(268 days)
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
The Subject Device Spine and Trauma Navigation System consists of the following software's and hardware.
Software:
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- Spine & Trauma 3D Navigation 1.5
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- Instrument Selection 1.6
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- Fluoro 3D 1.0
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- Registration Software Paired Point 3.5
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- Registration Software Spine Surface Matching 1.0
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- Spine Planning 1.0
Hardware:
The Hardware accessories for the Subject Device are Platforms and Surgical Instruments.
The provided text describes a 510(k) premarket notification for the Brainlab AG Spine & Trauma Navigation System. It outlines the device, its indications for use, and a summary of the performance data provided to the FDA. However, the document does not contain specific acceptance criteria, detailed results of a study proving the device meets these criteria, or information on aspects like sample size, expert ground truth establishment, or human reader studies.
The document states that "The verification of the Spine & Trauma Navigation System has been carried out thoroughly both at the top level and on underlying modules according to the verification plan and following internal processes. The verification was done to demonstrate that the design specifications are met." It also mentions "Bench Testing" for instruments. However, it does not provide the quantitative data necessary to populate the requested table or answer the specific questions about the study design and results.
Therefore, I cannot provide the requested information from the provided text. The output will explicitly state what information is and is not available in the input.
Information Not Found in the Provided Text:
The provided 510(k) summary does not contain the detailed performance study results, acceptance criteria, or specific aspects of a clinical or bench study needed to answer the questions comprehensively. While it mentions "Software Verification and Validation Testing" and "Bench Testing," it does not provide the quantitative data, methodology details (sample size, ground truth generation, expert qualifications, adjudication methods), or comparative effectiveness study results requested.
Therefore, the following sections will indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states that "The verification was done to demonstrate that the design specifications are met," but the specific design specifications/acceptance criteria and the quantitative results validating them are not detailed. | Not provided in the document. The document states that "all test were passed successfully" for bench tests, but no specific performance metrics or their actual values are reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document mentions "patient's preoperative or intraoperative 2D or 3D image data" but does not detail the origin or nature of the data used for verification/validation.
- Retrospective or Prospective: Not specified in the provided document.
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)
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document.
- Ground Truth Establishment: The document refers to "preoperative or intraoperative scans" as the basis for navigation and planning, implying that these images serve as a form of ground truth for instrument placement relative to anatomy, but it does not describe a process involving human experts to establish ground truth for a test set to evaluate the device's accuracy against.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the provided document.
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
- MRMC Study: Not mentioned or described in the provided document. The device is a navigation system and planning software, not an AI-assisted diagnostic tool typically evaluated with MRMC studies focused on human reader improvement. The focus is on the system's ability to localize and guide instruments.
- Effect Size of Human Reader Improvement: Not applicable/not provided as no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the device's software components (e.g., Spine & Trauma 3D Navigation, Spine Planning) perform specific functions, and their "verification and validation testing" was conducted. However, the exact nature of "standalone" performance testing (e.g., algorithm-only accuracy on a dataset without human interaction, specifically for AI/ML components) is not explicitly detailed with performance metrics. The device is intended for human-in-the-loop surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that the "acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy" serves as the reference ("ground truth") against which the navigation system operates, by linking a tracked probe to this virtual computer image space. For planning, screws are proposed and reviewed ("approved") but the ultimate ground truth for the accuracy of a plan would typically relate to anatomical landmarks on these images, often confirmed by intraoperative imaging. No mention of expert consensus, pathology, or outcomes data being used as ground truth for a performance study is made.
8. The sample size for the training set
- Training Set Sample Size: Not applicable or not specified. The document describes a "verification" process for a regulated medical device, not explicit "training" of a machine learning model. While software verification and validation would use test data, this is distinct from a "training set" for AI/ML model development. The document does not indicate that the device uses an AI/ML model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable or not specified, for the same reasons as 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).