(204 days)
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.
The Contoured Articular Prosthetic (CAP) consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface.
The taper post component is manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The taper post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore. The taper post is available in a 25mm and 30mm length to provide for variation in humeral head size.
The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.
Utilizing the drill guide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the taper post is driven into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the taper post. With these offset measurements, the surgeon is able to select the articular component from a range of sizes that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage.
A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.
The provided text describes a 510(k) summary for a medical device called the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and study results for device performance in the way that would typically be seen for a new AI/software device.
Therefore, the requested information elements related to AI device evaluation (such as sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of medical device submission.
Here's an attempt to answer the prompt based on the available information, noting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific quantitative "acceptance criteria" or report detailed "device performance" metrics as would be typically expected for a diagnostic or AI device. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, materials, and application. The "performance" is implicitly tied to meeting the functional requirements of a humeral head resurfacing prosthesis and being similar to legally marketed devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit/Claimed) |
|---|---|
| Intended Use | Functionally equivalent to predicate devices for reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis. |
| Materials | Ti-6Al-4V ELI alloy (taper post) and Cobalt-Chromium-Molybdenum alloy (articular component), coated with CP Titanium. These materials are accepted for orthopedic implants. |
| Application/Mechanism of Action | Taper interlock system for stable fixation, precise sizing, minimal bone resection, and congruency with existing cartilage. Similar to predicate devices. |
| Safety Profile | Potential risks are the same as other joint prosthetic devices (e.g., reaction to cement/materials, nerve palsy, embolus, loosening, infection, wear, revision). This implies the device does not introduce new or unmanageable risks compared to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a physical orthopedic implant. There is no "test set" in the context of an AI algorithm or diagnostic device. The evaluation is based on engineering design, material properties, and comparison to predicate devices, not data analysis of a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no "ground truth" establishment in the context of a diagnostic test set for this physical implant. The design and manufacturing process adhere to recognized standards and are reviewed for substantial equivalence by the FDA.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" for which adjudication would be required.
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 physical medical implant, not an AI or diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of a diagnostic dataset. The "ground truth" for the device's safety and effectiveness relies on:
- Adherence to established material standards (e.g., ASTM F136, F799, F1537).
- Predicate device history of safe and effective use.
- Engineering principles and mechanical testing (though specific results are not detailed in this summary, they would be part of the full submission).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for this physical implant.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" for this physical implant.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" presented in this 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices. The core argument is that the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System has:
- Identical Intended Use: Reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis, with similar requirements for bone stock and rotator cuff integrity.
- Similar Materials: The components are made from Ti-6Al-4V ELI alloy and Cobalt-Chromium-Molybdenum alloy, with a CP Titanium coating – materials commonly used and accepted for orthopedic implants.
- Similar Application/Technology: The device's design, including a taper interlock system, drill guide for axis definition, and selection of articular components for optimal fit, is presented as technically similar to predicates. The claims of "minimal bone resection" and flexibility in sizing and fitting are implied to be performance characteristics that align with or improve upon predicate devices.
- Established Safety Profile: The potential associated risks are explicitly stated to be the same as those associated with other joint prosthetic devices, implying no new or elevated risks compared to the predicates.
The FDA's letter (K023096) confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This determination signifies that the device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance metrics against specific acceptance thresholds as would be done for novel technologies or AI.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.