The AN6250 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.

Images from the AN6250 Digital Radiology System are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance by the operator, the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

Device Description

The AN6250 is a Stationary, General Radiology X-ray System.

AI/ML Overview

Here's an analysis of the provided text regarding the Analogic AN6250 Digital Radiology System, focusing on acceptance criteria and study information:

Based on the provided 510(k) summary for the Analogic AN6250 Digital Radiology System, there is no detailed information provided regarding specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The summary focuses on demonstrating substantial equivalence to a predicate device (Analogic AN6150 Digital Radiology System) based on similar design and technological principles. The "tests" mentioned are primarily non-clinical, related to safety, electromagnetic compatibility, mechanical integrity, and compliance with voluntary standards for medical electrical equipment.

Therefore, many of the requested details about a clinical performance study using a test set, ground truth, experts, etc., are not present in this document.

Here's a breakdown of what can be extracted or inferred:

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

Acceptance Criteria (Implied)	Reported Device Performance
Clinical Performance: No specific clinical performance criteria (e.g., sensitivity, specificity, image quality metrics relevant to diagnostic accuracy) are stated.	Not applicable - no clinical performance study results are reported for the AN6250 in this document.
Safety: Compliance with IEC 60601-1 and related collateral standards for medical electrical equipment.	"The AN6250 Digital Radiology System will be thoroughly validated at the unit and system level to meets all elements of its Requirements Specification. This includes the following non-clinical tests: IEC 60601-1:1988, +A1:1991, +A2:1995, IEC 60601-1-1, IEC 60601-1-3:1994, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32." (Implies compliance, but no specific performance metrics are given).
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.	"IEC 60601-1-2:2001, an FDA recognized consensus standard for electromagnetic compatibility." (Implies compliance, but no specific performance metrics are given).
Environmental/Mechanical Robustness: Withstand line dropout, voltage variations, mechanical shock, vibration, and transportation.	"Line Dropout and Variation Susceptibility were tested according to the FDA Reviewer Guidance for premarket Notification Submissions, November 1993." "Mechanical Shock and Vibration Tests." "Shipping Container Transportation Test." (Implies successful completion, but no specific performance metrics are given).
Image Availability: Images available for preview within seconds.	"Images from the AN6250 Digital Radiology System are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure." (This is a functional requirement, not a performance metric like diagnostic accuracy).

Regarding a "study that proves the device meets the acceptance criteria":

The document refers to "thorough validation at the unit and system level to meets all elements of its Requirements Specification" which includes the listed non-clinical tests. This implies a series of engineering and quality assurance tests rather than a clinical study evaluating diagnostic performance. The primary "proof" sought by the 510(k) pathway is substantial equivalence to a predicate device, not necessarily a de novo clinical efficacy study.

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

Not applicable / Not provided. The document does not describe a clinical test set or data for evaluating diagnostic performance. The "tests" mentioned are non-clinical hardware/software validation.

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)

Not applicable / Not provided. No clinical ground truth establishment is described.

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

Not applicable / Not provided. No clinical test set adjudication is described.

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 is not an AI-assisted device. It's a digital radiology system (hardware and associated software for image acquisition and display). Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable / No. The device is a complete X-ray system, not a standalone algorithm. Its performance is tied to the entire system (image acquisition, processing, display).

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

Not applicable / Not provided for clinical performance. For the non-clinical tests, the "ground truth" would be established engineering specifications and industry standards (e.g., a device must operate within specified voltage ranges, or external radiation leakage must be below a certain limit as defined by IEC standards).

8. The sample size for the training set

Not applicable / Not provided. This is not a machine learning/AI device that undergoes "training."

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

Not applicable / Not provided. As above, no training set for an AI/ML algorithm is mentioned.

Summary:

The provided 510(k) summary for the Analogic AN6250 Digital Radiology System is focused on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with non-clinical safety and performance standards. It does not contain information about clinical performance studies, diagnostic accuracy metrics, or the use of AI/ML algorithms. The "acceptance criteria" are predominantly related to engineering specifications and regulatory compliance for medical devices, rather than clinical efficacy.

Summary

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NOV 1 9 2004

Image /page/0/Picture/1 description: The image shows the word "ANALOGIC" in bold, black letters. To the right of the word is a registered trademark symbol. A black square is located to the right of the trademark symbol. The letters are sans-serif and appear to be a company logo.

K043825

510(k) Summary For Analogic Corporation AN6250 Digital Radiology System

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

1. Submitter's Name and Address:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

Date this Summary was Prepared: 2.

November 2, 2004

3. Contact Person:

Donald J Sherratt, Regulatory Affairs Manager (978) 977-3000 extension 3049 Tel: (978) 977-6808 Fax:

Device Name: 4.

Proprietary or Trade Name:	AN6250 Digital Radiology System
Common Name:	Digital Radiology Systems
Classification Name:	Digital Radiology Systems and Accessories
Device Classification:	Class II

5. Predicate Device:

The legally marketed device to which equivalence is being claimed is the Analogic AN6150 Digital Radiology System. The predicate system was cleared under Premarket Notification K040995.

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Device Description: 6.

The AN6250 is a Stationary, General Radiology X-ray System.

Intended Use 7.

Comparison of Technological Characteristics: 8.

The design of the new AN6250 Digital Radiology System is derived from the design of the AN6150 Digital Radiology System and uses the same technological principles.

Compliance with Voluntary Standards 9.

Before final market release, the AN6250 Digital Radiology System will be thoroughly validated at the unit and system level to meets all elements of its Requirements Specification. This includes the following non-clinical tests:

. IEC 60601-1:1988, +A1:1991, +A2:1995, an FDA recognized consensus standard for safety of medical electrical equipment.
IEC 60601-1-1: .
IEC 60601-1-3:1994. Medical electrical equipment Part 1: General . requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
. IEC 60601-2-7:
IEC 60601-2-28
. IEC 60601-2-32:
IEC 60601-1-2:2001, an FDA recognized consensus standard for electromagnetic . compatibility.
Line Dropout and Variation Susceptibility were tested according to the FDA . Reviewer Guidance for premarket Notification Submissions, November 1993
Mechanical Shock and Vibration Tests .
. Shipping Container Transportation Test

10. Conclusion

Based on the similarity in construction to the predicate device, same technological characteristics and the same intended use, the device is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an abstract symbol. The symbol resembles an eagle or a bird in flight, represented by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2004

*Mr. Donald J. Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Centennial Industrial Park PEABODY MA 01960

Re: K043025

Trade/Device Name: AN6250 Digital Radiology System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KRP Dated: November 2, 2004 Received: November 3, 2004

Dear Mr. Sherratt:

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) I mis lotter with and by the FDA finding of substantial equivalence of your device to a legally prematice notification. "Thesalts 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 If you desire specifice of Compliance at one of the following numbers, based on 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 60 : 77). I ou may or man curers, 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,

Nancy C. brogdon

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 word "ANALOGIC" in bold, black letters. The letters are sans-serif and appear to be a custom font. To the right of the word is a registered trademark symbol and a black square. The background is white.

510(k) Number: Ko43025 25 ---

Device Name: AN6250 Digital Radiology System

Indications For Use:

The AN6250 is a digital X-ray general radiography system intended for use by qualified/trained The IIN0250 Is a creatived to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.

Images from the AN6250 are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the X-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

Prescription Use ਮ (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043025

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.