(263 days)
The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.
The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-SI Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.
This document describes a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or standalone AI performance) is not applicable.
The document is a 510(k) premarket notification for the "Patriot-SI Posterior Implant System," which is a physical medical device for sacroiliac joint fusion. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device (NADIA® SI Fusion System, K190580) based on non-clinical mechanical tests and cadaver testing.
Here's a breakdown of the provided information, emphasizing why the AI/ML-specific questions are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a physical implant, "acceptance criteria" and "reported device performance" are based on mechanical properties and safety/effectiveness relative to its predicate, rather than AI model metrics like sensitivity, specificity, or AUC. The document lists the types of non-clinical mechanical tests performed to support substantial equivalence:
| Test Type | Standard/Method | Purpose/Outcome (as implied by context) |
|---|---|---|
| Static Shear Testing | ASTM F3574 | Evaluate resistance to shearing forces. |
| Static and Dynamic Torsion Testing | ASTM F3574 | Assess resistance to twisting forces (static/dynamic). |
| Static Pushout Testing | ASTM F3574 | Determine force required to dislodge the implant. |
| Driving Torque Testing | ASTM F3574 | Measure torque required for implantation. |
| Static and Dynamic Compression-Shear Testing | ASTM F2077 | Evaluate performance under combined compression and shear loads. |
| Cadaver Testing | Not specified | Support surgical approach and implant function. |
The conclusion states that "performance testing provided in this 510(k) application demonstrates that the Patriot SJ Posterior Implant System is capable of performing as intended and is as safe and effective as the legally marketed predicate device." Specific numerical acceptance criteria or performance values are not included in this summary document.
2. Sample Size for Test Set and Data Provenance:
Not applicable, as this is a physical device. Mechanical tests involve test specimens, and cadaver testing involves human cadavers, but these are not "datasets" in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth for mechanical testing is derived from engineering principles and standards, and for cadaver testing, it pertains to the anatomical and biomechanical performance, typically evaluated by biomechanical engineers and potentially surgeons. There isn't a "ground truth" established by a panel of medical experts in the way it would be for an AI diagnostic algorithm.
4. Adjudication Method:
Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI training/testing, which is not relevant for a physical implant's mechanical and cadaver testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study assesses the impact of AI on human reader performance for diagnostic tasks. The Patriot-SI system is a surgical implant, not a diagnostic AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. There is no algorithm to evaluate in a standalone manner.
7. Type of Ground Truth Used:
For the mechanical tests, the "ground truth" is defined by the requirements of the ASTM standards (F3574 and F2077) and the performance characteristics of the predicate device. For cadaver testing, it relates to the successful implantation and biomechanical stability observed. This is distinct from pathology, expert consensus, or outcomes data used for AI models.
8. Sample Size for the Training Set:
Not applicable. There is no AI model, and therefore no training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there's no training set, there's no ground truth to establish for one.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.