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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial), Intra-Operative (Neurological, Abdominal, Peripheral vascular). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.

The SA8000 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA8000 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA8000 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Seventeen different models of transducers are available and any three may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA8000 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal 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), LMP (last menstural period.), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index. % stenosis, ICA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method which has its images flow from the right to the left on the monitor. The SA8000 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The Medison America, Inc. SA8000 Diagnostic Ultrasound System and its associated transducers are general purpose diagnostic ultrasound systems. The provided documentation primarily focuses on establishing substantial equivalence to previously cleared predicate devices (SA 9900 - K002185 and SA8800/HDI1500 - K974269) by demonstrating equivalent technological characteristics and intended uses.

Based on the provided information, typical "acceptance criteria" for this type of device are related to its technical specifications and intended uses being substantially equivalent to legally marketed predicate devices, as well as meeting safety standards. The study described is a submission for 510(k) clearance, which is a regulatory pathway to demonstrate substantial equivalence, rather than a clinical trial with specific performance metrics against a defined ground truth.

Here's an analysis of the provided information relative to your requested points:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for a 510(k) submission like this often revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing substantially equivalent technological characteristics and intended uses.

1. A table of acceptance criteria and the reported device performance
See table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices primarily through technical specifications and intended uses, rather than a clinical performance study with a "test set" in the typical sense of AI/algorithm evaluation. Therefore, information about a specific sample size for a test set, data provenance (country of origin, retrospective/prospective), etc., is not available in this document. The "study" here is the regulatory submission itself, comparing the new device's specifications to existing ones.

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)
As there is no described clinical performance study with a test set requiring expert-established ground truth, this information is not applicable/not provided in the document. The regulatory review process involves FDA experts evaluating the submission against established standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there's no defined "test set" for performance evaluation, an adjudication method is not applicable/not provided.

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
This submission predates the widespread use of AI in medical imaging devices and focuses on foundational ultrasound technology. No MRMC study involving AI assistance for human readers was conducted or reported in this document. This information is not applicable/not provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a diagnostic ultrasound system, which inherently requires a human operator for image acquisition and interpretation. It is not a standalone algorithm in the sense of AI. Therefore, a standalone algorithm performance study is not applicable/not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that this is a 510(k) submission for a general-purpose ultrasound system based on substantial equivalence, there isn't a "ground truth" for disease detection or diagnosis that would typically be established in a clinical trial for an AI-powered diagnostic device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices and compliance with recognized safety standards. This information is not applicable/not provided.

8. The sample size for the training set
This document does not describe a machine learning algorithm or AI component that would typically require a "training set." Therefore, information on a training set size is not applicable/not provided.

9. How the ground truth for the training set was established
As there is no described training set, this information is not applicable/not provided.

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