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510(k) Data Aggregation
(103 days)
The Integra® External Fixation System is an external fixation device in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- · Correction of deformity
- · Revision procedures where other treatments or devices have been unsuccessful
- · Bone reconstruction procedures
- · Fusions and replantations of the foot
- · Charcot reconstruction and Lisfranc dislocations
- · Ankle distraction (arthrodiastasis)
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. The modifications to the device include material and minor design updates to the Universal Wire Fixation Bolt and Slotted Posts which do not affect the safety and effectiveness of the device. An update was also made to the position of the olive on the 530mm olive wire. Lastly, the sharpness of the olive wire and k-wire were modified.
The provided text describes a 510(k) submission for the Integra® External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that establishes acceptance criteria for a novel device's performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this specific document. This document details modifications to an existing device and confirms that these modifications do not negatively impact its safety and effectiveness compared to the predicate.
However, I can extract information related to the performance comparison and the "acceptance criteria" as defined by substantial equivalence to the predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" for the modified device (Integra® External Fixation System K160830) is that its performance should be statistically equivalent to the predicate device (Integra® External Fixation System K140463) for the specific elements that were modified.
| Acceptance Criteria (for modified components) | Reported Device Performance (K160830) |
|---|---|
| Stiffness statistically equivalent to predicate | Stiffness was statistically equivalent to predicate. |
| Acceptable Torsional Strength | A torsional strength test was performed. (Result implicitly positive, otherwise substantial equivalence would be denied). |
| Acceptable Static Wire Retention | A static wire retention test was performed. (Result implicitly positive). |
| Acceptable Dynamic Wire Retention | A dynamic wire retention test was performed. (Result implicitly positive). |
| Olive wire position validation | Validation performed, no further verification needed. |
| Wire sharpness validation | Validation performed, no further verification needed (no effect on part strength). |
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: The document does not specify the exact sample sizes used for the dynamic, static, and torsional tests. It mentions "constructs were tested" implying multiple samples of the modified components.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer as part of their design control and validation processes. It is prospective testing aimed at proving specific performance characteristics of the modified components.
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 is not applicable. The "ground truth" here is the physical and mechanical performance of the device components, measured through engineering tests, not an interpretation by medical experts. The evaluation is based on objective measurements and comparison to predefined engineering standards or the performance of the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are quantitative and typically assessed against pre-defined engineering thresholds or comparative data from the predicate device.
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 (a physical medical device), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance assessment of the modified components is their measured mechanical properties and physical characteristics (e.g., stiffness, tensile strength, wire retention forces, olive position, sharpness). These are objective engineering measurements compared against the predicate device's corresponding properties.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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