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The NBX® Non-Bridging External Fixator – Hand, is used for definitive external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the metacarpals and phalanges of the hand.

The NBX® Non-Bridging Fixator - Hand is provided sterile. The fixator consists of the body with its proprietary locking mechanism and a multiple of pins.

This device is an external fixator, a mechanical device. The provided text describes mechanical performance testing, not a study evaluating an AI algorithm or diagnostic performance. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text, focusing on the mechanical aspects of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the "Equivalence to accepted methods of treatment for the products indications of use is covered in other sections of the application and based on nonclinical data." This implies that the acceptance criteria for the mechanical tests would be substantial equivalence to legally marketed predicate devices (K051605 Small Bone Innovations and K033476 Howmedica Osteonics). The exact numerical acceptance values are not provided in this excerpt, but the overall message is that the device's performance is demonstrated through non-clinical testing.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided text. The text mentions "Comparative Testing of External Fixation Devices" but does not detail the number of devices or test repetitions.
• Data Provenance: The data is non-clinical, meaning it's from laboratory testing rather than human subjects. The country of origin for the testing is not specified, but the applicant is based in Ft. Lauderdale, Florida, USA. The testing is assumed to be prospective, as it's conducted to demonstrate performance for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a mechanical device, and "ground truth" in the context of expert review for diagnostic AI is not relevant. The "ground truth" for mechanical testing would be the physical measurements and stress/strain data obtained from the tests, compared against established engineering standards and predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As this is mechanical testing, there is no adjudication process involving human interpretation of results in the way there would be for medical image analysis. Device performance is determined by direct physical measurement and comparison to predefined criteria or predicate device performance.

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-assisted diagnostic or predictive device. It is a physical external fixator for bones.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI algorithm. Its performance is entirely "standalone" in the sense that its mechanical properties are inherent to the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Engineering/Mechanical Standards and Predicate Device Performance. The "ground truth" is established by comparing the device's measured mechanical performance (e.g., strength, stability under load) to established engineering benchmarks and the performance of previously cleared, substantially equivalent predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set."

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The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.

The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.

This document is a 510(k) summary for the NBX™ Non-Bridging External Fixator - Shoulder. It does not describe an AI/ML device or software. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies, which are typically associated with performance evaluation of AI/ML software, are not applicable to this submission.

The document discusses a traditional medical device (an external fixator) and its substantial equivalence to previously marketed devices. The performance data mentioned ("Non-Clinical performance data: Equivalence to accepted methods of treatment for this products indication of use is covered in other sections of this application") refers to engineering and biocompatibility testing, not clinical studies involving AI performance metrics.

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Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-bridging device, which means that it does not cross the wrist. A non-bridging device gives patients the ability to utilize wrist function.

The device consists of two plates with multiple pin holes. Pins are inserted through the plates, into the bone and held in place by the interference of the two plates. The plate has an external bracket that allows pins to be inserted from the side for additional fixation. If desired, distraction of the fracture site may be achieved with adjustment of a threaded pin placed within a slot on the distal end of the plate.

The provided document is a 510(k) premarket notification for a medical device, the NBX - Non-Bridging External Fixator. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria through clinical or analytical performance testing.

Therefore, the specific information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not available in this document.

Here's why:

• The document states under "Clinical Testing: None provided."
• The primary purpose of a 510(k) submission for this type of device is often to demonstrate substantial equivalence through technological characteristics and non-clinical (mechanical) testing, as indicated by "Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device."

Without clinical testing or detailed analytical performance studies, there are no acceptance criteria, reported device performance metrics, or study designs to describe in the way your prompt expects.

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