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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular. Intended for use in military field settings in addition to hospital/clinic settings.

The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe.

This document is a 510(k) premarket notification for the TERATECH Model 2000 Imaging System, a diagnostic ultrasound system from 1999. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way contemporary AI/ML medical devices do.

Here's an analysis based on the provided text, highlighting what is (and isn't) present as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not present in the provided document. For a 510(k) submission of a diagnostic ultrasound system from 1999, the "acceptance criteria" primarily revolved around demonstrating that the device meets safety standards (electrical safety, acoustic output) and performance specifications that are comparable to legally marketed predicate devices, rather than clinical performance metrics typical of AI/ML or more advanced diagnostic devices today.

The "reported device performance" in this context refers to the technical specifications of the device itself, such as:

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not present in the context of this 1999 510(k) submission for a diagnostic ultrasound imaging system. The submission relies on comparative data to predicate devices and technical specifications rather than a clinical "test set" and associated performance metrics typical for AI/ML devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable/not present. As noted above, there isn't a "test set" in the sense of a collection of cases requiring expert annotations for ground truth as would be needed for an AI/ML device.

4. Adjudication Method for the Test Set

This information is not applicable/not present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance

This information is not applicable/not present. This device is a standalone diagnostic ultrasound imaging system, not an AI-assisted device. Therefore, no MRMC study involving AI assistance would have been conducted or required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable/not present. This is not an algorithmic device in the modern sense. Its performance is inherent in its hardware and basic signal processing capabilities. The closest equivalent is that the device itself is "standalone" in its function as an imaging system, but not as an "algorithm" being evaluated.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable/not present in the context of a clinical performance study using a test set. For a diagnostic ultrasound system from this era, "ground truth" for proving substantial equivalence was primarily established by demonstrating that the images produced were of diagnostic quality comparable to predicate devices, and that the device met established safety and performance standards. This would be inferred from technical specifications and comparisons, not from a direct clinical outcome study with pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable/not present. The TERATECH Model 2000 is a hardware-based diagnostic imaging system, not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not present.

Summary of the Study (as presented in the 510(k) submission):

The "study" presented in this 510(k) is a demonstration of substantial equivalence to predicate diagnostic ultrasound devices based on:

• Identical Intended Use: The TERATECH Model 2000 has the same intended uses (abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging) as the predicate devices.
• Similar Operating Features: The device offers comparable B-Mode imaging capabilities and other listed technical specifications (system frequencies, frame rate, number of lines, fields of view, display, image processing, etc.) to the predicate devices.
• Safety Compliance: The submission implicitly or explicitly (through adherence to general controls and FDA review) indicates compliance with electrical safety (leakage current, breakdown voltage) and acoustic output standards (as evidenced by the post-clearance special report requirement in the FDA letter).

The document states: "The TERATECH Model 2000 is substantially equivalent to other diagnostic ultrasound devices currently in commercial distribution in the United States. Examples of these devices are the ATL High-Definition Imaging UltraMark-9 (K903603), the B & K 3535 (K914945), and the Tetrad 2300 E/U (K946277). The Model 2000 has the same intended uses as each of these predicates and offers similar operating features. The main differences between the Model 2000 and the predicate devices are the compact size and low power consumption of the Model 2000."

The FDA's clearance letter confirms this finding of substantial equivalence based on the provided information, with a condition for submitting a post-clearance special report on acoustic output measurements.

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