Search Results

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the gleno-humeral joint; non-union humeral head fracture; displaced 3 and 4 proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.

The Aequalis Universal Shoulder Glenoid is intended for cemented use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the Tornier Aequalis Total Shoulder System. The Aequalis Universal Shoulder Glenoid is manufactured in four sizes from Ultra High Molecular Weight Polyethylene (UHMWPE). The component's articulating (or lateral) surface is concave and is designed to articulate with the head of an existing, commercially available Tornier Aequalis Shoulder humeral prosthesis. The Aequalis Universal Shoulder Glenoid aticulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and the humeral head is intended to allow the translation of the head in the superior/inferior and anterior/posterior directions.

The back surface of the Aequalis Universal Shoulder Glenoid is spherical in geometry, in order to conform to the geometry of the glenoid fossa. It is grooved in order to increase the interface glenoid implant / bone cement.

The back (or medial) surface of the component has either a keel or four pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in four sizes (small, medium, large and X-large) for each component, the keeled and pegged components.

• The Aequalis Universal pegged Glenoid features one centrally located peg and three t peripheral pegs placed in a triangular configuration. The peripheral pegs are fitted with transversal grooves that provide enhanced cement fixation. The three peripheral pegs provide resistance to rocking and rotational motion caused by translation of the prosthetic humeral head. The central peg features an X-ray marking wire in Cobalt-Chromium alloy.
• -The Aequalis Universal keeled Glenoid features a centrally located keel to provide translational and rotational stability of the implant. A groove around the middle of the keel provides enhanced cement fixation. The keel features an X-ray marking wire in Cobalt-Chromium alloy.

Materials. The Aequalis Universal Shoulder Glenoid is manufactured from implant grade ultrahigh molecular weight polyethylene (UHMWPE) according to ISO5834-2, with a small Cobalt-Chromium wire included as an opaque radiographic marker.

The provided text describes the 510(k) summary for the Aequalis Universal Shoulder Glenoid, a Class III medical device. However, it does not include information about specific acceptance criteria or a study designed to prove the device's performance against such criteria in the manner typically expected for AI/software-based medical devices (e.g., sensitivity, specificity, or reader performance metrics). Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices.

The document primarily discusses:

• Device Description: What the Aequalis Universal Shoulder Glenoid is made of (UHMWPE), its design (concave articulating surface, spherical back surface with grooves, keel or pegs for fixation), and its intended use (cemented glenoid component in total shoulder arthroplasty).
• Voluntary Standards: Tornier, S.A. Standard Operating Procedures (SOP), vendor certifications and qualification procedures, Quality System Regulations (QSR), ISO9001 & EN46001, and EN552 for sterilization.
• Premarket Notification (K994393): The process of seeking FDA clearance based on substantial equivalence.
• Comparison to Predicate Devices (Table 1): A table comparing features of the Aequalis Universal Shoulder Glenoid to other commercially available shoulder glenoid components (e.g., materials, method of fixation, presence of keel/pegs, indications for use, and an UHMWPE standard).
• Summary of Safety and Effectiveness: This section outlines potential risks (procedure-related like infection, nerve injury; device-related like component disassociation, wear debris, loosening) and argues that the Aequalis Universal Shoulder Glenoid's design (all-polyethylene, similar fixation methods) makes its expected failure modes and frequencies comparable to existing devices.

Missing Information related to your specific questions:

The document does not contain the following:

1. A table of acceptance criteria and reported device performance (in the context of quantitative functional performance like accuracy, precision, or reader study results). The "reported device performance" is essentially a qualitative comparison to predicate devices and an assessment of expected failure modes based on material and design.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
6. Standalone (algorithm-only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Conclusion based on the provided text:

This submission is for a physical orthopedic implant (Aequalis Universal Shoulder Glenoid) seeking clearance based on substantial equivalence to existing legally marketed devices, rather than a new AI/software medical device that would typically undergo rigorous performance studies with specific acceptance criteria related to diagnostic accuracy, sensitivity, or specificity. Therefore, the questions regarding AI performance criteria, ground truth, expert adjudication, and training/test set details are not applicable or addressed in this type of 510(k) submission.

The "study" that proves the device meets "acceptance criteria" here is primarily the comparison to predicate devices (Table 1) and a qualitative risk assessment detailed in the "Class III Summary," arguing that the Aequalis Universal Shoulder Glenoid's design and materials are comparable to existing devices, and thus its safety and effectiveness can be expected to be similar. The "acceptance criteria" are implied by the features and performance of the predicate devices.

Ask a specific question about this device