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The system is intended to be used by a trained/qualified healthcare professional in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), liver, peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology applications in B-Mode(B, 2B, 4B), M-Mode, Anatomical M-mode, Color M, Color Flow Map (CFM), Power Doppler Imaging (PDI), Directional Power Doppler Imaging (DPDI), Pulsed Wave Doppler (PWD), Continuous Wave Doppler(CWD), 3D/4D, Elastography, Contrast Harmonic Imaging(CHI), S-Beam, Panoscope, Trapezoidal/Extended Sector Imaging, Tissue Doppler Imaging(TDD), Tissue Harmonic Imaging(THI), Macro Fidelity Imaging(MFI), ECG, Vector Space Flow (VS Flow), DICOM.

Device Description

This system is a Track 3 device and the software used in Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Document Level for the Ultrasound Software is Basic.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Important Note: The provided document is a 510(k) summary for an ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, safety standards, and intended use. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence. Therefore, many of the requested items related to a clinical study (like test set sample size, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI algorithm) are not applicable to this submission.

The document discusses non-clinical testing related to compliance with various international standards for medical electrical equipment, software, biocompatibility, and risk management. This type of testing ensures the device meets safety and performance criteria, but it's not a performance study in the sense of evaluating diagnostic accuracy against a ground truth for a specific clinical application.

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria are primarily based on meeting safety standards and demonstrating comparable technical characteristics and intended use to the predicate device. There isn't a table of specific performance metrics for clinical accuracy as would be found in a study for an AI-powered diagnostic device.

Acceptance Criteria Category	Description	Reported Device Performance
Intended Use	The device's intended use and application sites should be practically identical or a logical extension (with appropriate justification) of the predicate device.	"Compared with predicate device Apogee 2300 (K173000), subject device adds description of imaging mode, and on the basis of predicate device imaging mode, adds Contrast Harmonic Imaging (CHI) and its corresponding application site: Liver. Other intended uses and application sites are practically identical." This was deemed acceptable as it's an addition of a known imaging mode and application.
Technical Characteristics	Basic and key technical features (Operation Principle, Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management, Acoustic power levels, Materials of probes, Probes) should be the same as or comparable to the predicate device, without raising new questions of safety or efficacy.	"The basic and key technical features of the subject Device are the same as the predicate device Apogee 2300 (K173000), including Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management."
"The Acoustic power levels of subject devices meet the limits of FDA same as the predicate device Apogee 2300 (K173000)."
"The materials of probes with subject device are same as the predicate device of Apogee 2300 (K173000)."
New probes were introduced but their applications were stated to be "within the indications for use of the primary predicate system Apogee 2300 (K173000)."
"Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices."
Safety Standards Compliance	The device must comply with relevant international and national safety and performance standards for medical devices and ultrasound equipment.	The device "comply[s] with and/or were tested in accordance with the following FDA guidance and International Standards:"

IEC 60601-1 (Basic safety & essential performance)
IEC 60601-1-2 (EMC)
IEC 60601-2-37 (Ultrasonic diagnostic & monitoring equipment)
IEC 60601-2-25 (Electrocardiographs)
ISO 14971 (Risk management)
ISO 10993 (Biocompatibility parts 1, 5, 10, 23)
IEC 62304 (Software life cycle)
IEC 60601-1-6 (Usability)
IEC 62366-1 (Usability engineering)
ISO 15223-1 (Symbols for labels)
ISO 13485 (Quality management systems)
FDA Guidance for PMS for Software in Medical Devices
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |
| Software Document Level | Software documentation should meet the basic document level requirements, indicating proper development and verification processes. | "The Document Level for the Ultrasound Software is Basic." |

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. The document explicitly states: "Clinical testing is not necessary for the Apogee C2... Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set in the traditional sense of a performance study to evaluate diagnostic accuracy. The "test set" for this submission refers to the physical device being tested against safety and performance standards, and comparison of its specifications to the predicate device.

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 explained above, no clinical test set requiring expert-established ground truth was part of this 510(k) submission.

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

Not Applicable. No clinical test set with adjudication was part of this 510(k) submission.

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 is for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

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

No. This submission is for an ultrasound imaging system. It states the software is "Ultrasound Software by SIUI" and is "based on the predicate device." It does not describe a standalone AI algorithm for diagnostic interpretation.

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

Not Applicable. For the non-clinical testing performed (compliance with standards), the "ground truth" is adherence to the specifications of those standards (e.g., electrical safety limits, EMC performance, software lifecycle processes) and comparison of technical parameters to the predicate device. There was no clinical ground truth established for diagnostic performance.

8. The sample size for the training set

Not Applicable. This submission does not describe an AI/machine learning model that would require a training set of patient data. The "software" referred to is the operating system and imaging processing software of the ultrasound machine, not a data-driven AI algorithm in the diagnostic sense implied by this question.

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

Not Applicable. As no training set was used, no ground truth needed to be established for it.

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