(224 days)
The bone density estimates from the Apollo™ bone densitometer can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related 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 Apollo bone density estimates can be used as an aid to physicians in determining fracture risk.
The Apollo™ Multi-Racial Reference Population capability compares patient values 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. 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 be normal with a low risk of fracture. Patients with T-Scores from -1 to -2.5 have low bone mass and an increased risk of fracture. Likewise, patients with T- Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The Apollo™ scans the heel using the industry standard DXA pencil beam technology to assess bone density of the Os Calcis. A water bath is NOT used; and gels are not necessary. The dose to the patient is 0.2 mRem and the scatter/leakage radiation is <0.1 mRem/hour at 3 feet.
This 510(k) summary for the Apollo™ Multi-Racial Reference Population does not contain the detailed study information typically found in a clinical trial report. The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a standalone performance study with specific acceptance criteria and results.
However, based on the information provided, we can infer some details and highlight what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary. The document focuses on establishing comparability to existing reference populations rather than setting novel performance thresholds for accuracy or diagnostic efficacy. The "Safety and Effectiveness" section merely states: "This Apollo Multi-Racial Reference Population is comparable to reference population capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised with this capability."
Therefore, a table with specific acceptance criteria (e.g., accuracy, precision) and corresponding reported performance metrics cannot be constructed from this document.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document describes the purpose of the reference population (comparing patient values to average values for people without bone-related disease, of the same gender and ethnic background) but does not detail the specific population used to create or test this "Multi-Racial Reference Population." It only states that the reference populations include "Caucasian, Afro-American, Hispanic, and Asian men and women." No sample sizes, geographical origin, or whether the data was retrospective or prospective is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. Given that this is a reference population for a bone densitometer, the "ground truth" would likely relate to the bone density measurements themselves and the health status of the individuals in the reference population. However, the exact methodology and expert involvement in establishing this "ground truth" for the reference data are not described.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the 510(k) summary. An adjudication method would typically be relevant for studies involving human interpretation or subjective assessments. For a reference population based on objective bone density measurements, this might not be directly applicable in the same way it would be for a diagnostic image analysis algorithm. However, any process for selecting or classifying the individuals within the reference population for inclusion or exclusion would involve some form of consensus or criteria, which is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore not provided in this 510(k) summary. The Apollo™ Multi-Racial Reference Population is a reference database used by a bone densitometer (DXA pencil beam technology) to interpret bone density values (T-scores, Z-scores). It is not an AI-powered diagnostic algorithm that assists human readers in interpreting images or making a diagnosis in a comparative effectiveness study. Therefore, an MRMC study and effect size related to AI assistance would not be part of this submission. The device is a database, not an AI model.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable in the typical sense of an algorithm's standalone performance. The "device" here is a reference population database. Its "performance" is implicitly tied to the accuracy and representativeness of the data it contains, which then allows the interpretation of bone density measurements from the Apollo™ densitometer. The 510(k) focuses on the comparability of this reference population to others in the industry, implying its utility is recognized rather than presenting a novel standalone performance study for the database itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document mentions that the reference population compares patient values to "average values for people without bone related disease." This implies that the "ground truth" for the individuals included in the reference population is their lack of bone-related disease, and their actual bone density measurements (from DXA). The method for determining "without bone related disease" is not specified but would likely involve clinical assessments, medical history, and potentially other diagnostic tests, all contributing to a clinical "truth" of health status.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document describes a "reference population," which implies a dataset used to establish normal ranges. This would be analogous to a "training" or "development" dataset if it were an AI model, but for a reference population, it's the fundamental data itself. The size of this population for each gender and ethnic group (Caucasian, Afro-American, Hispanic, and Asian men and women) is not disclosed.
9. How the Ground Truth for the Training Set Was Established
The document states the reference population includes "average values for people without bone related disease, who have the same gender and ethnic background as the patient." Therefore, the implicitly established "ground truth" for the individuals whose data forms this reference population is that they were identified as healthy (i.e., "without bone related disease") and their demographics (gender, ethnicity) were recorded. The specific diagnostic criteria or medical evaluations used to confirm the absence of bone-related disease for inclusion in this reference data are not detailed in this summary.
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93337
510k Summary
as required by 807.92(c) for
Apollo™ Multi-Racial Reference Population
Prepared September 1999
| Submitted by: | Norland CorporationW6340 Hackbarth RoadFort Atkinson, WI 53538Reg. # 2124648 |
|---|---|
| Contact Person: | Mr. Terry Schwalenberg, Director Regulatory Affairs |
| Device Trade Name: | Apollo™ Multi-Racial Reference Population |
| Common Name: | Reference Population for DXA bone densitometer |
| Classification: | Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II |
| Predicate Devices: | Norland Apollo™ with Reference Population (K980125), andNorland Fracture Risk Assessment (K980569) |
| Description ofDevice: | The Apollo™ Multi-Racial Reference Population capability comparespatient values to average values for people without bone related disease,who have the same gender and ethnic background as the patient. Itspurpose is to aid the physician in determining the presence of bone diseaseother than age related bone loss. Both age matched and young referencecomparisons are made. T-Score, Z-Score, % Young Reference, % AgeMatched, and a graphical representation are presented. 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 be normal with a low risk of fracture. Patients with T-Scores from -1 to -2.5 have low bone mass and an increased risk of fracture. Likewise, patients with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The Apollo™ scans the heel using the industry standard DXA pencil beam technology to assess bone density of the Os Calcis. A water bath is NOT used; and gels are not necessary. The dose to the patient is 0.2 mRem and the scatter/leakage radiation is <0.1 mRem/hour at 3 feet. |
| Safety andEffectiveness: | This Apollo Multi-Racial Reference Population is comparable to referencepopulation capabilities in use with other bone densitometers in the industry.No new safety or effectiveness issues are raised with this capability. |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2000
Terry Schwalenberg Director Regulatory Affairs Norland Corporation W-6340 Hackbarth Rd. Fort Atkinson, WI 53538
Re:
K993337 Apollo™ Multi-Racial Reference Population Dated: February 18, 2000 Received: February 28, 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 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 pror 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.
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 equivalion 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 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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in xitco 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/dsmaldsmamain.html".
Sincerely yours,
David C. Stoltz, MD
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
K 99 3337 510(K) Number (if known):
Device Name: Apollo™ Multi-Racial Reference Population
Indications For Use:
The bone density estimates from the Apollo™ bone densitometer can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related 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 Apollo bone density estimates 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 | |
| (Per 21 CFR 810.109) | |
| Over-The-Counter-Use |
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| (Division Sign-Off) | |
|---|---|
| Division of Reproductiva odominal, ENT, and Radiological Device | |
| 510(k) Number | K993337 |
§ 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.