(87 days)
The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.
Apollo™ is a low cost, portable, easy-to-use bone densitometer which uses low dose x-ray technology to asses the bone density of the heel. Because Apollo 1 uses the DXA technique, a water bath is not required.
Here's an analysis of the provided text regarding the Norland Apollo™ Bone Densitometer, outlining the acceptance criteria and study information:
Norland Apollo™ Bone Densitometer Performance Analysis
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on comparing the Apollo™ to predicate devices rather than explicit, pre-defined acceptance criteria with quantifiable targets. However, based on the comparative table and descriptive text, we can infer the performance metrics considered important and the device's reported capabilities. This resembles how substantial equivalence is often demonstrated with respect to performance relative to established devices.
| Item | Acceptance Criteria (Inferred/Predicate) | Reported Apollo™ Performance |
|---|---|---|
| Precision (CV) | High Speed: ≤ 1.8% (pDEXA) | High Speed: 1.8% |
| High Precision: ≤ 1.4% (pDEXA) | High Precision: 1.2% | |
| Scan Time | High Speed: < 2 min (pDEXA) | High Speed: < 1 minute |
| Hi Precision: < 5 min (pDEXA) | High Precision: < 3 minutes | |
| Accuracy | ~2% to hydroxapatite (pDEXA) | 2% to hydroxapatite |
| Machine-to-machine variance | ~2% for BMD (pDEXA) | 2% for BMD |
| Patient Dose | < 4.5 mrem (pDEXA) or 1.3 mrem (OsteoAnalyzer) | < 1 mrem |
| Scatter Radiation | Not explicitly defined for predicates | < 0.1 mrem/hr |
| Technology | DXA (pDEXA) | DXA (no water bath required, unlike SXA) |
| Scan Site | Os calcis (same as OsteoAnalyzer) | Os calcis (heel) |
| Scan Method | DXA, pencil beam (pDEXA); SXA (OsteoAnalyzer) | DXA, Pencil beam, Rectilinear scanning |
| Uses | BMC, Area, BMD, % Change (same as predicates) | BMC, Area, BMD, % Long & Short term change |
| Detectors | Two CdZnTe/CdTe (pDEXA) | Two CdZnTe (or CdTe) |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions one clinical study for precision:
- Sample Size: 33 subjects
- Data Provenance: Not explicitly stated, but clinical study implies prospective data collection. Country of origin is not specified but would likely be the USA given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense (e.g., for diagnostic accuracy). The clinical study mentioned was for precision, which is an inherent characteristic of the device's measurement consistency. It involved repeated scans on the same subjects, not an expert assessment of a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. The study focused on precision (Coefficient of Variation) by comparing results from multiple scans of the same subject. There was no diagnostic interpretation or ground truth requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not mentioned. The device is a bone densitometer that provides quantitative measurements (BMC, Area, BMD), not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.
6. Standalone Performance
Yes, the precision and scan time values represent the standalone performance of the Apollo™ device, as these are intrinsic characteristics of the densitometer's operation. The data for precision (1.8% and 1.2% CV) and scan times (<1 min and <3 min) were established directly from the device's measurements.
7. Type of Ground Truth Used
- For Precision Study: The "ground truth" for precision was effectively the statistical consistency of repeated measurements on the same subject. There isn't an external "gold standard" ground truth in the way there would be for diagnostic accuracy (e.g., pathology for cancer). The data itself, collected from multiple scans, served to establish the Co-efficient of Variation (CV).
- For Accuracy: The accuracy was reported as "2% to hydroxapatite," implying comparative measurements against a known standard material (hydroxapatite phantoms or similar).
8. Sample Size for the Training Set
Not applicable. This device is a bone densitometer, not an AI/ML algorithm that requires a training set in the conventional sense. The device's operation is based on established DXA physics and algorithms, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The device's "knowledge" is embedded in its design, physics-based algorithms, and calibration routines.
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Apollo TM 510(k) Summary - Appendix 5
August 1997
510k Summary as required by 807.92(c) for Norland ApolloTM Bone Densitometer Prepared 4 August 1997
OCT 31 1997
Submitted by: Norland Corporation W6340 Hackbarth Road Fort Atkinson, WI 53538 Reg. # 2124648 920-563-8456
Mr. Terry Schwalenberg Contact Person: Director Regulatory Affairs
Norland Apollo TM X-Ray Bone Densitometer Device Trade Name:
Common Name: Dual energy x-ray bone densitometer
Classification: Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II
Predicate Devices: OsteoAnalyzer bone densitometer (K891582) Dove Medical Systems, Newbury Park, CA
pDEXA bone densitometer (K931996) Norland Corporation, Fort Atkinson, WI
Apollo™ is a low cost, portable, easy-to-use bone densitometer which Description of Device: uses low dose x-ray technology to asses the bone density of the heel. Because Apollo 1 uses the DXA technique, a water bath is not required.
The Apollo The can be used whenever it is desirable to do a bone Intended Use: assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo " assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.
Substantial Apollo is is similar to the pDEXA in that it uses the dual energy x-ray Equivalence to absorptiometry (DXA) technique and the proven pencil beam scan Predicate Devices: method. Apollo is similar to the OsteoAnalyzer in that it scans the same area of the heel as does the OsteoAnalyzer.
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The Apollo The is an improvement over the OsteoAnalyzer because its DXA technology inherently eliminates the water bath; and because it has reduccd scan times. Apollo 1M uses two detectors so that two radiometric scans are performed for each mechanical scan; thereby doubling the scan speed without complicating the mechanicals. The detectors are small enough and close enough to preserve the bone edge and area performance inherent in the pencil beam geometry; unlike the distortions seen with fan beam and cone beam geometries.
Apollo 101 provides two scan modes, High Speed, and High Precision. The High Speed mode completes a scan in < 1 minute with a precision of 1.8 % coeficient of variation (CV). The High Precision mode takes < 3 minutes for a scan and delivers a precision of 1.2 % CV. These precision values were established via a clinical study involving 33 subjects with 6 scans each. Patient dose is about 1 mrem and scatter radiation is less than 0.1 mrem/hr.
| ITEM | APOLLO™ | OSTEOANALYZER | pDEXA |
|---|---|---|---|
| Scan Site | Os calcis (heel) | same | Forearm |
| Scan Method | DXAPencil beamRectilinear scanning | SXAsame | DXAsame |
| Indications for Use | Heel bone assessment | same | Forearm assessment |
| Intended Uses | Provides BMC, Area,BMD, % Long term change,& % Short term change | same | same |
| Operating Modes | Hi SpeedHi Precision | StandardHi Speed | StandardHigh SpeedHigh Precision |
| Scan Time | < 1 minute (High Speed)< 3 minutes (High Precision) | 3.5 min. (Standard)2.0 min. (Hi Speed) | < 2 min. (High Speed)5 min. (High Precision) |
| Precision | 1.8 % (High Speed)1.2 % (High Precision) | < 1 % | 1.8 % (High Speed)1.4 % (High Precision) |
| Accuracy | 2 % to hydroxapatite | dipotassiumhydrogen phosphate | hydroxapatite |
| Machine-to-machine variance | 2 % for BMD | not specified | 2% for BMD |
| Dose | < 1 mrem | 1.3 mrem | < 4.5 mrem |
| Technology | DXA (no water) | SXA (water needed) | DXA (no water) |
| Detectors | two CdZnTe (or CdTe) | one CdTe | two CdZnTe (or CdTe) |
| Tube Voltage | 60 kVdc (constant) | 36 kVdc (constant) | 60 kVdc (constant) |
| Tube Current | 0.10 - 0.20 mA | 0.1 mA | 0.12 mA |
| Filtration | >1.5 mm Al equivalent | same | same |
Comparison Table
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 1997
Terry Schwalenberg Director, Regulatory Affairs Norland Corporation W6340 Hackbarth Rd. Fort Atkinson, WI 53538-8999 Re:
K972882 Norland Apollo Bone Densitometer Dated: August 4, 1997 Received: August 5, 1997 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 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 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 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 vitro 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 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.
h Lillian Yin, Ph.D.
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
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Apollo 510(k) - Appendix 1
510(k) Number (if known):
cvice Name:
Norland Apollo X-Ray Bone Densitometer
Indications For Use:
The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.
(printed on FDA Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyices 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Formal 1-2-46)
August 1997
§ 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.