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The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex Univers II Shoulder Pegged Glenoid is manufactured in three sizes from UHMWPE. The glenoid articular (lateral) surface is concave and articulates with the humeral head of the Univers or Univers II humeral stems. The fixation (medial) surface is convex and is designed with three pegs for cement interdigitation fixation.

The provided text describes the Arthrex Univers II Shoulder Pegged Glenoid, a shoulder prosthesis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/ML performance.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical or AI/ML study. The determination of substantial equivalence for a non-AI/ML device typically relies on a comparison of design, materials, manufacturing processes, and intended use with a legally marketed predicate device, rather than quantitative performance metrics from a specific study against acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states: "The Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the predicate Arthrex Univers Shoulder Prosthesis in which the basic features and intended uses are the same. Any differences between the Arthrex Univers II Shoulder Pegged Glenoid and the predicate Arthrex Univers Shoulder Prosthesis or Univers II Shoulder Prosthesis are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the currently marketed predicate device."

This indicates that the primary "proof" of meeting safety and effectiveness is through demonstrating substantial equivalence to an existing device, not through a new performance study with acceptance criteria as typically seen for AI/ML devices.

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The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex Univers II Shoulder Prosthesis consists of a stem for attachment to the humerus, a spherical head for replacing the humeral head, and a trunnion construct to connect the stem to the spherical head. The modified device is identical to the cleared predicate (K010124) except for how it addresses two of the three key angles that can be adapted to match the geometry of the humeral head.

This is a 510(k) summary for a medical device, the Arthrex Univers II Shoulder Prosthesis, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training sets is not applicable in the context of AI/ML performance evaluation.

This document describes a medical device submission based on "substantial equivalence" to a predicate device (Arthrex Shoulder Prosthesis (Univers Shoulder), K010124). For devices cleared via 510(k), particularly those seeking substantial equivalence to a predicate, the "study" demonstrating that the device meets "acceptance criteria" often refers to non-clinical testing (e.g., mechanical, materials, biocompatibility) and a comparison of the new device's characteristics and intended use to those of the predicate device. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, I cannot provide the requested information as it is not present in the provided text, nor would it typically be part of a 510(k) for a non-AI medical implant.

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The PROMOS® Shoulder is indicated for:

• Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis
• Fracture or avascular necrosis of the humeral head
• Post-traumatic loss of joint configuration, especially in the case of functional impairment
• Humerus fracture
  The humeral component is intended for cemented or cementless use.
  The glenoid component is for use with bone cement only.

The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain.
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights.
The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.

This document is a 510(k) summary for the PROMOS® Shoulder device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The "Summary Non-clinical Tests" section briefly states: "The results of laboratory testing indicate that the PROMOS Shoulder will survive the expected in-vivo loading." This is a very high-level statement and does not provide quantifiable acceptance criteria or detailed results of the study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you're looking for (performance metrics, study details, sample sizes, etc.) is typically found in the full 510(k) submission, not in the summary document.

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