(163 days)
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.
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.
The provided text describes the Radionics Operating Arm System (OAS), a surgical planning and guidance system.
Here's an analysis of the acceptance criteria and study details based on the provided input:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stereotactic CT/MR localizer transformation equations correctly encoded and accurate | System testing verifies correct encoding and accuracy of transformation equations. |
| All target coordinate input and displays accurate | System testing verifies accuracy of target coordinate input and displays. |
| Mechanical Arm accuracy for sampling points over clinically significant surgical volume | Mean accuracy: 0.36 ± 0.28 mm (mean ± std dev). |
| Accuracy maintained over extended operation | Accuracy is maintained over a period of extended operation. |
Note: The document does not explicitly state "acceptance criteria" but rather describes the testing performed and the results that presumably demonstrate the device meets the manufacturer's performance specifications for safety and effectiveness.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patient cases or images, but the testing was done on a phantom. The phantom used had "targets of known position."
- Data Provenance: The test data (phantom) is not from a specific country or patient cohort; it is a controlled test artifact. The study is a prospective engineering validation study using a phantom.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for the test set was established by the known positions of targets within the physical phantom. No human experts were involved in establishing this particular ground truth.
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Adjudication method for the test set:
- Not applicable. The "known positions" in the phantom serve as the objective ground truth, not requiring human adjudication.
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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:
- No MRMC comparative effectiveness study was done or reported in this document. This device is a surgical planning and guidance system, not an AI-assisted diagnostic tool that aids human readers in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the system has a human-in-the-loop for surgical procedures, the accuracy testing described for the mechanical arm and software transformation was a standalone algorithm/device performance test using a phantom. The reported accuracy of 0.36 ± 0.28 mm is a measurement of the system's precision against a known standard, not involving a human surgeon's interaction as part of that specific measurement.
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The type of ground truth used:
- Known physical measurements (phantom targets): The ground truth for the primary accuracy claim (0.36 ± 0.28 mm) was the precisely "known positions" of targets within a phantom.
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The sample size for the training set:
- The document does not describe a training set in the context of machine learning or AI model development. The system functions based on predefined transformation equations and an articulated mechanical arm, not a trained AI model. Therefore, a "training set" as understood in AI is not applicable here.
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How the ground truth for the training set was established:
- Not applicable, as there is no described "training set" in the context of an AI model that requires establishing ground truth. The system's underlying mathematical models and engineering design are based on principles of physics, geometry, and mechanical engineering.
§ 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).