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The Univers Revers Shoulder Prosthesis 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 joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Univers Revers Shoulder Prosthesis 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.

(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The subject devices are comprised of size 33 humeral suture-cups, spacers and inserts. The subject devices are made of either titanium or UHMWPE. The subject devices are smaller versions than those cleared in K161782 and K142863. The subject devices are compatible with the Univers Revers Shoulder Prosthesis System and Univers Revers Modular Glenoid System devices.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. Instead, it is a 510(k) premarket notification for a medical device called the "Univers Revers Humeral Cup Implant," which is a shoulder prosthesis.

The document discusses:

• Device Name: Univers Revers Humeral Cup Implant
• Manufacturer: Arthrex Inc.
• Regulatory Classification: Class II
• Product Codes: HSD, PHX
• Purpose of Submission: To obtain clearance for smaller size 33 humeral cup components for use with an already cleared shoulder prosthesis system.
• Technological Characteristics: The new components are made of the same materials (titanium or UHMWPE) as the predicates, have the same intended use/indications, packaging, shelf life, and sterilization. They simply expand the size range of cleared humeral implants.
• Performance Data: "Mechanical testing (i.e., PE liner/cup interface per ASTM F1820) was performed."
• Conclusion: The device is substantially equivalent to predicate devices, and mechanical testing demonstrates equivalent performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI/ML, as this document is about a mechanical orthopedic implant, not an AI/ML powered device.

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The 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 and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

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

The proposed devices are augmented modular glenoid baseplates made of titanium with BioSync coating. The proposed devices are half-wedge augmented modular glenoid baseplates available in two sizes (24 and 28). The baseplates are designed to be used cementless with peripheral screws and glenospheres (cleared under K193372 and K173900).

The provided document is a 510(k) summary for a medical device (Univers Revers Modular Glenoid System, Half Augment Baseplate). It focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, rather than presenting clinical study results for diagnostic accuracy or efficacy with human participants. Therefore, many of the requested criteria (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, and specific ground truth types like pathology or outcomes data) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract the acceptance criteria related to mechanical performance and the study that was performed to demonstrate that the device met these criteria.

Acceptance Criteria and Study for Univers Revers Modular Glenoid System, Half Augment Baseplate

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of human participant data, as this is a non-clinical submission for a Class II medical device. The studies mentioned are primarily benchtop or in-vitro tests:

• Mechanical Testing (ASTM F2028): The sample size for this testing is not explicitly mentioned but would typically involve multiple units of the device to ensure statistical robustness. The provenance is from laboratory testing.
• MRI Testing (FDA guidance and ASTM F2182): The sample size for this testing is not explicitly mentioned but involves the device itself. The provenance is from laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The studies performed are mechanical and MRI safety tests, not studies requiring expert clinical interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis and the submission focuses on its physical and material properties, not diagnostic performance or human-AI interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant, not an algorithm or AI-based software.

7. Type of Ground Truth Used

The "ground truth" for the performance studies is based on established engineering standards and regulatory guidelines:

• Mechanical Performance: The "ground truth" is defined by the requirements of ASTM F2028, a recognized standard for testing glenoid component stability.
• MRI Safety: The "ground truth" is defined by FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and ASTM F2182, a standard for measuring RF-induced heating in MRI.

8. Sample Size for the Training Set

Not applicable. There is no training set in the context of this device and the presented performance data. This is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

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The 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 and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The 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 Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The proposed device is comprised of augmented modular glenoid baseplates and modular posts made of the same materials as the predicate (titanium/ BioSync). The baseplates are full wedge augmented versions of the cleared size 24 and size 28 modular baseplates. The posts are offered in lengths ranging from 20 mm to 40 mm. The proposed device is a line extension to the Univers Revers Modular Glenoid System was cleared under K173900.

The provided text describes a 510(k) premarket notification for a medical device, the "Univers Revers Modular Glenoid System (Augmented baseplates)". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific clinical acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.

However, I can extract the relevant information from a mechanical testing perspective, as this is the "performance data" provided for this specific device clearance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Mechanical testing (i.e., Rocking horse testing per ASTM F2028, disengagement testing per ASTM F2009) was performed to demonstrate that the proposed device meets the standards requirements." It also states for endotoxin testing that it "demonstrate[s] that the proposed device meets pyrogen limit specifications," and for MRI that "MRI testing were conducted in accordance with FDA guidance ... and ASTM F2182." The implied acceptance criterion for each is meeting the respective standard/guidance's requirements or specifications, and the device is reported to have met them. The specific quantitative results of these tests and the exact "acceptance values" are not detailed in this summary document.

The subsequent points (2 through 9) primarily apply to studies involving AI algorithms or clinical trials with human readers and ground truth established by experts/pathology. This device, a modular glenoid system, is a physical implant, and its performance evaluation for 510(k) clearance is based on bench testing (mechanical, biocompatibility, MRI safety) and demonstration of substantial equivalence to a predicate device, not clinical performance studies with "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in the way an AI medical device would be evaluated.

Therefore, for aspects related to AI/diagnostic performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples used in bench testing (e.g., glenoid components, constructs for mechanical testing). The provenance of these physical samples is the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biocompatibility testing is established by the specifications of the ASTM, ANSI/AAMI, USP, and EP standards themselves.
4. Adjudication method for the test set: Not applicable. Testing against engineering standards does not typically involve human adjudication in the sense of consensus on diagnostic findings.
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 implant, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation consists of the established engineering and biological safety standards (e.g., force limits, pyrogen limits, MRI artifact levels) against which the physical device samples were tested.
8. The sample size for the training set: Not applicable. This is a physical implant.
9. How the ground truth for the training set was established: Not applicable. This is a physical implant.

In summary: The provided document is for a medical implant and details bench testing results demonstrating adherence to established engineering and safety standards, rather than clinical performance data against diagnostic accuracy metrics. The entire submission aims to demonstrate substantial equivalence to a previously cleared device.

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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.

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The Arthrex Univers Revers CA Heads and Adapters are indicated for

• . salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
• . conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
  The patient's joint 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 CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.

The provided text describes a 510(k) premarket notification for a medical device called "Arthrex Univers Revers CA Heads and Adapters." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria. Therefore, the document does not contain information about acceptance criteria and a study to prove the device meets specific performance metrics in the way your request outlines for AI/software-based devices.

The information provided only discusses the substantial equivalence summary based on bench testing. Here's a breakdown of what is available and what is not in relation to your request:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for clinical performance in a typical sense for AI, but rather a demonstration of equivalence to predicates. The acceptance for this 510(k) submission is that the device's design, materials, and mechanical performance are comparable to cleared predicate devices and do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) was performed and demonstrated that the performance of the proposed devices is "substantially equivalent to that of the predicate devices." No specific numerical performance metrics from these tests are provided, nor are the acceptance criteria for these mechanical tests detailed.

Table (based on available information, highly summarized):

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

• Test Set (for in-vitro mechanical testing): Not specified in this document. Since it's mechanical testing, the "sample size" would refer to the number of devices tested for each mechanical property.
• Data Provenance: The nature of in-vitro testing suggests it's likely conducted in a lab setting, presumably by the manufacturer (Arthrex, Inc.). No country of origin is mentioned for the test data itself, but the manufacturer is based in Naples, Florida, USA. The testing is prospective in the sense that it's performed to support the 510(k) submission for this specific device.

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

• Not applicable. This document describes mechanical testing of a physical implant, not clinical performance based on expert review or ground truth labeling like in an AI study.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical or interpretative studies, not mechanical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study applies to diagnostic imaging or interpretation devices, typically AI-powered. The device in question is a physical orthopedic implant. The document explicitly states: "Clinical data and conclusions are not needed for this device."

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. For mechanical testing, the "ground truth" would be the measured physical properties against established engineering standards or predicate device performance.

8. The sample size for the training set:

• Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning.

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

• Not applicable. Again, no training set for a physical implant.

In summary: The provided document is a 510(k) clearance letter for a physical orthopedic implant, focusing on its substantial equivalence to previously cleared predicates through in-vitro mechanical testing. It does not contain the detailed performance criteria, clinical study designs, or AI-specific information requested.

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