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Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.

Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.

Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Pulsed wave Doppler mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.

With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional), pediatrics, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).

With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).

With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatric, 40 kg and above), abdominal, fetal/obstetrics, gynecological, urology, thoracic/ lung, pediatrics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).

Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.

Vscan Air consists of an app which can be installed on Android™ or iOS devices, and 2 probes which use wireless technology for communication.

Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.

Here's a breakdown of the acceptance criteria and the study details for the Vscan Air's Auto Bladder Volume feature, extracted from the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Auto Bladder Volume

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Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.
Vscan Air supports black/white (B-mode), color flow (Color Doppler mode, M-mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).

Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and 2 probes which use wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.

The provided text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vscan Air, outlining its substantial equivalence to predicate devices. It does not contain information on specific acceptance criteria and the detailed study results that prove the device meets these criteria in terms of clinical performance (e.g., accuracy, sensitivity, specificity) for a particular AI function.

The document primarily focuses on:

• Regulatory information: Device name, regulation, product codes, predicate devices.
• Intended Use/Indications for Use: Describes the general applications of the ultrasound system.
• Technological comparison: Explains how the Vscan Air is similar to its predicate and reference devices in terms of technology, modes, transducers, and software features.
• Non-Clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning/disinfection, and electrical/electromagnetic/mechanical safety, and adherence to various safety standards.
• Absence of Clinical Studies: Explicitly states, "The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence."

Therefore, based on the provided input, I cannot fulfill the request for:

1. A table of acceptance criteria and reported device performance (for clinical/AI performance).
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document confirms that this particular submission for Vscan Air did not require clinical studies, implying that the performance evaluation relied on non-clinical testing and comparison to predicate devices, rather than a prospective clinical trial with a defined test set and established ground truth for an AI algorithm.

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Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.

Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.

Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Combined (B + Color Doppler) and Harmonic imaging modes with both the curved and linear array transducers.

With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).

With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).

Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and a probe which uses wireless technology for communication.

Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.

The provided document indicates that the Vscan Air device did not require clinical studies to support substantial equivalence. Therefore, there is no detailed information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria.

The document primarily focuses on non-clinical tests to demonstrate substantial equivalence to predicate devices. These non-clinical tests pertain to acoustic output, biocompatibility, cleaning and disinfection, as well as thermal, electrical, electromagnetic, mechanical safety, and wireless communication. The device was found to conform to applicable medical device safety standards.

Summary of Non-Clinical Tests and Conformance:

Key takeaway regarding clinical studies:

• Clinical Studies: "The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence."

Therefore, the requested information regarding a study proving acceptance criteria for clinical performance is not available in the provided text. The submission relied on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

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