(211 days)
The Curiteva Sacroiliac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Curiteva Sacroiliac Joint Fusion System consists of screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The screws are designed to be implanted across the sacroiliac joint to stabilize and aid in the fusion of the sacroiliac joint. Optional washers are included to aid in the distribution of load across the bone surface directly apposing the screw head.
The Curiteva Sacroiliac Joint Fusion System implants are manufactured from medical-grade titanium alloy in accordance with ASTM F136. All system implants are intended for single use only and should not be reused under any circumstances.
The provided text describes a 510(k) premarket notification for the Curiteva Sacroiliac Joint Fusion System. This submission focuses on establishing substantial equivalence to previously cleared devices through non-clinical performance data, primarily mechanical testing, rather than clinical studies involving AI or diagnostic performance. Therefore, many of the requested details about acceptance criteria for AI performance, clinical study design, and ground truth establishment are not applicable.
Here's an analysis based on the available information:
Assessment of Acceptance Criteria and Device Performance:
The "acceptance criteria" in this context refer to the mechanical performance standards that the device must meet to demonstrate safety and effectiveness comparable to predicate devices. The study conducted was non-clinical mechanical testing.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Type of Test) | Standard Followed | Reported Device Performance (Summary) | Meets Criteria? |
|---|---|---|---|
| Static four-point bending | ASTM F2193 | Sufficient for intended use and substantially equivalent to predicate devices. | Yes |
| Dynamic four-point bending | ASTM F2193 | Sufficient for intended use and substantially equivalent to predicate devices. | Yes |
| Static torsion | ASTM F543 | Sufficient for intended use and substantially equivalent to predicate devices. | Yes |
| Static axial pullout | ASTM F543 | Sufficient for intended use and substantially equivalent to predicate devices. | Yes |
*Note: The specific numerical values for strength and performance are not provided in the summary, only the conclusion that they were "sufficient" and "substantially equivalent."*
2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated in the provided text for each mechanical test. Mechanical testing typically involves multiple samples to ensure statistical validity, but the exact number isn't quantified here.
* Data Provenance: The data is non-clinical, originating from laboratory mechanical testing. There is no patient data involved, so country of origin or retrospective/prospective status is not applicable in the typical sense.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth. The "ground truth" for mechanical testing is established by the test standards (ASTM F2193, ASTM F543) and physical measurements.
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Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical or image interpretation studies to resolve discrepancies among experts. For mechanical testing, adherence to a standard and objective measurements are the primary methods.
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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 device is not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical implant, not an algorithm.
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The Type of Ground Truth Used:
- The "ground truth" for this non-clinical study is defined by the objective physical properties and performance characteristics measured against established ASTM standards (ASTM F2193 for bending, ASTM F543 for torsion and pullout). The performance is then compared to predicate devices.
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The Sample Size for the Training Set:
- Not applicable. This device is not an AI system that requires a "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI model.
§ 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.