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510(k) Data Aggregation
(28 days)
Medline UNITE® IM Fibula Implants are in bone reconstruction, osteotomes, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Implants are intended for single use only.
The Medline UNITE® IM Fibula Implants are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device. The Medline UNITE® IM Fibula Implants are manufactured from Titanium Alloy per ASTM F136 and ISO 5832-3. The implants are offered in a 3.7/4.0mm tapered diameter with fully threaded lengths ranging from 65mm to 150mm. The implants are single use only and provided non-sterile.
The provided FDA 510(k) summary for the Medline UNITE® IM Fibula Implant (K220511) does not contain information about the acceptance criteria or a study proving that the device meets such criteria in terms of clinical performance or diagnostic accuracy. This type of device (a metallic bone fixation fastener) undergoes a different type of evaluation for substantial equivalence.
Here's why and what information is provided instead:
- Device Type: This is a Class II medical device, specifically a smooth or threaded metallic bone fixation fastener. For such devices, the primary pathway to market clearance via a 510(k) is to demonstrate substantial equivalence to a currently marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials.
- Focus of Evaluation: The evaluation for this type of device heavily relies on bench testing (non-clinical) to ensure mechanical properties, material biocompatibility, and design features are comparable or superior to the predicate device, and that it doesn't raise new questions of safety or effectiveness.
Therefore, the sections you've requested regarding acceptance criteria for clinical performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this 510(k) submission. These details are typically found in submissions for diagnostic AI/ML devices or other devices requiring clinical performance endpoints.
However, I can extract information related to the equivalence testing conducted for this device:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" in terms of specific thresholds for clinical performance metrics (like sensitivity, specificity, or surgical success rates). Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device (Medline Cannulated Screws, K130319) through a comparison of technological characteristics and non-clinical performance.
The primary "performance" reported is that the subject device's mechanical properties are comparable to or better than the predicate such that it does not represent a new worst-case.
| Criterion Category (Implied for Substantial Equivalence) | Acceptance Criteria (Implied: Comparable to Predicate without raising new safety/effectiveness questions) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate | "Medline UNITE® IM Fibula Implants are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Implants are intended for single use only." (Which is the same as the predicate). |
| Technological Characteristics | Materials, Design, Sterility, Single Use, Prescription Status should be same or equivalent. | Materials: Titanium Alloy (Same as predicate). |
| Design Feature: Torx drive mechanism, Self-drilling and self-tapping (Same as predicate). | ||
| Prescription vs. OTC: Prescription (Same as predicate). | ||
| Sterile vs. Non-Sterile: Non-Sterile (Same as predicate). | ||
| Single Use vs Reusable: Single Use (Same as predicate). | ||
| Biocompatibility | Compatible with body tissue, no adverse biological reactions. | "manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The subject device and the predicate device are both manufactured from the identical raw material using the same manufacturing process, therefore, biocompatibility testing was leveraged from the predicate submission". |
| Mechanical Performance (Bench Testing) | Not a new worst-case for structural integrity (e.g., pullout force, torsional yield strength) compared to predicate. | "An engineering analysis was performed to determine that the subject screws do not present a new worst-case for pullout force and torsional yield strength when compared to the predicate." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The evaluation was based on non-clinical bench testing and engineering analysis, rather than a clinical test set with patient data.
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 applicable, as there was no clinical test set requiring expert ground truth for classification or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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 applicable. This device is a bone fixation fastener, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. For this type of device, "ground truth" relates to material properties meeting specifications and device designs fulfilling mechanical performance requirements, assessed via engineering standards and tests.
8. The sample size for the training set
This information is not applicable. There was no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles, historical data, and established standards for medical implants.
9. How the ground truth for the training set was established
This information is not applicable.
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