The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure.

Device Description

The QCT Pro Asynchronous Calibration Module is intended to extend the capabilities of QCT Pro bone mineral densitometer products (K894854. K002113. K030330) currently marketed by Mindways to the measurement of bone mineral content (BMC) and bone mineral density (BMD) from patient-specific CT images acquired without the simultaneous use of a CT calibration phantom. The QCT Pro bone mineral densitometer products distributed with or supplemented with the QCT Pro Asynchronous Calibration Module will be marketed under the name QCT Pro CliniQCT or more simply CliniQCT. Mineral calibration with the asynchronous calibration method is obtained from phantom measurements acquired on the same CT scanner, operated in a substantially similar mode used to acquire a patient CT scan. The phantom measurements used for calibration purposes may be acquired before or after a patient CT scan to which they are to be applied. The asynchronous calibration mode facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure. Retrospective bone density analysis provides bone density information without exposing a patient to additional ionizing radiation while combining CT studies results in an overall reduction in patient exposure to ionizing radiation relative to the expected radiation dose associated with performing the studies separately.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document, restructured to address your specific points:

The document describes the QCT Pro Asynchronous Calibration Module (marketed as CliniQCT), which provides an alternative calibration method for QCT data sets without requiring a simultaneous CT calibration phantom scan with the patient.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (CliniQCT)	Reported Device Performance (CliniQCT)	Predicate Device Performance (QCT Pro)
Performance	In vitro Precision (relative to calibration reference standard)	Non-inferior to QCT Pro	Non-inferior to QCT Pro (Implied to meet or exceed predicate precision)	Volume Density: 1.4 mg/cm³ (0.7% at a nominal volume density of 200 mg/cm³)Area Density: 0.007 g/cm² (0.7% at a nominal area density of 1.0 g/cm²)
	In vivo Precision (patient)	Non-inferior to QCT Pro	Non-inferior to QCT Pro (Implied to meet or exceed predicate precision)	Spine: Up to 1%Total Hip ROI: 0.011 g/cm² (1.1% at 1.0 g/cm²)Femoral Neck: 0.012 g/cm² (1.2% at 1.0 g/cm²)
	Accuracy (relative to calibration reference standard)	Unbiased	Unbiased	Unbiased
	Equivalence of BMC/BMD estimates	Similar to those obtained from predicate QCT Pro devices for spine and proximal femur.	CliniQCT provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate QCT Pro bone densitometer devices.	Yes
Safety/Usability	Radiation dose with examination	Within currently accepted guidelines and equivalent to predicate use cases.	Facilitates retrospective assessment without additional radiation exposure beyond the initial scan.	Radiation dose associated with examination is within currently accepted guidelines regarding radiation health risks associated with common radiologic diagnostic procedures. (Note: QCT Pro does not directly control radiation delivery).
	Ability to provide retrospective measurements from CT scans acquired for other purposes.	Yes (primary benefit of asynchronous calibration)	Yes, without exposing the patient to additional ionizing radiation.	No (Predicate QCT Pro requires simultaneous phantom scanning, limiting retrospective analysis without re-scanning).
	Ability to provide dual-use BMD/BMC measurements from CT scans for multiple purposes.	Yes (primary benefit of asynchronous calibration)	Yes, without exposing the patient to additional ionizing radiation beyond the other, non-QCT, purpose(s).	No (Predicate QCT Pro requires simultaneous phantom scanning, making dual-use for unrelated CT scans challenging without additional radiation for QCT-specific phantom scan).

Note: The document states that the new device has "the same technological characteristics as its predicate QCT Pro devices" with the exception of the asynchronous calibration method, and that "BMD estimates derived with the asynchronous calibration method are suitable for comparison to the same reference data sets as are used with the QCT Pro predicate devices." This implies that the performance metrics (precision, accuracy) of CliniQCT are expected to be on par with the predicate devices.

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

The document states that the testing involved:

Retrospective data analysis
Phantom testing
Prospective patient studies

However, specific sample sizes for the test set (number of images, patients, or phantoms) are not explicitly provided in the excerpt. The data provenance (e.g., country of origin, retrospective or prospective) is partially indicated by "retrospective data analysis" and "prospective patient studies," but further details (like country/institution) are missing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The device appears to be for quantitative measurements (BMC/BMD) rather than diagnostic image interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since the device provides quantitative measurements (BMC/BMD) rather than classification/diagnosis for which human readers would typically adjudicate, an adjudication method for a "test set" in the traditional sense of diagnostic image review is not applicable here. Performance is evaluated against objective reference standards and comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted, or at least not described in this document. The device is a quantitative measurement tool (densitometer) and not designed for human-in-the-loop diagnostic image interpretation where AI assistance to human readers would be evaluated. The focus is on the accuracy and precision of the quantitative measurements produced by the device itself, compared to existing, validated methods.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the study primarily describes the standalone performance of the CliniQCT device. The "non-inferiority" and "unbiased" claims for precision and accuracy directly reflect the algorithm's performance in generating BMC and BMD values. It is a tool that provides quantitative data, and its performance evaluation is centered on the accuracy and reliability of these quantitative outputs.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device appears to be:

Calibration Reference Standard: For in vitro precision and accuracy, the device's output is compared against established calibration reference standards (e.g., aqueous K2HPO4 bone density standard).
Predicate QCT Pro device outputs: For in vivo precision and similarity of BMC/BMD estimates, the device's performance is compared against the performance characteristics of its predicate QCT Pro devices, which are already legally marketed and established.

8. The Sample Size for the Training Set

The document does not specify a separate training set sample size. The testing described ("retrospective data analysis, phantom testing and prospective patient studies") appears to be for evaluating the device's performance (validation), not for initial model training data, as the device's underlying principles are based on Quantitative Computed Tomography (QCT) and existing predicate technology.

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

Since a separate "training set" is not explicitly mentioned for a machine learning model, the concept of ground truth establishment for a training set in that context is not directly applicable here. The device's calibration and underlying algorithms would be based on established QCT principles and phantom measurement protocols. The phrase "calibration data necessary for use with the QCT Pro Asynchronous Calibration Module is obtained from a standard QCT Pro QA phantom CT scan performed on the same CT scanner" suggests calibration is done using physical phantoms with known density values.

Summary

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

August 29, 2014

Mindways Software, Inc. % Keenan Brown, Ph. D. President/ Director of Research and Development 3001 S Lamar Blvd. Suite 302 AUSTIN, TX 78704

Re: K140342

Trade/Device Name: OCT Pro Asynchronous Calibration Module, CliniOCT Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Mineral Densitometer Regulatory Class: II Product Code: KGI Dated: July 25, 2014 Received: July 31, 2014

Dear Dr. Brown:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
for

Janine M Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140342

Device Name

QCT Pro Asynchronous Calibration Module, CliniQCT

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Mindways Software, Inc. 3001 S Lamar Blvd, Suite 302 Austin, TX 78704, USA

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

Contact Information:	J. Keenan Brown, Ph.D.
	President and Director of Research and Development
	Mindways Software, Inc
	3001 S Lamar Blvd, Ste 302
	Austin, TX 78704
	Phone:512-912-0871
	Fax: 512-912-0871
	Email: keenan@qct.com
Date:	July 24, 2014
Model Number:	CLINIQCT
Device/Trade Name:	QCT Pro Asynchronous Calibration Module, CliniQCT, QCT ProCliniQCT
Common/Usual Name:	Bone Mineral Densitometer
Classification Name:	Bone Densitometer, 21 CFR 892.1170, Class II
Predicate Devices:	K894854: Mindways QCT Pro Bone Mineral Density AnalysisSoftwareIntended Use: Estimate bone mineral density within the spine.

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K002113: Mindways QCT Pro CTXA Hip Bone Mineral Densitometer Intended Use: Estimate bone mineral density at the proximal femur, T-Score calculation, aid in determining fracture risk.

K030330: OCT Pro CTXA Hip Extended Reference Data Intended Use: Reference data for Z-Score calculation between ages 20 and 80.

Device Description

The OCT Pro Asynchronous Calibration Module is intended to extend the capabilities of OCT Pro bone mineral densitometer products (K894854. K002113. K030330) currently marketed by Mindways to the measurement of bone mineral content (BMC) and bone mineral density (BMD) from patient-specific CT images acquired without the simultaneous use of a CT calibration phantom. The QCT Pro bone mineral densitometer products distributed with or supplemented with the QCT Pro Asynchronous Calibration Module will be marketed under the name QCT Pro CliniQCT or more simply CliniQCT. Mineral calibration with the asynchronous calibration method is obtained from phantom measurements acquired on the same CT scanner, operated in a substantially similar mode used to acquire a patient CT scan. The phantom measurements used for calibration purposes may be acquired before or after a patient CT scan to which they are to be applied. The asynchronous calibration mode facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure. Retrospective bone density analysis provides bone density information without exposing a patient to additional ionizing radiation while combining CT studies results in an overall reduction in patient exposure to ionizing radiation relative to the expected radiation dose associated with performing the studies separately.

Intended Use

The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with currently marketed QCT Pro Spine and Hip application modules. Installation of the OCT Pro Asynchronous Calibration Module does not alter the intended use of the QCT Pro Spine and Hip application modules, however, it facilitates an additional means of providing calibration data to QCT Pro that does not require the

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simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Calibration data necessary for use with the QCT Pro Asynchronous Calibration Module is obtained from a standard OCT Pro QA phantom CT scan performed on the same CT scanner used to acquire patient CT images intended for analysis within OCT Pro operating in conjunction with the OCT Pro Asynchronous Calibration Module. The phantom CT scans used to obtain calibration data may be obtained either prior to or subsequent to patient CT scans.

Summary of Technological Characteristics and Comparison with Predicate Devices

QCT Pro when operated with the QCT Pro Asynchronous Calibration Module, collectively marketed as CliniQCT. provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate OCT Pro bone densitometer devices (K894854. K002113. K030330) for regions of interest in the spine and proximal femur. With the exception of the use of an asynchronous calibration method, the new device has the same technological characteristics as its predicate QCT Pro devices that calibrate bone mineral density with reference to a CT calibration phantom scanned simultaneously with a patient. BMD estimates derived with the asynchronous calibration method are suitable for comparison to the same reference data sets as are used with the QCT Pro predicate devices. Such reference data comparisons provide an aid to the physician in identifying patients with abnormally high or low bone mineral density.

Device Characteristic	CliniQCTInstalled and Used inConjunction withQCT Pro	QCT Pro(K894854, K002113,K030330)
Device provides estimates of bone mineral content (BMC).	✓	✓
Device provides estimates of bone mineral density (BMD).	✓	✓
BMC and BMD estimates are provided for the spine and hip.	✓	✓
BMC and BMD estimates are derived using the principals ofQuantitative Computed Tomography (QCT)	✓	✓
BMC and BMD estimates are provided standardized to anaqueous K2HPO4 bone density standard.	✓	✓

BMC and BMD estimates are derived relative to a phantomstandard scanned:with the patientseparate from the patient, either before or after patientscan	both scan modesaccessible withinstallation ofCliniQCT
Precision, ( in vitro ) relative to calibration reference standard.	Non-inferior to QCTPro	Volume Density: 1.4mg/cm3 (0.7% at anominal volume densityof 200 mg/cm3)Area Density: 0.007g/cm2 (0.7% at anominal area density of1.0 g/cm2)
Precision, ( in vivo ) patient.	Non-inferior to QCTPro	Spine: Up to 1%Total Hip ROI:0.011 g/cm2 (1.1% at1.0 g/cm2)Femoral Neck:0.012 g/cm2 (1.2% at1.0 g/cm2)
Accuracy, relative to calibration reference standard	Unbiased	Unbiased
Radiation dose associated with examination is within currentlyaccepted guidelines regarding radiation health risks associatedwith common radiologic diagnostic procedures.Note, QCT Pro does not directly control the delivery ofradiation to a patient, but rather makes use of images acquiredfrom medical CT scanners approved for diagnostic, medical x-ray, CT imaging purposes.
Device can be used to provide retrospective measurementsfrom CT scans acquired for other purposes without exposingthe patient to additional ionizing radiation beyond that requiredfor the other purposes.
Device can be used to provide BMD and BMC measurementsfrom CT scans acquired for multiple purposes (e.g., dual use ofimages acquired for CT colonography and bone densityscreening) without exposing the patient to additional ionizingradiation beyond that required for the other, non-QCT,purpose(s).

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Device Testing

The design and performance of CliniQCT installed with QCT Pro was evaluated and compared to QCT Pro using retrospective data analysis, phantom testing and prospective patient studies. Software validation was performed using standard techniques.

Summary

Based on the similarities in analytical methods, calibration standards and performance testing, it is concluded that CliniQCT used in conjunction with QCT Pro is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new safety or effectiveness issues are raised by CliniQCT.

Signature

J. Keenan Brown, PhD Director of Research and Development Mindways Software, Inc.

Regulation Number and Section

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.