Search Results

The Arthrex Univers Revers Modular Glenoid System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's ioint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers Modular Glenoid System cleared under K173900 consists of a monoblock or modular baseplate that is centrally anchored by a central screw or post for cementless use with peripheral screws, a glenosphere, and humeral insert as part of the Univers Revers Shoulder Prosthesis System, K142863.
This Special 510(k) introduces size 45 glenospheres manufactured from Cobalt Chromium (CoCr) and as well as combination humeral inserts manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), same materials as K173900.

The provided text is an FDA 510(k) Summary for the Arthrex Univers Revers Modular Glenoid System. It describes the device, its indications for use, and how it was determined to be substantially equivalent to a predicate device.

However, this document does NOT contain information about a study proving the device meets acceptance criteria for an AI/ML-enabled medical device.

The 510(k) summary focuses on the mechanical and material properties of the shoulder prosthesis components (glenospheres and humeral inserts). The acceptance criteria and "study" described are related to:

• Mechanical testing: Fatigue testing, corrosion testing, and PE/Cup interface testing. These demonstrate that the new sizes of the device perform equivalently to the predicate device in terms of physical integrity.
• Biocompatibility testing: Bacterial Endotoxin testing. This ensures the device meets pyrogen limit specifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-enabled medical device meets its acceptance criteria based on the provided text, as the document is about a mechanical orthopedic implant, not an AI/ML device.

To answer your request, I would need a document detailing the evaluation of an AI/ML-enabled medical device.

Ask a specific question about this device

The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is porous coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM consists of a monoblock baseplate or a modular baseplate; both baseplates are available with either a central screw or central post. The baseplate is designed to be used cementless with peripheral screws and a glenosphere. A humeral insert has been included in this system, to be used with the humeral side of the predicate Univers Revers Shoulder Prosthesis System (K142863).

The UNIVERS REVERS MODULAR GLENOID SYSTEM is comprised of known materials. The baseplates, central screws and posts are comprised of titanium with a BioSync coating, the peripheral screws are titanium and the glenospheres are available in either titanium or cobalt chrome. The humeral inserts are comprised of UHMWPE.

The provided text details a 510(k) premarket notification for a medical device, the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness de novo. Therefore, the information provided focuses on comparative performance, particularly mechanical and material testing, rather than clinical study data from human subjects or AI algorithm performance as might be seen for devices utilizing AI.

Based on the provided text, there is no information regarding acceptance criteria or a study proving an AI device meets acceptance criteria. The document describes a shoulder prosthesis, not an AI device.

However, if we interpret "acceptance criteria" and "study" in the context of this non-AI medical device (shoulder prosthesis), we can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the precise number of physical samples used for each mechanical and material test (e.g., how many glenoid components were subjected to rocking horse testing). It refers to tests being "conducted" but not the exact quantity of items.
• Data Provenance: The data comes from non-clinical testing (mechanical and material laboratory tests) performed by the manufacturer, Arthrex Inc. The location of the testing facility is not specified, but the company is based in Naples, Florida, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to this type of device. The "ground truth" for a mechanical orthopedic implant is established by engineering standards (e.g., ASTM standards) and validated test methodologies, not by expert human interpretation of results like in an AI imaging study. The tests evaluate physical properties against established benchmarks for similar devices.

4. Adjudication method for the test set:

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or expert consensus in AI model validation. For mechanical and material testing, the acceptance is based on quantitative measurements meeting predefined criteria from industry standards.

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:

• This question is not applicable. This is a physical medical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable. This device is a mechanical prosthesis, not an algorithm or software. "Standalone performance" in this context would refer to the purely mechanical performance of the device itself, which is what the mechanical and material tests evaluated.

7. The type of ground truth used:

• The ground truth for this device is based on engineering standards and established performance benchmarks for similar predicate orthopedic implants. Specifically:
  • Mechanical Integrity: Compliance with ASTM standards (F2028, F2009, F543) ensures the device's physical strength, stability, and resistance to wear meet accepted anatomical and functional requirements for shoulder prostheses.
  • Biocompatibility/Material Safety: Compliance with pyrogen limits (EP 2.6.14/USP ) and FDA guidance on plasma sprayed coatings ensures the materials are safe for implantation and do not elicit adverse biological responses.
  • Magnetic Resonance Compatibility: Compliance with ASTM standards (F2182, F2052, F2119) ensures the device is safe for patients undergoing MRI procedures.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a mechanical prosthetic device. The design and manufacturing processes are informed by existing biomechanical knowledge, material science, and the performance of predicate devices, not by a data-driven training process for an algorithm.

9. How the ground truth for the training set was established:

• This question is not applicable as there is no "training set." The engineering principles and material science knowledge applied in the design and testing of such devices are established through decades of research, manufacturing experience, and regulatory guidance, rather than a specific "ground truth" for a training set.

Ask a specific question about this device