(84 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular.
ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping and Amplitude Doppler, The MOD.7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.
The MOD. 7250 can drive annular array, phased, convex and linear array probes. In addition. Mod.7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simoson rule: specifically, it can be used to measure volumes of irregular structures since it does not reguire a geometrical assumption.
The MOD.7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes. The MOD.7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, MOD.7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through the keyboard.
The provided text describes the "7250 Ultrasound Imaging System" by Biosound Esaote. This document is a Summary of Safety and Effectiveness for a 510(k) premarket notification to the FDA, issued in 1998.
Acceptance Criteria and Study for the 7250 Ultrasound Imaging System:
The acceptance criteria for the 7250 Ultrasound Imaging System are implicitly defined by its substantial equivalence to a predicate device, the Esaote 7050 (K944287). The core of the acceptance criteria here is that the new device (7250) is as safe and effective as the predicate device (7050) for its intended uses.
The study proving the device meets these acceptance criteria is a comparison to a legally marketed predicate device. This is a common method for 510(k) clearance, where a new device demonstrates substantial equivalence to an existing device rather than undergoing full clinical trials for novel devices.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "sensitivity > X%"). Instead, substantial equivalence relies on demonstrating that the new device is as safe and effective as the predicate device. The "reported device performance" is a comparative list of features and capabilities against the predicate.
| Feature | Acceptance Criteria (based on predicate 7050) | Reported Device Performance (7250) | Device Meets Criteria? |
|---|---|---|---|
| Electrical Safety | EN60601-1 | EN60601-1 | Yes |
| Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Yes |
| Intended Use - Cardiac (Transthoracic) | YES | YES | Yes |
| Intended Use - Cardiac (Transesophageal) | YES (Monoplane) | YES (Multiplane) | Yes (Improved) |
| Intended Use - Vascular | YES | YES | Yes |
| Intended Use - Abdominal | YES | YES | Yes |
| Intended Use - Fetal | YES | YES | Yes |
| Intended Use - Adult Cephalic | YES | YES | Yes |
| Intended Use - Neonatal Cephalic/Small Organ | YES | YES | Yes |
| Intended Use - Endovaginal | YES (Sagittal & Transverse Planes) | YES (Sagittal & Transverse Planes) | Yes |
| Intended Use - Endorectal | YES (Sagittal & Transverse Planes) | YES (Sagittal & Transverse Planes) | Yes |
| Probe Technology - Annual Array | YES | YES | Yes |
| Probe Technology - Electronical Array | YES | YES | Yes |
| Probe Technology - Bi-Scan Probes | NO | YES | Yes (New Feature) |
| Probe Technology - Doppler Probes | YES | YES | Yes |
| Modes of Operation | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler | Yes |
| Imaging Frequencies | 2.5, 3.5, 5.0, 7.5, 10 MHz | 2.5, 3.5, 5.0, 7.5, 10 MHz | Yes |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | Yes |
| Biopsy Guidance - General Purpose (ABS11 & ABS13) | General Purpose | General Purpose | Yes |
| Biopsy Guidance - Transrectal/transvaginal (ABS12) | Transrectal/transvaginal | Transrectal/transvaginal | Yes |
| Biopsy Guidance - Biopsy Line Depth Marker | 1 cm | 1 cm | Yes |
| Biopsy Guidance - Needle Guide Angle | ABS11: 25-45°; ABS12: fixed; ABS13: 30-50° | ABS11: 25-45°; ABS12: fixed; ABS13: 30-50° | Yes |
| Display Type | RGB | SVGA | Yes (Improved/Modern) |
| Digital Archival Capabilities | YES | YES | Yes |
| VCR/Page Printer | YES | YES | Yes |
| M&A Capabilities | Cardiac, Vascular, Fetal and general purpose measurements | Cardiac, Vascular, Fetal and general purpose measurements | Yes |
2. Sample size used for the test set and the data provenance
The document does not detail a specific test set, patient cohort, or data provenance. The substantial equivalence argument relies on a comparison of device specifications and performance parameters rather than human clinical study data in this context. The included "Intended Use" forms for various transducers list "N" for new indications and "P" for previously cleared indications (referring to the predicate device, AU3 unit K944287, or K953716 for TRT12). This indicates that for "P" indications, the performance is considered similar to the predicate. For "N" indications, it implies the new device has been validated for these uses, but the document doesn't provide details on the validation data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert readers establishing ground truth for image interpretation.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
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. The document is for an ultrasound imaging system from 1998, predating the widespread use of AI in medical imaging in the context of regulatory submissions. There is no mention of AI assistance or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is an ultrasound imaging system and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly described in terms of a study with ground truth. The "ground truth" for demonstrating safety and effectiveness in this context is the predicate device's established performance and the industry standards for ultrasound systems (e.g., EN60601-1 for electrical safety, Track 3 for acoustic output display). For "new indications" ("N" in the transducer tables), the performance would have been verified through engineering and possibly limited clinical testing, but specifics are not in this summary document.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.