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In Anatomic:
The stem and head may be used by themselves, as a hemiathroplasty, 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 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 uncement is intended for cement 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), optional humeral spacer (Titanium), and optional post extension (Titanium with Titanium plasma spray).

This document is a 510(k) Premarket Notification from the FDA regarding the AETOS Shoulder System. It is primarily concerned with establishing substantial equivalence to previously cleared devices based on non-clinical performance data and technological similarities/differences.

Therefore, a study proving the device meets acceptance criteria related to AI/algorithm performance (as described in your prompt, e.g., sensitivity, specificity, human reader improvement) was not performed nor is it relevant to this specific FDA submission.

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

Instead, the acceptance criteria for this device are established through engineering and mechanical testing, ensuring the physical device components meet design specifications and performance standards comparable to legally marketed predicate devices.

Here's how to interpret the available information in the context of your request:

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

The acceptance criteria are implied by the non-clinical performance data testing listed, which assess the mechanical integrity and function of the shoulder system components. The "reported device performance" is that the device met these standards, demonstrating substantial equivalence to the predicate devices. This type of submission relies on the device performing as well as the predicate in relevant mechanical and material property tests to prove safety and effectiveness.

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

• Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the physical components of the shoulder system subjected to mechanical testing. The sample size for these engineering tests would typically be a specific number of manufactured components.
• Data Provenance: This is not patient- or human-read data. It's likely from internal laboratory testing conducted by the manufacturer (Smith & Nephew, Inc. at Cordova, Tennessee). It's not retrospective or prospective clinical data.

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

This is not applicable. The "ground truth" for mechanical performance of an orthopedic implant is established through standardized engineering tests (e.g., ASTM standards) and material science principles, not expert consensus from medical professionals. The "experts" would be engineers, material scientists, and quality assurance personnel.

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

Not applicable, as this refers to human expert review of clinical data, which was not the basis of this submission. The "adjudication" is met by demonstrating compliance with established engineering and material standards through testing.

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 device is a physical orthopedic implant, not an AI/software as a medical device (SaMD) that assists human readers.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's acceptance is established through compliance with existing engineering standards and successful completion of specified mechanical and material property tests. These tests are designed to simulate physiological loads and conditions to ensure the device's durability and performance.

8. The sample size for the training set:

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable.

In summary: The provided document is a 510(k) clearance for a physical medical device (shoulder system). The "acceptance criteria" and "study" details you requested are tailored to AI/software products. For this device, acceptance is based on non-clinical (engineering) performance data demonstrating substantial equivalence to older, already cleared devices, rather than clinical trials or AI performance metrics.

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Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
• Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).

The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.

The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."

The non-clinical testing performed includes:

• Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
• Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
• Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
• Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Identical to previously cleared devices.
• Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
• Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
• MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
• Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.

These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.

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The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

The ASHCOM Shoulder System is intended for reverse shoulder arthroplasty.

Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for
• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Omarthrosis.
• Rheumatoid arthritis.
• Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Inverse/Reverse System and the ASHCOM Shoulder System are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
• Fracture instability after osteosynthesis of 3- and 4part fracture fragments of the proximal humerus
• Posttraumatic necrosis of the humeral head
• Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis.
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations (including revision shoulder arthroplasty).

The Anatomical Shoulder Combined System is intended for cemented or cementless use.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
• Anatomical Shoulder Standard Cemented Humeral Stem.
• Anatomical Shoulder Revision Stem.

When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.

When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

The ASHCOM Shoulder AC-Connector is a double tapered Adaptor that allows the combination of the Anatomical Shoulder Humeral Stems with the Comprehensive Trays. The male oval cone taper of the ASHCOM Shoulder AC-Connector is compatible with the cemented, uncemented and fracture humeral stems of the Anatomical Shoulder System. The female round taper is compatible with the Comprehensive Reverse Trays. In combination with compatible Zimmer Biomet reverse glenoid the implant is intended for a reverse application. The existing Anatomical Shoulder System, for which MR conditional labeling is proposed, is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty. The existing Anatomical Shoulder Combined System, for which MR conditional labeling is proposed, allows the combination of a Bigliani/Flatow® Head with any Anatomical Shoulder Humeral Stem.

The provided text does not contain detailed acceptance criteria for a medical device or a comprehensive study demonstrating that the device meets these criteria. The document is primarily a 510(k) premarket notification for shoulder prosthetic systems (ASHCOM™ Shoulder System, Anatomical Shoulder™ System, Anatomical Shoulder™ Combined System), aiming to establish substantial equivalence to previously cleared predicate devices.

Instead, the document focuses on:

• Indications for Use: What conditions the devices are intended to treat.
• Device Description: The components and general design of the prosthetic systems.
• Comparison to Predicate Device: How the new devices are similar to existing, legally marketed devices.
• Performance Data (Nonclinical): A list of non-clinical tests performed to support safety and effectiveness, particularly for the ASHCOM Shoulder System and the MRI compatibility of the Anatomical Shoulder systems.

Here's an analysis based on the information provided, highlighting what's present and what's explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data to demonstrate compliance.

Instead, it lists the types of non-clinical tests performed to show safety and equivalence:

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

For the non-clinical tests listed, the document does not specify sample sizes (e.g., number of prostheses tested) or data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found within the full test reports, which are not included in this summary.

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

This section is not applicable as the document describes non-clinical performance testing of physical devices (implants), not a study involving evaluation by medical experts to establish ground truth for a diagnostic or AI-driven system.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3.

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 section is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

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

This section is not applicable. The device is an orthopedic implant and does not involve an algorithm.

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

For the non-clinical performance tests, "ground truth" would not be established by expert consensus, pathology, or outcomes data in the traditional sense. Instead, the "ground truth" or reference state is defined by engineering specifications, material properties, and regulatory standards (e.g., ASTM F2009 for taper connection testing). The tests aim to demonstrate that the physical properties and performance of the device meet these predefined engineering and safety criteria.

8. The sample size for the training set

This section is not applicable. The device is an orthopedic implant, and there is no mention of an algorithm or AI model that would require a training set.

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

This section is not applicable for the same reasons as point 8.

Summary of what the document does indicate regarding device performance and acceptance:

The submission relies on non-clinical performance testing and analysis to demonstrate the safety and effectiveness of the ASHCOM Shoulder System and the existing Anatomical Shoulder systems (for MRI compatibility labeling) and establish their substantial equivalence to predicate devices. The listed tests (FEA, cyclic fatigue, corrosion fatigue, static taper connection) are standard for orthopedic implants to assess mechanical integrity, durability, and material performance. For MRI compatibility, the evaluation followed FDA guidance, suggesting a series of tests to confirm the "MR Conditional" status.

The statement "Results of non-clinical performance testing and analyses demonstrate that the ASHCOM Shoulder System is safe and effective and substantially equivalent to the predicate devices" serves as the overall conclusion regarding acceptance based on the conducted studies, without detailing the specific quantitative acceptance criteria or results in this summary. The FDA's clearance (K170711) indicates that they found the provided non-clinical data sufficient to establish substantial equivalence.

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The Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and non-repairable rotator cuff-tear with pain disabled by:

• · Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Revision of the devices if sufficient bone stock remains.

The Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed Glenoid are intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed glenoid component assembly must be used in association with a Tornier humeral component:

• Humeral implants Aequalis Reversed, Aequalis Reversed Fracture or Aequalis Adjustable ● Reversed Shoulder
• . or Humeral implants Aequalis Ascend Flex Shoulder System in reverse configuration
• or humeral implants Aequalis Reversed FX2 ●

The glenoid component assembly includes a modular system including a baseplate with central screw or press-fit post, peripheral anchoring screws and a glenosphere. The baseplates are available in various design configurations including: standard, lateralized, half-wedge augment and full-wedge augment. The glenospheres are available in various design configurations including: standard, lateralized and eccentric. The press-fit post may be used with the standard baseplate in lieu of the central anchoring screw. The baseplates and the press-fit posts are manufactured using additive manufacturing technology.

The document provided does not describe an acceptance criteria or study that proves the device meets specific performance metrics in the way a clinical or standalone study for an AI/algorithm-based device would.

Instead, this is an FDA 510(k) Premarket Notification for a medical device (Aequalis PerFORM Reversed and Aequalis PerFORM+ Reversed Glenoid – a shoulder prosthesis). The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria as would be typical for a diagnostic or AI device.

Here's how the information provided relates to your request, with an emphasis on what's not relevant for a typical AI/algorithm acceptance criteria study:

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

• Acceptance Criteria: Not explicitly stated as pass/fail numeric targets for performance metrics like sensitivity, specificity, or AUC, as these are not relevant for a mechanical prosthesis 510(k). The "acceptance criteria" here is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
• Reported Device Performance: The document lists "Performance Data" which consists of a series of non-clinical bench tests (mechanical testing). These demonstrate the physical properties and durability of the prosthesis. Examples include:
  • Compressive Strength and Elastic Modulus Testing of Titanium Porous Metal Verification
  • Titanium Porous Structure Stereological Evaluation
  • Titanium Porous Structure Mechanical Verification
  • PerFORM Reversed Fixation Pull-out Test
  • Fatigue Test
  • Range of Motion Analysis
  • PerFORM Reversed Taper Pull-Off Test
  • Glenoid Loosening Test (100,000 cycles)
  • PerFORM+ Reversed Augment Baseplate compared to the Exactech Equinoxe Reverse Augmented Baseplate Analysis
  • PerFORM Reversed Lateralization Comparison
  • PerFORM Reversed and PerFORM+ Reversed Peripheral Screw Angulation
  • Direct Metal Laser Sintering (DMLS) Process Validation
  • Endotoxin (

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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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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.

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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.

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