General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall.
Pediatric scans of organs, superficial, 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.
Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Monitoring of cardiac function during procedures using transesophageal echocardiography.
Biopsy guidance for tissue or fluid sampling.
Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery
Study of myocardial function in adults
Study of eye anatomy including blood flow in retinal vessels and branches
Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe
Study of abdominal and pelvic organs and masses using laparoscopic probe
Examination of organs, masses and vessels during surgical procedures
Study of muscles, ligaments, nerve bundles and connective tissue

Device Description

Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, Mmode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the opertor 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. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.

The Level 10 HDI system is designed to accept scanheads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz

scanhead types: Linear array Curved linear array Phased array Static probes

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Level 10 HDI Ultrasound System:

Summary of Acceptance Criteria and Device Performance:

The provided document does not explicitly state specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other quantitative performance metrics for disease detection or measurement). Instead, it focuses on the device's adherence to intended uses, technological characteristics matching predicate devices, and compliance with electromechanical safety and acoustic output standards.

The "device performance" reported is primarily in terms of its capabilities and specifications, rather than quantitative clinical outcomes against predefined targets.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (Derived)	Stated Performance / Compliance
Intended Use	Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging, and ophthalmic intended uses as defined by FDA guidance documents, covering a broad range of examinations including abdominal, pelvic, small parts, pediatric, vascular, fertility monitoring, pregnancy, prostate, neonatal head, transcranial, cardiac, TEE, biopsy guidance, cardiac surgery, myocardial function, eye anatomy, endoscopic, laparoscopic, and surgical procedures.
Technological Characteristics	Operates identically to predicate devices (ATL HDI 3000 and Storz Renaissance A/B Scan) in terms of piezoelectric transducers, sound wave transmission/reflection, conversion to electrical signals, and display as 2D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler. Scanhead patient contact materials are biocompatible.
Acoustic Output (Non-Ophthalmic)	ISPTA.d: 720 mW/cm² (Maximum) TIS/TIB/TIC: 0.1 - 4.0 (Range) Mechanical Index (MI): 1.9 (Maximum) ISPP.A.d: 0 - 700 W/cm² (Range) These limits are stated to be the same as predicate Track 3 devices.
Acoustic Output (Ophthalmic)	ISPTA.d: 50 mW/cm² (Maximum) TIS at Surface / Thermal Index (TIC): 0.1 - 1.0 (Range) Mechanical Index (MI): 0.23 (Maximum) ISPP.A.d: 0 - 50 W/cm² (Range) These limits are stated to be the same as predicate Track 3 devices.
Safety Standards Compliance	Meets IEC 601-1, UL 2601-1, C22.2 No. 601.1 (Medical Electrical Equipment), CEI/IEC 1157:1992 (Acoustic Output Declaration), and IEC 601-1-2 (Electromagnetic Compatibility). Conforms to AIUM/NEMA 1992 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices. A user education program is provided.
Image Modes	2D, M-mode, 2D Color Doppler, M-mode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes.
Measurement & Analysis	Ability to measure anatomical structures and offers analysis packages that provide information used to diagnose.
Scanhead Compatibility	Designed to accept a large selection of scanheads (2.0 - 10.0 MHz frequency range; Linear array, Curved linear array, Phased array, Static probes), with up to three array scanheads and one static probe connected concurrently.
Optimization	Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by system software in response to user inputs.

Detailed Information Regarding Study and Ground Truth:

The provided 510(k) summary does not appear to describe a formal clinical study with a test set, ground truth established by experts, or quantitative performance metrics in the way typically expected for AI/ML device submissions. This is largely because the document is from 1996, a time before AI/ML diagnostic devices were common and regulatory requirements for their validation were established. This submission focuses on substantial equivalence to predicate devices.

Therefore, for aspects related to clinical performance studies (items 2-7), the answer is that the information is not provided or not applicable based on the content.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document focuses on technological equivalence and safety standards, not a specific clinical performance study with a test set.
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 provided. No explicit ground truth establishment for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. No adjudication method is mentioned as a clinical performance test set is not described.
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 done/Not applicable. This document predates the widespread use of AI in medical imaging, and no such study is described. The device itself is a diagnostic ultrasound system, not typically an AI-assisted diagnostic tool in the modern sense.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. As the device is an ultrasound system intended to be operated by a human, the concept of "standalone algorithm only" performance as distinct from a human-in-the-loop system doesn't apply in the context of this submission. The device's function is to acquire and display data for human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided/Not applicable. As no specific clinical performance study based on a test set is described, no ground truth type for such a study is mentioned. The implicit "ground truth" for this submission's regulatory approval is the established performance and safety profiles of the predicate devices and general knowledge of ultrasound technology.
The sample size for the training set:
- Not applicable. This document describes a diagnostic ultrasound system whose underlying principles are well-established physics and signal processing. It is not an AI/ML device that requires a "training set" in the contemporary sense. Any software optimization is likely based on engineering principles and general data, not a specific, labeled "training set" for an AI model.
How the ground truth for the training set was established:
- Not applicable. See point above regarding the nature of the device and the submission.

Summary

{0}------------------------------------------------

K961459

SECTION 8 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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, contact person: 1)

Terrence J. Sweeney Director, Worldwide Quality and Regulatory Affairs Advanced Technology Laboratories, Inc. P.O. Box 3003 Bothell, WA 98041-3003 (206) 487-7602

Date prepared: April 10, 1996

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

Diagnostic Ultrasound System with Accessories

Proprietary Name

Level 10 HDI 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 90MD, 21 CFR America 901YO 892.1560 3/11/97

Identification of the predicate or legally marketed device: 3)

Advanced Technology Laboratories, Inc. believes that Level 10 HDI is substantially equivalent to the currently marketed ATL HDI 3000 diagnostic ultrasound system and Storz Renaissance A/B Scan.

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

4) Device Description:

The Level 10 HDI system is designed to accept scanheads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz

scanhead types: Linear array Curved linear array Phased array Static probes

Level 10 HDI has been designed to meet the following electromechanical safety standards:

IEC 601-1, International Electrotechnical Commission, Medical ● Electrical Equipment
UL 2601-1, Underwriters Laboratories Standards, Medical Electrical ● Equipment
C22.2 No. 601.1, Canadian Standards Association, Medical Electrical .

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

Equipment

CEI/IEC 1157:1992, International Electrotechnical Commission, . Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
IEC 601-1-2, Collateral Standard: Electromagnetic Compatibility ●

5) Intended Use:

Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.

Typical examinations using Level 10 HDI are:

General abdominal and pelvic studies including organ surveys, ● blood flow assessment, and retroperitoneal cavity studies.
Study of small parts and superficial structures including breasts, . shoulders, thyroid/parathyroid, and the abdominal wall.
Pediatric scans of organs, superficial, 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. .
Transcranial studies of middle cerebral arteries, internal carotid ● artery, and vertebral arteries.
Cardiac studies in adults and children. .
Monitoring of cardiac function during procedures using . transesophageal echocardiography.
Biopsy guidance for tissue or fluid sampling. ●
Assessment of cardiac muscle, coronary arteries and great vessels ● during cardiac surgery
Study of myocardial function in adults ●
Study of eye anatomy including blood flow in retinal vessels and ● branches
Study of the esophagus, stomach, biliary sytem, pancreas and ● gastrointestinal tract using endoscopic probe
Study of abdominal and pelvic organs and masses using ● laparoscopic probe
Examination of organs, masses and vessels during surgical

{3}------------------------------------------------

procedures

Study of muscles, ligaments, nerve bundles and connective tissue .

Technological Characteristics: ୧)

This device operate identical to the predicate devices in that piezoelectric 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 a 2D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, Color Flow, Color Mmode. Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible.

This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen 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 output in accordance with the ALARA (as low as reasonably achievable) principle.

The device's acoustic output limits are:

All Applications Other Than Ophthalmic:

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

Ophthalmic Applications:

ISPTAd	50 mW/cm²	(Maximum)
TIS at Surface /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.