(272 days)
The bone density estimates from the pDEXATN and Discovery™ Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women.
The bone density estimates from the pDEXA™ and Discovery™ bone densitometers can be used as an aid to physicians in determining fracture risk.
In general, the Multi-Racial Reference Population capability for the pDEXA and Discovery bone densitometers compares the pDEXA and Discovery scan results to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented.
The Norland pDEXA and Discovery bone densitometers scan the forearm using the industry standard DXA pencil beam technology to assess bone density of the distal and proximal radius plus ulna sites. The Discovery is a newer, smaller version of the pDEXA with faster scan speeds and lower dose. The Discovery dose is < 1 mRem and the pDEXA is < 3 mRem. Discovery scan time is about 90 seconds and the pDEXA about 3 minutes.
This reference population also includes Fracture Risk Assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores between 1 to -1 are considered to have a low risk of fracture; with T-Scores from -1 to -2.5 are considered to have a medium risk of fracture; and T-Scores below -2.5 are considered to have a high risk of fracture.
The provided text describes the 510(k) summary for the "Multi-Racial Reference Population for pDEXA™ and Discovery™ Bone Densitometers." The device is not an AI/ML algorithm in the modern sense but rather a reference population used for interpreting bone density measurements. Therefore, many of the typical acceptance criteria and study design elements for AI/ML devices, such as performance metrics, ground truth establishment, training sets, and expert adjudication, are not directly applicable.
Instead, the "acceptance criteria" here relate to the validation of the multi-racial reference population's comparability and appropriateness for use with the pDEXA and Discovery bone densitometers. The study demonstrates that this new reference population is comparable to existing ones and does not raise new safety or effectiveness concerns.
Here's an attempt to structure the information as requested, adapting for the nature of this device:
Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparability to Predicate Device Reference Populations: The multi-racial reference population should be comparable to reference population capabilities in use with other bone densitometers in the industry (especially the predicate devices: Norland pDEXA with Reference Population (K931996) and Norland Fracture Risk Assessment (K980569)). | The 510(k) summary explicitly states: "This pDEXA and Discovery multi-racial reference population is comparable to reference population capabilities in use with other bone densitometers in the industry." This implies that the statistical characteristics and clinical utility of the developed multi-racial reference population align with established and accepted reference populations for bone densitometry. |
| No New Safety or Effectiveness Issues: The introduction of the multi-racial reference population should not introduce any new safety or effectiveness concerns compared to existing practices. | The 510(k) summary states: "No new safety or effectiveness issues are raised with this capability." This indicates that the new reference population was assessed and found not to adversely impact patient safety or the accuracy/reliability of bone density measurements and fracture risk assessments when used with pDEXA and Discovery devices. |
| Inclusion of Diverse Ethnicities: The reference population should include relevant multi-racial data. | The Indications for Use statement confirms: "These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women." This meets the stated intent of providing a multi-racial reference. |
| Ability to Aid in Bone Disease Determination: The reference population, when applied to bone density estimates, should provide T-Score, Z-Score, % Young Reference, and % Age Matched values for aid in diagnosis. | The device description and Indications for Use confirm: "T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented." And "The bone density estimates... can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease..." |
| Ability to Aid in Fracture Risk Determination: The reference population, when applied, should support fracture risk assessment based on established criteria. | The device description states: "This reference population also includes Fracture Risk Assessment based on the World Health Organization (WHO) criteria." And "The bone density estimates... can be used as an aid to physicians in determining fracture risk." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not detail the specific sample size used to construct or validate the multi-racial reference population, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically found in the full 510(k) submission, not the summary document. However, given the nature of a reference population, it would typically be derived from a large, representative, and prospectively collected cohort study or a collection of such studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable in the typical sense for this device. A "ground truth" for a reference population is established through epidemiological studies defining normal bone mineral density across different demographics. This involves large-scale data collection, statistical analysis, and potentially clinical consensus on thresholds (e.g., WHO criteria for fracture risk) rather than individual expert review of cases for algorithm performance.
4. Adjudication Method for the Test Set
Not applicable. This is not a device that processes individual cases requiring human adjudication for performance evaluation. The "adjudication" for a reference population would be the scientific and statistical rigor applied to its construction and validation against established medical standards.
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 reference dataset, not an AI/ML diagnostic tool that assists human readers in interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is a "standalone" reference population. It processes bone density measurements from the hardware (pDEXA/Discovery) and provides comparative metrics (T-Score, Z-Score, etc.) without a human-in-the-loop interpretation being part of the function of the reference population itself. Physicians then use these metrics to aid their diagnosis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a bone mineral density reference population is based on:
- Epidemiological data: Large-scale population studies that define normal bone mineral density across various age, gender, and ethnic groups.
- Clinical outcomes data: Particularly for fracture risk assessment, the "truth" is often derived from longitudinal studies correlating bone mineral density values with actual fracture incidence (e.g., the basis for WHO criteria).
- Expert consensus: Derived from scientific bodies (like the WHO) establishing diagnostic thresholds (e.g., T-scores for osteoporosis).
8. The Sample Size for the Training Set
Not explicitly stated in the 510(k) summary but would typically be large, encompassing thousands or tens of thousands of individuals to create a robust and representative reference population. For AI/ML, this would be the "training set." For a reference population, it's the "derivation cohort."
9. How the Ground Truth for the Training Set Was Established
For a reference population, the "ground truth" (or normative data) is established through rigorous epidemiological studies:
- Participant Selection: Healthy individuals, representative of the target demographics (age, gender, ethnicity), are recruited, often excluding those with conditions or medications known to affect bone metabolism.
- Data Collection: Bone mineral density measurements are performed using standardized DXA techniques.
- Statistical Analysis: The collected data is statistically analyzed to determine mean BMD and standard deviations for each demographic subgroup (age, gender, ethnicity).
- Clinical Validation: The derived reference values are often cross-referenced with established clinical guidelines and, for fracture risk, validated against observed clinical outcomes.
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K99 3176
510k Summary
JUN 2 0 2000
as required by 807.92(c) for
Multi-Racial Reference Population For pDEXA™ and Discovery™ Bone Densitometers
Prepared September 1999
| Submitted by: | Norland CorporationW6340 Hackbarth RoadFort Atkinson, WI 53538Reg. # 2124648 |
|---|---|
| Contact Person: | Mr. Terry Schwalenberg, Director Regulatory Affairs, 920-563-8456 x229 |
| Device Trade Name: | Multi-Racial Reference Population for pDEXATM and Discovery™ |
| Common Name: | Reference Population for DXA bone densitometer |
| Classification: | Bone densitometer, (21 CFR 892.1170). product code 90KGI; Class II |
| Predicate Devices: | Norland pDEXA with Reference Population (K931996). andNorland Fracture Risk Assessment (K980569) |
| Description ofDevice: | In general, the Multi-Racial Reference Population capability for the pDEXAand Discovery bone densitometers compares the pDEXA and Discovery scanresults to average values for people without bone related disease, who havethe same gender and ethnic background as the patient. Its purpose is to aidthe physician in determining the presence of bone disease other than agerelated bone loss. Both age matched and young reference comparisons aremade. T-Score, Z-Score, % Young Reference, % Age Matched, and agraphical representation are presented.The Norland pDEXA and Discovery bone densitometers scan the forearmusing the industry standard DXA pencil beam technology to assess bonedensity of the distal and proximal radius plus ulna sites. The Discovery is anewer, smaller version of the pDEXA with faster scan speeds and lowerdose. The Discovery dose is < 1 mRem and the pDEXA is < 3 mRem.Discovery scan time is about 90 seconds and the pDEXA about 3 minutes.This reference population also includes Fracture Risk Assessment based onthe World Health Organization (WHO) criteria. In general, this means thatpatients with T- Scores between 1 to -1 are considered to have a low risk offracture; with T-Scores from -1 to -2.5 are considered to have a medium riskof fracture; and T-Scores below -2.5 are considered to have a high risk offracture. |
| Safety andEffectiveness: | This pDEXA and Discovery multi-racial reference population is comparable toreference population capabilities in use with other bone densitometers in theindustry. No new safety or effectiveness issues are raised with this capability. |
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Image /page/1/Picture/0 description: The image shows a partial view of a logo and the word "DEPART". The logo is a circular emblem with three curved lines inside, possibly representing a stylized human figure. The word "DEPART" is in bold, uppercase letters, suggesting it is the beginning of a longer word or phrase, likely "DEPARTMENT".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2000
Terry Schwalenberg Director, Regulatory Affairs Norland Medical Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538
Re:
K993176 Multi-Racial Reference Population for the pDEXA™ and Discovery™ Bone Densitometers Dated: May 16, 2000 Received: May 22, 2000 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Schwalenberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 and prohibitions against misbranding and adulteration.
lf 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 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 notfication 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) 594-4591. 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" (21CFR 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,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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INDICATIONS FOR USE STATEMENT
510(K) Number (if known):
Device Name: Multi-Racial Reference Population for the pDEXATM and Discovery TM Bone Densitometers
Indications For Use:
The bone density estimates from the pDEXATN and Discovery™ Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women.
The bone density estimates from the pDEXA™ and Discovery™ bone densitometers can be used as an aid to physicians in determining fracture risk.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-Use
Per 41 CFR 810.109
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993176
Page 1-1
§ 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.