(63 days)
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), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, 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 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, PW mode and Color Doppler 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 S7, Samsung Galaxy S10, Samsung Galaxy S21, Google Pixel 4, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPad Pro 11-inch (Gen2), and iPad Air (Gen4).
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 healthcare is provided by trained healthcare professionals.
This FDA 510(k) summary for the Apache Ultrasound System does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.
The document states that the Apache Ultrasound System is a "Track 3 system" and that its substantial equivalence is primarily determined by comparison to a predicate device (Clarius Ultrasound Scanner K192107), specifically focusing on non-clinical performance tests rather than clinical efficacy studies in the way you've outlined.
Here's a breakdown of what the document does provide, and what it lacks in relation to your specific questions:
Key Takeaways from the Document:
- Substantial Equivalence: The primary method for proving the device is acceptable is by demonstrating "substantial equivalence" to a legally marketed predicate device (Clarius Ultrasound Scanner K192107). This is a common pathway for medical devices where new clinical efficacy studies are not deemed necessary because the fundamental technology and intended use are similar to existing, cleared devices.
- Focus on Non-Clinical Tests: The document explicitly states: "Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output. The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance."
- No New Indications/Technologies Requiring Clinical Testing: "Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."
Addressing Your Specific Questions Based on the Provided Text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document lists standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, IEC 62304, ISO 14971) that the device must comply with for non-clinical performance (electrical safety, EMC, usability, biological evaluation, software lifecycle, risk management). These standards implicitly define acceptance criteria in terms of meeting their requirements.
- Reported Device Performance: The document states, "The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance." However, it does not provide a detailed table with specific numerical performance metrics (e.g., measurement accuracy values, sensitivity values) or thresholds for these non-clinical tests. It merely states compliance.
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Sample sized used for the test set and the data provenance:
- Not Applicable/Not Provided: Since the substantial equivalence is primarily based on non-clinical performance and a comparison to a predicate device without new clinical indications, there is no mention of a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The testing described is laboratory-based non-clinical testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided: This information pertains to studies involving human interpretation or ground truth establishment for diagnostic accuracy, which was explicitly not performed as a clinical study for this 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided: Same as above, not relevant for the type of submission described.
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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 states, "Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing." This device is an ultrasound system itself, not an AI assisting human readers, and no MRMC study was performed as part of this 510(k) submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone performance evaluation in the usual sense of algorithm-only accuracy. Its "performance" is in generating images and fluid flow analysis, and its safety and effectiveness are established through engineering and non-clinical tests to meet standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Provided: For the non-clinical tests, "ground truth" would be defined by calibrated instruments, reference materials, and engineering specifications. It's not clinical "ground truth" (e.g., pathology, expert diagnosis).
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The sample size for the training set:
- Not Applicable/Not Provided: This refers to the training of an AI model. While the device (like any modern medical device) contains software, the 510(k) summary does not describe it as an AI/ML-driven device that underwent a training phase on a specific dataset for diagnostic interpretation. Its software lifecycle processes are governed by IEC 62304, which is about software engineering, not AI model training.
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How the ground truth for the training set was established:
- Not Applicable/Not Provided: Same as above.
In summary: The provided document is a 510(k) summary from the FDA, which outlines the basis for demonstrating "substantial equivalence" for a medical device. For the Apache Ultrasound System, this was primarily achieved through comparison to a predicate device and rigorous non-clinical testing against established safety and performance standards. It explicitly states that no new clinical efficacy testing was required because the device did not introduce new indications, modes, features, or technologies. Therefore, the detailed information about clinical studies, expert-derived ground truth, sample sizes for test/training sets, and AI-related performance metrics (like MRMC studies) you requested are not present in this type of submission for this particular device.
§ 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.