Search Results

The Zimmer Trabecular Metal Shoulder System is indicated for the following:

Hemiarthroplasty/Anatomic application:

• the treatment of severe pain or significant disability in degenerative, theumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-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.

Reverse application:

• the treatment of severe pain or significant disability in degenerative, theumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for initial fixation. When used in a total shoulder application, the allpolyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The proposed devices are a line extension of the Zimmer® Trabecular Metal™ Reverse Shoulder System, which consists of conventional (anatomic) and reverse, semi- and non-constrained shoulder prostheses for total or hemiarthroplasty applications.

This document is a 510(k) premarket notification for a medical device called the "Zimmer® Trabecular Metal™ Reverse Shoulder System, Mini Glenoid." It's an FDA clearance letter, not a study report, so it doesn't contain information about acceptance criteria or a study proving device performance in the way requested. Instead, it demonstrates substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Acceptance Criteria of the Device: The document focuses on showing substantial equivalence to a legally marketed predicate device rather than providing specific performance acceptance criteria for the new device. The "Summary of Performance Data (Nonclinical and/or Clinical)" section mentions that non-clinical testing "demonstrated that the proposed devices meets performance requirements as defined by Design Control activities," but it does not enumerate those requirements or concrete acceptance criteria with specific thresholds.
• Study Proving Device Meets Acceptance Criteria: This document is a regulatory submission for premarket clearance, not a clinical trial report or a detailed engineering test report. It summarizes performance data but doesn't present the full studies.

However, based on the information provided, here's what can be extracted and inferred regarding performance and ground truth, with clear acknowledgment of the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this summary. The general statement is that the devices meet "performance requirements as defined by Design Control activities."
• Reported Device Performance: The document states that non-clinical testing demonstrated that the proposed devices met their performance requirements and are "substantially equivalent to the predicate device in terms of safety and efficacy." Specific numerical performance metrics or acceptance criteria for each test are not provided.

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

• Sample Size for Test Set: Not specified in this 510(k) summary. These would be details within the individual non-clinical test reports, which are not included here.
• Data Provenance: The tests are non-clinical (laboratory/bench testing), not from human patients. Therefore, country of origin or retrospective/prospective does not apply in the same way it would for clinical data.

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

• Ground Truth Establishment for Non-Clinical Tests: For non-clinical (bench) tests, "ground truth" is typically established by engineering specifications, material science standards, and established testing methodologies (e.g., ISO, ASTM standards). The specific number and qualifications of experts overseeing these tests are not mentioned but would typically involve qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Not applicable as this involves non-clinical testing against engineering requirements, not human-read interpretations requiring adjudication.

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

• Not Applicable. This document pertains to a shoulder implant, not an AI or imaging device that would typically undergo an MRMC study. It is a submission demonstrating substantial equivalence of a physical medical device.
• Effect Size of Human Readers with/without AI Assistance: Not applicable.

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

• Not Applicable. This is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• For Non-Clinical Tests: The "ground truth" for the non-clinical tests would be established engineering specifications, mechanical properties, material integrity standards, and safety/performance benchmarks derived from the predicate device and relevant industry standards.
• Clinical Ground Truth: No clinical data were needed or provided for this 510(k) submission, as stated: "Clinical Tests: Clinical data and conclusions were not needed for this device."

8. Sample Size for the Training Set

• Not Applicable. This device is a physical implant, not an AI model that requires a training set.

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

• Not Applicable. As above, no training set for an AI model.

In summary, this document is a regulatory clearance for a medical device, focusing on its substantial equivalence to an existing device through non-clinical testing. It does not provide the detailed study results, acceptance criteria, or ground truth methodologies that would be presented for, for example, a new diagnostic AI device.

Ask a specific question about this device

The Trabecular Metal™ Reverse Shoulder System Vivacit-ETM Vitamin E Highly Crosslinked Polyethylene Liners are indicated for:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

The Zimmer Trabecular Metal Reverse Shoulder System Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are a series of liners manufactured from Vitamin E (a-tocopherol) blended, highly crosslinked ultrahigh molecular weight polyethylene (HXPE) and are designed for use with the Zimmer Trahecular Metal (TM) Reverse Shoulder System in the reverse shoulder application. The liners provide a bearing interface between the TM Reverse Humeral Stem and the glenosphere component. They are offered in two different diameters (36mm and 40 mm) and three thicknesses (+0mm, +3mm and +6mm). The liners are also offered as either 60° standard liners or 65° retentive liners. The retentive liners cover a larger surface of the glenosphere component.

The provided text is a 510(k) summary for the Zimmer® Trabecular Metal™ Reverse Shoulder System, specifically focusing on the Vivacit-ETM Vitamin E Highly Crosslinked Polyethylene Liners. It is a regulatory submission to the FDA, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, device performance from a test set, ground truth establishment, or clinical study details for an AI/ML device.

The document indicates that clinical performance data was not needed for this device, as it is a modification of an already cleared device. The "Non-Clinical Performance and Conclusions" section describes laboratory testing for the physical components of the shoulder system (e.g., locking mechanism, torque, fatigue, wear), which are not measures of AI/ML device performance.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device

The Zimmer Trabecular Metal Shoulder System is indicated for the following: Hemiarthroplasty/Total application: - the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-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. Reverse application: - the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components are intended for either cemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. fn the USA. the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The Zimmer Trabecular Metal Reverse Shoulder System consists of conventional and reverse, semi- and non constrained shoulder prostheses for total or hemiarthroplasty applications.

The provided text is a 510(k) premarket notification document for a medical device, the Zimmer® Trabecular Metal™ Reverse Shoulder System. This document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study designed to establish acceptance criteria or device performance in the manner of an AI/ML product.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, and expert involvement for an AI medical device cannot be extracted from this document. This document primarily describes the device's indications for use, its classification, and a labeling modification based on non-clinical MRI compatibility testing.

However, based on the limited information related to "performance" in this document, I can provide the following, interpreting "acceptance criteria" and "device performance" in the context of the MRI compatibility evaluation mentioned:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified beyond "the components of the Zimmer Trabecular Metal Reverse Shoulder System". It implies testing of the physical components themselves.
• Data Provenance: Not specified, but the testing was conducted to meet US FDA guidance.
• Retrospective/Prospective: Neither. This was a non-clinical testing of physical implants.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth, in this context, would be the physical properties and behavior of the implants when subjected to MRI conditions, measured directly according to established test methods. No human experts were involved in "establishing ground truth" in the diagnostic sense. The "ground truth" for MRI compatibility is determined by established physical phenomena and measurement standards for magnetic fields, heating, and artifact generation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This was physical testing of implants against engineering standards, not a diagnostic assessment requiring adjudication.

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

• No MRMC study was done. This document is not about an AI device.

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

• Not applicable. This document is not about an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For theMRI compatibility, the "ground truth" was established by direct physical measurement and evaluation of the components' properties (e.g., magnetic susceptibility, induced heating, artifact generation) under specified MRI conditions, in accordance with the referenced FDA guidance.

8. The sample size for the training set

• Not applicable. This document is not about an AI/ML product, so there is no training set.

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

• Not applicable. There is no training set.

Ask a specific question about this device

The Zimmer Trabecular Metal Shoulder System is indicated for the following:

Hemiarthroplasty/Total application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-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.

Reverse application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The humeral components are intended for either cemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The proposed Non-Porous Humeral Stems are a line extension of the Zimmer Trabecular Metal Reverse Shoulder System, which consists of conventional and reverse, semi- and non-constrained shoulder prostheses for total or hemi-arthroplasty applications. The proposed devices differ from the predicate humeral stems in that the proposed devices do not have Trabecular Metal in the proximal region of the stem.

This document is an FDA 510(k) clearance letter for a medical device (Zimmer Trabecular Metal™ Reverse Shoulder System, Non-Porous Humeral Stems). It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of an AI/ML medical device.

The provided text focuses on the regulatory clearance process for a shoulder implant, including:

• Substantial equivalence determination to predicate devices.
• Indications for Use.
• Device description and comparison to predicates.
• Mention of non-clinical performance data (fatigue testing, stability testing) but no details on acceptance criteria or results.
• A clear statement that "Clinical data and conclusions were not needed for this device." This explicitly means no clinical study, as understood for AI/ML device performance evaluation, was performed or required for this 510(k) submission.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies because the document pertains to a physical orthopedic implant and its FDA clearance, not an AI/ML medical device or its performance evaluation against defined criteria in a clinical or validation study setting.

Ask a specific question about this device

The Zimmer Trabecular Metal Shoulder System is indicated for the following:

Hemiarthroplasty/Total application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-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.

Reverse application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The humeral components are intended for either cemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The proposed Base Plates and Humeral Stems are a line extension of the Zimmer Trabecular Metal Reverse Shoulder System, which consists of conventional and reverse, semi- and non-constrained shoulder prostheses for total or hemiarthroplasty applications.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) premarket notification for the Zimmer Trabecular Metal Shoulder System, primarily focusing on its substantial equivalence to previously cleared predicate devices. It lists the device's indications for use, its classification, and mentions that non-clinical performance testing was conducted according to FDA guidance. However, it explicitly states:

"Clinical data and conclusions were not needed for this device."

This indicates that a study with the detailed performance criteria and methodologies you requested was not a requirement for the clearance of this specific device based on the information provided in this document.

Ask a specific question about this device

The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

Reverse application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

Hemiarthroplasty/Total application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-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 assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.

The provided document describes the acceptance criteria and a non-clinical study for the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm.

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 separate "test set" in the context of evaluating a medical imaging or AI device. Instead, it refers to non-clinical performance testing. No sample size for a test set (e.g., number of patients or images) is provided, as this is a medical device and not a diagnostic AI system with patient data.

The data provenance is non-clinical testing, meaning it likely involved bench testing, mechanical simulations, and material characterization rather than human subject data. The country of origin for the data is not explicitly stated beyond the submitter's location (Warsaw, IN, USA).

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

Not applicable. As this is a medical implant system and not an AI-driven diagnostic device evaluated with a test set requiring expert ground truth annotations, this information is not relevant to the described study. The "ground truth" for this type of device would be established by engineering and material science standards for safety and efficacy.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of "ground truth" establishment by experts or adjudication methods in the context of this non-clinical performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission (a shoulder implant device).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (shoulder implant), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm without human-in-the-loop is not relevant. The "standalone performance" of this device would refer to its physical function and integrity, which was assessed through non-clinical testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance evaluation is established through engineering standards, material specifications, and biomechanical principles. This includes demonstrating mechanical strength, durability, and biocompatibility that are comparable to or better than the predicate device. The document explicitly states "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices." This implies that the 'ground truth' for establishing safety and effectiveness relied on established scientific and engineering methodologies for implantable devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

Ask a specific question about this device

The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

Reverse application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

Hemiarthroplasty/Total application:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-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 assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.

The provided text is a 510(k) summary for a medical device called the "Zimmer Trabecular Metal™ Reverse Shoulder System," submitted to the FDA. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Instead, this document is a premarket notification for a new device, demonstrating its substantial equivalence to previously cleared predicate devices. The information provided focuses on the device's description, intended use, comparison to predicates, and regulatory classification.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided text.

The "Performance Data (Nonclinical and/or Clinical):" section explicitly states: "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System is as safe and effective as the predicate devices." This general statement does not provide specific acceptance criteria or detailed study results. The FDA's clearance (K052906) indicates that they found it "substantially equivalent" based on this information and comparison to predicates, not necessarily on a detailed study against pre-defined performance acceptance criteria unique to this device that would be included in this summary.

Ask a specific question about this device