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Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.

Typical examinations using Level 10 HDI are:

• General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
• Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall.
• Pediatric scans of organs, superficial, 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.
• Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
• Cardiac studies in adults and children.
• Monitoring of cardiac function during procedures using transesophageal echocardiography.
• Biopsy guidance for tissue or fluid sampling.
• Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery
• Study of myocardial function in adults
• Study of eye anatomy including blood flow in retinal vessels and branches
• Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe
• Study of abdominal and pelvic organs and masses using laparoscopic probe
• Examination of organs, masses and vessels during surgical procedures
• Study of muscles, ligaments, nerve bundles and connective tissue

Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, Mmode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the opertor 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. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.

The Level 10 HDI system is designed to accept scanheads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz

scanhead types: Linear array Curved linear array Phased array Static probes

Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Level 10 HDI Ultrasound System:

Summary of Acceptance Criteria and Device Performance:

The provided document does not explicitly state specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other quantitative performance metrics for disease detection or measurement). Instead, it focuses on the device's adherence to intended uses, technological characteristics matching predicate devices, and compliance with electromechanical safety and acoustic output standards.

The "device performance" reported is primarily in terms of its capabilities and specifications, rather than quantitative clinical outcomes against predefined targets.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Information Regarding Study and Ground Truth:

The provided 510(k) summary does not appear to describe a formal clinical study with a test set, ground truth established by experts, or quantitative performance metrics in the way typically expected for AI/ML device submissions. This is largely because the document is from 1996, a time before AI/ML diagnostic devices were common and regulatory requirements for their validation were established. This submission focuses on substantial equivalence to predicate devices.

Therefore, for aspects related to clinical performance studies (items 2-7), the answer is that the information is not provided or not applicable based on the content.

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

   • Not provided. The document focuses on technological equivalence and safety standards, not a specific clinical performance study with a test set.

2. 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):

   • Not provided. No explicit ground truth establishment for a test set is described.

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

   • Not provided. No adjudication method is mentioned as a clinical performance test set is not described.

4. 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 done/Not applicable. This document predates the widespread use of AI in medical imaging, and no such study is described. The device itself is a diagnostic ultrasound system, not typically an AI-assisted diagnostic tool in the modern sense.

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

   • Not applicable. As the device is an ultrasound system intended to be operated by a human, the concept of "standalone algorithm only" performance as distinct from a human-in-the-loop system doesn't apply in the context of this submission. The device's function is to acquire and display data for human interpretation.

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

   • Not provided/Not applicable. As no specific clinical performance study based on a test set is described, no ground truth type for such a study is mentioned. The implicit "ground truth" for this submission's regulatory approval is the established performance and safety profiles of the predicate devices and general knowledge of ultrasound technology.

7. The sample size for the training set:

   • Not applicable. This document describes a diagnostic ultrasound system whose underlying principles are well-established physics and signal processing. It is not an AI/ML device that requires a "training set" in the contemporary sense. Any software optimization is likely based on engineering principles and general data, not a specific, labeled "training set" for an AI model.

8. How the ground truth for the training set was established:

   • Not applicable. See point above regarding the nature of the device and the submission.

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