(75 days)
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Here's an analysis of the provided text regarding acceptance criteria and study information for the Avanta Orthopaedics External Fixator.
Important Note: The provided document is a 510(k) summary for a medical device (external fixator). 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies in the way an AI/ML device or a novel therapeutic might. Therefore, many of the requested fields related to AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies) will not be applicable to this traditional device submission.
Acceptance Criteria and Device Performance for Avanta Orthopaedics External Fixator
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Avanta Orthopaedics) |
|---|---|---|
| Intended Use | Unilateral external fixation for limb lengthening, osteotomies, arthrodesis, fracture fixation, and other amenable bone conditions (as per EBI/Orthofix K831576 predicate). | Same as predicate device. |
| Device Type | External Fixator | External Fixator |
| Pin Type | Implantable | Implantable |
| Compression/Distraction | Allows for application of both compression and distraction. | Yes, allows for application of compression or distraction. |
| Pin Length Range | 80-160 mm (EBI/Orthofix) | 50-90 mm (Avanta Orthopaedics) - This is a difference noted but deemed acceptable for substantial equivalence. |
| Components | Includes various size frames, bars, pin clamps, pins, accessories, and instruments to accommodate anatomies and injuries. | Includes various size frames, bars, pin clamps, pins, accessories, and instruments. |
| Material | Smooth or threaded metallic bone fixation fastener. | Smooth or threaded metallic bone fixation fastener (implied, as this is a general characteristic of the product code). |
| Classification | Class II (Orthopaedic, Product Code JWD) | Class II (Orthopaedic, Product Code JWD) |
Study Proving Device Meets Acceptance Criteria:
The document describes a substantial equivalence determination based on a comparison to a predicate device, not a specific study proving performance against pre-defined acceptance criteria in a clinical trial sense. The "study" here is essentially the 510(k) submission itself, which argues that the Avanta Orthopaedics External Fixator is as safe and effective as the legally marketed predicate device (EBI/Orthofix K831576).
The key findings from the comparison table (provided in the document) are:
- The Avanta device and the predicate device have similar design characteristics and intended use.
- The primary difference noted is the pin length range, which is 50-90 mm for Avanta compared to 80-160 mm for EBI/Orthofix. Despite this difference, the FDA determined the device to be substantially equivalent, implying that this difference does not raise new questions of safety or effectiveness for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a "test set" of data in the context of an AI/ML device. The "test set" in this case would be the Avanta Orthopaedics External Fixator itself, compared against the predicate device's established performance and characteristics. The "provenance" is the device's design and manufacturing specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on medical images) is not relevant for this type of 510(k) submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process as described for AI/ML validation was performed.
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 a traditional medical device, not an AI/ML-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an AI/ML algorithm, which is not what this device is.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device (EBI/Orthofix K831576), which has been legally marketed in interstate commerce prior to May 28, 1976, or has been reclassified. This is based on the history of that predicate device's use and regulatory clearances.
8. The Sample Size for the Training Set
Not applicable. No "training set" in the context of AI/ML algorithms was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. No "training set" was used.
§ 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.