Search Results

The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Cephalic (adult), Peripheral Vessel, Carotid, Urology, FAST/EFAST, Lung, Ocular, Nerve, Cardiac (Pediatric and Adult) and Pediatric. The system provides diaging in B, Color Doppler, M, Power Doppler and Combined (B+M; B+CD ; B+PD) modes. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes.

The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S6 Lite, Samsung Galaxy Tab S7, Samsung Galaxy Tab S7 FE, Samsung Galaxy Tab S8, Samsung Galaxy S10, Samsung Galaxy S21, Xiaomi Pad 5, Google Pixel 4, Google Pixel 6, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPhone 14, iPad Pro 11-inch (Gen2), iPad Air (Gen4), iPad Air (Gen5), iPad 9.

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

This document describes the FDA clearance for the Aco Apache Ultrasound System, a portable color ultrasound imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device, the Clarius Ultrasound Scanner (K213436).

Here's an analysis of the provided information regarding acceptance criteria and study data:

Unfortunately, the provided FDA 510(k) summary does not contain details about specific acceptance criteria, reported device performance metrics, or a formal study that proves the device meets those criteria, especially in a comparative effectiveness context. The document primarily focuses on non-clinical testing and a claim of substantial equivalence to a predicate device based on similar intended use and technology.

Let's break down what information is available and what is missing based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed breakdown of requested information:

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

• No information provided. The document explicitly states: "Aco Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Ultrasound Scanner) that require clinical testing." This indicates that no separate clinical test set or study data, with specific sample sizes or provenance, was generated or presented for this 510(k) submission to demonstrate clinical performance.

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)

• No information provided. As no clinical test set was presented or required, there was no need for experts to establish ground truth for a clinical study.

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

• No information provided. No clinical test set or study requiring adjudication was conducted or described.

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 MRMC comparative effectiveness study was done or reported. The device is a general-purpose diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of providing automated readings or interpretations that would typically warrant an MRMC study. The comparison is primarily against a predicate device, not against human reader performance or human reader improvement with AI assistance.

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

• Not applicable / No such study reported. The Aco Apache Ultrasound System is a diagnostic imaging device controlled by a human operator, not a standalone AI algorithm performing diagnoses. While it is software-controlled, its core function is to produce images for human interpretation.

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

• No ground truth data from a clinical study is discussed. The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical verification against established engineering and safety standards.

8. The sample size for the training set

• Not applicable / No information provided. The document does not describe the use of machine learning or AI models that would require a "training set" in the context of diagnostic interpretation. It is a general imaging system. While the device is software-controlled, the software development would adhere to IEC 62304 (Medical Device Software - Software Life Cycle Processes), which focuses on software quality and safety, not on training data for a diagnostic algorithm.

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

• Not applicable / No information provided. As no training set for a diagnostic algorithm is indicated, the method of establishing its ground truth is not relevant or provided.

Summary of Device Verification Methods Presented:

The 510(k) submission for the Aco Apache Ultrasound System primarily relies on two pillars for demonstrating substantial equivalence:

1. Comparison to a legally marketed predicate device (Clarius Ultrasound Scanner K213436): The document highlights that the subject device has the same intended use, indications for use (with some minor variations in specific applications that are still covered by the predicate), product codes, regulation numbers, portability, power source, and fundamental imaging modes (B, M, Color Doppler, Power Doppler, PW Doppler, and combined modes) as the predicate.
2. Non-clinical performance testing and compliance with recognized standards: The document lists numerous international and national standards (e.g., electrical safety, EMC, usability, biological compatibility, acoustic output, software lifecycle, risk management) that the device complies with. These tests ensure the device's technical specifications, safety, and functionality meet established industry benchmarks.

The basis for clearance is that the new device does not introduce new technological characteristics or indications for use that would raise new questions of safety or effectiveness compared to the predicate device, thereby negating the need for de novo clinical studies for this 510(k) submission.

Ask a specific question about this device