The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.

Device Description

The Solas OR cabinet x-ray system is a self-contained, direct-detection digital imaging system for imaging small to medium surgical and biopsy specimens. The system is comprised of the x-ray cabinet, optional cart and the PC with DICOM compliant software which provides the user interface, the means to enter patient details (either directly or from a DICOM Modality Worklist, if available) and the means to acquire, review and save or transmit DICOM images to the Picture Archiving and Communication System (PACS). The cabinet incorporates shielding and interlock circuits to meet regulatory requirements. The cabinet cart is mounted on casters to allow for easy transportation.

Specimen radiography units are utilized to confirm removal of the intended tissue, lesion, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution x-ray image of the specimen, the presence of a lesion, marker or calcification in the extracted sample can be confirmed by the user reviewing the digital image.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) Summary for the Solas OR, focusing on its substantial equivalence to a predicate device.

However, I can extract the information that is present and indicate what is missing:

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

The document mentions compliance with various standards and image quality tests. Here's a table based on the information provided, noting that specific numerical acceptance criteria and direct performance metrics against those criteria are not detailed:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
IEC 61010-1:2010. Ed.3 compliance	Solas OR software supports the DICOM Store and Modality Worklist services.
IEC 61010-2-091:2012. Ed.1 compliance	Passed design control verification and validation tests.
IEC 61010-2-101:2015. Ed.2 compliance	Complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems).
IEC 61326-1:2013. Ed.2 compliance	Complies with international EMC standards/regulations including FCC.
21 CFR 1020.40 compliance	Compliance to IEC 61010 standards was demonstrated by a third-party test house which is a member of the NRTL scheme.
47 CFR 15.107, 15.109 compliance	Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets.
Compliance with 47 CFR 15.107, 15.107	Device performance benchmarked against the predicate in a clinical setting.
Software Level of Concern: Moderate	Software Level of Concern: Moderate
DICOM Modality Worklist functionality	YES (Solas OR)
PACS connectivity	YES (Solas OR)
Imaging Area: 12 cm x 15 cm (nominal)	Imaging Area: 12 cm x 15 cm (nominal)
Resolution (contact mode): 10 lp/mm	Resolution (contact mode): 10 lp/mm

2. Sample size 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 document mentions "Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets" and that "the device performance has been benchmarked against the predicate in a clinical setting," but no details on sample size or data provenance for these tests are given.

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 provided in the document. The text indicates "benchmarked against the predicate in a clinical setting," but does not mention expert involvement or their qualifications.

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

This information is not provided 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

The document describes the device as a "cabinet X-ray system used to provide digital X-ray images." It is a hardware device for image acquisition, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not applicable and not mentioned. The benchmarking mentioned is against a predicate device, not in the context of human reader performance with or without AI.

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

The device is an imaging system, not an algorithm, so this question is not directly applicable in the context of "algorithm only." The document states, "Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets," which implies standalone performance evaluation of the imaging system's technical specifications.

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

This information is not explicitly stated for the "benchmarking against the predicate in a clinical setting." For the non-clinical tests, "accredited phantom test objects and High Contrast resolution targets" were used, which serve as a form of ground truth for image quality measurements.

8. The sample size for the training set

This device is an X-ray imaging system, not an AI/machine learning model that typically requires a "training set." Therefore, the concept of a training set sample size is not applicable in the context of the information provided for this device.

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

As the device is an X-ray imaging system and not an AI/machine learning model, the concept of a "training set" and its associated ground truth establishment is not applicable here.

Summary

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Cirdan Imaging Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K213691

Trade/Device Name: Solas OR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: November 22, 2021 Received: November 23, 2021

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213691

Device Name Solas OR

Indications for Use (Describe)

Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for CIRDAN. The logo consists of a green spiral on the left and the word "CIRDAN" in black on the right. The spiral is made up of several concentric circles, and the word "CIRDAN" is in a sans-serif font.

Section 5. 510(K) Summary

K213691

Premarket Notification 510 (k) Summary, as required by 21 CFR 807.92

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

15th October 2021 Date Prepared:

Identification of the Device:

Trade Name:Regulation Name:Classification Requlation:Product Code (Precode):Device Class:Panel:	Solas ORStationary X-Ray System21 CFR 892.1680MWPClass IIRadiologic Devices Panel
Manufacturer:	Cirdan Imaging LtdRiverbank,The Green,Tullynacross RoadLambeg,County Antrim,Northern Ireland,United KingdomBT27 5SR
Contact:	Paul MatthewsHead of QARAPhone +44 (0)2892 660880

Legally Marketed Predicate Device

Trade Name:	BioVision Digital Specimen RadiographySystem
Regulation Name:	Stationary X-Ray System
Classification Regulation:	21 CFR 892.1680
Product Code (Precode):	MWP
Device Class:	Class II
Panel:	Radiologic Devices Panel
Submitter/510K Holder:	Bioptics, Inc.
Clearance	K091558 (Cleared July 17, 2009)

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Image /page/4/Picture/0 description: The image shows the logo for CIRDAN. The logo consists of a green spiral symbol on the left and the word "CIRDAN" in black letters on the right. The spiral symbol is made up of several concentric circles that curve inward towards the center. The word "CIRDAN" is written in a bold, sans-serif font.

DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)

INDICATIONS FOR USE - as required by 807.92(a)(5)

A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

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Image /page/5/Picture/0 description: The image shows the logo for CIRDAN. The logo consists of a green spiral on the left and the word "CIRDAN" in black letters on the right. The spiral is made up of several concentric circles that get progressively smaller towards the center. The word "CIRDAN" is written in a bold, sans-serif font.

DEVICE CLAIMS – as required by 807.92(a)

The Solas OR cabinet X-ray system has been designed to comply with the following standards and requlations:

. IEC 61010-1:2010. Ed.3
IEC 61010-2-091:2012. Ed.1 .
IEC 61010-2-101:2015. Ed.2 .
IEC 61326-1:2013. Ed.2 .
21 CFR 1020.40, ●
47 CFR 15.107, 15.109 .
47 CFR 15.107, 15.107 .

Solas OR software supports the DICOM Store and Modality Worklist services.

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

The Solas OR cabinet x-ray system has the same indications for use, general configuration, and principles of operation as the predicate device cited. The technological characteristics of the Solas OR cabinet x-ray system have been compared to the predicate device cited and is covered in detail in the Substantial Equivalence section of this submission.

COMPARISON WITH PREDICATE DEVICE.

Characteristic	Bioptics BioVision(Predicate K091558)	Solas OR
Environment of Use	surgical suite, biopsy suite	surgical suite, biopsy suite
Used for excised surgical andpercutaneous biopsy specimens	YES	YES
Integrated shielding	Yes	Yes
Anode material	Tungsten	Tungsten
Window Filtration	Beryllium	Beryllium
Detection technology	Indirect	Direct
Sensor Technology	CMOS	CdTel Hybrid CMOS
Imaging Area mm(nominal)	10 cm x 15 cm	12 cm x 15 cm
Resolution (contact mode)	10 lp/mm	10 lp/mm
Software Level of Concern	Moderate	Moderate
DICOM Modality Worklist	YES	YES
PACS connectivity	YES	YES
UI	Traditional Windows UI(toolbar, dropdown menusetc. )	Streamlined touch drivenUI

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Image /page/6/Picture/0 description: The image shows the CIRDAN logo. The logo consists of a green spiral on the left and the word "CIRDAN" in black letters on the right. The spiral is made up of several concentric circles that get smaller as they move towards the center. The word "CIRDAN" is in a sans-serif font and is all uppercase.

PERFORMANCE DATA TESTING AND REVIEW- as required by 807.92(b)(1)

The Solas OR system successfully performed design control verification tests and validation tests.

The Solas OR complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems) and international EMC standards/regulations including FCC.

Compliance to IEC 61010 standards was demonstrated by a third-party test house which is a member of the NRTL scheme.

Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets. Additionally, the device performance has been benchmarked against the predicate in a clinical setting.

Results of these performance tests, combined with design and comparison with the predicate device, support substantial equivalence.

SUBSTANTIAL EQUIVALENCE SUMMARY

The Solas OR X-ray Specimen Cabinet has the same indications for use as the predicate device cited. The technical characteristics of the Solas OR Xray Specimen Cabinet are the same or similar to the predicate device and do not raise any new questions on the safety and effectiveness of the proposed device.

CONCLUSIONS - as required 807.92(b)(3)

We conclude that the documentation and testing included in this submission indicates that the Solas OR X-ray Specimen Cabinet is safe and effective and substantially equivalent to the predicate device cited.

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.