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The AETOS Shoulder System is intended for:
• Replacement of shoulder joints in primary anatomic or primary reverse arthroplasty.
• Replacement of shoulder joint devices in revision cases if sufficient bone stock is present.
• The AETOS Shoulder System also allows for conversions from anatomic to reverse in case of revision.

Indications for Use

In Anatomic:
The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The AETOS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral component is intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:
The AETOS Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Shoulder System consists of:

In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty.

In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), and optional post extension (Titanium with Titanium plasma spray).

The provided text is a 510(k) Summary for the AETOS Shoulder System. It details the device's description, indications for use, and a summary of nonclinical performance data. However, it explicitly states that "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets these criteria in the context of clinical performance, as no such clinical study was deemed necessary or performed for this 510(k) submission.

The document focuses on nonclinical performance data to establish substantial equivalence to predicate devices. Here's what can be extracted regarding the nonclinical evaluation:

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

The document does not provide a table with explicit acceptance criteria (e.g., "Must withstand X N of force") and specific reported device performance values (e.g., "Device withstood Y N of force"). Instead, it lists the types of nonclinical testing performed to demonstrate substantial equivalence. The implication is that the performance in these tests was considered acceptable compared to the predicate devices and relevant standards.

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

• Sample Size: Not specified in the provided text for any of the nonclinical tests.
• Data Provenance: The tests are nonclinical (bench testing) and were performed by the manufacturer, Smith & Nephew, Inc. No country of origin for the data or whether it was retrospective/prospective is given, as these are typically not relevant for bench testing in the same way they are for clinical studies.

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

This information is not applicable as there was no clinical study, and thus no "ground truth" established by experts in a diagnostic context. The "ground truth" for the nonclinical tests would be the measurement results against engineering specifications or established standards.

4. Adjudication method for the test set:

This information is not applicable as there was no clinical study requiring adjudication of expert interpretations.

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. The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."

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

This information is not applicable as the AETOS Shoulder System is a physical orthopedic implant, not an AI algorithm or software device.

7. The type of ground truth used:

For the nonclinical (bench) testing, the "ground truth" would be the engineering specifications, material science properties, and performance standards relevant to orthopedic implants, against which the device's performance in mechanical and material tests was evaluated for substantial equivalence to predicates.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

This information is not applicable for the same reason as above.

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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.

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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.

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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.

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