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510(k) Data Aggregation
(114 days)
The Scopis Extended Instrument Set EM is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to the following ENT procedures:
- Transsphenoidal access procedures;
- Intranasal procedures:
- . Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies:
- . ENT related anterior skull base procedures.
The Scopis Extended Instrument Set EM is a set of accessories for the Scopis Hybrid Navigation Unit EM and is intended to localize the patient, track the position of the patient, display the position of navigated instruments on a model of the patient's anatomy based on preoperative images (CT or MRI) using electromagnetic tracking technology. The position of the instruments and the patient are localized within an electromagnetic field produced by a field generator. The navigation of instruments relative to the patient's anatomy is established via registration of the patient's anatomy to the image set via fiducial markers, anatomical landmarks, or surface matching. The position of navigated instruments is then displayed on the model from the image set.
The Scopis Extended Instrument Set EM consists of:
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- Navigation Software (NOVA AR)
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- Navigated instruments with integrated localizers
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- Patient tracker with integrated localizer
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- Non-tracked accessories for mechanical fixation
The Scopis Extended Instrument Set EM is a set of accessories for the Scopis Hybrid Navigation Unit EM, intended to localize the patient, track the position of the patient, and display the position of navigated instruments on a model of the patient's anatomy based on preoperative CT or MRI images using electromagnetic tracking technology.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate devices) | Reported Device Performance (Scopis Extended Instrument Set EM) |
|---|---|
| Fiagon predicate K133573: Navigation Accuracy of 0.9 mm ± 0.34 mm (for Precision Pointer equivalent) | Scopis Hybrid Navigation System EM (K161491) Navigation Accuracy (Precision Pointer EM): 0.49 mm ± 0.27 mm |
| Fiagon predicate K141456: Bench Accuracy of 0.7 mm to 1.2 mm ± 0.29 mm to 0.42 mm (for Registration pointer equivalent) | Scopis Extended Instrument Set EM Bench Accuracy (Registration pointer EM-D): 0.64 mm ± 0.27 mm |
2. Sample Size Used for the Test Set and Data Provenance:
The document only states "bench testing of the navigation accuracy was performed". It does not specify the sample size (number of measurements or trials) for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The ground truth for the test set appears to be based on physical measurements of navigation accuracy on a test bench, not on expert consensus of medical images.
4. Adjudication Method for the Test Set:
Not applicable. The "study" appears to be a bench test involving physical accuracy measurements, not a human-adjudicated test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing for navigation accuracy, not a study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the described performance testing is a standalone assessment of the device's accuracy. The "bench testing of the navigation accuracy" assesses the algorithm and hardware's ability to precisely track and display instrument positions, independent of a human operator's performance in a surgical setting.
7. Type of Ground Truth Used:
The ground truth used for the performance testing was physical measurements of navigation accuracy. This likely involves comparing the device's reported position of an instrument to its actual physical position, as measured by a highly accurate reference system on a test bench.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size for a training set. This is a medical device clearance, and the focus is on the safety and effectiveness of the device as a whole, not specifically on the details of an AI model's training if one were present as a distinct component. The "Navigation Software (NOVA AR)" is listed, but its development methodology (e.g., if it uses machine learning and thus a training set) is not detailed.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information on how ground truth for a training set was established. As mentioned in point 8, details about the software's development, especially if it involved machine learning requiring a training set, are not present in this document.
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(126 days)
The CARTO® ENT System is intended for use during intranasal image-guided navigation procedures for patients who are eligible for sinus procedures.
The CARTO® ENT System is intended as an aid for precisely locating anatomical structures during intranasal and paranasal image-guided navigation procedures.
The CARTO® ENT System is intended to be used during intranasal and paranasal surgical procedures to help ENT physicians to track and display the real-time location of the tip of navigated instruments relative to pre-acquired reference images, such as CT. The CARTO® ENT device enables ENT physicians to access sphenoid, frontal, and maxillary sinuses by using the system magnetic tracking technology. The system incorporates a Navigation Console, Field Ring, Instrument Hub, Patient Tracker, Workstation and accessories. A magnetic field generated by the Field Ring induces a current in the magnetic sensor embedded in the tip of the flexible navigated tool, which helps to accurately calculate the tool tip position. A CT image is imported and registered to the patient coordinates and a tool tip icon is displayed on top of the registered image, indicating the position of the tool in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the navigation procedure.
The CARTO ENT System is an image-guided surgery system. The information provided describes the acceptance criteria and study proving its performance.
1. Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Fiagon Navigation System) | Reported Device Performance (CARTO® ENT Navigation System) |
|---|---|---|
| Bench test location accuracy | 0.9 mm (Standard deviation 0.34 mm) | 0.55 mm (Standard deviation 0.7 mm) |
| Simulated Use Accuracy | 1.79 mm (Standard deviation 0.4 mm) | 0.63 mm (Standard deviation 0.2 mm) |
| Location update rate | 15 to 45 Hz | 10 Hz |
2. Sample size used for the test set and data provenance
The document does not specify an exact "test set" sample size or data provenance in terms of country of origin or whether it was retrospective or prospective for the accuracy tests.
- Bench Test Location Accuracy: The test involved comparing the CARTO® ENT System's electromagnetic locations to those provided by a "very accurate robot system over the entire navigation volume." No specific sample size (e.g., number of measurements) is given.
- Simulated Use Accuracy: This involved performing "a complete CT image registration and instrument navigation workflow." Again, no specific sample size (e.g., number of simulated procedures or measurements) is provided.
- Pre-clinical (cadaver) tests: These were conducted to mimic surgical procedures "in a simulated clinical environment." No sample size (number of cadavers or procedures) is specified.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided. The accuracy tests rely on a "very accurate robot system" for bench accuracy and the overall system workflow for simulated use, rather than expert-established ground truth in the traditional sense of medical image interpretation. For pre-clinical cadaver tests, qualitative estimation of clinical accuracy was performed, but no details on expert involvement or qualifications are given.
4. Adjudication method for the test set
This information is not explicitly provided. Given the nature of the bench and simulated use accuracy tests (comparison to a robot system or workflow performance), an "adjudication method" as typically applied in human reader studies would not be directly applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
An MRMC comparative effectiveness study was not done. The document states, "Clinical data was not necessary for the CARTO® ENT System."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance tests described (Bench test location accuracy, Simulated Use Accuracy) primarily evaluate the device's intrinsic capabilities and accuracy as an algorithm/system standalone. While a human operates the system during simulated use, the focus is on the system's ability to track and display positions accurately. The "pre-clinical (cadaver) tests" involved a human performing a sinuplasty procedure workflow, but the evaluation of "system clinical accuracy" was qualitative, and the primary accuracy metrics come from controlled technical tests.
7. The type of ground truth used
- Bench test location accuracy: Ground truth was established by a "very accurate robot system."
- Simulated Use Accuracy: Ground truth seems to be derived from the "complete CT image registration and instrument navigation workflow" itself, implying a reference standard within the controlled simulation.
- Pre-clinical (cadaver) tests: The "ground truth" for these tests was for "qualitatively estimate the system clinical accuracy" rather than a defined, measurable anatomical truth.
8. The sample size for the training set
This information is not provided. The document describes a medical navigation system, and while it involves software, there's no mention of an "algorithm training set" in the context of machine learning, which is typically where a training set sample size would be relevant. The system's functionality is based on electromagnetic tracking technology, not explicitly on a learned model from a training data set described here.
9. How the ground truth for the training set was established
This information is not provided as a "training set" is not mentioned in the context of this device's validation.
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(137 days)
The KARL STORZ NAV 1 electromagnetic navigation system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures under visual control. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to radiological image data or digitized landmarks of the anatomy.
The NAV1 Electromagnetic is an intraoperative image guided localization system that links a navigated instrument tracked by an electromagnetical sensor to a virtual computer image space on a patient's preoperative diagnostic image data set (CT or MRI). The system is intended to be used as a positioning aid for navigation in ENT stereotactic surgery, including but not limited to the endoscopic surgery. The NAV1 Electromagnetic is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the radiological imaging-based model of the anatomy (CT or MRI). Surgical procedures include but are not limited to the following: maxillary antrostomies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, extensive sino-nasal polyposis, frontal sinusotomies, intranasal procedures, intranasal tumor resections, otologic surgery, and extracranial skull base diseases.
The provided text describes the Karl Storz NAV1 Electromagnetic Navigation System (K161555) and its performance characteristics. However, it does not include specific acceptance criteria with numerical thresholds, nor does it detail a study that explicitly proves the device meets such criteria in terms of diagnostic performance or clinical outcomes.
Instead, the document focuses on:
- System Verification and Validation: Ensuring the device functions as intended and does not introduce new safety or effectiveness concerns.
- Bench Testing: Evaluating accuracy, time accuracy, and user acceptance.
- Biocompatibility Testing: Ensuring patient-contacting components are safe.
- Electrical Safety and EMC Testing: Conforming to relevant electrical and electromagnetic compatibility standards.
- Software Verification and Validation: Following FDA guidance for software in medical devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not present in the provided document.
Here's a summary of what can be extracted or inferred from the text:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1, FDA Guidance) | Passed all tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity). "The biological-toxicological safety of the patient is not affected by the materials used in the tested items." |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1 standards. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 standards. |
| Software Verification & Validation | Documentation provided as recommended by FDA guidance for "moderate" level of concern software. (Implies satisfactory performance, but no specifics given). |
| Bench Testing (Specific Criteria Not Quantified) | Evaluation of the accuracy of electromagnetically tracked instruments (before and after Reprocessing): Performed to ensure no new issues of safety or effectiveness. (No specific accuracy metric or threshold reported). Evaluation of time accuracy of the ENT Navigation Software: Performed to ensure no new issues of safety or effectiveness. (No specific time accuracy metric or threshold reported). User acceptance testing: Performed to ensure no new issues of safety or effectiveness. (No specific user acceptance metrics reported). |
| Cleaning and Sterilization Efficacy | Demonstrated "sterility assurance level of 10⁻⁶" for specific steam and V-PRO® sterilization cycles. Manual cleaning effectiveness demonstrated with "sufficient recovery efficiency for residual protein and residual hemoglobin." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document refers to "system verification and validation testing," "bench testing," and "biocompatibility testing," but does not provide details on the number of units or cases tested for any of these.
- Data Provenance: Not specified. Given the nature of the device (surgical navigation system), the "bench testing" would likely involve laboratory setups, while biocompatibility testing would be conducted on materials. The document does not mention any clinical data or specific geographical origin for the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe studies that involve expert-established ground truth for diagnostic accuracy, as it is a navigation system and not a diagnostic device in the traditional sense. The testing focuses on system performance, safety, and functionality.
4. Adjudication method for the test set:
- Not applicable as there is no mention of expert-adjudicated performance studies in the provided text.
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. The device is a surgical navigation system, not an AI-assisted diagnostic tool for "human readers." No MRMC study is mentioned. The document states, "Animal and Clinical performance data are not required to demonstrate substantial equivalence for this type of device."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a "standalone" system in operation (the algorithm provides the navigation aid without a separate "human-in-the-loop performance" study described here for its accuracy). The bench testing mentioned relates to the algorithm's performance (e.g., accuracy of tracked instruments, time accuracy of software). However, the document doesn't explicitly delineate "standalone" performance from integrated system performance.
7. The type of ground truth used:
- For biocompatibility: Laboratory standards and chemical/biological analysis results (e.g., cytotoxicity assays, irritation indices).
- For electrical safety and EMC: Compliance with international standards (IEC 60601-1, IEC 60601-1-2) implies validation against the requirements defined by these standards.
- For software verification and validation: Likely internal specifications, functional requirements, and error detection/prevention.
- For bench testing (accuracy): Likely comparison against known physical reference points or highly accurate measurement systems (e.g., a "true" position established by a more precise measurement device to verify the electromagnetically tracked instruments). No specific type of ground truth is explicitly stated beyond "verification and validation testing."
8. The sample size for the training set:
- Not applicable. The document describes a "traditional premarket notification submission" for a navigation system, not a machine learning or AI-based diagnostic tool that would typically involve a separate "training set" in the context of image analysis. The software validation is for system functionality, not for learning from data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or machine learning components requiring ground truth establishment in this context.
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(336 days)
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection)
- Skull Base Procedures
- Cranial Biopsies
- General Catheter Shunt Placement
The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. For cranial procedures, the use of this device is restricted to rigid fixation with a patient reference localizer attached directly to the skull clamp. The position of the instrument with integrated sensor and the patient referencing localizer (attached to the skull clamp) are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.
The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching.
Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.
The device Fiagon Navigation System utilizing similar technology than the proposed device has been previously cleared for a different intended use. This device is listed as a reference device.
The components of the navigation system are
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- Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
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- Navigation sensor (Headrest with field generator)
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- Navigation instrument
- Patient reference localizer (with fixation of the localizer on the skull clamp using the adhesive pad)
The navigation unit is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) is imported to the system by means of CD-ROM. USB storage media or LAN network and displayed in appropriate way (defined by the software).
The navigation unit compromises the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient reference localizer and the navigation instrument.
Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.
The patient reference localizer is fixed to the skull clamp and references the patient's anatomy, while the instrument is tracked in relation to the patient reference localizer and thus to the patient's anatomy.
Here's a breakdown of the acceptance criteria and study information for the "Fiagon Navigation System" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Accuracy) | Reported Device Performance (Bench Accuracy) |
|---|---|
| Position Mean: < 2mm | Mean Positional Error: < 2mm |
| Angular: Mean < 2° | Mean Angular Error: < 2 degrees |
2. Sample Size for Test Set and Data Provenance
The document mentions "Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism." However, it does not specify the sample size used for the test set (e.g., number of measurements, number of trials, or number of phantom setups).
The data provenance is from bench testing, meaning it was conducted in a controlled laboratory environment rather than on human subjects. The country of origin of the testing is not explicitly stated, but the company, Fiagon GmbH, is based in Germany. The study is a prospective test in the sense that the device was specifically designed and then tested to meet these criteria.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set. Bench testing typically relies on metrology equipment to define ground truth.
4. Adjudication Method
The document does not mention an adjudication method as it relates to expert review. For bench testing, the "adjudication" is typically the comparison of the device's output against a known, highly accurate reference measurement performed by the testing equipment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study primarily focuses on the interpretation and decision-making of human readers, which is not applicable to an image-guided navigation system's direct performance. The document focuses on the technical accuracy and precision of the device itself.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The entire "Performance Data" section describes bench tests performed on the device (the algorithm and hardware) to determine its precision and accuracy, without human interpretation or intervention in the measurement process. "Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism."
7. Type of Ground Truth Used
The ground truth for the bench accuracy tests was established using technical measurements and co-ordinate measurement systems. For example, the document states: "measurement of technical accuracy with co-ordinate measurement system followed by measurement of positional and angular accuracy without registration to measure the angular accuracy of the instrument itself."
8. Sample Size for Training Set
The document does not mention a training set or its sample size. Image-guided navigation systems like the Fiagon Navigation System are typically engineered with deterministic algorithms and robust calibration methods, rather than being "trained" in the machine learning sense with large datasets. Their performance is validated through precision and accuracy testing against known physical benchmarks.
9. How Ground Truth for Training Set Was Established
Since a "training set" in the machine learning context is not mentioned or implied for this device, the question of how its ground truth was established is not applicable. The system's underlying principles are based on electromagnetic tracking and geometry, rather than data-driven learning from a labeled training set.
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(128 days)
The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access.
The Fiagon Navigation - Extended Instrument Set ENT are reusable instruments intended to be used with the Fiagon Navigation system. The instruments in the Set are electromagnetically navigated devices that are
- Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
- b. Navigated pointing devices (flexible, sensor within the tip)
- c. Registration probe (designed for non.sterile patient registration)
- d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)
Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
Here's a breakdown of the acceptance criteria and study information for the Fiagon Navigation - Extended Instrument Set ENT, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a numerical target format (e.g., "accuracy must be less than X mm"). Instead, it compares the device's performance to that of its predicate devices. The implied acceptance criterion is that the new device's accuracy should be comparable to or better than the predicate devices, specifically remaining under 2mm at the 95% confidence level.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Navigational Accuracy (95% Confidence Level) < 2 mm (based on predicate performance) | < 2 mm (All 95% confidence levels for different instruments) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "different instruments" were tested, but doesn't quantify how many instances or repetitions were performed per instrument or for the entire set.
- Data Provenance: The study was "Bench testing," indicating it was conducted in a laboratory setting. The location of the testing is not specified, but the applicant is based in Germany. The data is retrospective in the sense that it's a post-design performance evaluation, but not observational or collected from real-world clinical patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. This was bench testing against a known, controlled physical target, not a subjective interpretation task requiring expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was established by the physical setup of the bench test (e.g., precise measurement of actual position vs. navigated position), not through expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done. This device is a surgical navigation instrument, and the performance assessment described is related to its mechanical and electromagnetic tracking accuracy, not a diagnostic imaging interpretation task requiring human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, the described "Bench testing" is a form of standalone performance evaluation. It assesses the device's inherent accuracy in tracking and displaying positions without direct human surgical intervention in a real patient. The navigation system's software and hardware (including instruments) performance are tested in a controlled environment.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by precise physical measurements in a controlled bench test environment. This likely involved highly accurate measurement tools to determine the true position of the instrument's tip, which was then compared to the position reported by the navigation system.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a navigation device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibration and internal algorithms, which are developed and refined by the manufacturer, but not typically referred to as a "training set" in the context of regulatory submissions like this unless it's a new AI algorithm component.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a traditional training set for an AI algorithm. The device's internal calibration and algorithmic parameters would have been established during its development and manufacturing processes using engineering principles and testing against known physical standards.
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