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510(k) Data Aggregation
(16 days)
Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precise locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Silony Medical's VERTICALE® navigation instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.
The VERTICALE® Navigation Instruments include awls, probes, taps, drivers and inserts. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System cleared under K171421.
All instruments are made of stainless steel per ASTM F899. The VERTICALE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.
The provided text does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission (K223649) is for VERTICALE® Navigation Instruments, which are physical surgical instruments used with a stereotactic navigation system, not an AI or algorithm-based device.
Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this medical device submission.
The "Performance Data" section (page 5) refers to testing performed per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard is for evaluating the accuracy of surgical navigation systems, and the submitter states that these data are applicable because the new instruments complement existing ones and a technical evaluation confirmed compatibility and functionality. The relevant performance for this device is its navigational accuracy and compatibility with the Medtronic StealthStation®, not an AI-driven diagnostic or prognostic capability.
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(93 days)
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The purpose of this submission is to add the Posterior Oblique approach technique.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Simpact Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine Simpact Sacroiliac Joint Fixation System components should never be reused under any circumstances.
Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called the "Life Spine SIMPACT Sacroiliac Joint Fixation System." This type of document does not contain the details of a study on device performance against specific acceptance criteria for AI/ML-based devices. The content focuses on the regulatory clearance process for a traditional implantable medical device, asserting substantial equivalence to existing predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device or studies.
The document discusses:
- Device Name: Life Spine SIMPACT Sacroiliac Joint Fixation System
- Regulation Number/Name: 21 CFR 888.3040, Smooth Or Threaded Metallic Bone Fixation Fastener
- Regulatory Class: Class II
- Product Code: OUR, HWC
- Indications for Use: Sacroiliac fusion for specific conditions (dysfunction, augmentation in sacropelvic fixation, fractures).
- Device Description: Fully threaded and partially threaded cannulated screws made from titanium alloy 6AL-4V-ELI.
- Purpose of Submission: To add the Posterior Oblique approach technique.
- Predicates: Medtronic, Inc. Rialto Sacroiliac Fusion System (K161210) and others.
- Substantial Equivalence: Based on design, materials, indications for use, sizing, and mechanical performance (for the new technique).
There is no mention of AI or ML, nor any performance data related to algorithms, expert readers, or ground truth for diagnostic accuracy studies. The "Performance Data" section explicitly states: "There are no new devices in this submission, only Design of Experiment validating Posterior Oblique approach." This refers to non-clinical performance (e.g., mechanical testing, not clinical AI performance).
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(96 days)
iFuse-Navigation instruments are intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis 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. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
The iFuse-Navigation instrument set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.
The provided text describes a 510(k) premarket notification for the iFuse Implant System - iFuse Navigation. Let's extract the requested information regarding acceptance criteria and the study proving the device meets them.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a dedicated table format with reported device performance values. It describes the types of tests performed and implies that the device passed these tests to achieve substantial equivalence.
Based on the "Performance Data" section (Page 4), the following can be inferred:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Registration | Instruments can be registered to the StealthStation.® (Implies successful registration) |
| Accuracy | Performed for comparison to reference instruments. (Implies satisfactory accuracy compared to reference) |
| Rigidity | Connection between the TeraTracker and the instruments was evaluated. (Implies sufficient rigidity) |
| Compatibility with iFuse Implant System | Evaluated to ensure compatibility. (Implies successful compatibility) |
Note: The document only states that testing was "completed to ensure the functionality and compatibility" and that "verification and validation results support substantial equivalence." No specific numerical thresholds or measured performance values are provided.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (e.g., number of tests, number of devices tested, number of simulated procedures) used for any of the performance tests.
It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not refer to the use of experts to establish ground truth for the performance tests. The tests described (Registration, Accuracy, Rigidity, Compatibility) appear to be engineering verification and validation tests rather than clinical studies requiring expert interpretation of results against a medical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the tests do not appear to involve human interpretation necessitating such a method.
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 was done or mentioned. This device is a surgical navigation instrument, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an instrument used with a navigation system and by a surgeon, not a standalone algorithm. The performance tests appear to be evaluations of the instrument's interaction with the navigation system and its physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically understood in medical device validation (e.g., against pathology for a diagnostic device) does not seem applicable here in the traditional sense. The "ground truth" for the performance tests would be the established engineering specifications, system requirements, and the expected functional behavior of the instruments in conjunction with the StealthStation® system and iFuse Implant System. The tests aim to verify that the device meets these pre-defined specifications.
8. The sample size for the training set
The document does not mention a training set. This is consistent with the nature of the device as a physical surgical instrument and not an AI/machine learning system that requires a training phase.
9. How the ground truth for the training set was established
Not applicable, as no training set is discussed or implied.
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