(268 days)
The Easy Out™ system is indicated for temporary internal fixation of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
Easy Out™ system consists of various, partially threaded solid screws designed to create lag compression used for temporary internal fixation small bones and fragments. The Easy Out™ bone screws are self-tapping, self-drilling screws with thread diameters of 2.0 mm, 2.5 mm, 3.0 mm, 3.5mm, 4.0 mm, and lengths that range from 12 mm 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 sterile".
The document describes a medical device called Easy Out™, a system for temporary internal fixation of osteotomies and fractures. It is a 510(k) premarket notification to the FDA, and as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy. Therefore, much of the requested information about clinical studies, ground truth establishment, and expert involvement is not present in this type of document, as those are typically required for Novel devices or PMA submissions.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table. Instead, it describes performance testing conducted to characterize the device and demonstrate substantial equivalence to predicate devices. The reported performance is that the device "functioned as intended" and the test results "demonstrate substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static 3-point bend strength | Functioned as intended; demonstrated substantial equivalence to predicate devices |
| Dynamic 3-point bend strength | Functioned as intended; demonstrated substantial equivalence to predicate devices |
| Static torsional strength | Functioned as intended; demonstrated substantial equivalence to predicate devices |
| Axial pull-out strength | Functioned as intended; demonstrated substantial equivalence to predicate devices |
| Biocompatibility: | Complies with applicable voluntary standards |
| Sterilization: | Complies with applicable voluntary standards |
| Intended Use: | Same as predicate devices |
| Technological Characteristics: | Similar to predicate devices |
| Safety and Effectiveness: | Does not raise new issues of safety and effectiveness compared to predicates |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Performance testing and engineering analysis," including "Static and dynamic 3-point bend tests, static torsional tests and axial pull-out tests." However, it does not specify the sample sizes used for these tests. It also does not provide any information regarding data provenance (country of origin, retrospective/prospective) for these non-clinical performance tests.
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 or available from the document. The study described is non-clinical performance testing (mechanical and material characterization), not a clinical study involving diagnosis or interpretation by experts to establish a "ground truth" for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or available from the document for the reasons stated in point 3.
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
There was no MRMC comparative effectiveness study and therefore no effect size relating to human readers or AI is provided. The device is a bone fixation screw system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable or available from the document. The device is a physical medical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" would be the physical properties and mechanical behavior of the device measured against established engineering standards (ASTM F1264-03 (07), ASTM F543-07(e1)). It is not a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
This information is not applicable or available from the document. The document describes a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable or available from the document for the reasons stated in point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.