The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD) of the proximal femur using digital antero-posterior hip or pelvis radiographic images. This information may be used by the physician in the assessment of fracture risk in conjunction with the World Health Organization ("WHO") criteria and to compare the derived BMD estimate with reference populations of young (20 - 39) and age matched normals to compute T-scores and Z-scores respectively.

Device Description

The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays. The program utilizes a quantitative bone structural algorithm that measures a composite of weighted cortical and trabecular parameters in proximal femur projection radiographs from which total hip bone mineral density (BMD) is mathematically derived. Image analysis can take place remotely or at the point of care.

The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score).

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance validation against predefined criteria.

However, based on the available information, I can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The document refers to "standard methods for evaluation of BMD estimates," implying that the device's performance was compared against established benchmarks or methods for BMD measurement.
Reported Device Performance:
- The document states: "The device design was evaluated using standard methods for evaluation of BMD estimates in patient populations including patients across the spectrum of age."
- It also mentions: "Software validation was performed using standard techniques."
- The results are "expressed as gm/cm2" and "can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score)."
Table (Inferred Acceptance Criteria based on common BMD device evaluation and what's mentioned):

Acceptance Criterion (Inferred)	Reported Device Performance
Accuracy of BMD Estimate (vs. a reference standard/method)	"The device design was evaluated using standard methods for evaluation of BMD estimates in patient populations..." (No specific quantitative results like mean difference, R-squared, or Bland-Altman agreement with a gold standard are provided in this summary.)
Reproducibility/Precision	Not explicitly mentioned but often part of "standard methods for evaluation of BMD estimates."
Ability to generate T-scores and Z-scores	"The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score)." Implies the system successfully computes these scores.
Robustness across patient age spectrum	"...evaluated using standard methods for evaluation of BMD estimates in patient populations including patients across the spectrum of age." (No specific results for different age groups are provided.)
Software Validation	"Software validation was performed using standard techniques." (This typically covers functionality, bugs, data integrity, and security, but specific criteria or outcomes of this validation are not detailed.) The device is stated to be "substantially equivalent" to predicate devices, implying its performance meets a comparable standard, but the specific metrics are not detailed in this summary.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "patient populations including patients across the spectrum of age" but does not give a number.
Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be clinical data used for evaluation, but whether it was retrospective or prospective is not mentioned.

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 in the document. The document refers to "standard methods for evaluation of BMD estimates," but does not detail how ground truth was established for the specific dataset used in their evaluation.

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

This information is not provided in the document.

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:

An MRMC comparative effectiveness study is not mentioned in the document. The device is a "stand-alone software" intended to provide an estimate of BMD, not explicitly an AI-assisted interpretation tool for human readers in the way an MRMC study typically evaluates. It processes images to derive BMD, which physicians then use in their assessment.

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

Yes, the device is described as "stand-alone software" and "algorithm only" in its function of estimating BMD. The document states: "The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD)..." and "The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays." This confirms it's a standalone algorithmic performance.

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

The direct ground truth for BMD values would typically come from reference BMD measurements (e.g., from a DEXA scan, which is considered the gold standard for clinical BMD) or potentially from a very meticulously calibrated physical phantom. The text only mentions "standard methods for evaluation of BMD estimates," but does not specify the ground truth methodology used for their evaluation studies.

8. The sample size for the training set:

The document does not mention the sample size for a training set. This summary describes an evaluation of the device as a whole, not the specifics of its development (like training data for an AI model, even though it uses an "algorithm").

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

This information is not provided as the training set itself is not mentioned.

Summary

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SECTION 2

K082402

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of the 510(k) Premarket Notification for the Imaging Therapeutics OsDx Hip BMD System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

CONFIDENTIAL

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PREDICATE DEVICES

The Imaging Therapeutics OsDx Hip BMD System is substantially equivalent to FDAapproved predicate devices with regard to indications for use and technological characteristics. These predicate devices are:

Technological Characteristics and Indication for Use
• CTXA Hip: K002113
• Pronosco X-Posure System Bone Densitometer: K984178
• Hologic Hip Structural Analysis Software K061561

INTENDED USE

PRODUCT DESCRIPTION

The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score).

SUBSTANTIAL EQUIVALENCE

Use of the Term "Substantial Equivalence"

The term "Substantial Equivalence" is used in this submission within the confines of the statutory use in the FDA's evaluation of a Pre-Market Notification Submission. Any statement regarding Substantial Equivalence used in this submission relates only to whether the device that is the subject of this submission may be lawfully marketed in the United States without pre-market approval or reclassification, and should not be interpreted as an admission, or any kind or type of evidence, in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office.

CONFIDENTIAL

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The present submission and statements therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in the submission, or its use, may be considered indistinct, from a patentability perspective, from any other device referred to in this sub mission.

Technological Characteristics

The technological characteristics (including anatomic site analyzed) of the OsDx Hip BMD System are substantially equivalent to those of the cited predicate devices. Standard x-ray images are scanned and evaluated to provide an estimate of BMD and a comparison to a normative data cohort for interpretation, including T-Score and Z-Score determination.

Indications for Use

Substantial equivalence is also supported for the OsDx Hip BMD System by the predicate devices previously cited and cleared in the treatment for the estimation of BMD.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

The device design was evaluated using standard methods for evaluation of BMD estimates in patient populations including patients across the spectrum of age. Software validation was performed using standard techniques.

SUMMARY

Based on the similarities in analytical approach, anatomic site evaluated and technological characteristics, the OsDx Hip BMD System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition OsDx Hip BMD System raises no new safety or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2008

Patrick Hess, Ph.D. Chief Executive Officer Imaging Therapeutics, Inc. 400 Seaport Court, Suite 250 REDWOOD CITY CA 94063

Re: K082402

Trade/Device Name: Imaging Therapeutics OsDx Hip BMD System Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: August 15, 2008 Received: August 20, 2008

Dear Dr. Hess:

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 (PMA), 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.

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Page 2

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.

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.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jaque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K 08 24 02

Device Name: Imaging Therapeutics OsDx Hip BMD SYSTEM

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-

CONTINUE ON ANOTHER PAGE IF NEEDED)

Hulh Ruse
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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.