(173 days)
Femoral neck BMD and clinical risk factors are used to estimate the patient's 10year risk of hip fracture and 10-year risk of fracture using the World Health Organization (WHO) algorithm (FRAX™). The physician may use the 10-year percent probability of fracture, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment po the obtained 10-year percent probability results to determine if therapeutic intervention is necessary.
Software option for Bone Densitometers
The provided document, Koro7// Hologic: 10-year Fracture Risk Questionnaire Option 510(k) Premarket Notification, is a 510(k) summary for a software option for bone densitometers. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically found in a clinical trial or performance study.
Therefore, many of the requested elements regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical performance studies if substantial equivalence can be shown through other means (e.g., comparison of technical characteristics, performance claims).
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the 510(k) summary.
A 510(k) summary typically focuses on substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and a comprehensive study report with quantitative results. The submission states: "The Hologic 10-year Fracture Risk Questionnaire option is substantially equivalent to the presently marketed predicate devices... and no new safety or efficacy questions are raised." This statement itself implies that the device's performance is deemed acceptable because it is equivalent to approved devices.
The "performance" described is that the software uses "Femoral neck BMD and clinical risk factors... to estimate the patient's 10-year risk of hip fracture and 10-year risk of fracture using the World Health Organization (WHO) algorithm (FRAX™)." The acceptance is that it correctly implements this established algorithm.
2. Sample size used for the test set and the data provenance
Not provided. This information would typically be found in a detailed performance study report, which is not part of this 510(k) summary. The FRAX™ algorithm itself was developed and validated on various cohorts, but this submission is about the software's implementation of that algorithm, not a re-validation of FRAX™.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This device implements an existing algorithm (FRAX™). The "ground truth" for the algorithm itself would have been established during its development and validation by the WHO, likely involving extensive epidemiological studies and expert consensus. For this 510(k), the "truth" is the correct implementation of the algorithm.
4. Adjudication method for the test set
Not applicable/Not provided. No explicit test set or adjudication method is described in this 510(k) summary.
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
Not applicable/Not provided. This device is a software option that calculates fracture risk using an existing algorithm. It does not involve "human readers" interpreting images assisted by AI in the traditional sense of an MRMC study. The output is a risk score for a physician to use, not an AI-assisted diagnostic read.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The device itself is a standalone algorithm that calculates the 10-year fracture risk based on input data (Femoral neck BMD and clinical risk factors). The output is a quantitative risk percentage. The submission states, "The physician may use the 10-year percent probability of fracture...to determine if therapeutic intervention is necessary." This indicates the algorithm provides its output independently, which is then used by a human. The "performance" of the algorithm is its accurate calculation of the FRAX™ score, but the 510(k) does not include a detailed "standalone performance study" report.
7. The type of ground truth used
Algorithm-based calculation. The "ground truth" for this device's performance is the accurate implementation and calculation of the 10-year fracture risk according to the "World Health Organization (WHO) algorithm (FRAX™)". The FRAX™ algorithm itself was developed based on extensive epidemiological data and patient outcomes to predict fracture risk. For the regulatory approval of this software option, the ground truth would be that the software correctly computes the FRAX™ score given appropriate inputs, consistent with how the original FRAX™ tool would calculate it.
8. The sample size for the training set
Not applicable/Not provided. This device implements an existing, published algorithm (FRAX™). It's not a machine learning model requiring a new training set. The "development" data for the FRAX™ algorithm itself would have involved large, multi-national cohorts, but that's distinct from this specific device's approval process.
9. How the ground truth for the training set was established
Not applicable/Not provided. As stated above, this is about implementing an existing algorithm, not training a new model. The ground truth for the FRAX™ algorithm's development was established through longitudinal studies observing fracture outcomes in large populations.
{0}------------------------------------------------
Koro7//
Hologic: 10-year Fracture Risk Questionnaire Option 510(k) Premarket Notification
G. 510(k) Summary
SEP - 2 2008
Manufacturing Establishment and Contact Information G.1
G.1.1 Manufacturer Name and Address:
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
G.1.2 Establishment Registration Number:
1221300
G.1.3 Name, Title, and Telephone Number of Contact:
Bryan Cowell, RAC Regulatory Affairs Specialist Phone: (781) 999-7300, ex. 7085 Fax: (781) 999-0614 Bryan.cowell@hologic.com
G.2 Device Identification
G.2.1 Device Trade Name:
10-year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers
G.2.2 Common / Usual Name:
Software option for Bone Densitometers
G.2.3 Proposed Intended Use:
Femoral neck BMD and clinical risk factors are used to estimate the patient's 10year risk of hip fracture and 10-year risk of fracture using the World Health Organization (WHO) algorithm (FRAX™). The physician may use the 10-year percent probability of fracture, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment po the obtained 10-year percent probability results to determine if therapeutic intervention is necessary.
G.3 Device Classification
Radiology
G.3.1 Classification:
Class II
{1}------------------------------------------------
G.3.2 Classification Name and Rule
Bone Densitometer: 21 CFR 892.1170
G.3.3 Classification Panel
Radiology
G.3.4 Product Code
90 KGI
G.3.5 Predicate Devices
| 510(k) No.: | K963363 |
|---|---|
| Trade Name: | NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers |
| SE Date: | November 22, 1996 |
| Manufacturer: | Hologic, Inc. |
- . 510(k) No.: K983028 Trade Name: Estimation of Fracture Risk from BMD using Hologic QDR X-Ray Bone Densitometers November 13, 1998 SE Date: Manufacturer: Hologic, Inc.
G.4 Conclusion:
The Hologic 10-year Fracture Risk Questionnaire option is substantially equivalent to the presently marketed predicate devices, the Hologic Estimation of Fracture Risk from BMD using Hologic QDR X-Ray Bone Densitometers (K983028) and the Hologic NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers (K963363), and no new safety or efficacy questions are raised.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2008
Mr. Bryan Cowell Regulatory Affairs Specialist Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730
Re: K080711
Trade/Device Name: 10-year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers
Regulation Number: 21 CFR 892.1170
DEPARTMENT OF HEALTH & HUMAN SERVICES
Regulation Name: Bone densitometer
Regulatory Class: II
Product Code: KGI
Dated: July 10, 2008
Received: July 11, 2008
Dear Mr. Cowell:
. . . . .
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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 Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
A.2 Indication for Use Statement
510(k) Number (if known):
Device Name: 10-year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers
Indication for Use: Femoral neck BMD and clinical risk factors are used to estimate 10-year risk of hip fracture and 10-year risk of major osteoporotic fracture using the World Health Organization (WHO) algorithm (FRAX™) in adults. The physician may use the 10-year fracture risk, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.
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 OF NEEDED)
Concurrence of CDRA, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K080711 |
§ 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.