(163 days)
Not Found
No
The description focuses on mechanical articulation, image-guided localization based on pre-operative images, and geometric calculations. There is no mention of AI/ML terms, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a surgical planning system that provides visual information and facilitates localization of targets during surgery, but it does not directly treat or prevent a disease or condition.
No
The device is described as a "surgical planning system" and an "interactive, imageguided means of localizing targets in surgical procedures." Its purpose is to assist surgeons in planning and executing surgical procedures, not to identify or determine the nature of a disease. While it uses medical images, it does not interpret them to diagnose a condition.
No
The device description explicitly states that the system consists of an articulated Operating Arm, a computer workstation, application software, probes, and a Mayfield Attachment, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgical planning system" and provides "visual information to make assessments during a surgical procedure." It is used for "operative planning of surgical procedures." This describes a tool used during or for planning a surgical procedure on a patient, not a test performed in vitro (outside the body) on biological specimens.
- Device Description: The description details an "articulated Operating Arm, a computer workstation, application software, probes, and a Mayfield Attachment." This is a physical system used to guide surgical procedures, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
The device is a surgical navigation or guidance system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
OAS is a surgical planning system which enables the surgeon to plan a surgical procedure so as to optimize his approach. The OAS provides the surgeon with visual information to make assessments during a surgical procedure. OAS is indicated for the operative planning of surgical procedures, for example: tumor resection, ventricular shunt placement, craniotomy, and ENT-intranasal ethmoidectomy.
Product codes
Not Found
Device Description
The Operating Arm System, addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System (with CT images) and the ISG Viewing Wand System. New features described in this submission include the additional support of MR images and Radionics adhesive fiducial markers. The OAS provides an interactive, imageguided means of localizing targets in surgical procedures. It consists of an articulated Operating Arm, a computer workstation, application software, probes, and a Mayfield Attachment. The Operating Arm consists of a series of articulating joints and connecting links combined with an instrument holder. It is a five-jointed, five degree of freedom pointing device used for position (x, y, z) and angle measurement. Upon calibration of the instrument in the surgical environment, the surgeon manipulates the Arm to select points in surgical space which are interpreted by the computer and related to corresponding points in image space. Similarly, the ISG Viewing Wand System consists of an articulated Arm, a computer workstation, application software, probes, and a Mayfield Attachment. It is a six-jointed six degree of freedom electrogoniometer used for position (x, y, z) and angle measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR Imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
RSA Operating Arm System (OAS) system testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the OAS software. Further, it verifies that all target coordinate input and displays in OAS are accurate. The results from the OAS are compared to a phantom with targets of known position. As was previously reported for the OAS with CT images, the articulated mechanical Arm is accurate to a mean value of 0.36 ± 0.28 mm (mean ± std dev) when used to sample points over a clinically significant surgical volume. This accuracy is maintained over a period of extended operation.
Summary of Performance Studies
The articulated mechanical Arm is accurate to a mean value of 0.36 ± 0.28 mm (mean ± std dev) when used to sample points over a clinically significant surgical volume. This accuracy is maintained over a period of extended operation.
Key Metrics
Accuracy: 0.36 ± 0.28 mm (mean ± std dev)
Predicate Device(s)
Radionics Operating Arm System (with CT images), K951262; ISG Technologies Allegro Viewing Wand System, K911783; FLEXcon Company, Inc. Beekley XSpot stick-on fiducial markers included in RSA Operating Arm PMN, K951262.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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OCT 23 1996
Appendix 1
Summary of Safety and Effectiveness
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Surgical Planning and Guidance System |
| Device Trade Name: | Operating Arm System (OAS) with CT and MR |
| Imaging | |
| Intended Uses: | OAS is a surgical planning system which enables |
| the surgeon to plan a surgical procedure so as to | |
| optimize his approach. The OAS provides the | |
| surgeon with visual information to make | |
| assessments during a surgical procedure. OAS is | |
| indicated for the operative planning of surgical | |
| procedures, for example: tumor resection, | |
| ventricular shunt placement, craniotomy, and ENT- | |
| intranasal ethmoidectomy. | |
| Predicate Devices: | Radionics Operating Arm System (with CT |
| images), K951262; | |
| ISG Technologies Allegro Viewing Wand System, | |
| K911783; | |
| FLEXcon Company, Inc. Beekley XSpot stick-on | |
| fiducial markers included in RSA Operating Arm | |
| PMN, K951262. | |
| Establishment Name and Address: | Radionics Software Applications, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone: | Amy J. LaForte, PhD, |
| (617) 272-1233 | |
| Establishment registration number: | 1222895 |
| Performance Standard: | None established under Section 514. |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
1
Description of the Device and Basis for Substantial Equivalence
The Operating Arm System, addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System (with CT images) and the ISG Viewing Wand System. New features described in this submission include the additional support of MR images and Radionics adhesive fiducial markers. The OAS provides an interactive, imageguided means of localizing targets in surgical procedures. It consists of an articulated Operating Arm, a computer workstation, application software, probes, and a Mayfield Attachment. The Operating Arm consists of a series of articulating joints and connecting links combined with an instrument holder. It is a five-jointed, five degree of freedom pointing device used for position (x, y, z) and angle measurement. Upon calibration of the instrument in the surgical environment, the surgeon manipulates the Arm to select points in surgical space which are interpreted by the computer and related to corresponding points in image space. Similarly, the ISG Viewing Wand System consists of an articulated Arm, a computer workstation, application software, probes, and a Mayfield Attachment. It is a six-jointed six degree of freedom electrogoniometer used for position (x, y, z) and angle measurement.
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Safety Summary
RSA Operating Arm System (OAS) system testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the OAS software. Further, it verifies that all target coordinate input and displays in OAS are accurate. The results from the OAS are compared to a phantom with targets of known position. As was previously reported for the OAS with CT images, the articulated mechanical Arm is accurate to a mean value of 0.36 ± 0.28 mm (mean ± std dev) when used to sample points over a clinically significant surgical volume. This accuracy is maintained over a period of extended operation.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions ensure that the user understands all aspects of the Operating Arm System: mechanical, computer, and software and its intended functionality. This information promotes safe and effective use of the device.