The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

Device Description

AI/ML Overview

This document is a 510(k) summary for the Mayfield® ScanMate™ Mobile CT System, primarily focused on establishing substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.

Here's an attempt to extract the relevant information based on the provided text, with explicit notes where the information is not available:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(No specific performance metrics or acceptance criteria are provided in the 510(k) summary. The summary focuses on substantial equivalence to a predicate device.)	(No specific performance values such as sensitivity, specificity, accuracy, or image quality metrics are reported.)

Study Details

1. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: Not available.
Data Provenance: Not available. The document is a 510(k) summary for substantial equivalence and does not describe a clinical performance study with a distinct test set.

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

Number of Experts: Not applicable, as no specific test set ground truth establishment is described.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable, as no specific test set or adjudication process is described.

4. 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:

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described. The device is a CT system, not an AI-assisted diagnostic tool in the context of this document.
Effect Size of Human Readers with/without AI: Not applicable, as it's not an AI-assisted device for diagnostic improvement, but a standalone imaging system.

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

Standalone Performance: The device itself is a standalone CT system. However, the document does not describe a performance study for the algorithm only (as it's a medical device, not solely an algorithm). It's a system to produce images for human interpretation. The 510(k) process focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device.

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

Type of Ground Truth: Not applicable, as no specific performance study requiring ground truth establishment is detailed. The 510(k) relies on comparison to a predicate device.

7. The sample size for the training set:

Sample Size for Training Set: Not applicable. The document describes a CT system, not a machine learning algorithm that requires a training set in the conventional sense.

8. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not applicable, as it's not a machine learning algorithm.

Summary of Document's Focus:

The provided 510(k) summary primarily asserts that the Mayfield® ScanMate™ Mobile CT System is substantially equivalent to the Analogic Corporation's ANATOM 2000. It states that the ScanMate Mobile CT System shares "the same uses, indications for use, technological characteristics, and principles of operation" as its predicate device. This implies that the device's acceptable performance is demonstrated by its similarity to an already approved device, rather than through a detailed independent performance study with specific acceptance criteria, test sets, and ground truths as typically associated with new algorithmic or AI-based devices.

Summary

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KoS3210

JAN G 2006 510(k) SUMMARY

Schaerer Mayfield USA, Inc.'s Mayfield® ScanMate™ Mobile CT System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227

Phone: (513) 561-2241 Facsimile: (513) 561-0195

Contact Person: Teck W. Awa

Date Prepared: November 1, 2005

Name of Device and Name/Address of Sponsor

Mayfield® ScanMate™ Mobile CT System

Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227

Common or Usual Name

Computed Tomography X-ray System

Classification Name

Computed Tomography X-ray System

Predicate Device(s)

Analogic Corporation's ANATOM 2000

Intended Use / Indications for Use

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Schaerer Mayfield USA, Inc. % Mr. Jeffrey K. Shapiro Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K053210

2006

JAN 6

Trade/Device Name: Mayfield® ScanMate™ Mobile CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 16, 2005 Received: November 16, 2005

Dear Mr. Shapiro:

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 vour 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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) 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:

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 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/industry/support/index.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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· Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Mayfield® ScanMate™ Mobile CT System

Indications for Use:

The Mayfield® ScanMate™ Mobile CT System is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

Prescription Use __ X_ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _____ of

David A. Lyon

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

\\DC - 24236/0001 - 2212551 v 1

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.