(66 days)
Sirus intramedullary nail for femur with cap screw and corresponding locking screws:
- All compound and simple femoral shaft fractures
- Sub-trochanteric fractures
- Pseudarthrosis and delayed union
Sirus intramedullary nail for femur in combination with the Sirus cervical screws: - Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures
Sirus intramedullary nail for tibia with cap screw and corresponding locking screws: - Simple, compound first- and second-degree tibial shaft fractures
- Pseudarthrosis and delayed union
The Sirus Intramedullary Nails are manufactured from titanium alloy, and are available in a variety of lengths and diameters. They are intended for insertion into the medullary canal of the femur or tibia for the fixation of fractures.
The provided document is a 510(k) premarket notification for the "Sirus™ Intramedullary Nail" (K043270). It discusses the device description, intended use, and comparison to predicate devices. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
The document states: "The results of non-clinical analysis demonstrate that the device is safe and effective and substantially equivalent to the predicate device(s)." This indicates that non-clinical testing was performed to show substantial equivalence. However, the exact acceptance criteria, the specific studies performed, and their results are not detailed in this summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "The results of non-clinical analysis demonstrate that the device is safe and effective and substantially equivalent to the predicate device(s)." |
Missing Information: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for strength, fatigue, or other biomechanical properties). It only broadly states that non-clinical analysis demonstrated safety, effectiveness, and substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document mentions "non-clinical analysis" but does not provide any details about the sample sizes used for testing, the type of data (e.g., material testing, biomechanical testing), or its provenance.
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)
Missing Information: This information is not applicable and not provided. The study mentioned is "non-clinical analysis," which typically refers to mechanical or material testing, not studies involving human experts or ground truth in the context of diagnostic or treatment performance with patients.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: This information is not applicable and not provided. As mentioned above, the study is non-clinical.
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
Missing Information: This information is not applicable and not provided. The device is an intramedullary nail, which is a physical implant for fracture fixation, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing Information: This information is not applicable and not provided. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: This information is not applicable and not provided. The "non-clinical analysis" would involve engineering and material property measurements, not clinical ground truth.
8. The sample size for the training set
Missing Information: The document mentions "non-clinical analysis," but it does not describe any training sets, which are typically associated with machine learning or AI models. Given that this is a physical medical device, training sets in that context are not relevant.
9. How the ground truth for the training set was established
Missing Information: This information is not applicable and not provided, for the same reasons as point 8.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.