The DTX-200 candidate device is a dual 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 55 Kv, with a current of 0.3 mAmps. The detector uses a scintillating crystal and a solid state dual energy sandwich detector. A highly stable X-Ray output, together with a source collimation of 1 mm diameter, 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 0.1 micro Sievert per scan. Both the DTX-200 candidate and the DTX-200 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-200 candidate device and the DTX-200 predicate device are identical and use dual X-ray photon absorptiometry (DXA) to estimate bone mineral content (BMC) and bone mineral density (BMD). Both the candidate and predicate DTX-200 devices are identical and use water as soft tissue equivalent material. Both the DTX-200 candidate device and the DTX-200 predicate device use a line-by-line calibration system, ensuring good precision.

AI/ML Overview

The provided text describes the 510(k) summary for the DTX-200 Bone Densitometer. However, it does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (also a DTX-200 Bone Densitometer) by comparing technological characteristics and intended use. The "clinical tests" described are not designed to test the device's accuracy or precision against specific acceptance criteria, but rather to establish a reference database for a normal American female caucasian population.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study proving it meets those criteria, as this information is not present in the provided text.

Here is what can be extracted or inferred from the provided text regarding the closest relevant information, though it does not directly address acceptance criteria for performance:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The document states that "Accuracy and precision error of the DTX-200 candidate device is comparable to that of the DTX-200 predicate device," but does not provide specific numerical acceptance criteria or reported values for either device.
Sample size used for the test set and the data provenance:
- Sample Size: "at least 50 persons in ten year peer age groups" for each clinical study, to establish a reference data base. The studies covered ages 20 to 80, implying 6 age groups (20-29, 30-39, ..., 70-79). So, a minimum of 6 * 50 = 300 women per study, and a total of at least 600 women across both studies.
- Data Provenance:
  - Country of Origin: USA (Helen Hayes Hospital, West Haverstraw, NY; United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, MA).
  - Retrospective or Prospective: Prospective, as the studies involved "Determination of Forearm Bone Density in a Normal US Population" and "Mineral Density in a Normal American Population" conducted over specific timeframes (Feb-Sep 1996 and Mar-Oct 1996).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "clinical tests" were to establish a reference database of normal bone density values, not to establish a "ground truth" for diagnostic accuracy or performance against a standard. The measurements were taken directly by the device itself to form this database.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there was no expert adjudication of device outputs or diagnoses. The device directly measured BMC and BMD.
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-assisted diagnostic tool that involves human readers interpreting images.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance, in terms of measuring BMC and BMD, is inherently standalone. The clinical studies collected these measurements directly from the device. However, specific standalone performance metrics (e.g., accuracy, precision values) are not provided, only a statement of comparability to the predicate device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense of a diagnostic device. The "ground truth" here is the measurement of BMC and BMD taken by the device from a "normal American female caucasian" population to establish a reference database. There wasn't an external "gold standard" used to validate individual measurements against, but rather the statistical representativeness of the collected data for the target population.
The sample size for the training set: Not applicable. The "clinical tests" described were for establishing a reference database for a normal population, which serves as a statistical comparison point for future patient measurements, not for "training" an algorithm in the sense of machine learning. The device itself is a measurement instrument, not a learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, as there was no training set in the context of machine learning.

Summary

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K9L4561

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

AUG 22 1997 21 CFR 807.92(a): 21 CFR 807.92(a)(1): Submitter's name and address: 米 Osteometer MediTech A/S Glerupvej 2, DK-2160 Rodovre Denmark 011 45 44 92 42 00 Submitter's telephone number: * Contact person: * Ms. Anja Koue Official Correspondent Osteometer MediTech A/S Glerupvej 2, DK-2160 Rodovre Denmark

Date this 510(k) summary was prepared: November 5, 1996 水

21 CFR 807.92(a)(2):

DTX-200 Bone Trade/proprietary name of the device: * Densitometer

Classification name: Bone densitometer

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

Osteometer MediTech A/S model DTX-200 bone densitometer *

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

The DTX-200 candidate device is a dual energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath.

0.3 The X-Ray generator is driven at 55 Kv, with a current of

OM70

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157

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

510(k) Summary

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

The detector uses a scintillating crystal and a solid state mAmps. dual energy sandwich detector. A highly stable X-Ray output, together with a source collimation of 1 mm diameter, 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 0.1 micro Sievert per scan.

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

The intended use of the DTX-200 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 the subject device in comparison to those of the predicate of devices follows:

大 X-ray transmission source:

Both the DTX-200 candidate and the DTX-200 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-200 candidate device and the DTX-200 predicate device are and use dual X-ray photon absorptiometry (DXA) to identical estimate bone mineral content (BMC) and bone mineral density (BMD).

Soft-tissue equivalent material: *

Both the candidate and predicate DTX-200 devices are identical and use water as soft tissue equivalent material.

Calibration: *

Both the DTX-200 candidate device and the DTX-200 predicate device use a line-by-line calibration system, ensuring good precision.

Imaging technique, data acquisition, and quality control *

OM70

દ્વાદ

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

510(k) Summary

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

phantom:

These characteristics are the same on the DTX-200 candidate device as the DTX-200 predicate device.

Source collimation: 大

The source collimation for both the DTX-200 candidate device and the DTX-200 predicate device is the 1 mm diameter.

Reference location: 头

The reference location for both the DTX-200 candidate device and the DTX-200 predicate device is the 8 mm Ulna-Radius gap.

Accuracy and precision error: 女

Accuracy and precision error of the DTX-200 candidate device is comparable to that of the DTX-200 predicate device.

21 CFR 807.92(b);

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

tests Brief discussion of the nonclinical 21 CFR 807.92(b)(1); 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 two (2) 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 These clinical studies were conducted at: years.

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

"Determination of Forearm Bone Density in a Normal * Title:

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K964562

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

US Population and Comparison of Two New Procedures to Measure Bone Mineral Density".

Conducted from February 1996 through September 1996. *

States Department of Agriculture Human Nutrition 2 . United Research Center on Aging at Tufts University (Boston, MA); protocol # 3895

Title: "Mineral Density in a Normal American Population". *

Conducted from March 1996 through October 1996. 米

female, population (normal, American, a reference Data in valid quantity of of a statistically women caucasians) participating in the two clinical studies were collected using a model DTX-200 bone densitometer to estimate bone mineral content bone mineral density in the non-dominant forearm and 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 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.

ut of cea

221

END OF 510(k) SUMMARY ... .

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 22 1997

Bert Hudson. .. .. . . . . . . . . . Regulatory Consultant Osteometer Meditech A/S C/O Shotwell & Carr, Inc. 3003 LBJ Freeway Suite 100 Dallas, TX 75234

K964562 DTX-200 Bone Densitometer 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.

Re:

If your device is classified (see above) into either class II (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 yitro 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 Smal! Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmanam.hunl".

Sincerely yours.

h.7. Kiau Yi

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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Appendix G1

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-200 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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.(09)
OR
Over-The-Counter Use _

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
OM67.3

510(k) Number

OM67.3

226

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.