Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, feval imaging and other, and ophthaimic intended uses as defined FDA guidance documents.

Typical examinations shall include:

General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies.
Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
Pediatric scans of organs.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility applications.
First, second and third trimester pregnancy studies,
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal cephalic studies.
Transcranial studies of middle cerebral aneries, internal carotid artery, and vertebral . arteries.
Cardiac studies in adults and children. .
Biopsy guidance for tissue or fluid sampling.
Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

Device Description

Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-scroen display for thermal and mechanical values related to potential biocffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppier, Color M-mode, Color Power Angio, Pulsed (PW) Doppier or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.

The Atlas 2.0 / Hitachi 2.0 systems are designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanneads by means of a control located on the system control panel. All actions affecting the performance of the scanhead from the main system control panel.

The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanneads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz scanhead types: fiat linear array curved linear array phased array

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

AI/ML Overview

This inquiry concerns a 510(k) Premarket Notification (K961073) for the Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems, dated February 13, 1997. The document describes a general-purpose diagnostic ultrasound system.

Based on the provided text, the device is an ultrasound system and there is no mention of AI or machine learning capabilities. Therefore, the document does not contain information about acceptance criteria or studies related to AI-driven device performance. The details requested in your prompt, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, would typically be found in documents pertaining to AI/ML medical devices.

The provided text focuses on:

Device description: General purpose, mobile, software-controlled diagnostic ultrasound systems with on-screen display for thermal and mechanical values. It acquires ultrasound data and displays it in various modes (2-D, M-mode, Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed Doppler).
Predicate devices: ATL HDI 3000, ATL Ultramark® 9 HDI™, Atlantis Atlas 1.0, and Storz Renaissance A/B Scan.
Technological characteristics: Uses piezo material in the transducer, similar to predicate devices, for transmitting and receiving sound waves. Biocompatible scanhead materials.
Safety standards: Designed to meet IEC 601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, and IEC 601-1-2.
Intended use: Cardiac, peripheral vascular, fetal imaging, ophthalmic, and other general examinations (abdominal, pelvic, small parts, pediatric, prostate, neonatal cephalic, transcranial, biopsy guidance).
Acoustic output limits: Specified for all applications other than ophthalmic and for ophthalmic applications, with values for ISPTA, TIS/TIB/TIC, Mechanical Index (MI), and Isppa. These limits are stated to be "same as predicate Track 3 devices."

Therefore, it is impossible to answer the specific questions related to AI device performance, acceptance criteria, and study details based on the provided document. The document primarily addresses the substantial equivalence of a new ultrasound hardware system to existing ones, focusing on safety, intended use, and acoustic output, not on the performance of a diagnostic algorithm or AI.

Summary

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510(k) Premarket Notification K961073

Atlantis Atlan 2.0 / Hitachi 2.0 Ultrasound Systems Revision - February 13, 1997

SECTION 10 510(k) SUMMARY OF SAFETY AND EFFECTIVEN

FEB 1 9 1997

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

Submitter's name, address, telephone number, consact person:

Terrence J. Sweeney Director, Worldwide Quality and Regulatory Affairs Atlantis Diagnostics International, Inc. (ADI) 19015 North Creek Parkway, Suite 105 Bothell WA 98011 (206) 487-7602

Date prepared: February 13, 1997

Name of the device, including the trade or propriesary name if applicable, the common or 2) usual name, and the classification name, if known:
Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

Atlas 2.0 Diagnostic Ultrasound System

Hitachi 2.0 Diagnostic Ultrasound System

Classification Names:

Ultrasonic Pulsed Doppler Imaging System, Product Code 90 IYN, 21 CFR 892.1550

Diagnostic Ultrasonic Scanhead, Product Code 90 ITX, 21 CFR 892.1570

Ultrasonic Pulsed Echo Imaging System, Product Code 90IYD, 21 CFR 892.1560

1. Identification of the predicate or legally marketed device:
  ADII believes that Atlas 2.0 / Hirachi 2.0 are substantially equivalent to the currentlymarketed ATL HDI 3000 diagnostic ultrasound system. ATL Ultramark® 9 HDI™ diagnostic ultrasound system, Atlantis Atlas 1.0 system and Storz Renaissance A/B Scan.

4) Device Description:

{1}------------------------------------------------

510{k} Premarkel Notification K961073

Atlantis Allas 2.0 / Hitachi 2.0 Ultrasound Systems Revision - February 13, 1997

presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.

The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanneads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz scanhead types: fiat linear array curved linear array phased array

Atlas 2.0 / Hitachi 2.0 have been designed to meet the following electromechanical safety standards:

· IEC 601-1, International Electrotechnical Commission, Medical Blectrical Equipment
· UL 2601-1, Underwriters Laboratories Standards, Medical Eloctrical Equipment
C22.2 No. 601.1, Canadian Standards Association, Medical Blectrical Bquipment
CEVIEC 1157:1992, International Electrolechnical Commission. Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
IEC 601-1-2, Collateral Standard: Electromagnetic Compatibility .

2) Intended Use:

Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, feval imaging and other, and ophthaimic intended uses as defined FDA guidance documents.

Typical examinations shall include:

· General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies.
Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
· Pediatric scans of organs.
· Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
· Monitoring procedures for infertility applications.
· First, second and third trimester pregnancy studies,
· Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal cephalic studies.
Transcranial studies of middle cerebral aneries, internal carotid artery, and vertebral . arteries.
Cardiac studies in adults and children. .
· Biopsy guidance for tissue or fluid sampling.

510(k) Summary of Safety and Effectiveness

{2}------------------------------------------------

510(k) Premarket Notification K961073

Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems Revision - February 13, 1997

· Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

Technological Characteristics: ର)

These devices operate identical to the predicate devices in that piezo material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2-D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of these devices (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in itom 3. Scanhead patient contact materials are biocompatible and are also the same as the identified predicate devices.

These devices conform to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUMNEMA, 1992) for an on-sereen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic ourput in accordance with the ALARA (as low as reasonably achievable) principle.

The device's acoustic output limits are:

All Applications Other Than Ophthalmic:

ISPTAG	720 mW/cm2	(Maximum)
TIS/TIB/TIC	0.1 - 4.0	(Range)
Mechanical Index (MI)	1.9	(Maximum)
Isppad	0 - 700 W/cm2	(Range)

ISPTAd	50 mW/cm2	(Maximum)
Thermal Index (TIC)	0.1 - 1.0	(Range)
Mechanical Index (MI)	.23	(Maximum)
IsppAd	0 - 50 W/cm2	(Range)

The limits are same as predicate Track 3 devices.

Regulation Number and Section

§ 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.