(74 days)
The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm.
The provided text describes the SImmetry™ Sacroiliac Joint Fusion System which is a fixation device/bone screw, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and testing (like MRMC studies, training set details, or ground truth for AI) are not applicable to this submission.
The "study" referenced in this 510(k) is a non-clinical performance evaluation comparing the device's mechanical properties to predicate devices to establish substantial equivalence.
Here's the information extracted and categorized based on the available text:
Acceptance Criteria and Device Performance for SImmetry™ Sacroiliac Joint Fusion System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand expected loading without failure | "capable of withstanding expected loading without failure." |
| Mechanical properties equivalent to predicate device (Synthes 6.5mm Cannulated Screw K021932) | "substantially equivalent with respect to mechanical performance of the K021932 Synthes 6.5mm Cannulated Screw predicate device." |
| Provide necessary rigidity to support intended use | "provides the necessary rigidity to support the intended use." |
| Axial pull out strength | Demonstrates substantial equivalence to predicate. |
| Driving torque | Demonstrates substantial equivalence to predicate. |
| Static bend strength | Demonstrates substantial equivalence to predicate. |
| Bending fatigue strength | Demonstrates substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for each mechanical test. It refers to "test data" and "test results" in a general sense.
- Data Provenance: The data is from "mechanical testing" performed by the manufacturer, Zyga Technology, Inc. The country of origin is not explicitly stated, but the company is based in Minneapolis, Minnesota, USA, implying the testing was likely conducted in the USA. The testing is for non-clinical performance of the device, not patient data, so "retrospective or prospective" is not applicable in the typical clinical study sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a mechanical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a mechanical device performance study, there's no "adjudication" for human interpretation of results in the traditional sense. The mechanical testing results are compared directly against established performance benchmarks or predicate device results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance:
- No. This is a non-AI medical device; therefore, an MRMC study and AI assistance effects are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This product is a physical medical device (bone screw), not an algorithm or software. "Standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used:
- For the mechanical performance testing, the "ground truth" is typically derived from engineering standards, material science principles, and direct comparative measurements against a legally marketed predicate device's known performance characteristics. It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it in this context.
§ 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.