(260 days)
Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/ or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position. Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a three-dimensional image volume (3D CT or CBCT image), on which the surgeon may perform the Intraoperative Surgical Planning.
Spine Navigation and Robotic-Assistance Device is indicated to provide quidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.
The Spine Navigation and Robotic-Assistance Device is a medical device that provides stereotaxic quidance for spinal surgery. The Subject Device assists the surgeon to quide and position surgical instruments through two modes: Freehand Navigation and Robotic-Assisted Guidance.
The Subject Device includes:
-
A Navigation Station
-
A Robotic-Assisted Station
-
A Camera Station
-
Embedded Software
-
Integrated Guiding System components, composed of single use items, such as navigation Arrays, and reusable items, such as Patient Array fixation solutions.
The navigation of the instruments is based on the standard and established techniques of navigation systems utilizing optical position determination technology. As currently marketed optical tracking navigation systems, the operating principle of the navigation feature is based on the use of an infra-red camera allowing to determine a 3D position of markers, either passive reflective markers or active LED markers. This allows real-time tracking of the navigated instruments.
The Subject Device is compatible with:
-
Specific Instruments of DePuy Synthes, a Johnson & Johnson company. These Instruments are aimed to be quided with Robotic-Assisted Guidance Mode and/or with Freehand Navigation Mode.
-
Several third-partv 3D Imaging Systems.
Based on the provided FDA 510(k) summary, the device is a Spine Navigation and Robotic-Assistance Device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics for AI algorithms.
The document does not describe an AI/ML-driven diagnostic or assistive device that requires a study to prove its performance against acceptance criteria typically associated with such technologies (e.g., sensitivity, specificity, AUC). Instead, it describes a robotic surgical assistance system.
Therefore, the requested information regarding acceptance criteria, specific study designs (like MRMC), expert ground truth establishment, and training/test set details for proving AI/ML model performance is not present in this document.
The document primarily focuses on:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device.
- Performance and Safety Testing: This section primarily lists the types of tests and the standards to which they were conducted (e.g., electrical safety, usability, mechanical testing, software verification, sterilization, biocompatibility, packaging validation). It mentions that "All test requirements were met, no new issues of safety or effectiveness were raised, and substantial equivalence was demonstrated." However, it does not provide specific quantitative acceptance criteria or results for the device's accuracy or performance in a clinical scenario (like an AI algorithm's diagnostic performance).
Therefore, I cannot populate the table or answer the specific questions about AI/ML performance study details based on the provided text. The document does not describe a study that would generate such data.
If the request was based on a misunderstanding and assumed this was an AI/ML diagnostic device, please clarify.
However, I can extract information relevant to the types of tests performed and general statements about the device's performance from a regulatory perspective:
Types of "Performance Data" and "Acceptance" (as detailed in the document):
The document defines "Performance Data" not as clinical accuracy metrics in the AI sense, but rather as data demonstrating compliance with various engineering, safety, and quality standards. The "acceptance criteria" are implied by the successful completion of these tests in accordance with the listed international standards (e.g., IEC 60601-1, ASTM F2554-22).
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Design Verification: Conducted in accordance with ISO 14971 (risk management) and product requirements. | All design verification tests "were performed based on risk management activities... and product requirements." "All test requirements were met." |
| Electrical Safety and EMC: Compliance withIEC 60601-1 Ed 3.2 and IEC 60601-1-2 Ed 4.1. | Testing "were conducted in accordance with" the specified IEC standards. "All test requirements were met." |
| Usability: Compliance with IEC 60601-1-6 Ed 3.2 and IEC 62366-1 Ed 1.1. | "Usability was evaluated in accordance with" the specified IEC standards and FDA guidance. "All test requirements were met." |
| Safety and Performance: Compliance with IEC 80601-2-77 Ed 1.0 (for robotic surgical equipment). | "Safety and performance tests were performed in accordance with" the specified IEC standard. "All test requirements were met." |
| Software Verification and Validation Testing: Compliance with IEC 62304 Ed 1.1 and FDA guidances. | "Software development and testing activities were conducted in accordance with" the specified IEC standard and FDA guidances. "All test requirements were met." |
| Mechanical Testing: Compliance with ASTM F2554-22 (Positional Accuracy of Computer Assisted Surgical Systems). | "Bench testings were conducted in accordance with" the specified ASTM standard. "All test requirements were met." (Note: Specific quantitative accuracy results are not provided in this summary, only that the test was done to the standard.) |
| Sterilization & Shelf-life Testing: Compliance with ISO 11137-1, ISO 11137-2, ISO 17665-1, ANSI AAMI ST98. | "Sterilization testing activities were conducted in accordance with" specified ISO standards. "Reprocessing validation activities were evaluated and testing in accordance with" ANSI AAMI ST98. "All test requirements were met." |
| Biocompatibility Testing: Compliance with ISO 10993-1, -5, -10, -11, -17, -18, -23. | "Biological evaluation was evaluated and testing in accordance with" the specified ISO standards. "All test requirements were met." |
| Packaging Validation: Compliance with ISO 11607-1, ISO 11607-2. | "Packaging validation tests were performed in accordance with" the specified ISO standards. "All test requirements were met." |
| Clinical Performance: Not required for safety/effectiveness. | "Clinical testing was not required to demonstrate the safety and effectiveness of the Device." |
| Animal Study: Not required for safety/effectiveness. | "Animal performance testing was not required to demonstrate safety and effectiveness of the Device." |
| Overall: Device should not raise new issues of safety or effectiveness. | "Performance and Safety Testing activities have demonstrated that the Spine Navigation and Robotic-Assistance Device does not raise any concern of safety or effectiveness." "All test requirements were met, no new issues of safety or effectiveness were raised, and substantial equivalence was demonstrated." |
Regarding the specific questions about an AI/ML performance study:
- A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" are compliance with various engineering and safety standards, and the "reported performance" is that these tests were conducted and "all test requirements were met." No specific quantifiable performance metrics for an AI algorithm (e.g., sensitivity, specificity, accuracy) are provided or indicated as part of the evaluation.
- Sample sizes used for the test set and the data provenance: Not applicable. The document describes compliance with engineering and safety standards, not a data-driven AI performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is relevant for AI/ML performance studies, which this document does not describe.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This type of study is for evaluating the impact of AI on human reader performance, which is not described for this robotic guidance device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a regulatory submission for a robotic surgical assistance system, focusing on its functional, safety, and quality characteristics, and its substantial equivalence to predicate devices, rather than a data-driven performance evaluation of a diagnostic AI/ML algorithm.
§ 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).