(107 days)
The Align Radial Head System and accessories are designed specifically for
· Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o Joint destruction and/or subluxation,
- o Resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- · Revision following failed radial head arthroplasty.
The system is intended for press fit use.
The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.
The Align Radial Head System is comprised of:
- · Multiple sized CoCr Radial Heads with Locking Screw
- Multiple sized titanium alloy Stems, titanium plasma spray coated
- · System specific instrumentation.
This document is a 510(k) premarket notification for the "Align Radial Head System," a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria with quantifiable metrics. Therefore, many of the requested categories for device performance studies cannot be directly extracted or are not applicable.
Here's an attempt to answer based on the provided text, highlighting where information is unavailable or not directly relevant to the request as phrased for AI/software-centric device studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging. |
| Mechanical Performance | Passed static, shear, and abrasion testing. |
| Material Characterization | Performed as part of equivalence testing. |
| Biocompatibility | Implied through substantial equivalence to predicate device materials. |
| Sterility and Packaging | Found to be similar to the predicate device. |
Note: The document states "Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing." However, specific quantitative acceptance criteria (e.g., "shear strength must be > X MPa") and the exact numerical results are not provided.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing mentioned (mechanical and characterization) would involve physical samples of the device, not a "test set" of data in the context of an AI/software study. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of device testing described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. The ground truth for this device (an implantable prosthesis) would be established through engineering specifications, material science, and pre-clinical mechanical testing, not by expert consensus on a test set in the way AI/software studies use "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for human review of data or images to establish ground truth, which is not the type of testing described for this physical medical device.
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
This information is not applicable. This document describes an orthopedic implant, not an AI or software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established through engineering specifications, material properties, and physical mechanical testing results (static, shear, and abrasion tests) designed to confirm the device's functional integrity and safety. It's not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As above, this device does not use a "training set" in the computational sense.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.