(272 days)
The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position 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. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).
Astura Medical EGPS Navigated Instruments are non-sterile, reusable instruments including a drill and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Astura Medical screw implants. The instruments are manufactured from stainless steel per ASTM F899.
The provided text is a 510(k) summary for the Astura Medical EGPS Navigated Instruments. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have typical acceptance criteria and a study design as outlined in your request.
Instead, this document pertains to a Class II surgical instrument (Stereotaxic Instrument) that is intended for use with a pre-existing robotic navigation platform. The FDA's review for this type of device typically focuses on substantial equivalence to a predicate device, which involves demonstrating similar performance, design, materials, and indications for use.
Therefore, most of the specific points in your request regarding acceptance criteria for device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable to this submission, as it's not a diagnostic AI/ML device.
However, I can extract the relevant information concerning the non-clinical tests that were performed to demonstrate substantial equivalence for this surgical instrument.
Here's the closest interpretation of your request based on the provided text:
Device: EGPS Navigated Instruments
Device Type: Surgical Instrument (Stereotaxic Instrument) for spinal surgery, used with a robotic navigation platform.
Nature of FDA Submission: 510(k) Premarket Notification, seeking substantial equivalence to a predicate device.
Absence of AI/ML Study Data: The document explicitly states "No clinical studies were performed" and the "Non-clinical Test Summary" only lists "Comparative dimensional analysis of subject instruments with predicate." This indicates that the device's acceptance was based on non-clinical engineering and design verification, not on clinical performance metrics typically associated with AI/ML or diagnostic devices.
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or detailed performance metrics in the format of a clinical performance study for an AI/ML device. Instead, it relies on demonstrating equivalence through design and material comparisons.
| Acceptance Criteria Category | Description (as inferred from the document) | Reported Device Performance/Conclusion |
|---|---|---|
| Material Equivalence | Materials of construction are equivalent to predicate. | Manufactured from stainless steel per ASTM F899, same as predicate. |
| Design/Dimensional Equivalence | Dimensions and design should be comparable to the predicate device to ensure compatibility and safe function with the robotic navigation platform. | "Comparative dimensional analysis of subject instruments with predicate" was conducted. The conclusion states "similarities in geometry, principles of operation, technology". |
| Intended Use Equivalence | The intended use must be substantially equivalent to the predicate device. | The Indications for Use are listed and stated to be substantially equivalent. |
| Mechanical Safety | The instrument must meet mechanical safety standards. | Stated that the device is substantially equivalent in "mechanical safety and performance." Though specific tests aren't detailed, compliance with relevant standards and the successful dimensional analysis would contribute to this. |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The non-clinical test involved "Comparative dimensional analysis," which refers to comparing the manufactured subject instruments to the specifications or dimensions of the predicate, likely involving engineering measurements rather than a "sample set" of patient data.
- Data Provenance: Not applicable. The "data" here would be engineering measurements and material specifications, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of AI/ML, refers to validated clinical outcomes or expert labels. For a surgical instrument, "ground truth" would relate to engineering specifications and manufacturing tolerances, which are established by design engineers and quality control personnel, not typically clinical experts for labeling.
4. Adjudication method for the test set
- Not applicable. There was no "test set" of clinical data requiring expert adjudication.
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. This is a surgical instrument, not an AI/ML diagnostic or assistive technology that would be subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is not an algorithm. It is a physical instrument intended for use by a surgeon, assisted by a separate robotic navigation platform.
7. The type of ground truth used
- The "ground truth" for this device's acceptance is based on engineering specifications, material standards (ASTM F899), and documented design equivalence to the predicate device. There is no clinical "ground truth" in the typical sense of pathology or outcomes data for this specific submission.
8. The sample size for the training set
- Not applicable. There is no AI/ML training set involved.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML training set involved.
In summary, this 510(k) submission for the EGPS Navigated Instruments is for a physical surgical device, not a software-based AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices are not relevant to this document. The manufacturer demonstrated substantial equivalence primarily through non-clinical comparative analysis of the instrument's design, materials, and intended use with its predicate.
§ 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).