(218 days)
The KAPP Custom Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: 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 either joint destruction or subluxation visible on x-ray and or resistance to conservative treatment; primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty. It is intended for custom single use with bone cement.
The Kapp Custom Radial Head Elbow Implant includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
This submission describes the Kapp Custom Radial Head Elbow Implant, a medical device designed to replace the proximal radial head. The document is a 510(k) summary, which indicates that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.
Therefore, the typical acceptance criteria and study designs associated with novel AI/software applications are not applicable here. This device is an orthopedic implant, where "performance" is assessed through material properties, mechanical testing, and comparison to existing implants, rather than through accuracy, sensitivity, or specificity metrics of a diagnostic algorithm.
Here's a breakdown of why many of your requested points cannot be directly addressed from this document and what information can be inferred or is typically involved in such device submissions:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For orthopedic implants like this, acceptance criteria typically revolve around substantial equivalence to predicate devices in terms of:
- Indications for Use: Must be the same or very similar.
- Technological Characteristics: Materials, design, fixation, constraint must be similar or demonstrate equivalent performance.
- Safety and Effectiveness: Demonstrated through comparison to predicate devices, material testing, mechanical testing (e.g., fatigue, static strength), and biocompatibility.
- Reported Device Performance: The document primarily focuses on demonstrating equivalence to predicate devices, rather than establishing new performance metrics. Performance here means the implant's ability to mechanically function as intended and integrate into the body safely.
| Attribute | Acceptance Criteria (Implied by 510(k) Equivalence) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Indications for Use | Functionally identical to predicate devices. | "Replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or post-traumatic disabilities…primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty." (Matches predicate devices) |
| Fixation Method | Similar to predicate devices (Intermedullary Canal Stem). | "Intermedullary Canal Stem" (Matches predicate devices) |
| Constraint | Non-constrained, similar to predicate devices. | "Non-constrained" (Matches predicate devices) |
| Material | Biocompatible and mechanically suitable; comparison to predicate. | "316L Stainless Steel" (Different from Co-Cr/CpTi or Ti/Ti6Al4V/Co-Cr of predicates, but implied to be equivalent in performance/biocompatibility via other undisclosed data, e.g., established use of 316L for implants, mechanical testing, biocompatibility testing.) This difference would typically require specific data (e.g., mechanical testing, biocompatibility) to justify equivalence. |
| Sizes | Offer a range similar to or sufficiently covering patient needs. | "6 custom sizes – 2, 2.5, 3, 4, 5, and 6." (More sizes than one predicate, fewer than another, but demonstrates a range of available options.) |
| Use | Single Use, similar to predicate devices. | "Single Use" (Matches predicate devices) |
Study that Proves the Device Meets the Acceptance Criteria:
The "study" in a 510(k) for a device like this is not a clinical trial in the sense of comparing outcomes in patients directly. Instead, it relies on:
- Comparison to Predicate Devices: This is the primary "study" presented in the document (see the "Comparison to the Predicate Devices" table). The manufacturer argues that their device is substantially equivalent to the Avanta Radial Head Implant and Wright Medical Metallic Radial Head Implants based on shared attributes like indications for use, fixation, constraint, and general purpose.
- Bench Testing / Mechanical Testing (Implicit): While not detailed in this summary, a 510(k) for an orthopedic implant always includes data from in-vitro mechanical testing to demonstrate that the device meets appropriate strength, fatigue, and wear resistance standards. This would be crucial, especially since the material (316L Stainless Steel) of the candidate device differs from the predicates, requiring evidence that it performs equivalently in a simulated physiological environment. These tests would have their own acceptance criteria (e.g., withstand X load for Y cycles without failure).
- Material Biocompatibility (Implicit): Data showing the 316L Stainless Steel is biocompatible and suitable for implantation would also be part of the submission, typically adhering to ISO 10993 standards.
The following points are not applicable or cannot be answered from the provided 510(k) summary, as they relate to AI/Software studies, which this device is not:
- Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the AI sense for an orthopedic implant. Mechanical testing would involve a sample size of physical implants.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no "ground truth" established by experts for a diagnostic output.
- Adjudication method (e.g., 2+1, 3+1, none) 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical implant is its performance in specific mechanical tests and comparison to established, safe materials and designs.
- The sample size for the training set: Not applicable. There is no AI training set. The "training" in a sense comes from the established history of materials science and orthopedic implant design.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) summary for an orthopedic implant. Its "acceptance criteria" and "proof" primarily hinge on demonstrating substantial equivalence to already cleared predicate devices through direct comparison of indications and technological characteristics, supported by (undisclosed in this brief sumamry) mechanical testing and biocompatibility data. It does not involve the types of studies or performance metrics associated with AI/software medical devices.
§ 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.