(109 days)
The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
The provided document is a 510(k) summary for the "Blue Topaz Sacroiliac Screw System" which is a medical device. It does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI-assistance. Therefore, I cannot provide details on most of the requested points, as they are specific to AI/ML device evaluations.
However, I can extract information related to the device's performance data based on non-clinical testing.
Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions that the device was tested to demonstrate its strength for its intended use and substantial equivalence to predicate devices. However, specific numerical acceptance criteria and reported performance values are not explicitly stated in the provided text. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: sufficient strength for intended use and substantial equivalence to predicates) | "The results of this non-clinical testing show that the strength of the Blue Topaz Sacroiliac Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device, not a study involving a test set of data or human subjects.
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 information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Ground truth, in the context of expert review, is not relevant for this type of evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Adjudication methods are typically used in clinical studies or expert reviews.
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 information is not applicable as the document describes a physical medical device (sacroiliac screw system) and its non-clinical mechanical testing. There is no mention of AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device and its mechanical performance, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the document describes non-clinical mechanical testing. The "ground truth" for mechanical performance would be the direct measurement outcomes from the specified ASTM standards.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set involved.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set or ground truth in that context.
Summary of available information regarding the device itself (not AI/ML related):
The Blue Topaz Sacroiliac Screw System underwent the following non-clinical (mechanical) tests:
- Static and Dynamic Cantilever Bending per ASTM F2193
- Driving Torque per ASTM F543
- Static Torsion per ASTM F543
- Pullout per ASTM F543
The conclusion from this testing was that the device's strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
§ 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.