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510(k) Data Aggregation
(29 days)
The SafetyFix Easy Out System is indicated for temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
The SafetyFix Easy Out System is an implant device previously cleared by the FDA for temporary internal fixation and stabilization of osteotomies and fractures during normal healing (Easy Out K141401). The only changes from the previously cleared device are the name change, addition of cannulated screws and the addition of a cannulated screw head option. There are no other changes to the SafetyFix Easy Out System when compared to the device cleared under K141401.
The SafetyFix Easy Out System consists of various cannulated and partially threaded solid screws designed to create lag compression and used for temporary internal fixation small bones and fragments. The SafetyFix Easy Out bone screws are self-tapping, self-drilling screws with thread diameters of 2.0, 2.5, 3.0, 3.5 and 4.0 mm, and lengths that range from 8 to 60 mm. All compression screws are fabricated from medical grade titanium alloy (per ASTM F-136). Associated instrumentation is available. All compression screws are offered non-sterilization prior to use.
Here's an analysis of the provided text regarding the SafetyFix Easy Out System's acceptance criteria and studies:
Acceptance Criteria and Reported Device Performance
The device under review (SafetyFix Easy Out System, K180753) is a modification of a previously cleared device (Easy Out system, K141401). The primary acceptance criterion for the modified device is to demonstrate substantial equivalence to the predicate device, specifically that the added cannulated screws and modified screw head perform equivalently to the solid screws cleared in K141401 and do not raise new safety or efficacy concerns.
The reported device performance is that it functions as intended and the test results demonstrate substantial equivalence to the previously cleared device (K141401).
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | Medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F-136 (identical to predicate) | Identical: The SafetyFix Easy Out System uses medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F-136. |
| Biocompatibility | Complies with ISO 10993-1 (identical to predicate) | Identical: The SafetyFix Easy Out System complies with ISO 10993-1. |
| Mechanical Performance | Dynamic and Static 3-Point Bend Strength: Equivalent to predicate (K141401 solid screws), tested according to ASTM F1264-03 (07). | Demonstrated Equivalence: "The verification activities have been summarized to demonstrate that the cannulated screws have equivalent dynamic and static testing results as the screws cleared in K141401." and "Static and dynamic 3-point bend tests... were conducted to support substantial equivalence." |
| Static Torsional Strength: Equivalent to predicate (K141401 solid screws), characterized per ASTM F543-07(e1) and evaluated via engineering analysis. | Demonstrated Equivalence: "...static torsional tests... were conducted to support substantial equivalence." and "Furthermore, an engineering analysis was performed against the predicates to evaluate torsional strength... performance." The modified design is characterized as "more conservative." | |
| Axial Pull-Out Strength: Equivalent to predicate (K141401 solid screws), characterized per ASTM F543-07(e1) and evaluated via engineering analysis. | Demonstrated Equivalence: "...axial pull-out tests were conducted to support substantial equivalence." and "Furthermore, an engineering analysis was performed against the predicates to evaluate... pullout strength performance." | |
| Functional Equivalence | The addition of cannulated screws and modified screw heads does not raise any new safety or efficacy concerns compared to the predicate device. | Confirmed: "...The addition of the cannulated screws does not raise any new safety or efficacy concerns" and "The addition of the modified screw head does not raise any new safety or efficacy concerns." The device performed "as intended" and is "substantially equivalent." |
| Intended Use | Identical to predicate: temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist. | Identical: "The SafetyFix Easy Out System intended use and indications for use (cleared under K141401) remain identical." |
| Principles of Operation | Identical to predicate. | Identical: "There have been no changes made to the principles of operation..." |
| Manufacturing Processes | Identical to predicate. | Identical: "...no changes made to the... manufacturing processes..." |
| Sterility | Provided non-sterile (identical to predicate). | Identical: The device is "Provided Non-sterile." |
| Single-Use | Single-use device (identical to predicate). | Identical: The device is "Yes" for single-use. |
Study Details from the Provided Text:
This 510(k) submission is for a modification to an existing device, and therefore, the studies are focused on demonstrating equivalence rather than proving de novo safety and efficacy with clinical trials in humans.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of screws or tests for each type) used for the performance testing. However, it mentions "Performance testing was conducted to further characterize the performance of the SafetyFix Easy Out System's addition of the cannulated screws and modified screw head."
- Data Provenance: The data comes from non-clinical performance testing (mechanical bench testing) performed in a laboratory setting. There is no mention of human subject data or data from specific countries of origin beyond the general location of the sponsor and correspondent companies (USA). The study is non-clinical.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. The ground truth for mechanical testing is established by engineering standards (ASTM F1264-03 (07), ASTM F543-07(e1)) and direct comparison with the mechanical properties of the predicate device (K141401), not by human expert consensus or clinical assessment of a test set.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are used for clinical studies involving human interpretation or uncertain outcomes. For mechanical bench testing, results are objective measurements against predefined standards and comparative data.
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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:
- No, an MRMC study was not done. This is a mechanical device, not an imaging or an AI-powered diagnostic device, so MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone study was not done. This is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this submission is established through physical and mechanical measurements against recognized industry standards (ASTM F1264-03 (07), ASTM F543-07(e1)) and direct comparative engineering analysis with the mechanical properties of the predicate device's solid screws.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical device testing as there is no machine learning or AI component that requires training data.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
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