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510(k) Data Aggregation
(23 days)
ExcelsiusGPS® 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 to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
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 or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
Subject ExcelsiusGPS® instruments consist of array sleeve adapters and surgical instruments, including drivers, drills, taps, and probes, that may be used manually or navigated with the use of ExcelsiusGPS® or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.
The provided document is a 510(k) premarket notification for the ExcelsiusGPS® Instruments, specifically for additional instruments to be used with the existing ExcelsiusGPS® or ExcelsiusHub™ systems for navigating and/or guiding compatible surgical instruments for the placement of spinal and orthopedic bone screws.
There is no mention of an AI/ML component in this document. The device is a set of surgical instruments (array sleeve adapters, drivers, drills, taps, probes) that can be used manually or navigated with the existing ExcelsiusGPS® or ExcelsiusHub™ systems. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI algorithms, test set sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
The "Performance Testing" section describes verification tests including "instrument integration and comparison to the predicate devices" to confirm the instruments meet performance requirements. However, specific acceptance criteria and the results of these tests are not detailed in this summary. Biocompatibility was also confirmed by using materials consistent with predicate devices.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and study details because the document does not indicate that the ExcelsiusGPS® Instruments or its associated systems utilize AI/ML technology subject to such evaluation.
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(183 days)
The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.
The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. The navigation 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). Once this registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.
The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include guidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.
1. A table of acceptance criteria and the reported device performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Position | < 1.5mm (Mean) | Not explicitly stated as a single value for mean, but 99% CI is ≤ 2mm. |
| Position | ≤ 2mm (99% CI) | ≤ 2mm |
| Angle | < 2.0° (Mean) | Not explicitly stated as a single value for mean, but 99% CI is ≤ 2°. |
| Angle | ≤ 2° (99% CI) | ≤ 2° |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample size for the "human cadaveric quantitative validation" study or the "surgical simulations conducted on phantom models cranial sawbone models." It mentions "phantom models cranial sawbone models" and "human cadaveric quantitative validation under clinically relevant scenarios." The provenance of the data (country of origin, retrospective/prospective) is not specified.
3. 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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth or evaluating device performance.
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
No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The device is a computer-assisted surgical system, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described (navigational accuracy) appears to be a standalone assessment of the algorithmic/system accuracy for position and angle. The device itself is described as a "computer-assisted surgical device" that provides "real-time surgical navigation" and "visual assistance to the surgeon," implying that the reported accuracy values relate to the algorithm's ability to track and guide instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "surgical simulations conducted on phantom models cranial sawbone models," the ground truth was likely derived from the known physical properties and measurements of these models. For the "human cadaveric quantitative validation," the ground truth would typically be established by precise physical measurements of the actual position and angle of instruments relative to anatomical landmarks on the cadaver, using highly accurate measurement tools independent of the device under test. The document does not specify the exact method for establishing this ground truth.
8. The sample size for the training set
This information is not provided in the document. The document describes verification and validation testing, but not details about a training set for machine learning models.
9. How the ground truth for the training set was established
Since no training set information is provided, the method for establishing its ground truth is also not mentioned.
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(90 days)
The ExcelsiusGPS® 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 compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
The ExcelsiusGPS® Interbody Module includes hardware and software that enables real time surgical navigation using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation 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). Once this registration is created, the software displays the relative position of a tracked instrument, on the patient images. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments are non-sterile, re-usable instruments that are operated manually.
ExcelsiusGPS® Interbody Module instruments include registration instruments. patient reference instruments, and surgical instruments. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification adapters, surveillance marker, surgical instrument arrays, intra-op CT registration fixture, fluoroscopy registration fixture, and dynamic reference bases (DRB and DRB2). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRBs. Surgical instruments are used to prepare the implant site or implant the device, and include instrument handles, disc prep and trial instruments, interbody inserters, and a dilator holder. The Motion Lock End Effector attaches to the robotic arm and provides a rigid attachment connection for a surgical retractor or port.
The provided text is a Fragment and does not contain any information about acceptance criteria or specific studies that prove the device meets these criteria. It details the FDA clearance for the ExcelsiusGPS Spine 1.1 Interbody Module, its indications for use, technological characteristics, and general statements about performance testing. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies or effect sizes.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance Testing" section states:
- "Surgical simulations conducted on phantom models Sawbone models and registration matrix were used to quantify accuracy in a controlled setting."
- "Human cadaveric quantitative validation under clinically relevant scenarios - Demonstrated system accuracy in navigating interbody fusion devices to the desired location on patient images."
However, no specific data, acceptance criteria, or methodological details like sample sizes, ground truth establishment, or expert involvement are reported for these tests in the provided document.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the studies proving the device meets them based on the provided text.
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(26 days)
The ExcelsiusGPS® 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 compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
The High Speed Drill Instruments consist of an array, array sleeves, a drill guard, and drill bits. These instruments are provided non-sterile, except for the drill bits which are provided sterile or non-sterile. These instruments are intended to be used with ExcelsiusGPS® and are manufactured from stainless steel, per ASTM F899, and PEEK.
The provided text summarizes a 510(k) submission for the "ExcelsiusGPS High Speed Drill Instruments" for use with the ExcelsiusGPS system. However, the document does not contain explicit acceptance criteria and corresponding performance data as typically presented in a clinical study report. Instead, it states that "Verification and Validation testing and comparison to the predicate demonstrate that the ExcelsiusGPS® High Speed Drill Instruments can be used in accordance with its indications."
Therefore, based on the provided text, I cannot produce the requested table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed clinical performance metrics from a specific study.
Information that is available from the text:
- Device Name: ExcelsiusGPS® High Speed Drill Instruments
- Intended 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 compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
- Basis of Substantial Equivalence: Technological characteristics (design, intended use, material composition, function, and range of sizes) are the same as predicate instruments. Performance testing (Verification and Validation) was conducted to demonstrate the instruments can be used in accordance with their indications. Bacterial endotoxin testing (BET) was conducted, and biocompatibility was demonstrated by using standard materials or materials from 510(k) cleared devices.
- Regulatory Clearance Document: K190653
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