The piXarray 100 Digital Specimen Radiography (DSR) System is a cabinet digital Xray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.

Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.

Device Description

The piXarray 100 Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-rav imaging system to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.

The piXarray 100 Digital Specimen Radiography (DSR) System employs the use of Biopix image acquisition software. The Biopix software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Biopix software is the central part of this system. Biopix software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).

AI/ML Overview

Here's an analysis of the provided text regarding the piXarray 100 Digital Specimen Radiography (DSR) System, focusing on acceptance criteria and study details.

Based on the provided document, the submission for the piXarray 100 Digital Specimen Radiography (DSR) System (K052433) is a 510(k) premarket notification. This type of submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical studies proving new acceptance criteria.

The acceptance criteria are therefore focused on meeting regulatory standards and demonstrating equivalence to the predicate, the Mammopath™ cabinet X-ray system (K021113).

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Regulatory Compliance	- Compliance with 21 CFR 1020.40 (Cabinet X-ray systems) - Radiation emission not exceeding 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. - Compliance with FDA's performance standards for ionizing radiation emitting products (Part 1020). - Compliance with applicable general controls (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). - Software Level of Concern: "moderate".	- "The piXarray 100 Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40." - "Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits." - "The radiation emitted from the piXarray 100 Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. See Radiographic Control Certificate. Document # 1240 is included in this exhibit." - "Bioptics has determined that the submitted device has a 'moderate' software Level of Concern and has provided that documented record as part of this submission."
Substantial Equivalence to Predicate Device (Mammopath)	- Same Indications for Use as predicate. - Same technological characteristics as predicate (X-ray technology, power source, digital imaging, computer interface, hardware, OS, functionality). - Performance as well as the predicate.	- "The piXarray 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Mammopath cabinet X-ray system." - "The piXarray 100 Digital Specimen Radiography (DSR) System has the same technological characteristics as the Mammopath cabinet X-ray system." - "The submitter concludes that the piXarray 100 Digital Specimen Radiography (DSR) System employs the same type of technological characteristics..." - "The results of this testing substantiates that the piXarray 100 Digital Specimen Radiography (DSR) System performs as well as the predicate, the Mammopath cabinet X-ray system." - Differences noted but deemed not significant or evolutionary: Energy Range (5-45 kV vs 10-35 kV), Tube Current (0.5 mA vs 0.1 mA), X-ray Coverage (19.0 cm vs 14.6 cm), Window Filtration (0.2 mm Beryllium vs 0.8 mm Beryllium), Footprint (38cm w x 41cm d x 66cm h vs 36cm w x 34cm d x 39cm h).
Design Control & Verification/Validation	- Robust quality system. - Detailed design inputs and outputs. - Verification and Validation activities. - Risk assessment and management for software. - Software coding verification. - Alpha validation testing of all functionality and hazard addressing. - System software and operating software performance and environmental testing.	- "Additionally, the submitted device has been designed in a device design and manufacturing environment with a robust quality system." - "Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities." - "The submitter believes and claims that the submitted device was developed, tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation." - "The submitted device's software controls were subjected to significant verification and validation testing." - "Verification testing was performed during software coding and results were recorded as 'comments' in the software code." - "Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation." - "Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment. Refer to 'Software Revision History'. Document # 1239, included in Exhibit 9."
Intended Use & Functionality	- Rapid verification of correct tissue excision. - X-ray image creation. - Operation in biopsy procedure room/surgical suite. - Compact and portable design. - One-button operation with automatic exposure control. - High-resolution digital imaging. - DICOM 3.0 compliance.	- "Performing the verification directly in the same biopsy procedure room enables cases to be completed faster..." - "The piXarray 100 Digital Specimen Radiography (DSR) System employs the use of Biopix image acquisition software. The Biopix software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal." - "Biopix software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL)." - "The piXarray 100 Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shielding." - "The piXarray 100 DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. High resolution digital imaging with large area formats is available."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of clinical or performance data for image interpretation. The testing described is primarily for engineering, software, and regulatory compliance.

Sample Size (Test Set): Not specified for image-based performance evaluation. The "Alpha validation testing" implies internal software and system functionality testing, but not a dataset of medical images for diagnostic performance.
Data Provenance: Not applicable in the context of image data. The testing mentioned is internal to the manufacturer (Bioptics, Inc.) for system and software validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a test set of medical images for diagnostic purposes. The "ground truth" for the engineering and software validation would be the design specifications and expected system behavior.

4. Adjudication Method for the Test Set

Not applicable, as no external test set requiring expert adjudication is described in the document.

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

No. The document explicitly states: "To the submitter's knowledge, the predicate device, Mammopath cabinet X-ray system, did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing."

This indicates that no clinical comparative effectiveness study, including an MRMC study with or without AI assistance, was performed or presented as part of this 510(k) submission. The device is for "Digital Specimen Radiography," which typically involves immediate visual verification by a clinician, not necessarily a complex AI-assisted diagnostic workflow with multiple readers.

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

No specific standalone algorithm performance study is described as part of this submission. The device is a "system" (piXarray 100 DSR System) that includes the Biopix software, which "handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal." This is an integrated system for image generation and display for human interpretation, not an AI algorithm intended for standalone diagnostic output.

7. The Type of Ground Truth Used

The primary "ground truth" for this submission revolves around:

Regulatory Standards: Compliance with 21 CFR 1020.40 and general performance standards for X-ray emitting products.
Predicate Device Characteristics: The functional and technological characteristics of the Mammopath cabinet X-ray system.
Design Specifications: For the internal verification and validation of the piXarray system's own design, software, and hardware.

There is no mention of ground truth established from pathology, expert consensus on image findings, or patient outcomes data for clinical diagnostic performance.

8. The Sample Size for the Training Set

No training set is mentioned or applicable, as this device primarily relies on traditional X-ray imaging principles and software for image acquisition, processing, and display for human interpretation, rather than a machine learning or AI model that requires a training set of images.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set.

Summary

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K052433

PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92

Device Name - as required by 807.92(a)(2):

Trade Name:	piXarray 100 Digital Specimen Radiography (DSR) System
Common/Classification Name:	Specimen X-ray System/Cabinet, X-ray System
Classification Regulation:	21 CFR § 892.1680
Device Class:	Class II
Product Code (Procode):	MWP
Panel:	Radiologic Devices Panel
Premarket Notification submitter:Company Name:	Bioptics, Inc.
Company Address:	3496 S. Dodge Blvd, Ste 110Tucson, AZ 85629-5477
Contact:	Jeffrey Orach, V.P. Manufacturing and RegulatoryAffairs
Preparation Date:	September 2, 2005

LEGALLY MARKETED PREDICATE DEVICE – as required by A. 807.92(a)(3)

The piXarray 100 Digital Specimen Radiography (DSR) System is substantially equivalent to the Mammopath™ |trade mark of Fischer Imaging Corporation, Denver, Colorado] cabinet X-ray system. K021113.

DEVICE DESCRIPTION - as required by 807.92(a)(4) 13.

Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under

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examination. Specimen radiography can potentially limit the number of patient recalls.

DEVICE CLAIMS - as required by 807.92(a)(4) C.

The piXarray 100 Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shielding. The piXarray 100 DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. High resolution digital imaging with large area formats is available. Standard 18cm x 24cm cassette slot is available for film archival.

The Biopix software transfers images to Radiology and Pathology within seconds though DICOM interface.

D. PRODUCT AND TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4)

The piXarray 100 Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shiclding. The piXarray 100 DSR System offers onc-button operation utilizing automatic exposure control for optimal X-ray exposure. High-resolution digital imaging in large area formats is available.

Available imaging formats are: 50 mm x 50 mm 50 mm x 100 mm 100 mm x 100 mm Larger area formats are under development and can be made available upon request.

Standard 18cm x 24cm cassette slot for film archival is available.

The Biopix software handles the digital X-rav image acquisition, calibration. image display, image analysis and manipulation, patient database, image archiving, and transmittal. Biopix software is the central part of this system. Biopix software is Digital Imaging and Communications in Medicine (DIC OM) 3.0 compliant and comes with DICOM Print. Store and Modality Work List

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A device intended to provide rapid verification, through x-ray examination, . that the correct tissue has been excised during excisional or percutaneous biopsy.
A device intended to create an x-ray image of biopsy material, including in the . biopsy procedure room or wherever medical professionals deem appropriate, to enable the rapid x-ray examination of the biopsy specimen and the rapid verification that the correct specimen was excised.

INDICATIONS FOR USE F.

The piXarray 100 Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.

LEVEL OF CONCERN - as requested by recent FDA guidance G.

Bioptics has determined that the submitted device has a "moderate" software Level of Concern and has provided that documented record as part of this submission.

TECHNOLOGICAL CHARACTERISTICS SUMMARY -- as required by H. 807.92(a)(6)

The piXarray 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Mammopath cabinet X-ray system, K021113. The piXarray 100 Digital Specimen Radiography (DSR) System has the same technological characteristics as the Mammopath cabinet X-ray system. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the piXarray 100 Digital Specimen Radiography (DSR) System to the predicate Mammopath cabinet X-ray system.

The submitter claims that the piXarray 100 Digital Specimen Radiography (DSR) System is substantially equivalent to the predicate device. the Mammopath cabinet X-ray system.

The technological characteristics of the piXarray 100 Digital Specimen Radiography (DSR) System are very similar to those of the Mammopath cabinet X-rav system. The differences include:

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TABLE OF DIFFERENCES BETWEEN THE piXarray 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM AND THE MAMMOPATH CABINET X-RAY SYSTEM

Characteristic	Mammopath System	piXarray DSR System
Energy Range	10-35 kV	5-45 kV
Tube Current	0.1 mA	0.5 mA
X-ray Coverage	14.6 cm	19.0 cm
Window Filtration	0.8 mm Beryllium	0.2 mm Beryllium
Footprint(OverallDimensions)	36cm w x 34cm d x 39cm h	38cm w x 41cm d x 66cm h

The submitter concludes that the piXarray 100 Digital Specimen Radiography (DSR) System employs the same type of technological characteristics including X-ray technology, power source, digital imaging, computer interface for user functionality, computer hardware, operating system, and similar functionality to the Mammopath cabinet X-ray system. The majority of differences are either not significant or relate to evolutionary changes in technology that has occurred since the release of the Mammopath cabinet X-ray system.

NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as I. required by 807.92(b)(1)

As a cabinet or specimen X-ray device, the submitted device is required to comply with Part 1020. FDA's performance standards for ionizing radiation emitting products and specifically to 21 CFR 1020.40 Cabinet X-ray systems. The piXarray 100 Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits.

The radiation emitted from the piXarray 100 Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. See Radiographic Control Certificate. Document # 1240 is included in this exhibit.

Additionally, the submitted device has been designed in a device design and manufacturing environment with a robust quality system.

Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities. Some of these activities include, but are not limited to, detailed design specifications, verification and validation activities, and revision history and revision documentation. An emphasis on controlled software activities include risk assessment and management. level of concern and

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configuration management. These activities are thoroughly documented and reviewed and approved by appropriate authorized authorities.

The submitter believes and claims that the submitted device was developed, I ne such tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation. The results of these activities were reviewed by appropriate management and that review resulted in the documented determination that the submitted device met its design plan, is safe and effective, and, subsequent to FDA review of this submission, is ready for commercial distribution as a medical device.

The submitted device's software controls were subjected to significant verification and validation testing. Verification testing was performed during veftware coding and results were recorded as "comments" in the software code. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation.

Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment. Refer to "Software Revision History". Document # 1239. included in Exhibit 9.

Additionally, a few devices, labeled "Research Use Only." are being placed to further document the submitter 's performance claims and attempt to identify any unknown hazards. Any significant findings will be investigated and resolved appropriately. If a significant finding rises to an appropriate level, the submitter will take appropriate FDA notification action.

To the submitter's knowledge. the predicate device, Mammopath cabinet X-ray system. did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2). therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing.

SUBSTANTIAL EQUIVALENCE SUMMARY .J.

The piXarray 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Mammopath cabinet X-ray system. The piXarray 100 Digital Specimen Radiography (DSR) System has the same technological characteristics as the Mammopath cabinet X-ray system. However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation and performance testing to further document equivalence. The results of this testing substantiates that the

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piXarray 100 Digital Specimen Radiography (DSR) System performs as well as the predicate, the Mammopath cabinet X-ray system.

CONCLUSIONS K.

The performance testing and validation studies document that the piXarray 100 The performance testing and vandation station as substantially equivalent to the Mammopath cabinet X-ray system.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2005

Mr. Jeffrey Orach Vice President Manufacturing & Regulatory Affairs Bioptics, Inc. 3496 S. Dodge Blvd., Suite 110 TUCSON AZ 85713

Re: K052433

Trade/Device Name: piXarray 100 Digital Specimen Radiography (DSR) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Orach:

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 (Premarket Approval), it may be subject to such 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 Section 510(k) This letter will anow you to ocgin nameting your antial equivalence of your device to a legally premarket notheation: The PDA midning of vacion 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 If you desire spective advice for your device of earling of the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Thiseration on your responsibilities under the Art from the 197 807.97). You may obtain other gelerar mornational 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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: piXarray 100 Digital Specimen Radiography (DSR) System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Preseription Use

(Per 21 CFR 801.109)

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Over-The-Counter Use

Darryl Beaudoin

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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 radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray 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.