(196 days)
The system is intended to be used by a trained qualified physician 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), peripheral vascular, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, CWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
The SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex, phased array and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
This system is a Track 3 device and the software used in Apogee 6500 / Apogee 6300/Apogee 6200 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.
The provided text is a 510(k) summary for the Apogee 6500, Apogee 6300, and Apogee 6200 Digital Color Doppler Ultrasound Imaging Systems. This document aims to demonstrate substantial equivalence to a legally marketed predicate device (Apogee 5500).
Based on the provided information, the device is an ultrasound imaging system, not an AI/ML-driven device, and therefore the majority of the requested information (acceptance criteria, specific study details for AI/ML performance, ground truth, expert adjudication, MRMC studies) is not applicable or not provided in this type of regulatory document.
Here's an breakdown of the available information in response to your request, and why some parts cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance:
This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria for a novel AI/ML algorithm. The performance is assessed by comparison to the predicate device and compliance with relevant international standards.
- Acceptance Criteria (Implied for Substantial Equivalence): The device is substantially equivalent if it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate device.
- Reported Device Performance:
- Intended Use: Same as the predicate device (Apogee 5500, K160853).
- Technical Characteristics: Basic and key technical features (Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management) are the same as the predicate.
- Acoustic Power Levels: Meet FDA limits, same as the predicate device.
- Materials of Probes: Same as the predicate device.
- Probes: Similar probes as the predicate, with two new transducers (P5FC and V6LF) whose applications fall within the predicate's indications for use.
- Safety and Efficacy: Differences between the new device and the predicate have no impact on safety or efficacy and do not raise new potential or increased safety risks. The new device is equivalent in performance to existing legally marketed devices.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. As this is an ultrasound imaging system (not an AI/ML diagnostic algorithm), the performance is assessed through engineering tests, compliance with safety standards, and comparison of technical specifications to the predicate device. There is no "test set" in the context of image classification or detection algorithms with associated ground truth labels to be tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment using expert review is relevant for AI/ML performance studies, which are not described in this 510(k) summary for an ultrasound imaging system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication is relevant for resolving discrepancies in expert labeling of imaging data for AI/ML algorithm development/testing, which is not the subject of this document.
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. The document explicitly states: "Clinical testing is not necessary for the Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." MRMC studies evaluating human reader performance with and without AI are not mentioned or required for this type of device clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided in the context of diagnostic performance. This device is an imaging system, not a diagnostic algorithm. Its "performance" is assessed by its imaging capabilities, safety, and compliance with standards, not a standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The concept of "ground truth" as used in AI development is not relevant to the substantial equivalence demonstration for this general-purpose ultrasound system. Its performance evaluation relies on engineering verification, compliance with safety standards (e.g., IEC 60601 series), and direct comparison of specifications and intended use to the predicate device.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML algorithm requiring a training set. The "software" mentioned (Ultrasound Software by SIUI) is based on the predicate device's software and its "Level of Concern" is Moderate, implying it was developed and validated through standard software engineering practices for medical devices (e.g., IEC 62304), not through machine learning training on a dataset.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no AI/ML training set, the establishment of ground truth for such a set is not relevant.
In summary, this 510(k) pertains to a new generation of an existing ultrasound imaging system, demonstrating its substantial equivalence to a previously cleared model. The evaluation focuses on hardware, software (system-level, not AI/ML), safety standards, and technical specifications, rather than clinical performance metrics typically associated with AI/ML-driven diagnostic aids.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.