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510(k) Data Aggregation
(92 days)
Medtech S.A.S
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. It provides quidance of any surqical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touchscreen positioned close the operating table. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate quidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the ROSA ONE Brain application, a robotized image-guided device for neurosurgery. It's an FDA 510(k) submission seeking substantial equivalence to a previously cleared version of the same device. The submission focuses on non-clinical performance data to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for each test in a formal table with pass/fail. However, it does outline the tests performed and the results, implying that the predicate device's performance levels define the acceptance criteria for the new version. The most specific performance metric provided is for accuracy.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System applicative accuracy (In vitro) | Robot arm positioning accuracy |
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(128 days)
Medtech S.A.S
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. lt provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touch screen. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the 510(k) summary for the ROSA ONE Brain Application (K214065), a robotized image-guided device assisting in brain surgeries. The document highlights the substantial equivalence of the new version (v.3.1.6.0) to its predicate device (v.3.1.3.2) (K200511).
However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and equivalence. Instead, it refers to performance testing completed for the predicate device and states that the subject device was evaluated against that predicate testing and determined to be "substantially equivalent."
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those criteria directly from the provided text, as the document explicitly states: "All validation was performed based on non-clinical performance tests." and "Clinical data were not required to support the safety and effectiveness of ROSA ONE Brain application."
Based on the provided document, here's what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents the following performance data as part of the summary, largely relying on the predicate device's testing and then asserting equivalence for the new device. It does not explicitly state "acceptance criteria" but rather "results" from testing.
| Acceptance Criteria (Implied from Results) | Reported Device Performance and Remarks |
|---|---|
| Biocompatibility: | Conformity with FDA guidance document Use of International Standard ISO 10993-1. |
| Electrical Safety and EMC: | Compliance with IEC 60601-1 and IEC 60601-1-2 standards and FDA EMC guidance. |
| Software Verification and Validation: | Satisfaction of FDA guidance for Software in Medical Devices and IEC 62304 standard. Software considered "major" level of concern. |
| Cleaning- and Sterilization Validation: | Compliance with FDA guidance "Reprocessing of Reusable Medical Devices," ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. |
| System Applicative Accuracy (In vitro testing): | Robot arm positioning accuracy |
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(88 days)
Medtech S.A.
The device is intended for the spationing and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-quided device that assists the surgeon during brain surgeries. It provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touch screen. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 5.1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the ROSA ONE Brain application and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for a diagnostic algorithm).
Instead, this document focuses on demonstrating substantial equivalence based on engineering and quality control tests rather than clinical performance of an AI algorithm making diagnostic or treatment recommendations. The "performance data" section primarily discusses electrical safety, EMC, software verification, and biocompatibility, along with a statement about system applicative accuracy derived from the predicate device's testing.
Given the information provided, here's a breakdown of what is and is not available in the document regarding your request:
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "performance data" that could be interpreted as a performance criterion is the "System applicative accuracy."
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Inherited from Predicate) |
|---|---|
| Robot arm positioning accuracy |
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(78 days)
MEDTECH S.A.
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
The subject ROSA ONE Spine application is identical to the most recent clearance (K182848) with the exception of an additional calibration step (software) and stand-alone arrays (instrumentation).
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of two stands positioned around the operating table:
- a robot stand with a compact robot arm and a touchscreen .
- a camera stand with an optical navigation system and a touchscreen .
Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| System Applicative Accuracy (In vitro testing) | Robot arm positioning accuracy |
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(164 days)
Medtech S.A.
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or screws on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of two stands positioned around the operating table:
- a robot stand with a compact robot arm and a touchscreen .
- . a camera stand with an optical navigation system and a touchscreen
Different types of instruments may be attached to the end of the robot arm and changed according to the intended surgical procedure.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the ROSA ONE Spine application, a robotized image-guided device intended to assist surgeons during spine surgeries. The information focuses on its substantial equivalence to a predicate device (ROSA SPINE, K151511) and the non-clinical performance data supporting this claim.
Here's an analysis of the acceptance criteria and study proving device performance, based only on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Directly Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Robot arm positioning accuracy |
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(155 days)
MEDTECH S.A.
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries.
It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of a robot stand with a compact robotic arm and a touch screen.
Different types of instruments may be attached to the end of the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 5.1 for the placement of recording electrodes.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The ROSA ONE Brain Application device is a robotized image-guided device that assists neurosurgeons during brain surgeries by providing guidance for instruments.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| System Applicative Accuracy (In vitro) | Robot arm positioning accuracy |
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(226 days)
MEDTECH S.A.
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
The ROSA BRAIN device is a robotized platform providing guidance of any neurosurqical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle). The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed. The touch screen ensures the communication between the device and its user by indicating the actions to be done as well as by offering various commands. ROSA BRAIN is an image-quided device that assists the surgeon in planning the position of instruments or implants on preoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning. An image acquisition of the patient's head (MRI / CT images) is performed prior to surgery and loaded into the device. In the preoperative phase, the surgeon carries out the surgical planning on the patient images using the device software. The desired surgical parameters for positioning of the surgical instruments are defined (for example: target point, entry point and instrument lenath). During surgery, the device provides accurate and rigid guidance of the required instrument according to the previously completed planning. The optical distance sensor used with the ROSA BRAIN is susceptible to Electrostatic Discharge (ESD). The ROSA BRAIN device is intended to be used with anti-static sterile drapes which are designed for the device and listed in the list of compatible devices. The anti-static sterile drapes are mitigations to ROSA Brain device ESD immunity.
The provided text is a 510(k) summary for a medical device called ROSA BRAIN (v3.0.0.5), a computer-assisted surgical device (stereotaxic instrument). This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device (ROSA BRAIN v3.0.0.0).
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than setting new, specific acceptance criteria for this version's performance at a detailed algorithmic level. The performance data provided are primarily for safety and general functional aspects, and a key 'performance' metric mentioned is system applicable accuracy.
| Test Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Performance demonstrated to be substantially equivalent to the predicate device. Specific numerical targets for accuracy are given for the predicate and are implicitly the acceptance criteria for the new device. | - Robot arm positioning accuracy: |
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(214 days)
MEDTECH S.A.
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach
ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.
ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.
While the provided document is a 510(k) premarket notification for the ROSA Spine device, it primarily focuses on establishing substantial equivalence to predicate devices rather than detailing a specific clinical study with detailed acceptance criteria and ground truth establishment for a diagnostic or AI-driven medical device. The ROSA Spine is described as a computer-controlled electromechanical arm for surgical guidance, not a device that makes diagnoses or predictions based on medical images in the way an AI algorithm might.
Therefore, many of the requested details, particularly those related to "AI improvement," "multi-reader multi-case studies," "ground truth establishment," and "training sets" are not applicable or explicitly stated for this type of surgical guidance system's 510(k) submission.
However, I can extract the relevant performance data and address the questions to the best of my ability based on the provided text, making it clear where the information is not present or not applicable.
Here's an attempt to answer your questions based on the provided document:
Device: ROSA Spine (a computer-controlled electromechanical arm for spinal surgical guidance)
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present these as "acceptance criteria" in a formal table with pre-defined thresholds the way an AI or diagnostic device might. However, it does provide performance metrics tested and reported for the device and its predicates. I will interpret "acceptance criteria" as the performance levels achieved that demonstrate equivalence and safety/effectiveness for this type of device.
| Performance Metric | Acceptance Criteria (or equivalent reported predicate performance) | Reported Device Performance (ROSA Spine) |
|---|---|---|
| Robot Absolute Accuracy |
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(212 days)
MEDTECH S.A.
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
The ROSA Brain device is a robotized platform providing guidance of any neurosurgical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle). The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed. ROSA Brain is an image-guided device that assists the surgeon in planning the position of instruments or implants on preoperative or intraoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning.
The provided document is a 510(k) premarket notification for the ROSA Brain device. It does not describe a study proving the device meets specific acceptance criteria in the context of diagnostic or AI performance.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ROSA Surgical Device K101797) based on technological characteristics and non-clinical performance data, primarily related to safety, electrical compatibility, and software validation.
Therefore, many of the requested items (e.g., table of acceptance criteria vs. reported performance, sample sizes for test/training sets, expert ground truth, MRMC study, standalone performance) are not applicable or extractable from this specific document, as it pertains to a different type of device clearance (stereotaxic instrument rather than an AI/diagnostic device).
Here's a breakdown of what can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of quantitative performance acceptance criteria with corresponding device results in the way it would for an AI or diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). The "performance data" provided relates to compliance with standards and successful software verification/validation.
| Acceptance Criteria (related to general device function/safety) | Reported Device Performance |
|---|---|
| Biocompatibility requirements met (ISO-10993) | Met |
| Electrical safety (IEC 60601-1) | Complied |
| Electromagnetic compatibility (IEC 60601-1-2) | Complied |
| Software Verification & Validation (FDA Guidance, IEC 62304) | Verification activities performed, conformity with user needs/intended use |
| Mechanical and Acoustic Testing (general function) | Not explicitly detailed in criteria/results but implied by device description and predicate comparison |
2. Sample Size for the Test Set and Data Provenance:
Not applicable in the context of an AI/diagnostic test set. The document refers to "software tests" and "verification tests," but these are functional and safety tests, not performance evaluations against a labeled dataset for an AI algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of an AI/diagnostic test set. The device is a surgical guidance robot, not an AI diagnostic tool requiring expert-labeled ground truth for performance evaluation.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states: "The 510(k) does not contain clinical information for the ROSA Brain." and "The 510(k) does not contain animal study test results for the ROSA Brain." An MRMC study would fall under clinical information.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable for a surgical robotic system. The device is inherently "human-in-the-loop," assisting a surgeon. Its performance is evaluated through functional metrics and its ability to accurately position instruments, not as a standalone diagnostic algorithm.
7. The Type of Ground Truth Used:
For the software verification and validation, the "ground truth" would be the predefined functional requirements and expected outputs of the software modules. The "Conformity of software with the user needs and intended use of the device" serves as the ultimate validation.
For the mechanical and electrical performance, the ground truth is the established standards (e.g., IEC 60601-1) and the physical measurements/outputs of the device to ensure it meets specifications (e.g., accuracy of positioning).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI model that undergoes "training" on a dataset in the conventional sense. The "training" in this context would be the development and testing of the software and hardware components following engineering principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there's no "training set" in the context of an AI algorithm. The validation of the device's components and system is against design specifications, functional requirements, and established safety/performance standards. The "ground truth" for each specific test during development and verification would be defined by those specifications and the expected, correct behavior or output.
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(117 days)
MEDTECH S.A.
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
The ROSA Surgical Device is a computer-controlled electromechanical arm intended for the spatial positioning and orientation of an instrument holder or tool guide in neurosurgery. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial marker registration.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance. | "Device performance tests were performed to validate the accuracy and repeatability of the device." |
| Repeatability | Not explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance. | "Device performance tests were performed to validate the accuracy and repeatability of the device." |
| Electrical Safety | Compliance with IEC 60601-1 standard for electrical safety. | "Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety..." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 standard for electromagnetic compatibility. | "...and IEC 60601-1-2 standard for electromagnetic compatibility." |
| Software Regulations | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process). | "Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process)." |
2. Sample Size and Data Provenance
The provided text does not explicitly state a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Device performance tests were performed," but no details on the specifics of these tests are given.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not specify the number or qualifications of experts used to establish ground truth for any testing.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The submission focuses on the performance of the device itself, not on human-in-the-loop performance or the effect size of AI assistance on human readers.
6. Standalone Performance Study
Yes, the information implies a standalone (algorithm only without human-in-the-loop performance) study was done. The "Device performance tests" focused on validating the "accuracy and repeatability of the device" itself, suggesting an evaluation of the system's inherent performance.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, given the nature of a computer-controlled electromechanical arm for spatial positioning and orientation, it is highly likely that the ground truth for "accuracy and repeatability" would be established through precision measurements and validated spatial references within a controlled environment, rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.
8. Sample Size for the Training Set
The provided text does not state the sample size for the training set. It refers to "pre-operative planning developed with three-dimensional imaging software," which would require data for algorithm training, but no details are given.
9. How Ground Truth for the Training Set Was Established
The provided text does not describe how ground truth for the training set was established. The device uses "fiducial markers registration" and "three-dimensional imaging software" for planning, which implies that the training data would be related to accurate spatial mapping and image processing, but the method of establishing their ground truth is not detailed.
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