The Pronosco X-posure System™ is intended for use to estimate BMD in the forearm and to assess increased risk of osteoporotic fractures according to World Health Organization ("WHO") criteria. The device is specifically indicated for use to: (1) assist the physician in diagnosing subjects who have already been identified to be at risk of suffering from osteoporosis, together with other known risk factors (i.e., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of calcium and vitamin D, and smoking); and (2) compare the BMD estimate with reference populations of young normals and age matched normals to compute T-scores and Z-scores, respectively.

Device Description

The Pronosco X-posure System™ estimates BMD based on established principles of radiogrammetry. A standard x-ray is first scanned into the system. then analyzed by computer to assess cortical thickness and textural characteristics in the pre-defined region of interest, which consists of the radius, the ulna, and the second through fourth metacarpals. The BMD estimate may be compared to a reference database of young normals and age matched normals to compute T-scores and Z-scores, respectively.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pronosco X-posure System™ based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating "substantial equivalence" to existing predicate devices. The performance is described in a qualitative manner, affirming safety and effectiveness based on clinical and performance testing.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Clinical testing and performance testing have demonstrated the safety and effectiveness of the Pronosco X-posure System™ for its intended use.
BMD Estimation Quality	Estimates BMD based on established principles of radiogrammetry, assessing cortical thickness and textural characteristics in predefined regions (radius, ulna, 2nd-4th metacarpals).
Fracture Risk Assessment	Assesses increased risk of osteoporotic fractures according to WHO criteria.
Comparison to Reference Data	Compares BMD estimates with reference populations of young normals and age-matched normals to compute T-scores and Z-scores.
Substantial Equivalence to Predicates	Substantially the same intended use and indications for use as predicate devices. Minor differences in technical characteristics (BMD estimation method, specific regions of interest) do not raise new questions of safety or effectiveness.

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

The 510(k) summary does not specify the sample size for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It generally states "clinical testing and performance testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The 510(k) summary does not provide any information regarding the number or qualifications of experts used to establish ground truth for any test set.

4. Adjudication Method for the Test Set:

The 510(k) summary does not describe any adjudication method used for a test set.

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

The 510(k) summary does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is provided.

6. Standalone (Algorithm Only) Performance:

The 510(k) summary describes the device as performing the analysis ("analyzed by computer to assess cortical thickness and textural characteristics"). This implies standalone algorithm performance as a core component of its operation. However, no specific standalone performance metrics (e.g., sensitivity, specificity) are explicitly stated without human intervention, other than the general statement of safety and effectiveness. The device's output (BMD estimate, T-scores, Z-scores) is intended to "assist the physician," suggesting it's not a fully autonomous diagnostic tool but rather an aid.

7. Type of Ground Truth Used:

The 510(k) summary does not explicitly state the type of ground truth used for validation. Given that the device estimates BMD and assesses fracture risk in comparison to WHO criteria and reference populations, it's highly probable that:

Clinical diagnoses: For osteoporosis status.
Established BMD measurement techniques: As a gold standard for comparison of BMD values.
Epidemiological data/outcomes data: For validating fracture risk assessment against actual fracture occurrences, although this is more speculative based on the limited information.

8. Sample Size for the Training Set:

The 510(k) summary does not specify the sample size of the training set.

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

The 510(k) summary does not provide details on how the ground truth for the training set was established.

Summary

{0}------------------------------------------------

K984178

510(K) SUMMARY Pronosco X-posure System™

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

Submitter: Pronosco Torsana Osteoporosis Diagnostics A/S Torsana Park. Kohavevej 5 DK-2950 Vedbaek Denmark
Svenn Poulsen, MD, MBA, MFPM Contact Persons: Managing Director

Telephone number: (011) 45 45 65 06 00 (011) 45 45 65 06 06 Facsimile:

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Telephone number:	(202) 637-5794
Facsimile:	(202) 637-5910

November 18, 1998 Date Prepared:

Name of Device and Name/Address of Sponsor

Pronosco X-posure System™ Bone Densitometer

Sponsor: Pronosco Torsana Osteoporosis Diagnostics A/S Torsana Park, Kohavevej 5 DK-2950 Vedbaek Denmark

Telephone number:	(011-45) 45 65 06 00
Facsimile:	(011-45) 45 65 06 06

Common or Usual Name

Pronosco X-posure System™

{1}------------------------------------------------

Classification Name

Bone Densitometer

Predicate Devices

1. Hologic, Inc.'s QDR 2000 X-Ray Bone Densitometer (K913321)
1. Norland Medical Systems' Norland 178 Bone Mineral Analyzer (preamendments device)
1. Norland Medical Systems' pDEXA® Bone Densitometer with Fracture Risk Assessment Option (K973104)
1. Compumed, Inc.'s Osteogram (preamendments device)

Intended Use

{2}------------------------------------------------

Principles of Operation

Technological Characteristics

The Pronosco X-posure System™, the Hologic QDR-2000, the Norland Model 178, the Norland pDEXA®, and the Compumed Osteogram all provide estimates of BMD to aid the physician in diagnosing osteoporosis. While the Pronocco X-posure System™ derives the BMD estimate based on radiogrammetric principles, rather than absorptiometry methods, this approach does not raise any new questions of safety or effectiveness, because the Compumed Osteogram similarly derives BMD estimates from computerized analysis of radiographic images. In addition, all of the devices determine forearm BMD using similarly defined regions of interest, and several of the devices use similar methods to analyze fracture risk. Clinical testing and performance testing have also demonstrated the safety and effectiveness of the Pronosco X-posure System™ for this intended use.

{3}------------------------------------------------

Summary Basis for the Finding of Substantial Equivalence

The Pronosco X-posure System™ has substantially the same intended use and indications for use as the predicate devices. In addition, the minor differences in the technical characteristics of the devices, such as differences in the BMD estimation method or the precise regions of interest used to determine forearm BMD, do not raise new questions of safety or effectiveness, as confirmed by clinical and performance testing. Thus, the devices are substantially equivalent.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Jonathan S. Kahn, Esq C/o Hogan & Harston, LLP Torsana Osteoporosis Diagnostics A/S 555 13th Street, N.W. Washington, DC 20004

K984178. Re:

Pronosco X-posure System™ Dated: Novermber 20, 1998 Received: November 20, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Kahn:

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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 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(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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact 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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known):

Device Name: __ Pronosco X-posure System™

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jimid A. Seager

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.