(56 days)
The Internal Joint Stabilizer – Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.
The Skeletal Dynamics Internal Joint Stabilizer – Elbow is an internal elbow fixator, with three principal components:
- A Base Plate assembly consisting of a low profile Base Plate, contoured to fit within . the flat surface of ulna at the olecranon process; a Connecting Rod, a Boom and two Locking Joints designed to bridge over the anconeous muscle. The Connecting Rod and Boom are adjustable by means of the Locking Joints to accommodate different patient anatomies. The Base Plate assembly is made of titanium alloy and cobalt chrome.
- A cobalt chrome Axis Pin threads through the Boom of the Base Plate assembly and ● is inserted in the axis of rotation of the humerus, and
- . Titanium compression screws to attach the Base Plate Assembly to the ulna.
Specialized instrumentation includes Axis Trajectory Guides (available in 3 sizes), K- Wire Guide, K-Wires, Depth Gauges, Drills, a Counter-torque tool, and a T-10 driver and quick connect handle.
The Internal Joint Stabilizer - Elbow is intended to be removed once the elbow ligaments have healed, usually within 6 - 8 weeks after implantation.
The system is provided non-sterile and is sterilized in the user facility.
The provided document describes the FDA 510(k) premarket notification for the "Internal Joint Stabilizer - Elbow" device. The acceptance criteria and the study proving the device meets them are detailed under "Performance Data" and "Clinical Study" sections.
Here’s a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from "Primary Efficacy Objective") | Reported Device Performance (from "Clinical Study") |
|---|---|
| Primary Efficacy Objective: | |
| Confirmation that the IJS-E provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation as effectively as hinged external fixation, defined as: | Out of 24 subjects who completed the study: |
| a. Broberg Morrey Functional Rating was fair or better at six months post explant. | 23 out of 24 (95.83%) had a Broberg Morrey Functional Rating of Fair or better (95% Cl: 78.87%, 99.89%). |
| b. No recurrent dislocation occurred during use of the Internal Joint Stabilizer – Elbow or after its removal. | 23 out of 24 subjects (95.83%) did not have recurrent dislocations (95% Cl: 78.87%, 99.89%). |
| Primary Safety Objective: | |
| Confirmation that the IJS-E does not contribute to a greater number of device related adverse events than hinged external fixation. | The Internal Joint Stabilizer – Elbow did not contribute to a greater number of device related adverse events than the hinged external fixator studied in the retrospective data review. Only one device-related AE (Axis Pin back out) and one study-related AE (malreduction) were reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Clinical Study):
- Sample Size: 26 subjects enrolled (26 consented and screened). 24 subjects completed the study.
- Data Provenance: Prospective, multi-center, non-randomized, cohort study conducted at 6 sites in the US.
- Comparator Data (for outcomes comparison):
- Sample Size: Not explicitly stated for the retrospective cohort, but referred to as "a retrospective cohort of subjects who underwent external hinged fixation."
- Data Provenance: Retrospective data from a major metropolitan hospital in the US.
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)
The document does not explicitly mention "experts" establishing ground truth in the context of radiologists or specific medical professionals rating images. Instead, the "ground truth" for the clinical study's efficacy was based on:
- Broberg Morrey Functional Rating: This is a standardized outcome measure for elbow function, typically assessed by clinicians as part of patient follow-up.
- Recurrent Dislocation: An objective clinical event, which would be determined by treating physicians.
- Device-related Adverse Events: Reported by treating physicians and/or study investigators.
The qualifications of the individuals who assessed these outcomes (e.g., the clinicians using the Broberg Morrey score or reporting adverse events) are not specified beyond their role in conducting a clinical study at "6 sites in the US."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or adverse events in the clinical study.
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, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" was not conducted. This study is for an internal joint stabilizer device, not an AI-powered diagnostic tool. The comparison was between the device's clinical outcomes and those of a predicate external hinged fixator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, an internal joint stabilizer, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was based on clinical outcomes data (Broberg Morrey Functional Rating, incidence of recurrent dislocation) and safety data (device-related adverse events).
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set." The study evaluated the device performance in human subjects, which serves as the "test set" for its clinical effectiveness and safety.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/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.