(100 days)
The SIJF Cannulated Screw is intended for fracture fixation of long bones and of the pelvis for such conditions as degenerative sacroiliitis, trauma (fracture and/or dislocation) or tumor, iatrogenic instability and Osteitis Condensans IIii. The system is not intended for spinal use.
SIJF Cannulated Screws consists of cannulated screws available in titanium in two diameters of 6.5mm and 8.0mm with lengths ranging from 40mm to 50mm, in 2mm increments.
This document relates to a 510(k) premarket notification for the "SIJF Cannulated Screw System," a medical device for fracture fixation. The information provided heavily focuses on regulatory approval and device description, with very little detail regarding performance study data or acceptance criteria in the manner requested (e.g., statistical thresholds for diagnostic performance).
Therefore, I cannot provide a complete answer to all aspects of your request based solely on the provided text. The document is a regulatory submission summary and an FDA approval letter, not a detailed study report.
Here's what can be extracted and what cannot be, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., specific force thresholds, fatigue life cycles, or clinical outcome metrics with target percentages). It states, "Performance data were submitted to characterize the SIJF Cannulated Screw components," implying mechanical testing was performed, but it doesn't provide the results or the criteria for acceptance.
| Aspect | Acceptance Criteria (Not provided in extract) | Reported Device Performance (Not provided in extract) |
|---|---|---|
| Mechanical Strength | Specific force/torque thresholds | Quantitative values from tests |
| Fatigue Life | Number of cycles without failure | Number of cycles achieved |
| Biocompatibility | Compliance with ISO standards | Confirmation of compliance |
| Clinical Success Rate | Percentage of successful fixations | Not applicable for this type of device |
| Adverse Event Rate | Maximum acceptable rate | Not applicable for this type of device |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "performance data" mentioned would typically refer to mechanical testing of the screws themselves, not clinical data with a "test set" of patients.
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 provided and is not relevant for the type of device (cannulated screws) and the type of performance data mentioned (characterization of components). Ground truth by experts is typically for diagnostic AI systems.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided and is not relevant for this type of device. Adjudication is typically for clinical studies with subjective assessments.
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 provided and is not relevant. MRMC studies are for diagnostic imaging AI, not for orthopedic implants like cannulated screws.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided and is not relevant. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing of implants, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM F-136 for titanium alloy) and the physical properties measured (e.g., tensile strength, torsion limits). It's not clinical "ground truth" as described. The document does not explicitly state the specific engineering ground truths used beyond the material specification.
8. The sample size for the training set
This information is not provided and is not relevant. 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 information is not provided and is not relevant for this 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.