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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); Transesophageal; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 36 cm wide, 31.5 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 GE Vivid-i and Vivid-q Diagnostic Ultrasound System is a compact and portable diagnostic ultrasound system.

Here's an analysis of the provided information, addressing your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a premarket notification, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the modified device (GE Vivid-i and Vivid-q BT10) is as safe and effective as the previously cleared version (GE Vivid-i and Vivid-q BT09) and other cleared GE Ultrasound systems, and also to clear new transducers for specific indications. As such, it does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) that were met by the device itself in a typical clinical study, nor does it report numerical device performance against such criteria.

Instead, the acceptance criteria are implicitly related to:

• Safety and Effectiveness: The device being "substantially equivalent" to predicate devices in terms of safety and effectiveness.
• Conformance to Standards: Adherence to applicable medical device safety standards.
• Intended Uses: The modified device performing its stated indications for use reliably.

The document asserts that these criteria have been met through non-clinical tests and a comparison with the predicate.

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

No specific test set or clinical data (sample size, data provenance) is mentioned for evaluating the performance of the GE Vivid-i and Vivid-q BT10 system itself beyond the non-clinical tests. The submission states "Clinical Tests: None required."

For the new transducers (8C-RS, 4C-RS, SoundStar 3D 10F, AcuNav™ 8F), the document lists new indications for use that are "N = new indication (previously cleared by FDA...)" on other existing and cleared devices (GE LOGIQ Book K032477, Vivid 7 K051449, stand-alone devices K070242 by Biosense Webster, Inc., and K071234 by Siemens Medical Solutions). This implies that the safety and effectiveness for these indications with these transducers have been established in previous clearance processes and are being leveraged for this new comprehensive system. However, specific test set sizes or data provenance for these previous clearances are not detailed in this document.

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

Not applicable, as no dedicated clinical test set with ground truth establishment is described for this submission. The "Clinical Tests: None required" statement implies that existing knowledge and previous clearances were sufficient.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with adjudication is described.

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

No MRMC comparative effectiveness study is mentioned. The submission relies on substantial equivalence and "Clinical Tests: None required."

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The device is a diagnostic ultrasound system, not an algorithm-only device. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device's performance is intrinsically linked to its use by a qualified physician.

7. Type of Ground Truth Used

Not explicitly stated for this particular submission, as "Clinical Tests: None required." For the previously cleared devices supporting the new indications for the transducers, ground truth would have been established through standard medical practices (e.g., expert clinical diagnosis, other imaging modalities, pathology, or surgical findings).

8. Sample Size for the Training Set

Not applicable. This document pertains to the clearance of a medical device (ultrasound system) and not the submission of an AI/ML algorithm that would typically involve a separate training set. The device's functionality is based on established ultrasound physics and signal processing, not a trained AI model in the modern sense.

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

Not applicable, as there is no mention of an AI/ML training set.

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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); Transesophageal; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 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.

Here's an analysis of the provided text regarding the GE Vivid-i and Vivid-q Diagnostic Ultrasound System.

Acceptance Criteria and Study for GE Vivid-i and Vivid-q Diagnostic Ultrasound System (K082374)

Based on the provided document, the GE Vivid-i and Vivid-q Diagnostic Ultrasound System's acceptance criteria and proof of their being met are primarily based on substantial equivalence to a predicate device and compliance with recognized safety and quality standards, rather than a clinical performance study with specific quantitative acceptance criteria or statistical measures of device performance.

The document states: "The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems."

And under "Conclusion": "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vivid-i and Vivid -d Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

Furthermore, it explicitly states under "Clinical Tests: None required."

Therefore, the "acceptance criteria" here are framed around demonstrating equivalence to existing, legally marketed devices and adherence to established regulatory and engineering standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no specific quantitative performance metrics from a clinical study are reported, the table reflects the qualitative acceptance criteria related to substantial equivalence and safety/quality standards.

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

• Sample Size for the Test Set: Not applicable. No clinical test set or study validating specific performance metrics (like sensitivity/specificity) was conducted. The clearance is based on substantial equivalence to a predicate device and adherence to manufacturing and safety standards.
• Data Provenance: Not applicable for a performance test set. The predicate device (GE Vivid-i Ultrasound System, K061525) and other cleared GE Ultrasound systems provide the basis for equivalence.

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

• Not applicable. No new clinical trials or studies requiring ground truth establishment by experts for specific diagnostic performance were conducted for this 510(k) submission. The safety and effectiveness are inferred from the predicate device and the known history of diagnostic ultrasound.

4. Adjudication method for the test set

• Not applicable. No performance test set requiring adjudication was conducted.

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. This submission does not involve AI. The device is a diagnostic ultrasound system.

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

• No. This submission does not involve an algorithm. The device is a diagnostic ultrasound system.

7. The type of ground truth used

• Not applicable. No new clinical performance data requiring ground truth was generated. The approval relies on the established safety and effectiveness of the predicate device and the general class of diagnostic ultrasound systems.

8. The sample size for the training set

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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