The Osteo CT is intended to be used for routine assessment of bone mineral content in the vertebral bodies of the lumbar and thoracical spine with high precision through the use of SOMATOM CT scanners. It is also applicable to assessment of changes in bone mineral content over time.

Device Description

OSTEO CT is a scan/evaluation option added to the SOMATOM AR family, and Plus 4 CT scanners. It provides assessment of the bone mineral density (BMD) through the use of single energy quantitative CT technology. An Osteo package contains 1 reference calibration phantom designed for all SOMATOM CT systems, 1 tabletop pad specially designed for housing the reference phantom, 1 coupling pad designed to eliminate possible air bubbles between the patient and the reference phantom, 1 foam insert to prevent the phantom from moving vertically within the tabletop pad and to eliminate possible air bubbles between the table and the reference phantom, 1 pad insert to prevent the phantom from moving longitudinally within the tabletop pad, and the bone mineral density scanning/evaluation software.

AI/ML Overview

The provided text describes a 510(k) summary for the "Osteo CT Option for SOMATOM CT Systems," a device intended for assessing bone mineral density (BMD). However, it does not contain a detailed study with acceptance criteria and a comprehensive report of device performance against those criteria. The document is primarily a regulatory submission rather than a scientific publication of a clinical trial.

Therefore, many of the requested elements for describing acceptance criteria and a study proving the device meets them cannot be directly extracted from the provided text.

Based on the available information, here's what can be inferred and what is missing:

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

This information is not present in the provided document. The document states "A multi-center clinical study was carried out in Europe to collect cortical and trabecular bone CT images from individuals with normal bone mineral density. The collected data, after statistical analysis, served as the reference database." However, it does not specify any performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device itself or any acceptance criteria that these metrics needed to meet.

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

Sample size for test set: Not explicitly stated. The document mentions a "multi-center clinical study" but does not provide the number of participants or scans.
Data provenance: "Europe" (multi-center). The study collected data from "individuals with normal bone mineral density," suggesting it was for establishing a reference database rather than testing the device's diagnostic performance against a specific condition. It appears to be prospective data collection for establishing norms.

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

This information is not provided. The study collected data to serve as a "reference database" from individuals with "normal bone mineral density." It's unclear if expert interpretation was part of establishing this "normality" or if it was based solely on the CT images themselves.

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

This information is not provided. Given the described purpose of the study (establishing a reference database of "normal" bone density), a formal adjudication method for a "test set" in the diagnostic sense is unlikely to have been documented in this submission.

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:

MRMC study: Not indicated. The document describes the device as a "scan/evaluation option" that assesses BMD. The function is to provide assessment, not to assist human readers in a diagnostic capacity in the way an AI algorithm might. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device as described.
Effect size: Not applicable/not provided.

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

The device, "Osteo CT," is described as "assessment of the bone mineral density (BMD) through the use of single energy quantitative CT technology" and "calculates the patient's bone mineral density (BMD) with reference to the phantom, offer a reference database, and provide BMD results in both tabular and graphical forms." This suggests it is an algorithm-only (standalone) performance that provides calculated BMD values, which are then used by clinicians for interpretation. No human-in-the-loop interaction for performance improvement is implied for the device itself.

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

The study was conducted to establish a "reference database" of individuals with "normal bone mineral density." While the exact method for determining "normal" isn't detailed, it implies a baseline of healthy individuals. It's not stated that an independent "ground truth" like pathology or long-term outcomes data was used to validate the device's accuracy against a disease state, but rather to establish a normal range.

8. The sample size for the training set:

The document mentions that the "collected data, after statistical analysis, served as the reference database." This "reference database" likely functions as what would be considered a training/reference set for the device's internal calculations. The sample size for this set is not provided.

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

The ground truth for the "reference database" was established by collecting cortical and trabecular bone CT images from individuals with "normal bone mineral density" in a multi-center clinical study in Europe. The specific criteria for defining "normal" BMD for inclusion in this study are not detailed, but it suggests a population presumed to be healthy in terms of bone density.

Summary

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K971054

Appendix 1

510(k) Summary Osteo CT Option for SOMATOM CT Systems

Submitted by:

JUN 1 3 1997

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

March 21, 1997

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.

Contact Person: 1. Ms. Jing Zhang Fax: (908)321-4841 Phone: (908)321-4927

Device Name and Classification: 2.

Osteo CT for SOMATOM AR family, and Trade Name: Plus 4 Computed Tomography Systems Computed Tomography X-ray System Classification Name: 21 CFR §892.1750, Class II CFR Section: 90JAK Device Code:

3. Substantial Equivalence:

The Osteo CT option operating on SOMATOM AR family, and Plus 4 CT scanners is substantially equivalent to the following devices:

3D QCT Bone Mineral Densitometry 1) MindWaves Software, for assessing BMD
- - - - SOMATOM AR family, and Plus 4 CT scanners 2) Siemens Medical Systems, Inc., for scanning and image analysis

Device Description: 4.

An Osteo package contains 1 reference calibration phantom designed for all SOMATOM CT systems, 1 tabletop pad specially designed for

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SIEMENS

housing the reference phantom, 1 coupling pad designed to eliminate possible air bubbles between the patient and the reference phantom, 1 foam insert to prevent the phantom from moving vertically within the tabletop pad and to eliminate possible air bubbles between the table and the reference phantom, 1 pad insert to prevent the phantom from moving longitudinally within the tabletop pad, and the bone mineral density scanning/evaluation software.

5. Intended Use of the Device:

The Osteo CT is intended to be used for routine assessment of bone mineral content in cortical and trabecular bone. It is also applicable to assess changes in bone mineral content over time.

6. Summary of Technological Characteristics of the Device Compared to the Predicate Device:

The Osteo CT has the same technological characteristics as the predicate 3D QCT Bone Mineral Densitometry, except the Osteo CT is written for Siemens line of CT scanners while the predicate can take images from any CT scanners. They both use reference phantom, calculate the patient's bone mineral density (BMD) with reference to the phantom, offer a reference database, and provide BMD results in both tabular and graphical forms. The reference database and the comparison provide a reference for the clinical evaluation of bone diseases.

The Osteo software operates independent of the SOMATOM CT scanners reconstruction software, does not influence the determination of the CT numbers by the scanners, and does not affect the dosage characteristics or the imaging performance parameters of the SOMATOM CT scanners.

7. Clinical Study and Conclusion:

A multi-center clinical study was carried out in Europe to collect cortical and trabecular bone CT images from individuals with normal bone mineral density. The collected data, after statistical analysis, served as the reference database.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 1997

Jing Zhang Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830

Re: K971054

Osteo CT for the SOMATOM AR family and Plus 4 CT X-Ray Systems Dated: March 21, 1997. - .. Received: March 24, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK 21 CFR 892.1170/Procode: 90 KGI

Dear Ms. Zhang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 egainst misbranding and adulteration.

If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device as described in your 510(x) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please ontact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address ﺗﻜﻠﻴ "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Y

Lilian Yin, Ph.D. Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix 2 Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Osteo CT for the SOMATOM AR family, and Plus 4 CT Scanners

Indications for Use:

Concurrence of the CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K971054

Prescription Use

Check Mark

OR Over-The-Counter Use __________

(per 21 CFR 801.109)

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.