(27 days)
The SIDEKICK™ Rail Fixator System is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.
The SIDEKICK™ Rail Fixator System is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression/distraction and early weight bearing. The articulation pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, or arthrodesis of the foot or hand.
This 510(k) summary does not contain information on acceptance criteria or a study proving the device meets said criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device.
However, based on the provided text, here's what can be extracted and what information is missing:
Missing Information:
The provided text is a 510(k) summary for a medical device (SIDEKICK™ Rail Fixator System) seeking clearance based on substantial equivalence. This type of submission typically does not include detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The primary argument for 510(k) clearance is that the new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar design, materials, and intended use, rather than presenting novel clinical performance data against pre-defined acceptance criteria.
Therefore, the following information points are not available in the provided document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Information that can be inferred or is directly stated:
While specific performance data against acceptance criteria is not present, the core of a 510(k) is the demonstration of "substantial equivalence."
1. A table of acceptance criteria and the reported device performance:
As mentioned, this information is not provided because a 510(k) summary focuses on substantial equivalence rather than reporting performance against specific acceptance criteria for a new clinical study. The "performance" assessment here is primarily a comparison to the predicate device.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (from text) |
|---|---|
| Safety and Effectiveness (equivalent to predicate) | "The substantial equivalence information, materials information, and analysis data provided within this Premarket Notification adequately supports the safety and effectiveness of the SIDEKICK™ Rail Fixator system." |
| Indications for Use (identical to predicate) | "The indications for use of the SIDEKICK™ Rail Fixator System are identical to the predicate device." |
| Design Features (substantially equivalent to predicate) | "The design features and materials of the subject device are substantially equivalent to those of the predicate device." |
| Materials (substantially equivalent to predicate) | "The design features and materials of the subject device are substantially equivalent to those of the predicate device." |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable or not provided. The 510(k) hinges on comparing the proposed device to a predicate, not typically on new clinical studies with defined test sets.
- Data Provenance: Not applicable or not provided beyond the materials and design comparison to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no independent "ground truth" establishment for a new clinical test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no independent "test set" and adjudication process is described.
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:
- Not applicable. This device is an external fixator system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an external fixator system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of new clinical data. The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set:
- Not applicable as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.