(333 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:
- Joint destruction and/or subluxation,
- 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 to 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 into the medullary canal of the radius. Combined with its unique instrumentation, the ALIGN Radial Head offers 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 allov Stems, titanium plasma spray coated .
- Stainless Steel K-Wires for optimal prosthesis alignment (not to be implanted)
- System specific instrumentation
The provided document is a 510(k) summary for the Align Radial Head Arthroplasty System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a comprehensive study to prove device performance against such criteria as one might see for a diagnostic AI device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable for this type of medical device submission (an orthopedic implant). The submission relies on non-clinical testing (mechanical fatigue and static tests, and cadaver studies) and material biocompatibility.
Here's an analysis based on the available information:
Device: Align Radial Head Arthroplasty System
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present specific quantitative acceptance criteria in the format typically seen for AI/diagnostic devices (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" are implied by the demonstration of:
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Fatigue & Static Tests) | Device meets performance requirements under various positions to ensure structural integrity and mechanical connections. | Tests were performed to "evaluate the performance of the device and its mechanical connections." (Specific quantitative results or thresholds are not provided in this summary). |
| Surgical Procedure Repeatability (Cadaver Studies) | The surgical procedure for implantation is repeatable and consistent. | Cadaver studies were performed to "confirm the repeatability of the surgical procedure." (Specific quantitative results or metrics for repeatability are not provided in this summary). |
| Biocompatibility | Materials are recognized as safe for orthopedic implantation. | Materials (Ti-6AL-4V ELI per ASTM F 136-00 and CoCrMo per ASTM F-1537) have a "long history of safe use in the orthopedic industry." Titanium Plasma Spray coating is "similar to that found on other currently marketed orthopedic implant devices." |
| Material Equivalence | Materials are the same as or equivalent to predicate devices. | Utilizes "the same materials" as predicate devices (Acumed Anatomic Radial Head System - K041858 and Biomet Explore Radial Head - K051385). |
| Intended Use Equivalence | Indications for use are the same as predicate devices. | Has "The same indications for use and intended use" as predicate devices. |
| Basic Shape Equivalence | Basic shape is comparable to predicate devices. | Has "The same basic shape" as predicate devices. |
| Operating Principles Equivalence | Operates on the same principles as predicate devices. | Uses "the same operating principals" as predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical trials or AI/diagnostic performance. The "tests" here refer to non-clinical mechanical and cadaveric studies.
- Data Provenance: Not applicable. The studies are laboratory-based (mechanical tests) and cadaveric. No patient data (retrospective or prospective) from specific countries is mentioned or required for this type of submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical tests, the "ground truth" is determined by engineering specifications and material standards. For cadaver studies, the assessment of surgical repeatability would be performed by experienced surgeons, but specific numbers and their qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept applies primarily to image-based diagnostic studies involving multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers. The Align Radial Head Arthroplasty System is an implantable device, not a diagnostic tool.
6. Standalone Performance Study
- Standalone Performance Study: No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This concept is for AI algorithms. The "standalone performance" for this device would be its mechanical integrity and biocompatibility, as evaluated by the non-clinical tests described.
7. Type of Ground Truth Used
The "ground truth" for this device is established through:
- Engineering specifications and validated testing methods for mechanical properties (fatigue, static loads).
- Biocompatibility standards and historical safe use data for materials.
- Surgical expertise for assessing the repeatability of the implantation procedure in cadaveric models.
- Comparison to legally marketed predicate devices for substantial equivalence (e.g., indications for use, materials, basic shape).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set.
§ 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.