(74 days)
The intended use of the Fracture Risk Option includes the World Health Organization's (WHO) definition of osteoporosis and osteopenia based on the T-score and provides an estimate of Fracture Risk assessment based on WHO classification. The physician uses the Fracture Risk report in conjunction with other risk factors to arrive at diagnostic and patient management decisions.
The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR® X-Ray Bone Densitometers.
The Hologic QDR X-Ray Bone Densitometers with the added feature of estimation of Fracture Risk from BMD includes additional reports that provide an estimation of risk of fracture.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a device that estimates fracture risk from Bone Mineral Density (BMD). While it describes the device's intended use and substantial equivalence to a predicate device, it lacks the specific performance metrics, study design, and results typically found in a clinical study report.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis based on the available information:
- Device: Hologic® QDR® X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD.
- Added Feature: Provides an estimation of fracture risk based on WHO classification (T-score).
- Intended Use: The physician uses the Fracture Risk report in conjunction with other risk factors to arrive at diagnostic and patient management decisions.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document.
3. 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)
- Number of Experts: Not specified in the document.
- Qualifications of Experts: Not specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the document.
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
- MRMC Study Done?: No, this is not an AI-assisted diagnostic tool in the sense of image interpretation. It's an added feature to a bone densitometer that provides a calculation (estimation of fracture risk from BMD). The document does not describe an MRMC study or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study Done?: The device's "added feature" is an algorithm that estimates fracture risk directly from BMD measurements taken by the Hologic QDR densitometer. The document implicitly supports standalone performance in that the densitometer outputs a fracture risk estimation, which is then used by a physician. However, no specific "standalone study" results or performance metrics are detailed in the provided text. The output is a quantitative risk estimation based on BMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "added feature" relies on the World Health Organization's (WHO) definition of osteoporosis and osteopenia based on the T-score, and provides an Bestimation of Fracture Risk assessment based on WHO classification. Therefore, the ground truth for establishing the methodology of the risk estimation is based on established medical guidelines (WHO classification), not on a unique set of patient outcomes or expert consensus specifically for this device's validation.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This device feature calculates risk based on a defined formula/classification (WHO T-score), rather than a machine learning model that would require a "training set" in the conventional sense. The "training" here would be the development of the WHO classification itself.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set Established: Not applicable/Not specified. The "ground truth" for the basis of the fracture risk estimation is the World Health Organization's (WHO) definitions and classification schemes for osteoporosis, osteopenia, and fracture risk based on T-scores. This is a widely accepted medical standard, not something established for this specific device's 'training.'
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510(K) SUMMARY
HOLOGIC® QDR® X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD*
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 590 Lincoln StreetWaltham, MA 02451 |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 890-2300 |
| Fax Number: | (781) 890-8031 |
| Date Prepared: | August 28, 1998 |
| Device Trade Name: | Hologic® QDR® X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | NORLAND-CAMERON Bone Mineral Analyzer, Model 178,Preamendment device.Norland model pDEXA Bone Densitometer with Fracture RiskOption. (K973104, FDA clearance Jan 29, 1998) |
| Device Description: | The Hologic QDR X-Ray Bone Densitometers with the addedfeature of estimation of Fracture Risk from BMD includesadditional reports that provide an estimation of risk of fracture. |
| Intended Use: | The intended use of the Fracture Risk Option includes the WorldHealth Organization's (WHO) definition of osteoporosis andosteopenia based on the T-score and provides an estimate ofFracture Risk assessment based on WHO classification. Thephysician uses the Fracture Risk report in conjunction with otherrisk factors to arrive at diagnostic and patient managementdecisions. |
- BMD = Bone Mineral Density
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Nandini Murphy, RAC Regulatory Scientist Hologic, Inc. 590 Lincoln St. Waltham, MA 02154
Re: K983028
Estimation of Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers Dated: August 28, 1998 Received: August 31, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Ms. Murphy:
We have reviewed your Section 510(s) 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 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 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 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, piease 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/dsmadsmam.html".
Sincerely yours,
Lillian Yip, 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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Indications for Use Statement
The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR® X-Ray Bone Densitometers.
Hind G. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi 305 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.