The Accudxa 2 is a dual-energy x-ray (DXA) device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. Accudxa 2 BMD estimates, t-score and z-score can be used as an aid to the physician in determining fracture risk and for monitoring changes in bone mass over time.

Device Description

The Accudxa 2 Model 7200 is a Dual Energy X-ray Absorptiometer (DXA) screening device. The device is intended to calculate an index of bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, vielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals, which can be used by the physician as an aid to diagnose osteoporosis or osteopenia and to estimate fracture risk. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient, which can be used by the physician as an aid to diagnose other disorders affecting bone mass.

The BMD Test interaction with the operator is through a touchscreen LCD panel and a membrane switch/indicator panel on the front of the device. BMD Test options are presented to the operator through messages on the touchscreen.

The x-ray system state and x-ray controls are presented to the operator via the membrane switch/indicator panel on the front of the device.

The Accudxa 2 is a Class II medical device and a Class II laser product.

AI/ML Overview

Here's an analysis of the provided text regarding the Accudxa 2 Bone Densitometer, focusing on acceptance criteria and study details.

Important Note: The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study for the Accudxa 2. The core of their argument is that the Accudxa 2 uses the same algorithms, normative database, and sensor as its predicate (accuDEXA Model 7100). Therefore, the "study" demonstrating its performance is largely a comparison to the predicate's known performance.

Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, explicit "acceptance criteria" for a new, independent study on the Accudxa 2 are not detailed. Instead, the performance is evaluated by demonstrating equivalence to the predicate device.

Acceptance Criteria Category	Specific Criteria (Inferred/Demonstrated by Equivalence)	Reported Device Performance (Accudxa 2)
Bone Mineral Density (BMD) Measurement	Equivalence in BMD readings obtained from the device compared to the predicate (accuDEXA Model 7100).	The Accudxa 2 uses the same calibration phantom set as the accuDEXA Model 7100 "to ensure that BMD readings obtained from the device are equivalent to those of the accuDEXA Model 7100." The device also uses the same algorithms, normative database, and sensor as the predicate.
Bone Mineral Content (BMC) Measurement	Equivalence in BMC readings obtained from the device compared to the predicate.	(Implicitly covered by the above, as BMC is derived from the same analysis algorithms).
Reproducibility/Accuracy	Performance comparable to the predicate device in terms of generating t-scores and z-scores for clinical interpretation.	Performance is reported to be substantially equivalent to the predicate, which provides t-scores and z-scores for aid in diagnosing osteoporosis/osteopenia and estimating fracture risk.
Safety Standards	Compliance with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and radiation safety.	The Accudxa 2 "complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and radiation safety of medical and / or laser devices."

Study Information (Based on provided text)

Sample size used for the test set and the data provenance:
- The document does not explicitly state a sample size for an independent clinical test set for the Accudxa 2.
- The primary method for demonstrating performance is through comparison to a well-established predicate device (accuDEXA Model 7100). The implication is that the performance of the Accudxa 2 is directly tied to, and validated by, the long-standing performance data and regulatory clearances of the predicate.
- The normative database, which would involve data from individuals, is stated to be the same as that used by the predicate. Its provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The approach is based on technological equivalence to a predicate device, not on a new, independent clinical study requiring expert ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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:
- No. This device is a bone densitometer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in that context. It provides quantitative measurements (BMD, t-score, z-score) for physician interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The comparison to the predicate relies on the device's ability to consistently produce equivalent BMD readings using the "same algorithms" and "same sensor" as the predicate device. The performance of the algorithms themselves (which are the same as the predicate) is the standalone performance they are leveraging from the predicate device history.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's core functionality (BMD measurement) relies on the known BMC and BMD values of standardized calibration phantoms. The text states: "The Accudxa 2 uses the same calibration phantom set to ensure that BMD readings obtained from the device are equivalent to those of the accuDEXA Model 7100." The accuracy of these phantoms would have been established through a primary standard (e.g., gravimetric analysis or other highly precise methods). For clinical interpretation (t-scores, z-scores), the ground truth is derived from the normative database, which represents a statistical distribution of bone density in healthy populations.
The sample size for the training set:
- Not applicable/Not mentioned for the Accudxa 2 itself. The device uses the same algorithms and normative database as its predicate. The training of these original algorithms and the compilation of the normative database would have occurred with the predicate device, not described here.
How the ground truth for the training set was established:
- Not applicable/Not mentioned directly for the Accudxa 2. For the predicate device's algorithms and normative database, this would have involved:
  - Normative Database: Measurement of bone density in a large, diverse population subgroup defined as "healthy young individuals" and "age-matched individuals," with data potentially involving specific inclusion/exclusion criteria.
  - Algorithm Development: Likely involved imaging of phantoms with known properties and potentially human subjects, with ground truth established through other validated methods (e.g., in vitro assays for BMC, or comparison to established DXA systems).

Summary

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K113616

APR 2 7 2012

510(k) Summary

510 (k) Submitter/Owner	Lone Oak Medical Technologies
	3805 Old Easton Road
	Doylestown, PA 18902
	Phone: 215-230-7607
	Fax: 215-230-7609
Contact Person	David Comley
	Vice President
	215-230-7607
	Email: david@loneoakmedical.com
Date Prepared	December 6, 2011
Trade Name	Accudxa 2 Bone Densitometer
Common Name	Bone Densitometer
Classification Name	Bone Densitometer

Predicate Devices:

Company	Device name	Product Code	510(k)
SchickTechnologies	accuDEXA BoneDensitometer	KGI	K971735 K981124 K001429
Alara, Inc	Metriscan BoneDensity System	KGI	K000162
Lunar Corp	PIXI	KGI	K970224

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Device Description:

The x-ray system state and x-ray controls are presented to the operator via the membrane switch/indicator panel on the front of the device.

The Accudxa 2 is a Class II medical device and a Class II laser product.

Indications for Use:

The Accudxa 2 is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. Accudxa 2 BMD estimates, t-score and z-score can be used as an aid to the physician in determining fracture risk and for monitoring changes in bone mass over time.

Nonclinical Testing:

The previous generation accuDEXA Model 7100 used a set of five calibration phantoms of known BMC and BMD value, plus a sixth Quality Control phantom supplied to customers for QC activities in the field. The calibration phantoms are intended to calibrate the device across its operating range of BMD values. The Accudxa 2 uses the same calibration phantom set to ensure that BMD readings obtained from the device are equivalent to those of the accuDEXA Model 7100.

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The Accudxa 2 complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and radiation safety of medical and / or laser devices.

Technological Characteristic Comparison:

Lone Oak Medical Technologies purchased the accuDEXA Bone Densitometer design from Schick Technologies in August 2007. This design was repackaged and updated to reduce the size and weight of the unit. The same algorithms, normative database and sensor used in the Schick design (K971735, K981124, K001429) are used in the Lone Oak design. The software changes to the Schick design concern the Graphical User Interface, Operating System and communication protocol to the new hardware (touchscreen, memory, USB interface, controller board, etc.).

Conclusion:

Lone Oak Medical Technologies has demonstrated through its comparison of characteristics with the predicate devices and comparison of performance testing with the predicate devices that the Accudxa 2 Bone Densitometer is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

APR 2 7 2012

Mr. David Comley Vice President Lone Oak Medical Technologies 3805 Old Easton Road DOYLESTOWN PA 18902

Re: K113616

Trade/Device Name: accudxa2 Bone Mineral Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: April 20, 2012 Received: April 23, 2012

Dear Mr. Comley:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K113616

Device Name: accudxa2 Bone Mineral Densitometer

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113616

Page 4

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.