No clinical studies requiring ground truth were performed for this submission. The basis for clearance is substantial equivalence to a predicate device and compliance with safety standards.

8. The sample size for the training set

• Not applicable. No clinical training set was used as no new algorithm requiring such a set was part of this 510(k) submission.

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

• Not applicable. As there was no clinical training set, no ground truth needed to be established for it.

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The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

This is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ i/e, Vivid e Ultrasound) and does not contain detailed acceptance criteria and performance study results in the way a clinical trial submission for a novel device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores). Instead, it relies on a "substantial equivalence" argument to predicate devices. The "performance" is implicitly deemed equivalent to the predicate devices.

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

No specific test set or clinical data is mentioned. The submission states: "Clinical Tests: None required." Therefore, there is no sample size for a test set and no data provenance (country of origin, retrospective/prospective). The rationale is that "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Diagnostic ultrasound has accumulated a long history of safe and effective performance."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical tests or test sets were used, no experts were involved in establishing ground truth for a test set.

4. Adjudication Method

Not applicable, as no test set or clinical data requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Tests: None required." The device is cleared based on demonstrating substantial equivalence to predicate devices, not on proving improved effectiveness through head-to-head clinical trials with human readers.

6. Standalone Performance Study

No standalone performance study (algorithm only, without human-in-the-loop) was conducted or reported in this 510(k) submission. This device is a diagnostic ultrasound system, not an AI algorithm requiring standalone performance evaluation in the typical sense for medical imaging AI. Its performance is inherent in its imaging capabilities and user-controlled operation.

7. Type of Ground Truth Used

The ground truth for the device's performance, as argued in this 510(k), is essentially the established safe and effective performance of its predicate devices in clinical practice, along with compliance to recognized standards. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data for this specific submission's evaluation.

8. Sample Size for the Training Set

Not applicable. The GE LOGIQ i/e and Vivid e Ultrasound system is a conventional diagnostic ultrasound device, not an AI/machine learning model in the modern sense that requires a training set of data.

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

Not applicable, as there is no training set for this conventional diagnostic ultrasound device.

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