(206 days)
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:
- Standard Thread Screw (with and without slots)
- Lag Screw (with and without slots) and
- Washer Screw (with slots)
The provided text is a 510(k) premarket notification for the UNITY Sacroiliac Joint Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI might.
Therefore, many of the requested fields regarding acceptance criteria and study details for an AI-based device are not directly applicable or available in this document. The document describes mechanical performance testing and biocompatibility.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit via predicate comparison and standards) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Equivalent to predicate (Rexious Spinal Fixation System K111362) | Utilizes same manufacturing processes, materials, and sterilization as K111362. |
| Mechanical Performance | Function as intended and provide expected stability (per ASTM F2193-14 & ASTM F543-17) | "In all instances, the UNITY Sacroiliac Joint Fixation System functioned as intended and stability observed was as expected." |
| Intended Use | Same intended use as predicate devices. | "The UNITY Sacroiliac Joint Fixation System has the same intended uses..." |
| Technological Characteristics | Similar technological characteristics and principles of operation as predicate devices. | "The subject and predicate devices are based on the following same technological elements..." "The minor technological differences between the UNITY Sacroiliac Joint Fixation System and its predicate devices raise no new issues of safety or effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for the mechanical tests. It states that "Three motion and stress tests were performed" and lists four tests, implying a set of samples for each test type. The data provenance is implied to be from the manufacturer (Huvexel Co., Ltd. in South Korea) through their testing activities. The nature of these tests (mechanical stress and motion) is inherently prospective as new devices would be manufactured and tested.
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 field is not applicable. The device is a physical implant, not a diagnostic AI system requiring expert interpretation for ground truth. The "ground truth" for the mechanical performance is defined by the standards and the physical properties observed during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This field is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical device testing. The assessment of mechanical performance is based on adherence to engineering standards and observed physical behavior.
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
This field is not applicable. The UNITY Sacroiliac Joint Fixation System is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This field is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility, the ground truth is established by referencing the prior FDA clearance of the Rexious Spinal Fixation System (K111362) which used similar materials, manufacturing processes, and sterilization. This is a form of historical data/pre-established safe use.
For mechanical testing, the ground truth is established by engineering standards (ASTM F2193-14 and ASTM F543-17) which define acceptable ranges and behaviors for the specified tests. The "functioned as intended" and "stability observed as expected" implies meeting these standards.
8. The sample size for the training set
This field is not applicable. The device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This field is not applicable. The device is a physical implant, not 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.