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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; 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; and Intraoperative (abdominal, thoracic, and vascular).

The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

The GE Healthcare Vivid S5/S6 Ultrasound System is a diagnostic ultrasound device intended for various clinical applications. The submission K121063 does not contain acceptance criteria or study data that proves the device meets specific performance metrics. Instead, it is a 510(k) Premarket Notification Submission asserting substantial equivalence to predicate devices. This type of submission relies on demonstrating that the modified device is as safe and effective as a legally marketed device that does not require premarket approval.

Key points from the submission regarding performance:

• No new clinical studies were conducted or required. The submission explicitly states: "The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence." (Page 2)
• The device's performance is asserted to be "substantially equivalent to the predicate device(s)." (Page 2)
• The submission outlines non-clinical tests performed to ensure safety and effectiveness, including acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are general safety and performance checks, not specific clinical performance metrics.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance are not present in this 510(k) submission.

The tables provided (pages 6-26) list the "Indications for Use" for the Vivid S5/S6 system and its various transducers. These tables specify for each clinical application (e.g., Fetal/Obstetrics, Abdominal, Cardiac) and mode of operation (e.g., B-mode, PW Doppler, Color Doppler) whether that combination was:

• "P" - previously cleared by FDA
• "N" - a new indication in this submission
• "E" - added under Appendix E of the Ultrasound Guidance

These tables clarify the intended uses allowed for the device and its transducers, but they do not contain any quantitative acceptance criteria or reported device performance data. They merely state the cleared usage.

In summary, the provided document does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for the following reasons:

1. No Acceptance Criteria and Reported Performance Table: The document explicitly states that no clinical studies were required to support substantial equivalence, focusing instead on non-clinical safety and performance aspects. Therefore, there are no reported performance metrics against specific acceptance criteria.
2. No Test Set Sample Size and Data Provenance: Since no clinical studies were conducted, there are no test sets or associated provenance information.
3. No Number of Experts and Qualifications: There is no mention of experts establishing ground truth for test sets, as clinical studies were not performed.
4. No Adjudication Method: Not applicable as no clinical test set was used requiring adjudication.
5. No MRMC Comparative Effectiveness Study: No such study was performed or reported.
6. No Standalone Performance: While the device functions as an algorithm (ultrasound imaging), the submission does not present standalone performance metrics in the context of a study demonstrating its diagnostic effectiveness. It relies on the equivalence to previously cleared devices.
7. No Type of Ground Truth Used: Not applicable, as there were no clinical studies generating ground truth.
8. No Sample Size for Training Set: Since this is a hardware device modification and a substantial equivalence claim, it does not involve an AI algorithm with a training set in the conventional sense described for machine learning.
9. No Ground Truth for Training Set Establishment: Not applicable as there is no mention of a training set for an AI algorithm.

The submission focuses entirely on demonstrating the safety and effectiveness of the modified device by comparing its technical characteristics and intended uses to those of legally marketed predicate devices, along with adherence to general safety standards.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; 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; and Intraoperative (abdominal, thoracic, and vascular).

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

The Vivid i and Vivid q are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

The information provided pertains to the GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound Systems (K121062). This submission is a 510(k) for a modified device, primarily claiming substantial equivalence to predicate devices (Vivid i and Vivid q Diagnostic Ultrasound Systems, K102388; Vivid E9 Diagnostic Ultrasound System, K101149).

Crucially, no new clinical studies were conducted or required to support the substantial equivalence of the modified device. The submission focuses on non-clinical tests to demonstrate safety and performance. Therefore, the device does not have explicit acceptance criteria based on performance metrics from clinical trials, nor a study proving it meets such criteria in the context of this 510(k) submission.

The "acceptance criteria" for this 510(k) are the various safety and performance standards the device conforms to, and the "study" demonstrating this is the summary of non-clinical tests.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modified device relying on substantial equivalence to predicates, the "acceptance criteria" are implied by conformity to standards and safety reviews. There are no specific quantitative performance metrics reported in this document from a clinical test.

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

• Sample Size for Test Set: Not applicable. No clinical tests were conducted for this 510(k) submission. Non-clinical tests typically refer to engineering, laboratory, and bench testing, not patient-based data.
• Data Provenance: Not applicable for patient data. The provenance of the non-clinical test data (e.g., conducted internally by GE Healthcare or by external labs) is not specified beyond "GE Healthcare considers..." and "The device has been evaluated for...".

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

• Number of Experts: Not applicable. No clinical test set with ground truth established by experts was used, as clinical studies were not required.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set with expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. The document explicitly states: "The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was performed.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI assistance feature is discussed in the context of clinical performance evaluation for this 510(k). The "EchoPilot reporting software" is mentioned as providing guidance for quality and generating preliminary data analysis, but its clinical effectiveness or impact on human reader performance through a comparative study is not assessed in this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No. This submission is for an ultrasound system and its transducers, not a standalone algorithm. Any software components (like EchoPilot) are part of the overall device functionality, but their isolated "standalone" performance in a clinical context is not evaluated as part of this 510(k).

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical performance. The ground truth for non-clinical tests would involve engineering specifications, recognized standards, and established testing methodologies (e.g., using phantoms for acoustic output, material standards for biocompatibility).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This 510(k) is not for an AI/ML algorithm that requires a training set of clinical data.

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

• Ground Truth for Training Set: Not applicable. This 510(k) is not for an AI/ML algorithm that requires a training set.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; 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; and Intraoperative (abdominal, thoracic, and vascular).

The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

Here's a summary of the acceptance criteria and study information for the GE Vivid S5/S6 Diagnostic Ultrasound System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Summary) for the GE Vivid S5/S6 is a premarket notification for a modification to an already legally marketed device. It does not present specific quantitative acceptance criteria or detailed performance metrics in the typical sense of a clinical or analytical performance study. Instead, the "acceptance criteria" are implied through the concept of substantial equivalence to its predicate device (Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K092079).

The reported device performance is that it meets this substantial equivalence:

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

The document explicitly states: "The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence."

Therefore, there is no separate "test set" in the context of clinical performance evaluation described here. The evaluation relies on non-clinical tests (acoustic output, biocompatibility, safety, etc.) and comparison to the predicate device.

3. Number of Experts and Qualifications for Ground Truth

Not applicable, as no clinical studies requiring expert-established ground truth were performed for this specific submission to demonstrate substantial equivalence.

4. Adjudication Method

Not applicable, as no clinical studies requiring adjudication were performed.

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

No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence based on technical specifications and non-clinical testing, not on improved human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is an ultrasound system, not an AI algorithm intended for standalone performance evaluation in the context of this 510(k) submission. The document mentions "additional software features that are similar to other cleared GE Ultrasound systems," but does not detail any standalone performance studies for these features.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for this device relies on:

• Compliance with established safety and performance standards: Non-clinical tests (acoustic output, biocompatibility, electrical, thermal, mechanical safety).
• Comparison to predicate device specifications and performance: The existing cleared Vivid S5/S6 (K092079) serves as the benchmark for "truth" in terms of equivalence.

8. Sample Size for the Training Set

Not applicable, as this submission is for an ultrasound system based on established technology and substantial equivalence, not a new AI model requiring a training set.

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

Not applicable, as there is no mention of an AI model training set in this submission.

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Ultrasound imaging, measurement and analysis of the human body as follows: Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.

The Vivid-i and Vivid-q are compact and portable diagnostic ultrasound systems with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. They have an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provide 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 for the GE Healthcare Vivid i/q Diagnostic Ultrasound System. It is primarily focused on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance criteria and a study to prove those criteria.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is largely not present in the provided document. The 510(k) summary explicitly states:

"The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence." (Page 3)

However, I can extract the following relevant details from the document:

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

Since no clinical studies were performed to establish new acceptance criteria and performance metrics for the modified Vivid i/q, a table of specific clinical performance acceptance criteria and reported device performance cannot be generated from this document. The document instead relies on substantial equivalence to predicate devices, implying that their performance characteristics are maintained.

2. 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 sets were used for this 510(k) submission, as explicitly stated above. Therefore, details regarding sample size and data provenance are not applicable.

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 test sets requiring expert-established ground truth were used.

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

Not applicable, as no clinical test sets requiring adjudication 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:

Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool. No MRMC studies were conducted.

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

Not applicable. This submission is for an ultrasound system, which inherently involves human operation and interpretation.

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

Not applicable, as no clinical studies requiring new ground truth establishment were performed for this submission. The ground truth for the predicate devices would have been established through clinical validation relevant to diagnostic ultrasound.

8. The sample size for the training set:

Not applicable, as this submission is for a medical device (ultrasound system), not a machine learning algorithm that requires a training set.

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

Not applicable, as this submission is for a medical device (ultrasound system), not a machine learning algorithm.

Summary of Non-Clinical Tests (from Page 3 of the document for completeness, as this is the closest to "performance"):

The document highlights the following non-clinical evaluations to ensure safety and effectiveness:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

These tests comply with applicable medical device safety standards and voluntary standards. The following quality assurance measures were applied to the development of the system:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final Acceptance Testing (Validation)
• Performance testing (Verification)
• Safety testing (Verification)

The biocompatibility of transducer materials and other patient contact materials was also confirmed.

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