(181 days)
The Dynamis Robotic Surgical System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on intraoperative CT scans. The Dynamis Robotic Surgical System is indicated for the placement of non-cervical spinal pedicle screws.
The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System.
The Dynamis System is comprised of two computer-controlled robotic arms to support surgical robotic guidance, while a third robotic arm holds and controls the Scout navigation camera. All components are integrated into one physical cart located partially underneath the surgical table.
The Dynamis Robotic Surgical System functions as a stable platform that operates with intraoperative DICOM format images for intraoperative planning and operation. The system software is responsible for all motion, control, navigation, data storage, user management, case management, and safety functions. The navigation and guidance system establishes registration between the virtual patient (points on the patient images) and the physical patient (corresponding to the patient's bony anatomy). The information of the plan, coupled with the registration, provides the necessary information to give visual assistance to the surgeon during freehand navigation or during the robotic alignment of instruments. Navigation can also be achieved without robotic guidance with the proprietary navigation instruments provided with the Dynamis system.
Dynamis is designed and intended to be used with qualified surgical instruments, which are defined as legally marketed instruments that meet pre-specified criteria and that pass the Instrument Setup process, which is an instrument verification test integrated into the Dynamis Robotic Surgical System. To qualify a surgical instrument for use through the Dynacan, it must be legally marketed and meet the following criteria:
- Round
- Straight
- Rigid
- Concentric
In addition, the user must accurately measure the effective length of the instruments using the Dynamis system during the set-up phase.
The navigation-based robotic capabilities of Dynamis are intended for use with a variety of legally marketed, qualified surgical implantation instruments, as the adjustable end effector (Dynacan) is able to mechanically support a wide range of device diameters from 3 mm to 20 mm in diameter, including legally marketed taps and screwdrivers which can be checked and qualified by the user implementing the Dynamis Instrument Setup.
The provided FDA 510(k) clearance letter for the Dynamis Robotic Surgical System (K243326)** does not contain specific acceptance criteria, detailed study results, or the methodology of the studies conducted to prove the device meets these criteria. Therefore, I cannot directly extract the specific information requested in your prompt based on the provided text.
The document primarily focuses on establishing substantial equivalence to a predicate device (EXCELSIUS GPS) and lists the types of non-clinical testing performed. It lists the following categories of testing:
- Non-clinical system and instrument verification and validation testing
- Navigation accuracy verification per ASTM F2554-22
- Quantitative system level accuracy validation in a clinically relevant model
- Software verification and validation per IEC 62304 & IEEE/ISO/IEC 29119-1-2-3-5-2021
- Cybersecurity testing per IEC 62304:2006/AMD 1:2015, IEC 81001-5-1:2021, AAMI TIR57:2016/(R)2023
- Electromagnetic and Electrical Safety testing per IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 80601-2-77:2019, IEC 60601-1-6:2010, IEC 60601-1-8: IEC 60601-1-8:2006, and IEC 60825-1:2014
- Biocompatibility testing per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, ISO 10993-11:2017
- Cleaning and sterilization validation per ANSI/AAMI ISO 17665-1: 2006/(R) 2013, AAMI ST98:2022, AAMI TIR12:2020, AAMI TIR30:2011/(R)2016, EN ISO 17664-1:2021
- Human factors/usability testing per ANSI AAMI IEC 62366-1:2015 & AAMI/ANSI HE75:2009/(R)2018
Without the actual study reports or the full 510(k) submission, it's impossible to populate the specific details you requested.
However, I can provide a template of how one would present this information if it were available, along with some general assumptions based on the listed tests for a robotic surgical system.
Hypothetical Acceptance Criteria and Study Details for the Dynamis Robotic Surgical System
Disclaimer: The information below is hypothetical and illustrative, as the provided FDA 510(k) clearance letter does not contain these specific details. The details provided are common for robotic surgical systems undergoing regulatory review.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Limit (Hypothetical) | Reported Device Performance (Hypothetical) | Test Standard/Method |
|---|---|---|---|---|
| Navigation Accuracy | Translational | $\le$ 1.5 mm (RMSE) | 1.2 mm (RMSE) | ASTM F2554-22 (Navigation Accuracy Verification) / Quantitative System Level Accuracy Validation |
| Rotational | $\le$ 2.0 degrees (RMSE) | 1.8 degrees (RMSE) | ASTM F2554-22 (Navigation Accuracy Verification) / Quantitative System Level Accuracy Validation | |
| Instrument Tracking/Guidance | Dynamic Accuracy | $\le$ 1.0 mm (Max Deviation) | 0.8 mm (Max Deviation) | Non-clinical system and instrument verification and validation testing |
| System Reliability/Stability | Uptime Rate | $\ge$ 99.5% during simulated procedures | 99.8% | Non-clinical system and instrument verification and validation testing |
| Error Rate (Critical) | $\le$ 0.1% of procedures | 0.05% | Software verification and validation | |
| Safety Features | Emergency Stop Response Time | $\le$ 0.5 seconds | 0.3 seconds | IEC 60601-1 (Electrical Safety), Human Factors Testing |
| Usability/ Human Factors | Completion Rate of Critical Tasks | 100% | 100% | ANSI AAMI IEC 62366-1:2015 & AAMI/ANSI HE75:2009/(R)2018 |
| Number of User Errors (Serious) | 0 | 0 | ANSI AAMI IEC 62366-1:2015 & AAMI/ANSI HE75:2009/(R)2018 | |
| Sterilization/Cleaning | Sterility Assurance Level (SAL) | $10^{-6}$ | $10^{-6}$ | ANSI/AAMI ISO 17665-1, AAMI ST98 |
2. Sample Size Used for the Test Set and Data Provenance
Given this is a robotic surgical system primarily for mechanical and software function, "test set" and "data provenance" typically refer to:
- Quantitative Accuracy Testing (e.g., Phantom Studies):
- Sample Size: For navigation and system accuracy, typical sample sizes involve a sufficient number of fiducial markers, simulated surgical targets, and repetitions across various anatomical orientations. For example, N=30 phantom trials with 10 target points each, repeated across 3-5 different system setups.
- Data Provenance: Retrospective (controlled lab environment, using standardized phantoms and test procedures). Country of Origin: Likely where the manufacturer (LEM Surgical AG - Switzerland) conducts its R&D and testing, or designated testing facilities.
- Human Factors/Usability Testing:
- Sample Size: Typically 10-15 representative users (surgeons, surgical technicians) for formative studies, and often 5-8 for summative validation studies per IEC 62366-1.
- Data Provenance: Prospective (simulated use scenarios in a lab environment). Country of Origin: Varies depending on participant recruitment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
For a robotic surgical system, "ground truth" for performance testing (e.g., accuracy) is often established through highly precise metrology equipment rather than human experts, as human measurement is less reproducible and precise than the device's technical specifications require.
- Accuracy Testing:
- Ground Truth Establishment: Specialized precision measuring equipment (e.g., coordinate measuring machines (CMM), optical trackers with certified accuracy) are primarily used.
- "Experts": The operators of such equipment are certified metrologists or engineers with expertise in precision measurement and calibration, often without a specific number defined as "experts" in the clinical sense. Their qualification might be "Certified Metrology Technician" or "PhD in Robotics/Mechanical Engineering with expertise in precision measurement."
- Human Factors/Usability Testing:
- Ground Truth Establishment: Performance metrics (task completion, time to complete, errors) are objectively recorded according to pre-defined usability protocols. "Ground truth" errors or issues are identified through direct observation and user feedback against the intended safe and effective use of the device.
- Experts: Human factors engineers and potentially senior surgeons or surgical nurses oversee and interpret the results.
4. Adjudication Method for the Test Set
- Accuracy Testing: Not applicable in the traditional sense of clinical adjudication. Errors are quantified directly by metrology equipment. Any discrepancies in measurement would be resolved through re-measurement or calibration checks of the measuring equipment.
- Human Factors/Usability Testing: Adjudication is typically internal to the human factors team, reviewing recorded sessions and user feedback against a pre-established list of critical tasks and potential use errors. A consensus method among the human factors engineers and clinical subject matter experts (e.g., lead surgeon PIs involved in the study design) would be used to classify severity and root causes of observed issues, but not usually in a "2+1, 3+1" format.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The provided text for the Dynamis Robotic Surgical System focuses on non-clinical testing and substantial equivalence to a predicate device based on technical characteristics and performance in phantom/lab settings.
MRMC studies are typically performed for diagnostic imaging AI algorithms to compare human reader performance with and without AI assistance on a set of clinical images. A robotic surgical system, while it uses imaging (intraoperative CT), is a procedural device where the primary evaluation is accuracy, safety, and functionality, not diagnostic interpretation. Therefore, an MRMC study is not relevant for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, the Navigation Accuracy Verification (ASTM F2554-22) and Quantitative System Level Accuracy Validation tests represent a form of "standalone" evaluation of the system's core algorithmic and mechanical performance. These tests assess the device's ability to precisely locate anatomical structures and position instruments independent of actual human surgical action beyond setting up the system. The "human-in-the-loop" component for a robotic system like this is often covered under Human Factors testing, which evaluates the interaction between the human user and the system.
7. The Type of Ground Truth Used
- Accuracy Testing: Physical, objective measurements derived from precise metrology equipment against known spatial coordinates or intended trajectories on phantoms/test fixtures. This is a form of "gold standard" truth.
- Usability/Safety Testing: Defined protocols for task completion and identification of user errors. The "truth" is whether the user completed the task safely and effectively as pre-defined by the system's design and intended use.
8. The Sample Size for the Training Set
Not applicable in the context of this 510(k) submission as described.
The Dynamis Robotic Surgical System is a robotic device, likely rule-based or using classical control algorithms, rather than a machine learning (ML) algorithm that requires a "training set" of data in the common AI sense. If there were any ML components for perception (e.g., image segmentation or registration), the training data details would be provided, but the document does not indicate such use. Its function relies on mechanical precision, optical tracking, and control system software rather than learning from a large dataset of past procedures.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reasons stated in point 8.
§ 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).