(51 days)
Rush Medullary Pins are indicated for use in fixation of bone fractures, for bone reconstruction, and for skeletal traction in alignment of long bone fracture segments.
The Rush Medullary Pin is inserted into the medullary canal of long bones to provide internal shaft fracture fixation. It achieves stabilization through the opposition of dynamic forces. The beveled point enables the surgeon to insert from the side of the bone with little chance of driving the pin through the opposing cortex. These devices are made from stainless steel.
The provided text is for a medical device (Rush Medullary Pins) that is a physical implant used for bone fixation, not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as sample size for training/test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.
The document discusses the substantial equivalence of the Rush Medullary Pins to a predicate device.
Acceptance Criteria and Device Performance (Based on "Comparison to Predicate Device" and "Performance Data" sections):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Biocompatibility testing on the Rush Pin material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed. |
| Material Mechanical Properties | The subject devices conformed to material mechanical property standard ISO 5838-1. |
| Bending Strength | An engineering analysis showed that the subject and predicate devices have identical material and cross-sectional geometrical properties, and their bending strengths are substantially equivalent. |
| Shape | The subject Rush Medullary Pins are identical in shape to the predicate devices. |
| Materials | The subject Rush Medullary Pins are identical in materials to the predicate devices. |
| Performance Characteristics | The subject Rush Medullary Pins are identical in performance characteristics to the predicate devices. |
| Substantial Equivalence (Overall) | The data presented in the submission demonstrate that the subject devices are substantially equivalent to the predicate devices, despite differences in length (diameters are equivalent to predicate devices). The indications for use were also shown to be substantially equivalent. The subject device is provided non-sterile, as is the predicate device, further establishing equivalence. |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. The evaluation was based on non-clinical performance (biocompatibility, material properties, engineering analysis) and comparison to a predicate device, not on a test set of data like in AI/ML studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood in AI/ML is not relevant for this type of device submission.
- Adjudication method for the test set: Not applicable.
- 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 physical medical device, not an AI/ML product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: Not applicable. The "ground truth" here is compliance with established standards (ISO 10993-1, ISO 5838-1) and demonstrating substantial equivalence to a legally marketed predicate device through physical and engineering properties.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.