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The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton.

The Normed Titanium Osteotomy Plating System consists of titanium plates in two configurations, wedge and step, which are attached to the bone using screw fixation. The wedge plates are available in six lengths, namely, 3,4,5,6,7and 8 mm with 2.3 mm diameter screws extends from 10 to 28 mm long. The step plates are available in four lengths, namely, 3,4,5 and 6 mm with 3.5 mm diameter screws extends from 10 to 28 mm long. The plates screw holes are threaded and can accept locking screws with threaded and non-threaded screw head.

The provided text is a 510(k) summary for the Normed Titanium Osteotomy Plating System, which is a medical device for bone fixation. It describes the device, its intended use, and states that the FDA found it substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

Specifically, the following information, as requested in the prompt, is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not included. The document only describes the device and its intended use.
2. Sample size used for the test set and the data provenance: No test studies or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth is discussed.
5. Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned. This device is a bone plating system, not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no studies or ground truth establishment are discussed.
8. The sample size for the training set: Not applicable as no training sets or algorithms are discussed.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, often through bench testing and often does not require new clinical studies for Class II devices like this one. The document indicates that the device was deemed "substantially equivalent" to predicate devices, which means its safety and effectiveness are established by its similarity to already-approved devices, rather than through new, extensive clinical studies detailed in this summary.

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