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The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures.

The provided document is a 510(k) summary for a medical device (Radionics Optical Tracking System - OTS) and its FDA clearance letter. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document discusses:

• The device name and its classification.
• Its substantial equivalence to predicate devices.
• Revised indications for use (specifically for frameless cranial biopsy).
• General information about its function as a graphical planning and intraoperative navigation tool for cranial and spinal surgical procedures.
• The FDA's confirmation of market clearance.

Therefore, I cannot provide the requested table and study details based on the given information. The information needed to answer the prompt (acceptance criteria, study design, performance results, ground truth, sample sizes, expert qualifications, etc.) is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.

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The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS) provides an interactive, image-guided means of localizing targets in surgical procedures. A camera array tracks the position of probes and various tools. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon registration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

The provided text does not contain the detailed information required to answer all parts of your request. This document is a 510(k) summary for a medical device (Optical Tracking System) and focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study report with specific performance metrics and validation methodologies.

However, I can extract what is available and indicate where information is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document, a 510(k) summary for the Optical Tracking System (OTS), does not explicitly define quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and describes the safety testing performed. The "study" described is primarily internal system and unit testing rather than a formal clinical or controlled comparative performance study to prove specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance thresholds (e.g., "accuracy must be within X mm").

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document refers to "system and unit testing" but does not give details on the number of cases, images, or tests performed.
• Data Provenance: Not specified. Given it's internal "system and unit testing," it's likely internal simulated or lab data, but no details are provided. It does not mention retrospective or prospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Missing Information: The document does not describe the involvement of external experts or the process of establishing ground truth for any test sets beyond internal software verification.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

Missing Information: There is no mention of an adjudication process, implying that ground truth was likely established through internal validation/verification methods as part of the software testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's technical functionality and substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

• Standalone Study: Yes, the described "system and unit testing" appears to be a form of standalone performance evaluation. The testing verifies the software's functionality, accuracy of transformations, and spatial accuracy of the digitizer independently. It's essentially an assessment of the algorithm and hardware's technical capabilities.

7. The Type of Ground Truth Used

• Type of Ground Truth: The document implies that ground truth was established through engineered or calculated accuracy standards for software and hardware components. For example, "spatial accuracy of the digitizer" and "accuracy of the transformations" suggest that known inputs were used to verify calculated outputs, rather than clinical ground truth like pathology or expert consensus on patient data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document does not describe a machine learning algorithm that requires a training set in the modern sense. It refers to a "graphical planning tool" and "application software" which are likely rule-based or algorithm-driven rather than learned models.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable/Not specified, as no training set for a machine learning model is mentioned.

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The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

Here's a breakdown of the acceptance criteria and study information for the Optical Tracking System (OTS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The text explicitly states: "The results from the OTS are compared to a phantom with targets of known position."

• Sample Size for Test Set: The text does not specify a numerical sample size for the targets on the phantom. It only mentions "targets of known position."
• Data Provenance: The data is generated through testing with a phantom (a physical model with known properties), not clinical patient data. Therefore, it is a simulated/laboratory setting, not retrospective or prospective clinical data from a specific country.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

The ground truth for this device's performance test is established by the known, pre-defined positions of targets on a phantom. Human experts are not involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

Since the ground truth is established by the known positions on a phantom, there is no need for human adjudication of the test results. The device's measurements are directly compared to these known values.

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

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done.

This submission is for an image-guided surgical planning tool, not an AI diagnostic tool. The performance evaluation focuses on the system's accuracy in tracking and localization, not on changes in human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, a standalone performance evaluation was done.

The reported accuracy of "0.3 mm" for the camera array appears to be a standalone measurement of the system's ability to track positions against a known phantom. While the system is intended for use with a surgeon ("human-in-the-loop"), the verification of its core accuracy is performed independently of a surgeon's interpretation or action, by comparing its output to predefined phantom targets. The statement "RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation" describes a standalone evaluation of the device's technical specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth used is based on known, pre-defined positions of targets on a phantom. This is a form of physical/engineering ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a training set. This device is described as an "Optical Tracking System," not a machine learning or AI algorithm that would typically require a training set in the modern sense. Its functionality is based on established principles of optical tracking and geometry.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned or implied for this type of device in the provided text.

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