(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Opthalmic, Fetal, Abdominal, Intra-Operative (Specify), Intra-Operative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Trans-Rectal, Trans-Vaginal, Trans-Urethral, Intra-Vascular, Peripheral -Vascular, Laparascopic, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial, Others (Specify)
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (B - M), Other (Specify)
Note 1: Abdominal, Solid organs, aneurysms,
Note 2: Small Organ: breast, thyroid, testes.
Note 3: Includes imaging for guidance of biopsy
The Interson USB Ultrasound Probe System is a self contained portable, multiple-mode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection eight transducers to be offered with the system permits a wide range of clinical applications including fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, cardiac, neonatal cephalic, urology, ophthalmology. With these general areas of intended use, the various transducers adapt the system for the specific imaging tasks. Eight different models of the USB Ultrasound Probe System are available and any two may be connected at the same time to a USB 2.0 port. In addition to the initial operational settings for each USB Ultrasound Probe System are preprogrammed in the system. User-customized parameter settings for each USB Ultrasound Probe System may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function. The Interson USB Ultrasound Probe System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz. These probes can be applied to a variety of fields such as fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, neonatal cephalic, cardiac, ophthalmology, and urology. The Interson USB Ultrasound Probe System provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), and LMP (last menstral period). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of Interson USB Ultrasound Probe System is B-Mode, The Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
This 510(k) Premarket Notification for the INTERSON USB Ultrasound Probe System does not contain any studies proving the device meets specific acceptance criteria.
Instead, it asserts substantial equivalence to a predicate device (Terason 2000, K992505) and lists the device's technological characteristics and proposed indications for use. The documentation focuses on demonstrating that the new device has similar intended uses and technological features to an already legally marketed device, which is the basis for a 510(k) clearance, rather than presenting a performance study with acceptance criteria.
The "acceptance criteria" and "device performance" in this context would generally refer to safety and effectiveness, which are implicitly covered by demonstrating substantial equivalence to the predicate device. The document does mention acoustic output limits as a safety characteristic.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such study is provided in the given text.
The document provides the following information:
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1. A table of acceptance criteria and the reported device performance: This information is not provided in a performance study format. The document states acoustic output limits for all applications:
- ISPTA.3: 94 mW/cm2 (Maximum)
- MI: 1.9 (Maximum)
It explicitly states these limits are "the same as predicate Track 1 devices." This indicates a comparison to the predicate rather than a new performance study against defined acceptance criteria for the new device.
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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, as no performance study data is presented.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study data is presented.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no performance study data is presented.
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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: Not applicable. This document predates widespread AI in medical imaging and focuses on a hardware device's substantial equivalence to a predicate, not an AI efficacy study.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware device submission, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study data is presented.
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8. The sample size for the training set: Not applicable, as no algorithm training data is presented.
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9. How the ground truth for the training set was established: Not applicable, as no algorithm training data is presented.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.