The 3Dscope is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. The 3Dscope acquires, processes, displays, and stores x-ray images, for image diagnosis.

AI/ML Overview

The provided text describes a 510(k) submission for the 3Dscope device, which is a mobile fluoroscopic system. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader studies for AI-powered devices.

Instead, the document focuses on:

Substantial Equivalence: The primary argument for the 3Dscope's clearance is its substantial equivalence to a legally marketed predicate device (Digiscope RX-2). This means it claims to have the same intended use, fundamental technology, and does not reduce safety or effectiveness compared to the predicate.
Compliance with Standards: The document lists various IEC and FDA CDRH standards that the 3Dscope conforms to. This is a form of acceptance criteria, but it relates to safety, electrical, and other engineering standards, not clinical performance or AI algorithm validation.

Therefore, most of the requested information cannot be extracted from this document. I will fill in what can be inferred and explicitly state what is missing.

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Regulatory Compliance	Compliance with IEC 60601-1 (1998) + A1(1991) + A2(1995)	Conforms	These are general safety and performance standards for medical electrical equipment.
	Compliance with IEC 60601-1-1 (2000)	Conforms	Safety requirements for medical electrical systems.
	Compliance with IEC 60601-1-2 (2001)	Conforms	Electromagnetic compatibility (EMC) requirements.
	Compliance with IEC 60601-1-3 (1994)	Conforms	General requirements for protection against radiation in diagnostic X-ray equipment.
	Compliance with IEC 60601-2-7 (1998)	Conforms	Specific requirements for high-voltage generators for diagnostic X-ray generators.
	Compliance with IEC 60601-1-4 (2000)	Conforms	Programmable electrical medical systems.
	Compliance with ISO 14971 (2000)	Conforms	Medical devices - Application of risk management to medical devices.
	Compliance with FDA CDRH 21CFR 1020.30	Conforms	Performance standards for X-ray equipment.
	Compliance with FDA CDRH 21CFR 1020.32	Conforms	Performance standards for X-ray equipment.
Clinical Performance	Not specified	Not specified	The document does not provide specific clinical performance metrics (e.g., image quality scores, diagnostic accuracy, sensitivity, specificity) for human readers or an AI algorithm.
Substantial Equivalence	To a legally marketed predicate device (Digiscope RX-2), with no change in intended use, fundamental technology, or reduction in safety and effectiveness.	The device meets the requirements for a special 510(k) by being a minor modification.	This is the primary "acceptance criteria" for regulatory clearance stated in the document.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. The document does not describe a clinical performance study with a test set of patient data to evaluate performance metrics typically associated with AI or diagnostic devices. The performance testing mentioned (Section 6. Performance Testing) refers to compliance with engineering and safety standards.
Data Provenance: Not applicable for clinical performance data. The device is cleared based on demonstrating adherence to established technical standards and substantial equivalence to a predicate device, rather than a prospective clinical study using patient data for performance evaluation in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set and ground truth establishment are described in this document.

4. Adjudication method for the test set

Not applicable. No clinical test set and adjudication method are described in this 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. This device is a fluoroscopic imaging system, not an AI-powered diagnostic assistant. No AI component is mentioned, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant for this submission type.

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

No. This device is a fluoroscopic imaging system, not an AI algorithm. Its performance is inherent in its ability to acquire, process, display, and store X-ray images, as per its design and compliance with technical standards.

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

Not applicable. The document does not describe a performance study requiring ground truth for clinical diagnostic accuracy. The "ground truth" in this context refers to the device meeting the specified engineering and safety standards.

8. The sample size for the training set

Not applicable. This device is a hardware imaging system, not an AI algorithm that requires a training set.

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

Not applicable. This device is a hardware imaging system, not an AI algorithm.

Summary of Missing Information and Context:

The provided 510(k) summary is for a traditional medical imaging device (a fluoroscopic X-ray system) seeking clearance based on substantial equivalence to a predicate device and compliance with established safety and performance standards. It does not concern an AI/ML-enabled device or a device requiring a clinical performance study with patient data to demonstrate diagnostic accuracy (e.g., sensitivity, specificity, AUC). Therefore, the specific details regarding clinical test sets, ground truth, expert readers, MRMC studies, and AI algorithm training data, which are standard for AI/ML device submissions, are not present in this document.

Summary

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12041213

JUL 2 2 2004 SECTION 6 - 510(k) SUMMARY

[Submitted pursuant to 21 CFR 807.87(h)]

1. Submitter Information

Submitter.	Direx Systems Corporation11 Mercer RoadNatick Business ParkNatick, MA 01760
Telephone:Fax:Contact Person	(508) 651-0900(508) 651-8125Larisa GershteinQA Manager
Contact Person e-mail address:	lgershtein@direxusa.com
2. Device
Trade/Proprietary Name:	3Dscope.
Classification Name:	System, x-ray, fluoroscopic, image-intensified.
Classification Name/ Product code:	90 JAA
Regulatory Class:	Class II
Regulation Number:	21 CFR 892.1650

3. Predicate Device

Digiscope RX-2 (9" option) K965013

4. Intended Use

The 3Dscope is a mobile apparatus used for fluoroscopic examination of a patient.

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5. Device Description

The 3Dscope is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. The 3Dscope acquires, processes, displays, and stores x-ray images, for image diagnosis.

6. Performance Testing

The 3Dscope conforms to the following standards: IEC 60601-1 (1998) + A1(1991) + A2(1995) IEC 60601-1-1 (2000) IEC 60601-1-2 (2001) IEC 60601-1-3 (1994) IEC 60601-2-7 (1998) IEC 60601-1-4 (2000) ISO 14971 (2000) FDA CDRH 21CFR 1020.30 FDA CDRH 21CFR 1020.32

7. Conclusion

The 3Dscope meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the intended use, fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Digiscope RX-2 (9" option).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Larisa Gershtein QA Manager DiREX Systems Corporation 11 Mercer Road MATICK MA 01760

AUG 2 3 2013

Re: K041213

Trade/Device Name: 3Dscope Regulation Number: 21 CFR 892.1650 2 3 2011 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO Dated: June 22, 2004 Received: June 24, 2004

Dear Ms. Gershtein:

This letter corrects our substantially equivalent letter of July 22, 2004.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment 4-1

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):_KO41213

Device Name:

3Dscope

Indications for Use:

The 3Dscope is a mobile apparatus used for fluoroscopic examination of a patient.

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

510(k) Number $\qquad$ \checkmark K041213

Prescription Use (Per 21 CFR § 801.109)

Over the Counter Use_

Daniel A. Ingram

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

11 Mercer Road ♦ Natick, Ma 01760 Phone: 1-888-TRIPTER ● Fax: 508-651-8125 c mail:promo@direxusa.com

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.