(28 days)
The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria.
The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
The Sectra Osteoporosis Package is intended for use to estimate bone mineral densitv (BMD) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (WHO) criteria.
Sectra Osteoporosis Package features:
- indirect "DICOM capability" via the Sectra IDS5 Radiology workstation, i.e. it uses digital image data according to the DICOM standard.
- . single screen user interface reached via a right click on an image in a Sectra IDS5 Radiology Workstation.
- operates in two modes: Clinical mode and Research mode.
Here's a summary of the acceptance criteria and study information for the Sectra Osteoporosis Package Bone Densitometer, based on the provided text:
Lack of Information:
It's important to note that the provided text is a 510(k) summary for a substantial equivalence determination. As such, it does not contain detailed performance study results, acceptance criteria, or ground truth methodologies in the way a clinical study report or more comprehensive technical documentation would. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily by showing that differences in image source (digital CR vs. digitized conventional X-ray) do not raise new safety or effectiveness concerns.
The document explicitly states: "Both in vitro and in vivo performance testing has been conducted to verify that this design difference does not impact either safety or efficacy." However, it does not provide the specific details of these tests, including acceptance criteria, sample sizes, or how performance was measured against a ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
Given the limitations of the provided document, specific numerical acceptance criteria and detailed performance metrics are not explicitly stated. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing quantitative performance against pre-defined acceptance criteria.
The implied "acceptance criterion" is that the device's performance in estimating Bone Mineral Density (BMD) and assessing osteoporotic fracture risk is equivalent to that of the predicate device, the X-Posure System Version 2 RAD (K002500), despite using different image sources.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent effectiveness in estimating BMD in the forearm. | Inferred to be met through in vitro and in vivo performance testing, though no specific metrics or comparison data are provided. The document states: "this design difference [image source] does not impact either safety or efficacy." and "Both devices use essentially the same DXR techniques to analyze the given images." |
| Equivalent effectiveness in assessing increased risk of osteoporotic fracture according to WHO criteria. | Inferred to be met for the same reasons as above. The device's intended use and indications for use are described as "identical" to the predicate, implying similar performance for this intended purpose. |
| Image quality sufficient for BMD analysis. | The document asserts that "the question of whether the images are of sufficient quality to permit BMD analysis is common to both devices," and that in vitro and in vivo testing verified that the design difference (CR images vs. digitized conventional X-rays) does not impact safety or efficacy. This suggests that the quality of CR images was deemed sufficient to enable comparable BMD analysis to the predicate. |
| Functionality and analysis quality are not impacted by integration with Sectra IDS5 Radiology Workstation or ability to retrieve DICOM images from PACS. | "validated by the company" that these integrations/capabilities "in no way affects how the software analyzes BMD or the quality of this analysis" and "in no way impacts the device's safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Both in vitro and in vivo performance testing has been conducted". However, no specific sample sizes for either the in vitro or in vivo test sets are provided.
Data Provenance: The country of origin of the data is not specified. It is also not specified whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not specified. The document does not provide any information on experts or how ground truth was established for the performance testing.
4. Adjudication Method for the Test Set
Not specified. The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not mentioned. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers improving with or without AI assistance. The device is a bone densitometer, an automated analysis tool for BMD, not an AI-assisted diagnostic aid for human readers in the typical sense of an MRMC study.
6. Standalone (Algorithm Only) Performance Study
The primary performance assessment described is a standalone (algorithm only) evaluation, as the device is an automated analysis tool. The document states the device "analyzes computed radiography ('CR') images obtained directly in digital format" and "uses essentially the same DXR techniques to analyze the given images" as the predicate device. The in vitro and in vivo tests were conducted to verify the algorithm's performance with the new image source.
7. Type of Ground Truth Used
Not specified. The document does not explicitly state the type of ground truth used for the in vitro or in vivo performance testing (e.g., bone mineral density measured by a gold standard, pathology, clinical outcomes, etc.). For BMD, a common ground truth in such studies might be a highly accurate densitometry method or phantoms with known BMDs for in vitro studies. However, this is not detailed in the provided text.
8. Sample Size for the Training Set
Not applicable/Not mentioned. The document describes the device as using "DXR techniques" and being "essentially the same as the predicate device". This implies a deterministic algorithm or a known analytical method, rather than a machine learning model that would typically require a distinct training set. Therefore, a "training set" in the context of machine learning is not mentioned as being used for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned. As a training set is not indicated, the method for establishing its ground truth is also not provided.
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JUN - 7 2002
K021527
Sectra Document Number: 3-02.832-1.0
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
May 8 2002
Submitter's Information:
Sectra Imtec AB Teknikringen 2 SE-583 30 Linköping Sweden Phone: +1 46 13 23 52 00 Fax: +1 46 13 21 21 85
Trade Name, Common Name, Classification:
Trade name: Sectra Osteoporosis Package Bone Densitometer Common Names: Classification Name: Bone Densitometer (90 KGI) (21 C.F.R. § 892.1170)
Predicate Device:
| Applicant: | Pronosco A/S |
|---|---|
| 510(k) Number: | K002500 |
| Device: | X-Posure System Version 2 RAD |
Device Description:
The Sectra Osteoporosis Package is intended for use to estimate bone mineral densitv (BMD) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (WHO) criteria.
Sectra Osteoporosis Package features:
- indirect "DICOM capability" via the Sectra IDS5 Radiology workstation, i.e. it uses digital image data according to the DICOM standard.
- . single screen user interface reached via a right click on an image in a Sectra IDS5 Radiology Workstation.
- operates in two modes: Clinical mode and Research mode.
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Indications for Use:
The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria. The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
Technological Characteristics:
The Sectra Osteoporosis Package will run on the Windows NT 4.0 and Windows 2000 operating systems for PCs (as a minimum and depending upon system configuration).
Performance Data:
The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Conclusion:
The Sectra Osteoporosis Package is substantially equivalent to the previously cleared X-Posure System Version 2 RAD (K002500). The intended use and indications for use are identical. The principal difference in technological features from the predicate devices is the image source. That is, the Sectra Osteoporosis Package analyzes computed radiography ("CR") images obtained directly in digital format. This is in contrast to the predicate devise, which is limited to analyzing either conventional X-ray images alone that must first be separately digitized by using a scanner. This difference in technical characteristics between the subject device and the predicate device does not raise any new questions of safety or effectiveness, because the question of whether the images are of sufficient quality to permit BMD analysis is common to both devices. Also, both devices use essentially the same DXR techniques to analyze the given images. Both in vitro and in vivo performance testing has been conducted to verify that this design difference does not impact either safety or efficacy.
Additionally, the Sectra Osteoporosis Package can receive digital DICOM images that have been stored in a third party's network or PACS system, while the predicate device did not have this option. However, the additional ability to retrieve digital images stored on these other information systems has been validated by the company and in no way affects how the software analyzes BMD or the quality of this analysis.
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The other difference is that the Sectra Osteoporosis Package is integrated with a Sectra IDS5 Radiology Workstation giving the operator direct access to the BMD analysis. However, essentially the Sectra Osteoporosis Package is the same as the predicate device, its stand-alone counterpart, and presents no new safety or effectiveness concerns (as discussed above). Furthermore, as validated by the company, the packaging of these systems together in no way impacts the device's safety and effectiveness. Therefore, the Sectra Osteoporosis Package and the predicate device are substantially equivalent.
Peter Ander
Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Teknikringen 2 SE-58330 Linköping Sweden
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 7, 2002 - 1
Sectra Imtec AB % Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208 Re: K021527
Trade/Device Name: Sectra Osteoporosis Package Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: May 8, 2002 Received: May 10, 2002
Dear Mr. Alletto:
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 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.
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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO21527
Page 1 of -1
510(k) Number:
Device Name: Sectra Osteoporosis Package
Indications for Use:
The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria.
The device is indicated specifically for use to:
- (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and
- (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
(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 | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices | |
| 510(k) Number | K021527 |
§ 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.