(35 days)
The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler data
This is not a study that proves a device meets acceptance criteria, but rather a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It declares the "Hitachi Prosound F75 Diagnostic Ultrasound System" substantially equivalent to a previously cleared predicate device (Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]).
Therefore, most of the requested information (acceptance criteria, reported device performance, sample size for test/training sets, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, and ground truth type) is not applicable as this document is not a clinical or performance study of a device against specific acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics and intended use.
Here's the relevant information found in the document:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) submission asserting substantial equivalence, not a performance study against specific acceptance criteria. It focuses on comparing technical features with a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used for this submission. The submission relies on non-clinical testing and comparison to an already cleared device.
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)
Not applicable. No ground truth establishment by experts was mentioned as part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used for this submission.
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. This is not an AI-assisted device, and no MRMC comparative effectiveness study was done or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm, and no standalone performance study was mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established or used for this 510(k) submission. The submission is based on substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable. No training set was used for this type of submission.
9. How the ground truth for the training set was established
Not applicable. No training set was used for this type of submission.
Summary of what is provided in the document:
- Device: Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System
- Predicate Device: Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]
- Basis for Acceptance/Clearance: Substantial Equivalence to the predicate device.
- Testing Performed (Non-Clinical):
- Acoustic output evaluation
- Biocompatibility (in accordance with ISO 10993-1)
- Cleaning & disinfection effectiveness
- Electromagnetic compatibility
- Electrical safety
- Findings: The device conforms to applicable medical device safety standards and is substantially equivalent in safety and effectiveness to the predicate device.
- Key points of equivalence (as stated in the document):
- Same indications for diagnostic ultrasound imaging and fluid flow analysis.
- Same gray scale and Doppler capabilities.
- Same essential technology for imaging, Doppler functions, and signal processing.
- Acoustic level below Track 3 FDA limits.
- Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.
- Designed and manufactured to the same electrical and physical safety standards.
- Manufactured with biocompatible materials.
- Provides instructions for cleaning, disinfection, and sterilization.
- Additional functions are enhanced or blended versions of previously cleared features.
§ 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.