(36 days)
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
The patient positioning system is a SCARA designed robotic arm allowing six degrees of freedom.
The provided 510(k) summary for the Forte Automation Systems Patient Positioning System (K122413) does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
This 510(k) pertains to a patient positioning system, which is a robotic arm for positioning patients during medical procedures. The submission focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device. Clinical efficacy or diagnostic performance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and a clinical study to prove them, are not applicable to this type of device submission.
Here's a breakdown of the available information based on your requested points, highlighting why some are not present for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility and Susceptibility Tests | Passed (by a third party) |
| Surge and Static Tests | Passed (by a third party) |
| Vibration Tests | Passed (by a third party) |
| Speed Tests | Passed (by Forte Automation) |
| Accuracy Tests | Passed (by Forte Automation) |
| Collision Detection Tests | Passed (by Forte Automation) |
It's crucial to understand that these are engineering/safety performance criteria, not clinical performance criteria in the context of diagnostic devices. The document states, "The submitted device does not impart energies into a patient. Therefore no clinical testing was needed." This confirms that the 510(k) submission relies on non-clinical engineering and safety performance to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The tests conducted were non-clinical engineering tests (e.g., electromagnetic compatibility, vibration, speed, accuracy, collision detection) on the device itself, not on a patient population. There is no "test set" of patient data.
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)
Not applicable. Ground truth, in the context of clinical or diagnostic performance, is established by experts (e.g., radiologists, pathologists). Since no clinical testing was performed and no patient data was analyzed, this information is not relevant to this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of clinical or diagnostic data. This was not part of the non-clinical testing performed.
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. MRMC studies are used to assess the clinical effectiveness of diagnostic devices and often involve human readers interpreting medical images. This device is a patient positioning system, not an imaging or diagnostic device with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. Standalone performance refers to the diagnostic accuracy of an algorithm without human intervention. This is not a diagnostic algorithm. The "performance" discussed for this device relates to its mechanical and electrical functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" was established by engineering specifications, industry standards, and the physical properties of the device. For example, the accuracy tests would compare the device's measured positioning to its programmed target position, with "ground truth" being the theoretically correct position based on the design.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" for model development.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for Forte Automation Systems. The word "FORTE" is displayed in a bold, sans-serif font at the top. Below "FORTE" is a thick, black horizontal bar with the words "AUTOMATION SYSTEMS, INC." printed in a smaller font. Underneath the bar, the word "FORTE" is repeated in a smaller, italicized font, creating a layered effect.
Forte Automation Systems, Inc.
5 510(k) Summary
1 3 2012
September 7, 2012 Submittal Date: Company Name: Forte Automation Systems, Inc. Street Address: 8155 Burden Road City, St, Zip: Machesney Park, IL 61115 Country: USA Phone: +1 (815) 633-236 00 +1 (815) 633-7131 Fax: Contact: Phil Reece Contact Title: Regulatory Manager
Device Name:
| Common Name: | Patient Positioning System |
|---|---|
| Device: | Couch, Radiation Therapy, Powered |
| Regulation Description: | Powered radiation therapy patient support assembly |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | JAI |
| Submission Type: | 510(k) |
| Regulation Number: | 892.5770 |
| Device Class: | 2 |
Device Description:
The patient positioning system is a SCARA designed robotic arm allowing six degrees of freedom.
Indications for Use:
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
Predicate Device:
A similar system has received Substantial Equivalence (SE) through Accuray Incorporated under number K042146 dated August 5, 2004.
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Image /page/1/Picture/0 description: The image contains a logo for FORTE. The logo is black and white and features the word "FORTE" in large, bold letters at the top. Below "FORTE" is the text "AUTOMATION SYSTEMS INC." in smaller letters. The word "FORTE" is repeated in reverse at the bottom of the logo.
Technolgical Characteristics:
The technological differences between the predicate and the submitted devices are as follows:
| Predicate Device | Submitted Device | |
|---|---|---|
| Vertical travel | Ball screw driven | Rack and pinion driven |
| Axes 4, 5, and 6 | Belt driven | Gear driven |
| Couch top coupling | Single couch top | Multiple couch tops |
| Measuring Patient weight | N/A | Load Cell |
Figure 1 Predicate Differences
Theses changes are included in another patient positioning system device that was included as a part of different submittal K 100766 with a different intended use.
Nonclinical Tests:
Electromagnetic compatibility and susceptibility tests as well as surge and static tests were performed by a third party on the submitted device and all passed. Vibration tests were performed by a third party on the submitted device and passed. Speed, accuracy and collision detection tests were performed by Forte Automation and passed.
Clinical Tests:
The submitted device does not impart energies into a patient. Therefore no clinical testing was needed.
Testing Conclusions:
Forte Automation has manufactured the predicate device as well as the submitted device. All of the tests performed on the submitted device were done to the industries normal criteria and passed proving the submitted device meets or exceeds the safety and effectiveness of both of the predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP 13 2012
Mr. Phil Reece Regulatory Manager Forte Automation Systems. Inc. 8155 Burden Road MACHESNEY PARK IL 61115
Re: K122413
Trade/Device Name: Patient Positioning System (PPS) Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II " 您 Product Code: JAI Dated: August 3, 2012 Received: August 8, 2012
Dear Mr. Reece:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass slavou in the extrebute) is the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1576) 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). alla Cosmette Act (1101) that ao not required to the general controls provisions of the Act. The T ou may, dicierore, market als 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 class II (Special Controls), it may be subject to such If your device is classified (see as regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Flease of advised that I Dri 3 issuance or a subscribe complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any rederal statutes and regulations and uncluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, artical device reporting (reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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4 Indications for Use Statement
510(k) Number if Known:
Unknown K122413
Device Name:
Patient Positioning System (PPS)
Indications for Use:
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
Prescription Use __ X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael D'Orten
Page = | 4-1
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.