This 510(k)submittal is for a SW modification to Hewlett-Packard ultrasound imaging systems that have been previously reviewed by the FDA and found to be substantially equivalent. This SW modification provides the capability to: 1) define a region of interest (ROI) in an image; 2) quantify the average brightness level in the ROI: 3) track the brightness level versus time for the ROI.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study to prove the device meets these criteria in the typical sense of a detailed clinical study with specific performance metrics and statistical analyses.

Instead, the document is a 510(k) summary for a software modification, primarily focusing on demonstrating substantial equivalence to a predicate device. The "performance" described is about functionality and characteristics, not diagnostic accuracy or effectiveness in a clinical context.

Here's an interpretation based on the provided text, addressing your points where possible, and noting when information is absent:

Acceptance Criteria and Study for Acoustic Densitometry Software Modification

The focus of this 510(k) submission is to demonstrate that a software modification to Hewlett-Packard ultrasound imaging systems, which provides the capability to define a region of interest, quantify average brightness levels, and track brightness over time, is substantially equivalent to a predicate device and does not raise new questions of safety or effectiveness.

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" in this context are primarily the functional and characteristic similarities to the predicate device. The table below presents the comparison provided in the document:

Feature	Predicate Device (Mipron Image Processing System)	HP Acoustic Densitometry (Proposed Device)	Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (HP Acoustic Densitometry)
Used w/ real time video ultrasound images	Yes	Yes	Yes	Yes
Used w/ ultrasound images played back from VCR	Yes	Yes	Yes	Yes
Ability to measure image brightness	Yes	Yes	Yes	Yes
Range of grey scale quantification (Grey Scale Acoustic Units: AU)	0-255	0-63	Equivalent functionality	0-63
Ability to generate time vs intensity graphs	Yes	Yes	Yes	Yes
# of images stored for time vs intensity graph	25	60	Equivalent or enhanced functionality	60
Use of triggered images	Yes	Yes	Yes	Yes
Ability to post process image brightness	Yes	Yes	Yes	Yes
Ability to define a region of interest for brightness measurement	Yes	Yes	Yes	Yes

Interpretation of "Acceptance Criteria" and "Performance": For this 510(k), the primary "acceptance criterion" is proving substantial equivalence, meaning the new device's features are either identical, similar, or functionally superior without introducing new risks compared to the predicate device. The "reported device performance" is the functionality described for the HP Acoustic Densitometry system.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on a software modification's functionality and comparison to a predicate, not clinical performance data from a specific test set of images or patients. There is no mention of a "test set" in the context of clinical evaluation.

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)

This information is not applicable/not provided. There is no mention of a test set requiring expert ground truth establishment for diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There is no described test set that would require adjudication.

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

An MRMC comparative effectiveness study was not performed or mentioned. This device is a measurement tool (quantifying brightness), not an AI-assisted diagnostic device, and the submission does not involve an evaluation of human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation in the context of diagnostic accuracy was not performed. The device's standalone performance is simply its ability to perform the stated functions: define ROI, quantify brightness, and track brightness over time. These are assumed to be directly testable through engineering validation, not a clinical study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

"Ground truth" in the diagnostic sense is not applicable here, as the device is a measurement tool, not a diagnostic one. The "truth" lies in the accuracy of its mathematical computations (e.g., correctly calculating average brightness from raw digital scan converter data), which would be verified through software validation and testing against known inputs and expected outputs.

8. The sample size for the training set

This information is not applicable/not provided. The software modification describes basic image processing functionalities, not a machine learning or AI model that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable/not provided. As there's no training set, there's no ground truth establishment for one.

Summary

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Attachment D to Cover Letter

Acoustic Densitometry 510 (k)

510(k) Summary of Safety and Effectiveness:21CFR 807.92

1. Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date summary was prepared: May 16, 1995
1. Trade Name: Sonos Imaging System Common Name: Ultrasound Imaging System Classification Name: Echocardiograph 74DXK

3) Identification of Predicate Device

The predicate device for this submittal is made by Kontron Electronics and is called the Mipron Image Processing System.The 510(k)number for the Mipron system is K891689.

4) Description of the device and or modification being submitted for premarket approval.

This 510(k)submittal is for a SW modification to Hewlett-Packard ultrasound imaging systems that have been previously reviewed by the FDA and found to be substantially equivalent.

Functionality

This SW modification provides the capability to:

1. define a region of interest (ROI) in an image;
1. quantify the average brightness level in the ROI:
1. track the brightness level versus time for the ROI.

Scientific concepts

2D images are created using different shades of grey.These shades of grey are assigned acoustic unit levels. The highest number (64,128,256) is given to the bright end of the scale. The lowest number (0,1) would be given to the dark or black end of the scale This SW feature looks at the grey levels stored in the digital . scan converter for a predefined region of interest selected by the operator. The average intensity or brightness for that region is then computed for one point in time. Successive calculations can be performed over time for the same region of interest using a time interval selected by the operator. There is no unique algorithm associated with the computation of the average brightness level from the data stored in the digital scan converter.

Significant characteristics of the device

This SW modification has only one characteristic that can be considered significant. It provides the user with a quantifiable assessment of image brightness. Image brightness assessment on earlier HP ultrasound systems was purely qualitative.

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The most significant aspect of this SW modification is the minimal impact it will have on system safety.

1)It does not affect acoustic output levels

2)It does not affect the dimensions of the product

3)It does not affect the patient contact materials of the product

4)The brightness level is not used to make a diagnosis

6)It does not affect the primary electrical specifications (current draw, ratings, leakage current etc)of the host system.

5) Statement of Intended Use

This SW modification does not affect the intended use statements of the previously reviewed HP imaging platforms.The users guide will be modified to indicate that the brightness measurement is available along with the other measurement primatives and mathematical quantities calculated from primatives such as: frequency, length, time, area, circumference, slope, velocity etc.

Feature	PredicateDevice	HP AcousticDensitometry
Used w/ real time video ultrasoundimages	Yes	Yes
Used w/ ultrasound images playedback from VCR	Yes	Yes
Ability to measure image brightness	Yes	Yes
Range of grey scale quantification(Grey Scale Acoustic Units: AU)	0-255	0-63
Ability to generate time vsintensity graphs (see Appendix E)	Yes	Yes
# of images stored for time vsintensity graph	25	60
Use of triggered images	Yes	Yes
Ability to post process imagebrightness	Yes	Yes
Ability to define a region ofinterest for brightness measurement	Yes	Yes

6) Predicate Device Comparison

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.