(88 days)
ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures.
The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System.
The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.
The ExcelsiusFlex™ is a robotic positioning system with a computer controlled robotic arm, hardware and software that works in conjunction with ExcelsiusHub™ , to enable real time surgical navigation and robotic guidance using patient tracking arrays and a positioning camera. The system assists the surgeon in implant placement planning and intraoperative tracking of patient anatomy by locating anatomical structures and stereotaxic positioning of surgical instruments relative to patient CT images or directly acquired anatomical structures. The navigation and quidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy), or directly acquired anatomical structures. Once this reqistration is created, the software positions the robotic arm on a planned resection plane.
The ExcelsiusFlex™ is intended for stereotaxic surqery in surgical knee procedures to assist the surgeon in spatial positioning and orientation of a sagittal sawblade, planning the position of the femoral and tibial implants, and for bone preparation during total knee arthroplasty (TKA) procedures. The system constrains the position of the robotic arm to planned resection planes based on the pre-operative or intra-operative plans developed using ExcelsiusFlex™-TKA software on either the ExcelsiusHub™ or a planning laptop.
ExcelsiusFlex™ instruments consist of patient tracking instruments, patient attachment instruments, navigation instruments, end effectors and end effector instruments. Patient attachment instruments provides a point of rigid fixation for the patient tracking instruments. Patient tracking instruments and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. End effectors attach to the distal end of the robotic arm and provide a rigid connection to the saw blade.
The provided text discusses the ExcelsiusFlex™ medical device and its clearance by the FDA. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets those criteria, such as a clinical performance study with specific quantitative metrics.
Instead, the document focuses on:
- Regulatory Clearance (510(k) Summary): It states that the device is "substantially equivalent" to predicate devices based on technological characteristics, performance, and intended use.
- Verification and Validation Testing: It lists the types of testing performed (non-clinical, surgical simulations, cadaveric quantitative/qualitative validation, electrical safety, EMC, software V&V) but does not provide the results or specific acceptance criteria met by these tests.
- Safety and Standards Compliance: It mentions compliance with various IEC standards related to electrical safety, EMC, usability, and software lifecycle.
Therefore, many of the requested details cannot be extracted directly from the provided text. Based on the information available, here's what can be provided:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in a readily extractable table format for clinical efficacy. The discussion of "substantial equivalence" implies that performance is comparable to predicate devices but no specific quantitative thresholds are provided.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance (Quantified) | Comments / Source of Information |
|---|---|---|
| Clinical Efficacy | ||
| (e.g., accuracy of navigation, precision of bone resection, success rate) | ||
| (Criterion not explicitly stated) | Not explicitly provided in quantitative terms. | The device is deemed "substantially equivalent" to predicates, implying similar performance. The document only lists types of V&V testing, not results with acceptance thresholds. |
| Electrical Safety | Compliance with IEC 60601-1:2020 | Stated as "Testing was performed to assure compliance." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 | Stated as "Testing was performed to assure compliance." |
| Usability | Compliance with IEC 60601-1-6:2020 and IEC 62366:2020 | Stated as "Testing was performed to assure compliance." |
| Software Quality | Compliance with IEC 62304:2015 and FDA Guidance for Software | Stated as "Software validation and verification testing was performed in accordance with..." |
| Design Inputs / User Needs | Not explicitly quantified. | "Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs." No specific metrics provided. |
Study Details (Based on provided text)
Since no full clinical study details with quantitative results are provided, many of these sections will indicate "Not provided in the text."
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Surgical simulations conducted on bone models" and "Cadaveric quantitative validation under clinically relevant scenarios" are mentioned. However, the specific number of bone models or cadavers used is not provided.
- Data Provenance: Not explicitly stated for the testing mentioned, but cadaveric studies typically involve human cadaveric specimens. The origin (e.g., country) is not provided. The mention of "pre-operative images" and "pre-op CT-based patient registration" for the device's operation implies that patient data is processed, but details for actual test sets are scarce. It's unclear if the testing was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not provided.
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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:
- The document describes a robotic positioning system and navigation aid, not an AI interpretation device for human "readers." Therefore, a traditional MRMC study comparing human readers with and without AI assistance is not applicable to this device in the context of the provided text. The device "assists the surgeon" but the nature of this assistance isn't described as AI-based interpretation for a human reader.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device is a "robotic positioning system" and "surgical navigation and robotic guidance" system. It is explicitly stated as "intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons," and "to assist the surgeon." This strongly implies a human-in-the-loop system. While components might operate autonomously (e.g., the robotic arm positioning itself), the overall performance as described is not a standalone, algorithm-only performance without human-in-the-loop.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "surgical simulations conducted on bone models" and "cadaveric quantitative validation," the ground truth would likely be established through highly precise measurement devices (e.g., metrology, optical trackers, CMMs) or anatomical landmarks verified by anatomical experts. However, the specific type of ground truth (e.g., expert consensus for image segmentation, direct physical measurement, etc.) is not explicitly detailed for each test.
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The sample size for the training set:
- The document describes verification and validation testing for performance and regulatory clearance. It does not explicitly mention a "training set" in the context of machine learning or AI model development testing. Therefore, relevant sample size for a training set is not provided.
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How the ground truth for the training set was established:
- As no "training set" for an AI model is explicitly mentioned, the method for establishing its ground truth is not provided.
§ 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).