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510(k) Data Aggregation
(64 days)
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
Synthes 4.0mm Ti. Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.
The Synthes 4.0mm Ti. Locking Screws feature a self-tapping tip, stardrive mechanishm, and have a flat head profile with rounded edges. They are available in lengths ranging from 14mm to 90mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.
The provided text describes a 510(k) premarket notification for Synthes 4.0mm Titanium Locking Screws. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive performance studies against specific acceptance criteria. Therefore, several of the requested sections regarding AI device performance studies (MRMC, standalone, training set, ground truth for training set) are not applicable or cannot be extracted from this document.
Here's the information that can be extracted:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. The primary "performance" discussed is the device's substantial equivalence to a predicate device, implying that its mechanical and material properties are comparable and acceptable for its intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail criteria. The overarching "acceptance criterion" is demonstrating substantial equivalence to the predicate device. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for its intended use. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an AI/algorithm performance study. The 510(k) process for this type of medical device (bone fixation fastener) typically relies on engineering and material testing, and comparison to a predicate device, rather than performance against a clinical test set with ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/diagnostic algorithm that relies on expert interpretation for ground truth establishment.
4. Adjudication method for the test set
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
Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's safety and effectiveness would be established through material testing (e.g., strength, biocompatibility), design verification, and comparison to the predicate device's established performance and safety record, rather than clinical ground truth like pathology or outcomes data in the context of an AI study.
8. The sample size for the training set
Not applicable. This is not an AI diagnostic device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI diagnostic device.
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