Search Results
Found 1 results
510(k) Data Aggregation
(71 days)
SYNTHES (USA) ELBOW HINGE FIXATOR
The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability.
The indications for guided joint bridging with external fixators are:
-Delayed treatment of dislocated and stiff elbows
-Chronic, persistent joint instability
-Acute joint instability after complex ligament injuries
-Unstable elbow fractures
-Additional stabilization of post-operative unstable internal fixation
The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults.
The Synthes Elbow Hinge Fixator consists of two rods, which are interconnected through a riveted joint, allowing a hinge-like movement. The rods are made of carbon fiber reinforced PEEK, and the joint is made of stainless steel. The overall length of the device is 180mm and the achievable range of motion averages 270 degrees.
The provided text [K063832] is a 510(k) summary for the Synthes (USA) Elbow Hinge Fixator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include details about acceptance criteria, specific device performance studies with sample sizes, expert ground truth establishment, or any AI-related information (such as MRMC studies, standalone algorithm performance, or training set details).
Based on the provided information, I can only provide the following:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in the manner typically found in a clinical or performance study report. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Stryker-Dynamic Joint Distractor II.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Substantial Equivalence Determination) |
|---|---|
| Mechanical and functional characteristics are comparable to a legally marketed predicate device. | The device consists of two rods interconnected through a riveted joint, allowing hinge-like movement. Rods are carbon fiber reinforced PEEK; joint is stainless steel. Overall length 180mm, achievable range of motion averages 270 degrees. This design and function are deemed substantially equivalent to the predicate. |
| Intended use and indications are equivalent to a legally marketed predicate device. | Intended for supplementary treatment of complex, unstable elbow injuries where early functional stress must be limited. Indications include delayed treatment of dislocated/stiff elbows, chronic/acute joint instability, unstable elbow fractures, and additional stabilization of post-operative unstable internal fixation. These indications are deemed substantially equivalent to the predicate. |
| Compatibility with existing external fixator components. | Compatible with Synthes Large External Fixator components for adults and Synthes Medium External Fixator components for children and small stature adults. This compatibility is a functional aspect of the device. |
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 provided in the 510(k) summary. The document does not describe a test set or data provenance for a performance study. The 510(k) process for this device relies on demonstrating substantial equivalence, which often involves engineering testing, material characterization, and comparison to the predicate device's specifications rather than a clinical trial with a "test set" as might be used for AI/diagnostic devices.
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 provided as the document does not detail a study involving expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document does not detail a study involving adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical orthopedic fixator, not an AI-based diagnostic or assistive software, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study of an algorithm was not done. This device is a mechanical orthopedic fixator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as the document does not describe a study involving ground truth. The basis for clearance is substantial equivalence to a predicate device, supported by engineering considerations and functional comparisons.
8. The sample size for the training set
This information is not provided. This device is a mechanical medical device, not an AI system, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not provided. As explained above, there is no "training set" for this type of device.
Ask a specific question about this device
Page 1 of 1