(87 days)
The Mazor X is indicated for precise positioning of surgical implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from 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 hosts guidance for spine and brain procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants (in spinal surgery). 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 intraoperative 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) K163221.
The provided text describes a 510(k) premarket notification for the "Mazor X" device. This submission is for a modification of an existing device (Mazor X System, K163221), and therefore, the performance testing focuses on demonstrating that the modifications do not adversely affect the device's safety, effectiveness, and performance compared to the predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Limited Information on Acceptance Criteria and Studies:
It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence of a modified device to a predicate device. As such, it does not detail a comprehensive study establishing novel acceptance criteria or a full clinical study with specific performance metrics (like sensitivity, specificity, accuracy) that would be typical for a new device's initial clearance or a comparative effectiveness study. The "acceptance criteria" here are primarily about demonstrating that the modified device performs as well as the predicate and meets its design requirements.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a modification submission, the "acceptance criteria" are implicitly tied to maintaining the performance and safety established by the predicate device and meeting design requirements for the modifications. Specific quantitative performance metrics are not provided in this document in a tabular format.
| Acceptance Criteria (Implicit from text) | Reported Device Performance |
|---|---|
| Software Validation: Meet design requirements of the Mazor X software version. | Demonstrated compliance through validation testing for procedure simplicity, system startup, security, user interfaces, diagnostics, error handling, performance, robustness, installation, and database. |
| Mazor X Align Module Functionality: Maintain or improve performance of the original Align module after modifications. | Retested according to the same functionality as the original Mazor X Align module, including: Validation of changes related to updating CT-based fluoroscopy images and pre-operative registration method (CT-Xray). Validation of lateral positioning. Validation of modifications to the vertebral end-plates recognition algorithm. Integration testing of the modified system. |
| Safety, Effectiveness, and Performance: Modifications should not adversely affect these aspects compared to the predicate. | The performance testing and comparison to the predicate device demonstrated that the Mazor X system is as safe, as effective, and performs as well as the legally marketed Mazor X System predicate device. The Mazor X system was tested according to the aforementioned validation and performance tests and found compliant. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for tests. The descriptions focus on "validation testing" and "retesting" of specific modules and algorithms. It does not mention clinical studies with human patient data or specific "test sets" in the context of typical AI/machine learning evaluation (e.g., a set of patient images for diagnostic accuracy).
- Sample Size: Not specified.
- Data Provenance: Not specified. The tests are described as software validation testing and functionality testing for the modified Align module. This implies testing with internal data or synthetic data relevant to the software functionalities, rather than patient data from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the nature of the tests described (software and functionality validation), there's no indication that a "ground truth" was established by medical experts for a diagnostic or interventional task, which would typically involve human reviewers. The tests are against design requirements and algorithmic performance.
- Number of Experts: Not mentioned.
- Qualifications: Not mentioned.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the described tests are technical validations against specifications and functionality rather than human-interpreted diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The document focuses on demonstrating that the modified device is as safe and effective as the predicate device, not on comparing human performance with and without AI assistance.
- Effect Size of Human Readers Improve: Not applicable; no MRMC study reported.
6. Standalone (Algorithm Only) Performance Study
The performance tests mentioned are for the integrated "Mazor X system" and its "software version" and "Align module." While these are tests of the algorithm's functionality, the document describes the system as enabling surgeons to position instruments and implants, and its imaging capabilities provide processing and conversion of fluoroscopic projections. This suggests the algorithm's performance is tested within the context of its intended function as part of a surgical guidance system, rather than as a standalone diagnostic tool. The "algorithm only" performance is embedded within the "Software validation testing" and "retraining" of the Align module.
7. Type of Ground Truth Used
The "ground truth" for the reported tests appears to be based on:
- Design requirements/specifications: For the software validation.
- Established functionality of the original Mazor X Align module: For retesting the modified Align module.
- Algorithmically derived correct states: For parameters like lateral positioning validation and vertebral end-plates recognition.
It is not based on expert consensus, pathology, or outcomes data as these are not clinical studies.
8. Sample Size for the Training Set
No information about a training set is provided. This 510(k) pertains to a device modification and validation, not the initial development or training of a machine learning model from scratch where a distinct "training set" would typically be detailed. The "software optimization" and "enhanced functionalities" likely involved development and testing, but the specific "training set" for any underlying machine learning components is not discussed.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described in this 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).