The DTX-100 candidate device is a single energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath. The X-Ray generator is driven at 40 kV, with a current of 0.2 mAmps. The detector uses scintillating crystal and a photomultiplier tube. A highly stable X-Ray output, together with a source collimation of 1 mm, and excellent pixel resolution, yields images of very high quality. The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.01 micro Sievert per scan.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the DTX-100 Bone Densitometer based on the provided 510(k) summary:

Given that this 510(k) is for a device declared "superseded" and the FDA's acceptance letter indicates substantial equivalence to a predicate device, the nature of the "acceptance criteria" and "study" are primarily focused on demonstrating equivalence rather than establishing new performance benchmarks. The core of the submission revolves around showing that the candidate DTX-100 device is identical or comparable to its predicate DTX-100 predecessor.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from 510(k) goal)	Reported Device Performance (DTX-100 Candidate)
Technological Equivalence to Predicate DTX-100:
- X-ray transmission source	Identical: Candidate and predicate consist of computer, keyboard, monitor, printer, scanner system using X-ray transmission source. Both use SXA to estimate BMC and BMD.
- Soft-tissue equivalent material	Identical: Both use water.
- Calibration	Identical: Both use a line-by-line calibration system, ensuring good precision.
- Imaging technique, data acquisition, QC phantom	Identical.
- Source collimation	Identical: 1 mm diameter.
- Reference location	Identical: 8 mm Ulna-Radius gap.
- Accuracy and precision error	Comparable to predicate device. (Specific values not provided, but asserted to be comparable).
Clinical Performance (Reference Data Base):
- Establishment of a reference data base for normal American female Caucasians (20-80 years old) to estimate BMC/BMD.	A reference data base was established based on BMD and BMC data collected from the non-dominant forearm of a representative sample of the reference population using a model DTX-100 bone densitometer. The data included at least 50 persons in ten-year age groups.
- Data statistically representative	The standard deviation of estimated BMC and BMD is statistically representative as required by FDA guidance (at least 50 people per 10-year age group).
- Reference data suitable for clinical use	The derived American reference data base is suitable for use by healthcare professionals to compare BMC/BMD with age-matched peers and against young adult mean values.

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

Sample Size for Test Set: The submission mentions a "statistically valid quantity of women" participating in four clinical studies. Specifically, the reference data base was established with "at least 50 persons in ten year peer age groups" for normal American female Caucasians ranging from 20 to 80 years. This implies a minimum of 6 * 50 = 300 participants (20-29, 30-39, 40-49, 50-59, 60-69, 70-79).
Data Provenance:
- Country of Origin: USA. The studies were conducted at:
  1. Helen Hayes Hospital (West Haverstraw, NY)
  2. New England Medical Center Hospitals (Boston, MA) (3 studies)
- Retrospective or Prospective: The provided information doesn't explicitly state whether the studies were entirely retrospective or prospective. However, the listed start and end dates for each protocol (e.g., "Conducted from May 1995 through May 1996") indicate they were
  - Prospective in nature, as data were collected for specific purposes of the studies during those stated periods.

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

The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for image interpretation) does not directly apply here. The "ground truth" for bone densitometers is typically established by the physical measurements performed by the device itself to estimate BMC and BMD according to established medical and scientific principles. The clinical studies were conducted to gather reference data on normal populations for these measurements. The "experts" would be the clinicians and researchers leading these studies, but their role was to conduct the measurements and analyze the statistical properties of the device's output against a defined normal population, not to interpret an output against a separate truth. The qualifications of these experts are not detailed, but they would presumably be medical professionals and clinical researchers associated with the listed hospitals.

4. Adjudication Method for the Test Set

Not applicable. The study involved collecting direct measurements (BMC and BMD) from individuals using the DTX-100, not interpreting cases that would require an adjudication process. The accuracy and precision of the device itself are inherent in its design and operation.

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

Not applicable. This device is a bone densitometer, not an AI-powered diagnostic imaging interpretation tool. There is no "human reader" component in the context of interpreting images or assisting with diagnoses where AI would improve performance. The device directly outputs BMC and BMD values.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in a practical sense, a standalone performance was done. The DTX-100 bone densitometer is a device that directly measures and calculates BMC and BMD. The clinical studies gathered data from the device's output on a population to establish a reference database. There isn't an "algorithm" being evaluated beyond the inherent functioning of the densitometer itself. The device functions without human interpretation of raw data points to arrive at its final output (BMC and BMD).

7. The Type of Ground Truth Used

The "ground truth" here is the actual bone mineral content (BMC) and bone mineral density (BMD) of the study participants, as measured by the DTX-100 device itself, within the context of establishing normative data for a defined population. It is not an external "ground truth" like pathology for a lesion. The goal was to establish a clinical reference range for the device's measurements in a normal population, which then serves as a comparison point for patients.

8. The Sample Size for the Training Set

The concept of a "training set" as understood in machine learning is not directly applicable here. The DTX-100 is a physical measurement device whose underlying principles are physics-based, not a learned algorithm requiring a separate training set. The data from the four clinical studies were used to establish a reference database for a normal population, not to train the device's internal algorithms. This reference database included "at least 50 persons in ten year peer age groups" for normal American female Caucasians aged 20-80. This implies a minimum of 300 participants for the reference database.

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

As explained above, there isn't a "training set" in the AI sense for this device. The "ground truth" for the reference database was established through direct

physical measurements of BMC and BMD using the DTX-100 bone densitometer itself, conducted on a defined population (normal American female Caucasians). The values obtained from these measurements, after statistical analysis, formed the basis of the reference data base. The accuracy and precision of these measurements are asserted to be comparable to the predicate device.

Summary

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K963787
superseded

510(k) Summary [This 510(k) summary is furnished in accordance with 21 CFR 807.92]

JUL 1 4 1997

21 CFR 807.92(a):

(

ు

(

21 CFR 807.92(a)(1):

Submitter's name and address: *

Osteometer Meditech A/S Glerupvej 2, DK-2160 Rodovre Denmark

011 45 44 92 42 00 ★ Submitter's telephone number:

Contact person: 水

Ms. Anja Koue Official Correspondent Osteometer Meditech A/S Glerupvej 2, DK-2160 Rodovre Denmark

September 15, 1996 ★ Date this 510(k) summary was prepared:

CFR 807.92(a)(2): 21

DTX-100 Bone * Trade/proprietary name of the device: Densitometer

オ Classification name: Bone densitometer

CFR 807.92(a)(3); Legally marketed device (predicate device) 21 to which equivalence is claimed:

Osteometer MediTech A/S model DTX-100 bone densitometer

21 CFR 807.92(a)(4); Description of the device that is the subject of this premarket notification:

The DTX-100 candidate device is a single energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath.

The X-Ray generator is driven at 40 kV, with a current of 0.2 mAmps . The detector uses scintillating and a crystal

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

510(k) Summary

[This 510(k) summary is furnished in accordance with 21 CFR 807.92]

photomultiplier tube. A highly stable X-Ray output, together with a source collimation of 1 mm, and excellent pixel resolution, yields images of very high quality.

The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.01 micro Sievert per scan.

21 CFR 807.92(a)(5); Intended use:

The intended use of the DTX-100 candidate device is the same as the labeled intended use of the predicate device to which equivalence is claimed; i.e., "To estimate bone mineral content (BMC, grams) and bone mineral density (BMD, grams/cm").

21 CFR 807.92(a)(6); Technological characteristics:

The design, material, chemical composition, energy source and other technological characteristics of the subject device are considered be the same as the technological characteristics of the to predicate devices. A summary of the technological characteristics of the subject device in comparison to those of the predicate devices follows:

X-ray transmission source: 大

DTX-100 subject Both the and the DTX-100 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-100 candidate device and the DTX-100 predicate device are identical and use single X-ray photon absorptiometry (SXA) to estimate bone mineral content (BMC) and bone mineral density (BMD).

大 Soft-tissue equivalent material:

Both the candidate and predicate DTX-100 devices are identical and use water as soft tissue equivalent material.

* Calibration:

Both the DTX-100 candidate device and the DTX-100 predicate device use a line-by-line calibration system, ensuring qood precision.

Imaging technique, data acquisition, and quality control ★ phantom:

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510(k) Summary

[This 510(k) summary is furnished in accordance with 21 CFR 807.92]

These characteristics are the same on the DTX-100 candidate device as the DTX-100 predicate device.

Source collimation: ★

(

The source collimation for both the DTX-100 candidate device and the DTX-100 predicate device is the 1 mm diameter.

Reference location: ★

The reference location for both the DTX-100 candidate device and the DTX-100 predicate device is the 8 mm Ulna-Radius gap.

Accuracy and precision error: 大

Accuracy and precision error of the DTX-100 candidate device is comparable to that of the DTX-100 predicate device.

21 CFR 807.92(b);

summaries for those premarket submissions in which a 510(k) substantial equivalence is also based on determination of performance data shall also contain the following:

807.92(b)(1); CFR Brief discussion of the nonclinical tests 21 submitted, referenced, or relied on in this premarket notification submission:

There were no nonclinical tests submitted, referenced, or relied on in this submission.

21 CFR 807.92(b)(2); Brief discussion of the clinical tests submitted, referenced, or relied on in this premarket notification submission:

The results of four (4) clinical tests were used to obtain data to establish a reference data base for a reference population of normal American female caucasians ranging in age from 20 to 80 years. These clinical studies were conducted at:

1. Helen Hayes Hospital (West Haverstraw, NY); protocol # 94-12:

"Determination of Forearm Bone Density in a Normal 大 Title: US Population and Comparison of Two New Procedures to Measure Bone Mineral Density".

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510(k) Summary

[This 510(k) summary is furnished in accordance with 21 CFR 807.92]

Conducted from May 1995 through May 1996. *

New England Medical Center Hospitals (Boston, MA); protocol # 2. 540 :

"Is the Current Recommended Dietary Allowance of Title: 水 Vitamin D Sufficient for Minimizing Bone Loss?"

Conducted from May 22, 1991 through August 17, 1993 米

New England Medical Center Hospitals (Boston, MA); protocol # 3. 620 :

"Effect of Calcium and Vitamin D on Bone Loss from * Title: the Hip"

Conducted from February 6, 1992 through February 8, 1996. 大

New England Medical Center Hospitals (Boston, MA); protocol # 4. 770 :

"Seasonal Changes in Bone Mass of Premenopausal Women" *

Conducted from January 31, 1993 through April 10, 1995. *

reference population (normal, in a American, female, Data a statistically valid quantity of women caucasians) of participating in the four clinical studies were collected using a model DTX-100 bone densitometer to estimate bone mineral content and bone mineral density in the non-dominant forearm of a representative sample of the reference population and included at least 50 persons in ten year peer age groups. The mean and standard deviations of the data was calculated using appropriate statistical methods and was used to establish the reference data base for the reference population.

The conclusions drawn from the nonclinical and 21 CFR 807.92(b)(3); clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as or better than the predicate device:

The standard deviation of estimated bone mineral content (BMC) and bone mineral density (BMD) of the reference population of participating female caucasians is statistically representative (as required by FDA's "Draft Guidance for Review of Bone Densitometer 510(k) Submissions"; i.e., at least 50 people in each ten year age

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510(k) Summary [This 510(k) summary is furnished in accordance with 21 CFR 807.92]

group) of the reference population and the American reference data base (derived from this data) is suitable for use by a health care professional to compare BMC and BMD with age matched peers and for comparison with young adult mean value.

.... END OF 510(k) SUMMARY .....

OM53.6

・・

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osteometer Meditech A/S c/o Mr. Bert Hudson Regulatory Consultant Shotwell & Carr. Inc. 3003 LBJ Freeway, Suite 100 Dallas, TX 75234-7755

UL 1 4 1997

Re: K963789 DXT-100 Bone Densitometer, Part # 9SCA0006 Dated: May 28, 1997 Received: May 29, 1997 Regulatory Class :- II ........................ 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Hudson:

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 against 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 Current Good Manufacturing Practice requirement, 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 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 question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation of titled, "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/dsmamain.html".

Sincerely yours,

W.Liliau Yin

Lillian 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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K 765'89

Appendix H1

FDA's New Form Describing "Indications for Use".

Page 1 of 1

510(k) Number (if known): Unknown; Not yet assigned by FDA .

Device Name: Model DTX-100 Bone Densitometer

Indications For Use for the device: Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²) in the distal section of the forearm.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ) (Per 21 CFR 801.109)

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

Raice Petty
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dev

M53.3

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.