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510(k) Data Aggregation
(133 days)
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
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as per Safety Summary) |
|---|---|
| Not explicitly defined (e.g., target accuracy, precision thresholds). | Functionality Testing: Rigorously tests the functionality of application software. Verifies capabilities to match and map markers on patient scan and patient. Verifies stereotactic CT and MR localizer transformation equations are correctly encoded. Verifies spatial accuracy of the digitizer. Verifies accuracy of transformations from image space to screen space and screen space to image space. |
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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