(284 days)
The Life Spine Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.
The Life Spine 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 provided document is a 510(k) summary for the Life Spine Sacroiliac Joint Fixation System, which is a medical device. This document focuses on demonstrating that the device is substantially equivalent to a predicate device, rather than providing a detailed study proving it meets specific acceptance criteria based on clinical outcomes or diagnostic performance.
Therefore, many of the requested categories for AI/diagnostic device studies (like expert ground truth, adjudication methods, MRMC studies, training set details) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Composition | Titanium alloy 6AL-4V-ELI per ASTM F-136 | Fabricated from titanium alloy 6AL-4V-ELI per ASTM F-136 |
| Static Cantilever Bending | Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028) | Performed, contributes to demonstration of substantial equivalence |
| Dynamic Cantilever Bending | Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028) | Performed, contributes to demonstration of substantial equivalence |
| Screw Pullout | Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028) | Performed, contributes to demonstration of substantial equivalence |
| Screw Insertion | Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028) | Performed, contributes to demonstration of substantial equivalence |
| Design Characteristics | Substantially equivalent to predicate device | Stated to be substantially equivalent |
| Sizing | Substantially equivalent to predicate device | Stated to be substantially equivalent |
| Indications for Use | Substantially equivalent to predicate device | Stated to be substantially equivalent |
| Intended Use | Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. | Same as predicate; stated as intended use. |
Explanation of Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device (Globus SI-LOK Sacroiliac Joint Fixation System, K112028) in terms of safety and effectiveness. This is shown through comparisons of design, materials, indications for use, sizing, and performance testing. The "reported device performance" effectively states that these equivalence criteria were met.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of devices tested or iterations for each test. The document refers to "Performance testing" conducted in accordance with ASTM F543 and ASTM F2191. These standards typically involve a specific number of samples for mechanical tests, but the exact count isn't stated here.
- Data Provenance: The testing was likely conducted in a laboratory setting by Life Spine, Inc. or a contracted testing facility. No country of origin for data is stated beyond the company's US location. It is prospective testing, as it's performed on the device to be marketed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is Not Applicable in the context of this device and submission type. The device is a bone fixation system, not a diagnostic or AI-driven tool. Ground truth in this context typically refers to validation against clinical outcomes or expert consensus for diagnostic accuracy. Here, "ground truth" for device performance is defined by adherence to material specifications and mechanical test standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in studies where human interpretation (e.g., of images) is being evaluated for accuracy. For mechanical testing of a medical implant, results are typically objective measurements against engineering standards, not subject to human adjudication of subjective interpretations.
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-driven or diagnostic device. MRMC studies are designed for evaluating diagnostic accuracy, particularly with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (sacroiliac joint fixation system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering standards and material specifications (ASTM F136, ASTM F543, ASTM F2191). The demonstration of substantial equivalence to the predicate device also acts as a form of "ground truth" for its safety and effectiveness profile.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. No "training set" of data for an algorithm is relevant here.
9. How the ground truth for the training set was established:
- Not Applicable. As above, there is no training set for this type of device.
§ 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.