(169 days)
The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in determining fracture risk, and for monitoring changes in bone mass over time.
The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability.
Here's an analysis of the provided text regarding the OsteoGram® 2000, addressing your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the OsteoGram® 2000. It generally claims "performs as well as the currently marketed device" and that "The precision and accuracy of the naïve operators and central lab operators were almost identical."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined with numerical thresholds. The core criteria is "performs as well as the currently marketed device." The "performance characteristics may not be sufficiently precise to assure equivalence" implies a need to demonstrate non-inferiority or equivalence to the predicate device. | "The results of this testing demonstrate that the modified OsteoGram 2000 performs as well as the currently marketed device." |
| "Precision and accuracy" | "The precision and accuracy of the naïve operators and central lab operators were almost identical." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "scanning and analysis of several patient x-rays." This indicates a very small, unspecified number, which is insufficient for rigorous statistical testing. It does not provide an exact count.
- Data Provenance: The document does not specify the country of origin. It does not explicitly state whether the data was retrospective or prospective, but the phrasing "several patient x-rays" suggests these were existing (retrospectively gathered) x-rays used for evaluation, rather than a new prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to "naïve operators and central lab operators" performing the scanning and analysis. It does not specify:
- The number of either "naïve" or "central lab" operators.
- Their qualifications (e.g., radiologist, years of experience). The term "naïve operators" suggests less experienced users, while "central lab operators" implies experienced individuals, but no specific professional credentials are given.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method (such as 2+1, 3+1, or none) for establishing ground truth or resolving discrepancies in readings. It seems to compare the device's output to that of the predicate device or a "central lab" without a formal adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study compared performance between "naïve operators" and "central lab operators" using the new system and the predicate, but it does not detail an MRMC design to quantify human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the device as a "change in software" and mentions "the analysis software has been mounted is a lows the OsteoGram x-improved patient revorus managers managers they are made." The testing involved "scanning and analysis... by both naïve operators and central lab operators," indicating a human-in-the-loop scenario. Therefore, a standalone (algorithm only) performance study was not explicitly described. The comparison is between the new device (with human operators) and the predicate device (also with human operators).
7. The Type of Ground Truth Used
The ground truth is implicitly established by the "currently marketed device" or the "central lab operators." The study compares the performance of the new device against the performance of the predicate device (or the standard practice of central lab analysis with the predicate). It does not explicitly state an independent, gold-standard ground truth like pathology or specific clinical outcomes. The goal was to demonstrate equivalence to the established method.
8. The Sample Size for the Training Set
The document does not provide any information about a training set since it focuses on a software modification to an existing device rather than the development of a new AI model from scratch that requires separate training. The "software" changes described are related to "user help and enhanced records keeping capability" and deployment, rather than a deep learning or machine learning algorithm requiring extensive training data in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.
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510(k) Summary
OsteoGram® 2000
Common/Classification Name: Bone Densitometer, 21 CFR 892.1170
CompuMed, Inc. 1230 Rosecrans Avenue Manhattan Beach, CA 90266
Contact: David Edelstein, Prepared: December 1, 1998
LEGALLY MARKETED PREDICATE DEVICES A.
The modified OsteoGram® 2000 device is substantially equivalent to the currently marketed OsteoGram device. The UsteoGram is a pre-Amendments device.
DEVICE DESCRIPTION B.
The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability.
C. INDICATIONS FOR USE
The OsteoGram 2000 is indicated for use in estimating me ostimoral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in escore may be association and for monitoring changes in bone mass over time.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The OsteoGram 2000 has the same indications for use as the currently marketed device. The OsteoGram 2000 has the same technological characteristics as the predicate device. However, the
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characteristics may not be sufficiently procise to assure equivalence.
The sufficiently because and welidation, and, nerformance characteristics may not be sumolonely providation and performance
Therefore, CompuMed has carried out valistrate, that the modified , Compulvied nas carred out vanstrate that the modified testing. testing. The results of this testing domently marketed device.
OsteoGram 2000 performs as well as the currently marketed device.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics of the modified device are very similar The technological charactenstics of the modified only difference is that to those of the currently marketed device. The oil / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / the analysis software has been mounted is a lows the OsteoGram ximproved patient revorus managers managers they are made.
TESTING F.
CompuMed carried out performance testing that compared the results of Compulvied carned out performance transmission and assays by both naïve
the scanning and analysis of several patient and annuracy of the the scanning and analysis of several pation and accuracy of the
operators and central lab operators. The precision and accuracy of the operators and central lab operators were almost identical.
CONCLUSIONS G.
The validation studies have demonstrated that the modified OsteoCram The validation studies nave demonstrator than currently marketed OsteoGram device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1999
Compumed, Inc. C/O T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh Associates, Inc. Medical & Regulatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
RE:
K984285 OsteoGram 2000 Bone Densitometer Dated: March 17, 1999 Received: March 17, 1999 Regulatory Class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We nower reviewed your ooking with a windications for uses stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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 Medical Dood, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls r cocial Programs Controls provisions of the Act include requirements for annual registration, listing of provices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may if your device to such additional control ajor regulations affecting your device can be found in the Code of be Subjict to odor additional Sontrolly equivalent determination assumes compliance with r Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Outlett Ooo manandelaning Praxion CEFR Part 820) and that, through periodic QS inspections, the Food and Mcalour Devilled (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in Drog Nammatication. In addition, FDA may publish further announcements concerning your device in the Federal register. In addition, PDF may pour 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 oquivalone of your dovice 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 il you desire specific devices), please control conficience at (301) 554-4613. Additionally for quostions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-9639. Allso, the promotion and dreitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other please not regulation entilibed with 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".
Sincerety yours.
APT 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
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate The OsteoGram 2000 is indicated for use in estimating bone innized collably (2007).
of BMD and t-score may be used as an and to the physician in determining fracture risk, an of BMD and t seers may -------------------------------------------------------------------------------------------------------------------------------------------------------
(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 A. Segura
(Division Sign-Off) Division of Reproductiv Abdominal, EN and Radiological D 510(k) Number
§ 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.