(322 days)
The TriMed Radial Bullet is intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. The implant design includes a tip that is placed up against the subchondral bone of the tip of the radial styloid to prevent loss of radial length during fracture healing. The TriMed Radial Bullet may be used with bone screws, washers, locking bone screws and/or locking fixation pegs of the same material. The principal site of application is along the radial column in the context of distal radius fixation for treatment of fractures or osteotomies. Other sites of application may be reserved for future use.
The TriMed Radial Bullet is indicated for:
- Fixation of fractures or non-unions of the distal radius
- Osteotomies of the distal radius to correct malunion
The TriMed Radial Bullet is a bone fixation implant that is used as an aid to fracture fixation. All components of the implant are manufactured either from medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy.
The provided text is a 510(k) summary for the TriMed Radial Bullet, a bone fixation implant. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested sections about study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not present in this type of regulatory document.
However, I can extract information related to the device's intended use, technological characteristics, and how its equivalence is established.
Here's an attempt to structure the available information, noting the absence of details requested that are typically found in a clinical or performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) as one would find for a diagnostic or AI device. Instead, the "acceptance criteria" for a 510(k) submission for a bone fixation plate generally revolve around demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing:
- Similar intended use: The device is intended for the same uses as the predicate.
- Similar technological characteristics: The device operates and is constructed similarly to the predicate.
- Safety and efficacy: The differences (if any) do not raise new questions of safety or effectiveness.
Therefore, the "reported device performance" in this context is the assertion that it meets these substantial equivalence criteria due to its identical technical characteristics and intended use compared to existing devices.
| Acceptance Criterion (for 510(k) submission) | Reported Device Performance (Statement of Equivalence) |
|---|---|
| Intended Use: Aid to fracture fixation, stabilization of bone fragments, prevent loss of radial length for distal radius fractures/osteotomies. | The TriMed Radial Bullet is intended for use as an aid to fracture healing, inserted across a fracture site to aid in stabilization of bone fragments until bone healing occurs. Its design prevents loss of radial length. It is indicated for fixation of fractures or non-unions of the distal radius and osteotomies of the distal radius to correct malunion, which are similar to predicate devices. |
| Technological Characteristics: Materials, design, function. | "The TriMed Radial Bullet has identical technical characteristics to existing bone fixation plates that are in common use." (e.g., medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy, plate-and-screw/peg fixation system) |
| Safety and Efficacy: No new questions of safety or effectiveness. | Implied by the "identical technical characteristics" and "substantial equivalence" determination by the FDA based on comparison to already cleared predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) submission for a medical device (bone fixation plate), not a study involving a "test set" of data or patient images for an AI algorithm. The evaluation is based on comparison to existing predicate devices and material specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "test set" or "ground truth" establishment in this context. The "expert" involved in the submission is Robert J. Medoff, MD, who prepared the 510(k) and is likely the device inventor/developer or a clinical consultant. His qualifications aren't explicitly detailed beyond being a Medical Doctor, but his role suggests expertise in orthopedics, given the device's application.
4. Adjudication Method for the Test Set
Not applicable. No "test set" to adjudicate.
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 bone fixation plate, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a bone fixation plate, not an algorithm.
7. The Type of Ground Truth Used
Not applicable for a typical "ground truth" definition for an AI or diagnostic study. For a medical device 510(k), the "ground truth" in a broader sense is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. This "ground truth" is established through years of clinical use, regulatory history, and potentially prior clinical studies for the predicate devices.
8. The Sample Size for the Training Set
Not applicable. No "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. No "training set" for an algorithm.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.