(30 days)
The Mazor X is indicated for precise positioning of surgical implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures.
Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic prom standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
The modified Mazor X hosts guidance for spine procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intra-operative planning based on Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The Mazor X is a device modification of the original Mazor X System cleared in 510(k) K182077.
This document is a 510(k) premarket notification for a medical device (Mazor X) and, as such, does not contain the detailed acceptance criteria and study data explicitly requested for the device's performance. The FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or detailed performance metrics against specific acceptance criteria.
However, based on the provided text, I can infer some aspects related to "acceptance criteria" through the lens of a 510(k) submission, mainly focusing on software and hardware validation, and the comparison to a predicate device for safety and effectiveness.
Here's a breakdown of the information that can be extracted or inferred, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" in this context are interpreted as the successful completion and verification of specified tests confirming the device's design requirements, safety, and functionality, particularly concerning software and hardware changes.
| Acceptance Criteria Category (Inferred from 510(k) context) | Reported Device Performance (Inferred from 510(k) text) |
|---|---|
| Software Validation (2D fluoroscopic projection to 3D image conversion, navigation, planning, user interface, diagnostics, error handling, security, performance, robustness, installation, database) | "Software validation tests demonstrate that the Mazor X software version meets the design requirements." |
| Hardware Changes Verification (System parts and accessories) | "The modified system parts and accessories were tested to verify that they meet the requirements." (Protocols identical to cleared Mazor X). |
| Safety, Effectiveness, and Performance (Overall system) | "The modifications do not adversely affect the safety, effectiveness and performance of the Mazor X system." |
| "The Mazor X system was tested according to the aforementioned validation and performance tests and found compliant." | |
| "The Mazor X system is as safe, as effective and performs as well as the legally marketed Mazor X System predicate device." | |
| Substantial Equivalence (Technological characteristics to predicate) | "The technological characteristics... of the Mazor X system are substantially equivalent to the predicate device cited above." |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of number of patients, cases, or images for a test set. The validation described refers to software testing and hardware verification.
- Sample Size: Not specified for performance testing. The "test cases" for software validation are mentioned but their number is not provided.
- Data Provenance: Not applicable in the context of this 510(k) as it describes engineering verification and validation rather than clinical study data. There's no mention of country of origin or retrospective/prospective study for performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for software and hardware validation is typically defined by engineering specifications and design requirements, rather than expert clinical review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided. Adjudication methods are typically used in clinical studies involving human readers, which is not the focus of the performance tests described here.
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 is mentioned. The submission is for a device modification (software and minor hardware changes) to an existing cleared device, Mazor X System (K182077). The focus is on demonstrating that the modifications do not adversely affect safety and effectiveness and that the new device is substantially equivalent to the predicate. The device's capabilities include "precise positioning of surgical instruments or spinal implants" and "navigation tracks the position of instruments," but there are no details on improved human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device's functions (3D imaging from 2D fluoroscopic projections, instrument tracking, surgical planning). The software validation tests mentioned ("design requirements," "procedure simplicity," "performance and robustness," etc.) imply standalone algorithm performance was evaluated against its design specifications without explicit human-in-the-loop performance details in this document. However, the device itself is an assistance system for surgeons, so it inherently has a human-in-the-loop component for its intended use. The performance tests mentioned focus on the device's ability to meet its functional requirements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests described here would be the design specifications and requirements of the software and hardware. For example, for "software validation testing," the ground truth is conformance to the established design requirements. For "hardware changes verification," the ground truth is meeting the technical requirements, presumably against engineering benchmarks or validated measurements. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for these specific performance tests within this 510(k) summary.
8. The sample size for the training set
Not applicable. The document describes software validation and hardware verification of modifications to an existing device, not the development or training of a de novo AI algorithm using a separate training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is discussed in this regulatory document.
§ 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).