Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.

Device Description

Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed. The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Delta 32 with optional add-on TACT® device:

Acceptance Criteria and Device Performance Study for Delta 32 with optional add-on TACT®

The evaluation for the diagnostic use of the Delta 32 and Delta 32 TACT® was based on a clinical study comparing the subjective image quality of the digital system to screen and diagnostic film systems. The study used a Likert scale from +4 (digital image absolute better) to -4 (film image absolute better).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The average Likert score must be greater than X"). However, the performance indicated by the statistical significance (p < 0.0001) suggests that the digital system was deemed statistically significantly better than film. This statistical significance likely serves as the implicit acceptance criterion.

Acceptance Criteria (Implicit)	Reported Device Performance (Average Likert Score)	Statistical Significance
Digital image quality is statistically significantly better than diagnostic film images (Implied by p < 0.0001)	TACT® 3D slices vs. DFM images: 0.82	p < 0.0001
Digital spot mammogram (DSM) image quality is statistically significantly better than diagnostic film images (Implied)	DSM against DFM images: 0.64	p < 0.0001

2. Sample Size and Data Provenance

Test Set Sample Size: 60 symptomatic cases.
Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective based on the description of performing exams on "symptomatic cases." The filing company is from Finland, so it is plausible the data came from Finland.

3. Number of Experts and their Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth or their qualifications. The study focused on subjective image quality, which implies expert assessment, but details on these experts are missing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the "subjective image quality" assessment, it is possible that individual expert opinions were averaged or a consensus was reached, but this is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is described where human readers improve with AI vs without AI assistance. The study described compares the image quality of different modalities, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The document states: "The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®." This implies the system's ability to display images independently, but it does not describe a standalone performance study of an algorithm without human-in-the-loop performance in terms of diagnostic accuracy or equivalent metrics. The study focuses on subjective image quality compared to film.

7. Type of Ground Truth Used

The ground truth used was subjective image quality assessed by comparing digital images (TACT® 3D slices and DSM) against diagnostic film images (DFM). This is an expert-based subjective assessment. It is not pathology, outcomes data, or an explicit expert consensus on a diagnosis.

8. Sample Size for the Training Set

The document does not provide information about a training set size. This study appears to be a clinical validation of the device's image quality rather than an evaluation of an AI/machine learning algorithm that would typically involve a separate training set. The device itself is a digital imaging system with an optional 3D reconstruction feature (TACT®).

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for an AI/machine learning model, the document does not describe how ground truth for a training set was established.

Summary

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10 July 2002

K022275

510(K) SUMMARY

SEP 1 2 2002

MANUFACTURER:

Instrumentarium Corp. Imaging Division (Street Address: Nahkelantie 160) P.O.Box 20 FIN-04301 Tuusula, Finland

+358-10-394 6500 Phone: Fax: +358-10-394 6501

Contact person: Kaija Jokela

UNITED STATES SALES REPRESENTATIVE (U. S. DESIGNATED AGENT):

Instrumentarium Imaging Inc. 300 West Edgerton Avenue Milwaukee, Wisconsin 53207

Phone: 414-747-1030 414-481-8665 Fax:

PRODUCT, CLASSIFICATION NAME

Delta 32 with optional add-on TACT® (Diagnostic digital mammography spot and 3D imaging, optional to digital stereotactic breast biopsy, system)

System, x-ray, mammographic/ IZH

Regulation number: 892.1710

SUBSTANTIAL EQUIVALENCE:

We consider this product is similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:

Delta 32 and Delta 32 Tact® #002472 Diamond #000976

The technological characteristics of Delta 32 and Delta 32 TACT® are the same than in the previous application (#K002472). This application shows that Delta 32 and Delta 32 TACT® can also be used for diagnostic examinations like Diamond (#K000976).

Instrumentarium Imaging (Nahkelantie 160) P.O. Box 20 • FIN-04301 TUUSULA, Finland • Tel. +358 10 394 6500 • Fax +358 10 394 6501 info@fi.instrumentarium.com · www.instrumentarium.com/imaging Instrumentarium Corporation · FIN-00031 INSTRUMENTARIUM. Finland · Trade Reg. No.12.570 · VAT FI01092226

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DESCRIPTION:

The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.

INTENDED USE:

PERFORMANCE DATA:

The evaluation of Delta 32 and Delta 32 TACT® for diagnostic use is based on the clinical study. The evaluation has been done by comparing the clinical diagnostic image quality of the three-dimensional mammography system and digital diagnostic spot mammography system to screen and diagnostic film system in terms of subjective image quality. The Likert scale was used from +4 to -4, where +4 means that digital image was absolute better than film image and -4 that film image was absolute better than digital image. Digital 3D mammography imaging (TACT®), digital spot mammogram (DSM), screen-film mammography imaging (SFM) and diagnostic film imaging (DFM) exams were performed on 60 symptomatic cases (female, age from 46 to 63).

Following table summaries the result of the tests:

(N=180)	Average	Std.Error	t-test
TACT® 3D slices vs. DFMimages	0.82	0.15	p<0.0001
DSM against DFM images	0.64	0.13	p<0.0001

Instrumentarium Imaging (Nahkelantie 160) P.O. Box 20 · FIN-04301 TUUSULA, Finland · Tel. +358 10 394 6500 · Fax +358 10 394 6501 info@fi.instrumentarium.com • www.instrumentarium.com/imaging Instrumentarium Corporation · FIN-00031 INSTRUMENTARIUM. Finland · Trade Reg. No.12.570 · VAT FI01092226

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is presented in a straightforward manner. The words are stacked on top of each other, with 'Public Health' on the top line and 'Service' on the bottom line.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Instrumentarium Corp. Imaging Division % Mr. Mark Masson Quality Regulatory Coordinator Instrumentarium Imaging, Inc. 300 West Edgerton Avenue Milwaukee, Wisconsin 53207

Re: K022275

Trade/Device Name: Delta 32 with optional add-on TACT Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: July 10, 2002 Received: July 15, 2002

Dear Mr. Masson:

. .

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050,

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Grigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Instrumentarium Imaging. The logo consists of a stylized lowercase "i" with three curved lines emanating from the top, enclosed in a circle. To the right of the "i" is the text "INSTRUMENTARIUM" in a bold, sans-serif font, stacked above the word "imaging" in a thinner, serif font. The overall design is clean and professional.

i 10 July 2002

Indications for Use

510(k) Number (if known):

K022275

Device Name:

Delta 32 with optional add-on TACT®

Indications for Use:

Instrumentarium Corp. Imaging Division

Kaija Jokela

Regulatory Affairs

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurence of CDRH, Office of Device Evaulation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)

David C. Seager

(Division Sign-Off) Division of Reproductive, and Radiological Dev 510(k) Number

(Optional Format 3-10-98)

Instrumentarium Imaging (Nahkelantic 160) P.O. Box 20 • FIN-04301 TUUSULA • Tel. + 358 10 394 6500 • Fax +358 10 394 6501 dental@fi.instrumentarium.com• alpha@fi.instrumentarium.com • omega@fi.instrumentarium.com http://www.instrumentarium.com/imaging Instrumentarium Corporation · FIN-00031 INSTRUMENTARIUM · Trade Reg. No. 12.570 · VAT FI01092226

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.