(58 days)
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. The subject submission introduces additional designs and sizes of the arch screw and locking screw.
- Arch Screw will be implanted in patient's bone then autograft will be inserted.
- Locking Screw can be used with washer or can be used on its own
- Self-tapping flute centers screw for easy insertion
The provided text is a 510(k) summary for the ZESPIN SI Joint Fusion System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance as would be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable or present in this document.
However, I can extract what is available regarding performance testing and regulatory conclusions:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria for device performance based on a study, nor does it report specific performance metrics like accuracy, sensitivity, or specificity. Instead, it relies on a "risk assessment, including FE analysis" and comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Do not introduce new issues of safety/effectiveness | Risk assessment and FE analysis confirmed no new safety/effectiveness issues. |
| Additional components are not worst-case | Confirmed that additional components are not the worst case. |
| Substantially equivalent to predicate | Overall technology characteristics lead to conclusion of substantial equivalence to predicate (K210035). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device submission, not an AI/ML device requiring a test set of data. The "test" here refers to engineering assessments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant for this type of device submission. The "ground truth" for proving safety and effectiveness relies on engineering principles, materials science, and established regulatory pathways for similar devices.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is not an AI/ML-driven diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
For this device, the "ground truth" for acceptability is based on:
- Engineering principles and analysis (e.g., Finite Element Analysis - FEA).
- Compliance with material standards (Ti-6Al-4V ELI titanium alloy per ASTM F136).
- Demonstration of substantial equivalence to a legally marketed predicate device (K210035).
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.