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510(k) Data Aggregation
(127 days)
The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating 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 fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
The S.E.A.L. Fracture Fusion Tube is a medical device for external fixation of fractures and reconstruction of small bones. The device did not undergo clinical studies to prove its performance. Instead, its substantial equivalence to predicate devices was claimed based on non-clinical testing.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in terms of mechanical safety and performance, as demonstrated by ASTM F1541-02 Annex 7 testing. | The analysis indicates that the S.E.A.L. Fracture Fusion Tube is equivalent to predicate devices. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set or human data was used.
- Data Provenance: Not applicable. The study involved non-clinical mechanical testing, not a test set derived from patient data.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. Ground truth from experts is not relevant for non-clinical mechanical testing.
4. Adjudication Method
- Not applicable. There was no test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done.
6. Standalone Performance Study
- A standalone (algorithm only without human-in-the-loop performance) study was not applicable as this is a medical device with no AI component.
- Non-clinical testing following ASTM F1541-02 Annex 7 was performed to assess the mechanical safety and performance of the device.
7. Type of Ground Truth Used
- Ground Truth Type: Mechanical testing results against established industry standards (ASTM F1541-02 Annex 7) and comparison to predicate devices. The "ground truth" here refers to the engineering and material science principles governing external fixators.
8. Sample Size for Training Set
- Not applicable. No training set was used for this device as it does not involve machine learning or AI.
9. How Ground Truth for Training Set was Established
- Not applicable. No training set was used.
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(76 days)
The DNE External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The DNE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The DNE External Fixation System assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints. Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.
The DNE External Fixation System is a medical device, and the provided text is a 510(k) summary for its clearance. It is crucial to understand that 510(k) clearance is not an approval based on meeting specific performance acceptance criteria from a study demonstrating efficacy. Instead, a 510(k) demonstrates substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market, not that it independently proves performance against predefined benchmarks through clinical studies.
Therefore, many of the questions regarding acceptance criteria and performance data for this device, in the typical sense of a clinical study proving efficacy, are not applicable based on the provided document.
Here's a breakdown of the information as it relates to the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: No specific numerical acceptance criteria (e.g., a certain percentage of efficacy or a specific mechanical strength threshold) are provided in the 510(k) summary for the DNE External Fixation System. The "acceptance criteria" for a 510(k) submission are generally that the device demonstrates substantial equivalence to a predicate device.
- Reported Device Performance: The document states that "No testing was performed." and "No clinical studies were performed." The "performance" claimed is therefore based on its similarity to the predicate device, the R&R External Fixator System (K052005). The conclusion is that "The DNE External Fixation System is substantially equivalent to the predicate device in terms of indications for use, design, material, performance and function."
| Acceptance Criteria (from a traditional study) | Reported Device Performance (from a traditional study) |
|---|---|
| Not applicable; no specific criteria defined for this 510(k) submission. | No performance data from studies were reported. |
| Substantial equivalence to predicate device. | Claimed to be substantially equivalent to the R&R External Fixator System. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No test set was used as no testing was performed.
- Data Provenance: Not applicable.
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)
- Not applicable. No ground truth was established for a test set as no testing was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication was performed.
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 fixation system, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an external fixation system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established as no testing was performed.
8. The sample size for the training set
- Not applicable. This device is an external fixation system; it does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
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