(44 days)
The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.
The imaging protocols and acquisition software of the MXA-II software option are the same as the Hologic Vertebral Morphometry software program. Using the MXA-II option, the patient would be scanned as under the currently distributed vertebral morphometry option. In the MXA-II option, however, the vertebral deformities can be evaluated either quantitatively or visually.
Here's an analysis of the provided text regarding the Hologic MXA-II Software Option for X-Ray Bone Densitometers, structured according to your requested points:
The provided documents do not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training data. The documents are primarily the 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than directly detailing performance studies against specific acceptance criteria.
Therefore, for most of your requested points, the answer will be "Information not available in the provided text."
Here's a breakdown of what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Information not available in the provided text. | Information not available in the provided text. The 510(k) submission states the MXA-II option uses the "same imaging protocols and acquisition software" as the predicate Hologic Vertebral Morphometry software program and allows evaluation of vertebral deformities "either quantitatively or visually." This implies its performance is considered comparable to the predicate. |
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: Information not available in the provided text.
- Data provenance: Information not available in the provided text.
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: Information not available in the provided text.
- Qualifications of experts: Information not available in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Information not available in the provided text.
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: Information not available in the provided text. The submission focuses on substantial equivalence to existing devices rather than a comparative effectiveness study showing human improvement with the new software.
- Effect size: Information not available in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance study done: Information not available in the provided text. The device is a "software option for the Hologic x-ray bone densitometers, allowing the visual or quantitative assessment of vertebral body deformities," implying human involvement in the assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Information not available in the provided text. Given the device's function (assessment of vertebral body deformities), it's highly probable that expert radiographic interpretation or similar clinical assessment would form the basis of ground truth, but this is not explicitly stated.
8. The sample size for the training set
- Sample size for training set: Information not available in the provided text.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Information not available in the provided text.
Summary of Device and Approval Context from Provided Information:
- Device Name: Hologic® QDR® X-Ray Bone Densitometers MXA-II Software Option
- Intended Use: "The product is a software option for the Hologic x-ray bone densitometers, allowing the visual or quantitative assessment of vertebral body deformities."
- Predicate Devices: Hologic Vertebral Morphometry Software Option, LUNAR Spine Morphometry Software Option, Radiographic identification of Vertebral Deformities, CT Scout views.
- Key Aspect of Submission: The 510(k) submission highlights that the "imaging protocols and acquisition software of the MXA-II software option are the same as the Hologic Vertebral Morphometry software program." This emphasizes substantial equivalence through shared underlying technology and methodology, rather than extensive new performance studies demonstrating novel capabilities or improved metrics. The key change seems to be the added flexibility for "visual or quantitative" assessment.
- Approval Date: August 17, 1999 (Date Prepared for Submission), August 18, 1999 (Received by FDA), FDA Clearance letter dated September 1, 1999.
- Regulatory Class: II (21 CFR 892.1170/Procode: 90 KGI)
- Type of Submission: 510(k) Premarket Notification, indicating reliance on substantial equivalence to legally marketed predicate devices.
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1 1999
OCT
વું વ MXA-II Software Option 510(k) Premarket Notification
510(K) SUMMARY
MXA-II software option for the X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 35 Crosby DriveBedford, MA 01730 |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 999-7300 |
| Fax Number: | (781) 280-0662 |
| Date Prepared: | August 17, 1999 |
| Device Trade Name: | Hologic® QDR® X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | Hologic Vertebral Morphometry Software OptionLUNAR Spine Morphometry Software OptionRadiographic identification of Vertebral DeformitiesCT Scout views |
| Device Description: | The imaging protocols and acquisition software of the MXA-IIsoftware option are the same as the Hologic VertebralMorphometry software program. Using the MXA-II option, thepatient would be scanned as under the currently distributedvertebral morphometry option. In the MXA-II option, however,the vertebral deformities can be evaluated either quantitativelyor visually. |
| Intended Use: | The product is a software option for the Hologic x-ray bonedensitometers, allowing the visual or quantitative assessment ofvertebral body deformities |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
001 1 1999
Nandini Murthy, RAC Regulatory Scientist Hologic, Inc. 35 Crosby Drive Bedford, MA 01730-1401 RE;
MXA-II Software Dated: August 17, 1999 Received: August 18, 1999 Regulatory Class: II 221 CFR 892.1170/Procode: 90 KGI
Dear Ms. Murthy:
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 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 redassified 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 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 defermination 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, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther 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/dsma/dsmamain.html".
Sincerely yours,
Dan Detist
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
ਸੀ। Enclosure
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|---|---|
| of |
510(k) Number (if known): _
Device Name:
Indications For Use:
The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Javid A. Sygm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.