(62 days)
The Fracture Risk option is used with the LUNAR PIXI bone densitometer system. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.
The use of the Fracture Risk option for PIXI is restricted to prescription use only.
The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.
This document is a 510(k) premarket notification for a software feature called "Fracture Risk option for EXPERT-XL Bone Densitometer," which assesses fracture risk based on a patient's bone mineral density T-score. The submission aims to establish substantial equivalence to a predicate device.
Here's an analysis of the provided text regarding acceptance criteria and the study:
Key Takeaways:
- No specific acceptance criteria or performance study is reported in this document. The submission relies on establishing substantial equivalence to a predicate device (Norland-Cameron Model 178 Bone Mineral Analyzer) rather than providing a new performance study with explicit acceptance criteria.
- The core argument is that the new software option does not introduce new safety or effectiveness concerns and does not change scan parameters or results produced by the bone densitometer.
Given this, I will answer the questions based on the absence of this information in the provided document, where applicable.
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Not stated. Not stated. Explanation: The document does not provide specific acceptance criteria (e.g., target accuracy, sensitivity, specificity) for the Fracture Risk option, nor does it report any performance metrics against such criteria. The submission's focus is on substantial equivalence, implying that its performance is implicitly considered equivalent to the predicate device because it doesn't alter diagnostic output.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No test set or performance study is described.
- Data Provenance: Not applicable. No data or study is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set and no adjudication method are described.
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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
- Was an MRMC study done? No. The document does not describe any MRMC comparative effectiveness study.
- Effect size of improvement: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The document does not describe a standalone performance study. The device is a "software accessory to aid the physician," implying human-in-the-loop use. However, no performance data for this aid is provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth is described as part of a performance study for this submission. The device provides "assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO)." This implies that the 'ground truth' for its classification logic is based on established WHO guidelines, not a newly gathered dataset with independent ground truthing.
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The sample size for the training set
- Not applicable. The document does not describe a training set as part of a machine learning or AI algorithm development process. The "Fracture Risk option" appears to be a rule-based software feature applying WHO criteria to existing bone density T-scores.
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How the ground truth for the training set was established
- Not applicable. No training set is described. The "ground truth" for the device's function is the established WHO categories for fracture risk based on T-scores.
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NOV 1 8 1998
Image /page/0/Picture/1 description: The image shows the word "LUNAR" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is horizontally oriented and appears to be a logo or brand name.
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
9.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Person: | Kenneth D. BurokerLUNAR Corporation313 West Beltline HighwayMadison, WI 53713 |
|---|---|
| Phone: | (608) 288-6460 |
| Fax: | (608) 274-0853 |
| Date: | September 15, 1998 |
| Device/Trade Name: | Fracture Risk option for EXPERT-XL Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer21CFR 892.1170 |
Predicate Device: Norland-Cameron Model 178 Bone Mineral Analyzer (preamendment)
DESCRIPTION OF THE DEVICE: 9.1
The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.
SUMMARY OF TECHNICAL CHARACTERISTICS 9.2
The Fracture Risk option for EXPERT-XL is a software accessory to aid the physician in assessing fracture risk from the results of an EXPERT-XL bone density examination. The Fracture Risk Assessment Feature does not cause any changes to the scan parameters used in the examination, and it does not affect the results produced.
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9.3 CONCLUSION
The Fracture Risk option for EXPERT-XL is substantially equivalent to the Norland-Cameron Model 178 Bone Mineral Analyzer, a pre-amendment device that was used to aid the physician in determining fracture risk. No new safety and effectiveness questions are raised with the Fracture Risk option for the EXPERT-XL bone densitometer.
Signed
Kenneth D. Buroker and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the Name
Director, Regulatory Affairs ........... Title
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image. The words are stacked on top of each other.
Image /page/2/Picture/1 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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Madison, WI 53713
Re: K983262
Fracture Risk Assessment Option for PIXI Bone Densitometer Dated: September 15, 1998 Received: September 17, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Buroker:
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (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 ecuivaliance compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) 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 the Electronic Product 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 classfilication 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 vitto 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/cdr/dsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE FORM 3.0
Page 1 of 1
- (983262 510(k) Number (if known) .
- Device Name: Fracture Risk option for PIXI Bone Densitometer .
- Indications for use: .
The Fracture Risk option is used with the LUNAR PIXI bone densitometer system. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.
The use of the Fracture Risk option for PIXI is restricted to prescription use only. The operator's manual for the PIXI system contains the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
The Fracture Risk option for PIXI poses no new safety or efficacy concerns.
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
David G. Laymon
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983262
7
§ 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.