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The Arthrex UNIVERS II Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration: irreducible 2- and 4-part proximal humeral fractures; of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.

The Arthrex Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Titanium humeral heads are intended to be used in the Arthrex Univers II Shoulder Prosthesis System. The humeral heads were originally cleared under predicate K071032 as cobalt-chromium (CoCr) devices. The design of the titanium humeral heads is identical to the CoCr heads cleared under predicate K071032. The only difference between the proposed device and the predicate is the material. The titanium humeral heads will provide an alternative to CoCr for use on patients with nickel allergies.

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, the Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads. This document describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of an AI-powered diagnostic device, nor does it refer to acceptance criteria or performance metrics such as accuracy, sensitivity, specificity, or AUC, or details about test set size, expert adjudication, or MRMC studies.

The "Performance Data" section of the document mentions:

• "Fatigue testing, pull-off testing, and wear testing were conducted to evaluate the strength and fatigue properties of the proposed titanium humeral heads."
• "Additionally, an engineering analysis was performed to address the substantial equivalence of hardness, adhesion, surface roughness, scratch resistance, young's modulus, and articulating congruency compared to the predicate device."
• "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that the performance data gathered relates to the physical and material properties of the orthopedic implant (a shoulder prosthesis), and its biocompatibility, not the performance of an AI or diagnostic algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance of an AI device based on this document. The information you've asked for (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth establishment) is specific to the validation of AI/ML-based diagnostic devices, which is not what this FDA notification is about.

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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.4part 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 is a 5 mm one-piece titanium alloy humeral stem that is 105 mm long and is designed with a distal conical section, a proximal rectangular section, and with a morsetaper for mating with humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation.

The provided text is for a 510(k) summary for a medical device (Arthrex Univers II Shoulder Prosthesis). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to software or AI/ML components, nor does it present any studies proving a device's performance against specific acceptance criteria for such components.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This document is a regulatory submission for a physical implant, not a software or AI/ML device.

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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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