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The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, submaxillar, gland, testes and breast.), Peripheral Vascular, Trans-vaginal, Trans-rectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled and ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode and THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.

The provided 510(k) K123616 submission for the SonoScape A6 Portable Ultrasonic Diagnostic System and its associated transducers concerns a traditional substantial equivalence determination. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, or that any differences do not raise new questions of safety or effectiveness.

Crucially, this document explicitly states: "No clinical testing was required." This means there was no study performed to directly test the diagnostic performance of the device against a set of acceptance criteria in a clinical setting. The acceptance criteria for this device are primarily related to meeting established medical device safety and performance standards for ultrasound systems, rather than diagnostic accuracy metrics like sensitivity or specificity.

Therefore, many of the requested points below about specific study details (like sample size for test sets, number of experts, adjudication methods, MRMC studies, or standalone performance) cannot be answered from this document because such clinical performance studies were not conducted.

Here's a breakdown of the information that can be extracted or inferred from the provided text, particularly in the context of device acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of traditional 510(k), acceptance criteria are typically met by adherence to recognized standards and by demonstrating that the device functions according to its technical specifications and intended use without raising new safety or effectiveness concerns compared to the predicate. The "reported device performance" is essentially that it meets these standards and functions as intended, similar to the predicate.

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

• Not applicable / No specific clinical test set: The submission explicitly states, "No clinical testing was required." The acceptance was based on engineering and performance verification against recognized standards and comparison to a predicate device, not on diagnostic performance in a test set of patient data.

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 testing was required, there was no test set requiring ground truth established by experts.

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

• Not applicable: As no clinical testing was required, there was no test set requiring adjudication.

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 was not a comparative effectiveness study involving human readers or AI. It's a 510(k) for an ultrasound system, comparing it to a previous version of the same system.

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

• No: The device is an ultrasonic diagnostic system, requiring a human operator (qualified physician) for its intended use. It is not an algorithm for standalone diagnostic performance.

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

• No clinical ground truth used: For the purposes of this 510(k), ground truth was established by adherence to technical specifications, engineering measurements against industry standards (e.g., NEMA UD 2, IEC 60601 series), and verification that the device's technical characteristics and intended use were substantially equivalent to the predicate device.

8. The sample size for the training set

• Not applicable: As no clinical testing was required and this is not an AI/algorithm-based submission, there was no training set in the conventional sense for diagnostic performance.

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

• Not applicable: No training set was used.

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The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.

The provided document describes the SonoScape A6 Portable Ultrasonic Diagnostic System and its associated transducers. The submission is a 510(k) Pre-Market Notification, indicating a device seeking clearance for being substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its diagnostic performance, nor does it report specific performance metrics for the device in a clinical context. Instead, the acceptance criteria are based on adherence to recognized safety and performance standards for diagnostic ultrasound equipment. The "performance" in this context refers to meeting these established standards, which serve as a proxy for substantial equivalence and safety/effectiveness.

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

The document explicitly states: "No clinical testing was required." This means there was no specific "test set" of patient data or samples used in the way one would for a clinical efficacy study. The testing performed was primarily laboratory-based to meet engineering and safety standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.

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

Since no clinical testing was required and therefore no clinical "test set" was used, there were no experts establishing ground truth for such a set. The "ground truth" for this device's clearance is its adherence to universally recognized safety and performance standards, verified through laboratory testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for diagnostic performance evaluation or adjudication. The evaluation was primarily against engineering and safety standards.

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

No MRMC comparative effectiveness study was mentioned or required for this 510(k) clearance. The device is a general-purpose ultrasound system, and its clearance relies on proving substantial equivalence to existing predicate ultrasound devices, not on demonstrating improved diagnostic performance with AI assistance.

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

Not applicable. This device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. It is not an AI algorithm performing diagnostic tasks independently.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the adherence to established international and national standards for medical electrical equipment safety (IEC 60601 series), acoustic output (NEMA UD 2), and biocompatibility (ISO 10993 series). The performance of the device's components and overall system was verified against the requirements outlined in these standards, in comparison to existing legally marketed predicate ultrasound devices.

8. The Sample Size for the Training Set

Not applicable. As a general-purpose diagnostic ultrasound system, this device's functionality is based on established physics and engineering principles of ultrasound imaging, not on machine learning or AI algorithms that require 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 type of device submission.

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