(151 days)
The NavioPFS™ System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The NavioPFS™ System is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement.
The NavioPFS™ System is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for the targery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The NavioPFS™ System then aids the surgeon in executing the surgical plan by using a standard off-theshelf surgical drill motor and bur (Anspach/Synthes eMax2 plus (K080802) which has been adapted using a tracking system. The surgical bur is located in a handpiece which allows the bur to move within the handbiece. In the NavioPFSM System the software controls the position of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached the tip of the bur is fully retracted within the guard.
An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping posterior surfaces of the condyle as well as placing post holes.
After the bone is prepared the surgeon is prompted to do a trial range of motion (ROM) test. Data collected using the tibial and femoral trackers is displayed as the knee and limb through a series of flexion, extension and rotational movements. Data is collected from the trackers and displayed in graphical formation is for use by the surgeon in determining fit of the implant (either the trial implant or the final implants after cementing) prior to finalization of the procedure.
The NavioPFS™ Computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and for data line entry, patient and procedure ID. implant ID. step in process and error messages. This data can be archived to a CD upon demand at the end of the procedure.
Here's an analysis of the provided text regarding the NavioPFS™ system's acceptance criteria and studies:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy must be within X mm"). Instead, it describes a series of verification and validation activities designed to demonstrate that the device performs as intended and is as safe and effective as its predicate devices. The "reported device performance" is thus articulated through the successful completion of these tests.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Software Functionality and Reliability | Software code reviews, unit testing, and integration testing were successfully performed, indicating that the software operates as designed. |
| Biocompatibility | Biocompatibility testing was completed, suggesting that the device materials are safe for human contact. |
| Usability and User Proficiency | Clinical simulation (usability testing) in simulated knees (sawbones) and cadaver labs demonstrated that trained users (surgeons, PAs, technical support) could successfully use the system and place implants per specifications. |
| Mechanical/Physical Performance (e.g., Bur Control, Navigation Accuracy) | Bench verification testing was performed, although specific quantitative results are not provided. The system's ability to control bur motion (retraction or speed control) as planned was implied by the successful simulation and cadaver testing. |
| Adherence to International Standards (Safety) | The device complied with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI/ANSI/ISO 11607-1 (packaging materials), ISO 11607-2 (packaging processes), ISO 10993-1 (biological evaluation), and ANSI/AAMI/ISO 11137-2 (sterilization dose), indicating it meets established safety standards. |
| Equivalence to Predicate Devices (Overall Safety and Effectiveness) | Based on the non-clinical testing, the NavioPFS™ was concluded to be "as safe and effective and performs as well as" the MAKO Surgical Robotic Arm Interactive Orthopedic System ("MAKO RIO") (K081867) and The Zimmer (ORTHOsoft) Navitrack® System - OS Unicondylar Knee Universal (K071714). |
Study Details:
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated with specific numbers for each test (e.g., number of sawbones or cadavers). The document mentions "simulated knees (sawbones) and cadaver lab testing."
- Data Provenance: The studies are non-clinical verification and validation tests, not human clinical trials. The provenance would be the test environment (e.g., US-based lab for bench testing and cadaver labs). These were prospective tests performed specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: The document states "Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the NavioPFS™ system." Specific experience levels (e.g., "10 years of experience") are not provided. For cadaver and sawbones testing, the "ground truth" would likely be established by the physical measurements or the known geometry of the prepared bone, and verified by the experienced clinical users performing the procedures.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not described. For non-clinical, performance-based testing, an adjudication method in the context of expert review for ground truth is generally not used in the same way as for diagnostic imaging studies. The "ground truth" for these tests (e.g., whether the bur cut accurately, or if the implant was placed according to specifications) would be determined by objective measurement and successful completion of the surgical steps.
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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:
- No MRMC comparative effectiveness study was done. The submission explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the NavioPFS™ System." The device (NavioPFS™) is a surgical navigation and burring system, not an AI-assisted diagnostic imaging device that involves "human readers."
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The NavioPFS™ System is inherently a "human-in-the-loop" device. Its function is to "assist the surgeon" and control the bur, so a standalone algorithm-only performance test separate from human interaction would not be relevant and was not performed/described. The verification tests (software code reviews, unit testing, integration testing, bench verification) assess the algorithmic and mechanical components, but the overall "performance" is always in the context of aiding a human surgeon.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the non-clinical tests would have been established through:
- Design Specifications/Product Requirements: For software and bench testing, compliance with predetermined functional and performance specifications.
- Physical Measurements/Known Geometries: For sawbones and cadaver testing, the accuracy of bone preparation and implant placement would be measured against the surgical plan or known anatomical landmarks.
- User Assessment: For usability, the ability of trained clinical users to successfully perform procedures and place implants to specification.
- The "ground truth" for the non-clinical tests would have been established through:
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The sample size for the training set:
- Not applicable. This device is a surgical navigation and burring system, not an AI/ML device that requires a distinct "training set" in the sense of supervised learning from labeled data. The system relies on intraoperative data collection and predefined mathematical models/algorithms.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of AI/ML. The device's "knowledge" is based on established anatomical models, surgical planning algorithms, and real-time intraoperative data collection, rather than learning from a labeled training dataset.
§ 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).