(30 days)
The Lunar iDXA Bone Densitometer provides an estimate of bonc mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
The Lunar iDXA bone densitometer is a full featured general purpose x-ray bone densitometer system. It consists of a scan table that provides x-ray source generation, digital x-ray detection and processing. The user interface includes a computer workstation and a color monitor display. This modification will provide users with improved image resolution and ease of use with patients of larger size.
The GE Medical Systems Lunar iDXA Bone Densitometer is a full-featured general-purpose x-ray bone densitometer system that provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for the iDXA bone densitometer. However, it does state that the device's accuracy and precision were verified and met design specifications. The performance is assessed by comparison to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy | Met design specifications | Verified to meet design specifications, comparable to predicate |
| Precision | Met design specifications | Verified to meet design specifications, comparable to predicate |
| Safety | Conforms with applicable medical device safety standards | Evaluation shows conformity with safety standards |
| Effectiveness | Comparable in key safety and effectiveness features to predicate device (Prodigy bone densitometer) | Substantially equivalent to currently marketed devices |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A 40-person in vivo study was conducted.
- Data Provenance: The document does not specify the country of origin of the data. It was a prospective in vivo study performed to verify design specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study involved in vivo measurements for accuracy and precision verification, likely against internal phantom standards and potentially expert review of the derived measurements, but the document does not specify the use of "experts" for establishing ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The study focused on the technical performance (accuracy and precision) of the device rather than diagnostic adjudication by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not explicitly described. The study focused on the device's technical specifications and substantial equivalence to a predicate device, not on the improvement of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Yes, the study primarily describes the standalone technical performance of the device in terms of accuracy and precision. The device itself is an apparatus that provides measurements, rather than an AI algorithm requiring human interpretation. The "algorithm" here refers to the internal processing of the iDXA system to derive bone mineral density and tissue mass.
7. Type of Ground Truth Used:
- For accuracy and precision: The ground truth was established by in vitro tests on phantoms and confirmed by the in vivo study to verify that design specifications were met. The phantoms likely have known, established values for bone mineral density and tissue composition.
- For safety and effectiveness: The ground truth was established by applicable medical device safety standards and comparison to the predicate device (Prodigy bone densitometer: K915535, K982267, K983564, K000826, K001756, K001812, K011917, K023554).
8. Sample Size for the Training Set:
Not applicable. The device is a bone densitometer, not a machine learning algorithm that typically requires a separate training set. The "training" would refer to the engineering and calibration of the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is not a machine learning device with a distinct training set and associated ground truth establishment process. The device's design, calibration, and validation are part of its engineering development process.
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0C1 2 0 2005
Special 510(k) Premarket Notification GE Medical Systems Lunar - Lunar iDXA Bone Densitometer September 19th, 2005
Attachment B 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and appears to be a vintage or slightly worn version.
GE Healthcare
Section a):
- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC division of Submitter: 1. General Electric Company GE Medical Sustems Lunar (business name) 726 Heartland Trail Madison, WI 53717
- James P. Raskob Contact Person: Safety and Requlatory Engineering Manager Telephone: 608-826-7425; Fax: 608-299-2132 September 19th , 2005 Date Prepared:
- Lunar iDXA bone densitometer Bone Densitometer, 71 CFR 892.1170, 90-KGI Device Name: 2.
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- Device Description: The Lunar iDXA bone densitometer is a full featured general purpose x-ray bone densitometer system. It consists of a scan table that provides x-ray source generation, digital x-ray detection and processing. The user interface includes a computer workstation and a color monitor display. This modification will provide users with improved image resolution and ease of use with patients of larger size.
- Indications for Use: The Lunar iDXA Bone Densitometer provides an estimate of bone mineral ഹ് density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
-
- Comparison with Predicate Device: The Lunar iDXA is of a comparable type and substantially equivalent to the current Prodigy bone densitometer. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has the some intended uses and basic operating modes as the predicate device.
Section b):
- Non-clinical Tests: The device has been evaluated for electrical and mechanical safety, and 1. has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.
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Special 510(k) Premarket Notification GE Medical Systems Lunar – Lunar iDXA Bone Densitometer September 19th, 2005
-
- Clinical Tests: No clinical tests were required to establish safety or effectiveness, however a 40 ennical reste.
person in vivo study was done to verify that the design specifications of accuracy and precision were met.
- Clinical Tests: No clinical tests were required to establish safety or effectiveness, however a 40 ennical reste.
-
- Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through independent evaluation with ongoing factory surveillance. The Lunar iDXA bone densitometer is substantially equivalent to currently marketed devices. No new safety and effectiveness questions are raised with the Lunar iDXA bone densitometer.
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Special 510(k) Premarket Notification GE Medical Systems Lunar – Lunar iDXA Bone Densitometer September 19th, 2005
Attachment C Truthful and Accurate Statement
PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(j)))
I certify that, in my capacity as of Safety and Regulatory Engineering Manager for GE r ecring that, in The best of my knowledge, that all data and information r icalcul Systems Land, I Donorbfication are truthful and accurate and that no material fact has been omitted.
Date:
James P. Raskob
510(k) number:
- Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2005
Mr. James P. Raskob Safety & Regulatory Engineering Manager GE Medical Systems Lunar GE Healthcare 726 Heartland Trail MADISON WI 53717
Re.: K052581
Trade/Device Name: Lunar iDXA Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: September 19, 2005 Received: September 20, 2005
Dear Mr. Raskob:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leve determined the device is substantially equivalent (for the indications for use stated in above and nave deceminerarketed 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 reay 20. 1770. the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approval of a provisions of the Act. The general controls provisions of the Act device, subject to the generation, listing of devices, good manufacturing practice, labeling. and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your de rice is chassilied (boo as a chards. Existing major regulations affecting your Apployal), It may oc stoped to sterral Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I TNA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the r caerial and outs including, but not limited to registration and listing (21 CFR Part 807): labeling (21 CHR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) (= regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your and premarket notification. The PDA inding of succeantial of a lowice 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), please If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Thisoransing of your responsibilities under the Act from the 807.97). You may obtain other general information on your its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Lunar iDXA Bone Densitometer provides an estimate of bonc mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
X___ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use -----------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Sypum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices Radologiour Book (2052581
Page 1 of 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.