FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

The SA8000 SE system 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, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA8000 SE 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 SE has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Ten different models of transducers are available and only one can be connected. 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 SE 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 various anatomical measurements and analysis packages. 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 SE 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the SA8000 SE Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood for performance metrics like sensitivity or specificity.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices by:

Device Description: Outlining the SA8000 SE's functions, modes, compatible transducers, and measurement capabilities.
Intended Use: Listing the clinical applications for which the device is intended (e.g., fetal, abdominal, cardiac imaging). The tables on pages 7-17 detail these indications for the system and each transducer, indicating "N" for new indications.
Technological Characteristics: Stating that the device operates identically to predicate devices and meets acoustic output limits comparable to predicate Track 3 devices.
Safety and Performance Standards: Listing various electromechanical safety standards met by the device (e.g., EN 60601-1, UL 2601-1, CEI/IEC 1157).
Hazard Analysis: Mentioning that a hazard analysis was performed and the "Level of Concern" was classified as "Moderate."

The FDA's letter (pages 4-6) confirms their review of the premarket notification and determination of substantial equivalence, allowing the device to be marketed. It does not mention specific performance acceptance criteria or a study demonstrating achievement of such criteria. The FDA's request for a "postclearance special report" with "acoustic output measurements based on production line devices" is a safety-related requirement, not a performance study for clinical efficacy or diagnostic accuracy.

Therefore, the requested information, particularly regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy (e.g., sensitivity, specificity), cannot be extracted from this document. This type of regulatory submission typically focuses on demonstrating the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a comparative clinical trial against specific acceptance criteria.

To specifically answer your questions based only on the provided text:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document in the format of performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on demonstrating that the device meets safety standards and performs functionally similarly to predicate devices. The "reported device performance" is implicitly that it operates with the modes and applications listed and meets the specified acoustic output limits of 720 mW/cm² ISPTA and MI 1.9, which are stated to be "the same as predicate Track 3 devices."

Acceptance Criteria (Stated/Implied)	Reported Device Performance
Acoustic Output ISPTA	720 mW/cm² (Max Range)
Acoustic Output MI	1.9 (Max)
Compliance with Safety Standards	Meets EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157, EN 60601-1-2, EN 60601-2-37, European MDD Certificate
Functional Equivalence	Operates identically to predicate devices in modes (B-mode, M-mode, Color-Flow Doppler, PW Doppler, Power Doppler, 3D), application range, and measurement capabilities.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document is a 510(k) submission, which demonstrates substantial equivalence, not a clinical study report with a test set of patient data and performance metrics.
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 applicable. No clinical test set or ground truth establishment based on expert review is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (see point 2).
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 device is a diagnostic ultrasound system, not an AI-powered diagnostic assist device. The submission does not mention AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (see point 5).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The document describes functional and safety characteristics, not diagnostic accuracy studies requiring ground truth.
The sample size for the training set: Not applicable. No machine learning algorithm or training set is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.