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Advanced destruction of the shoulder joint resulting from:

• Omarthrosis.
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head.
• Cuff-tear arthropathy (BF 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 Anatomical Shoulder (AS) Combined System consists of the following:

• AS Humeral Stem (cemented or uncemented)
• AS Fracture Humeral Stem
• Bigliani/Flatow Head
• Bigliani/Flatow Gleniod
• Trabecular Metal (TM) Glenoid
• AS Bigliani/Flatow (AS B/F) Adaptor

The AS B/F Adaptor is a new product designed to be used with the humeral stems of the Anatomical Shoulder System and Anatomical Shoulder Fracture System and with any humeral head of the Bigliani/Flatow (BF) System in a conventional hemi or total shoulder arthroplasty procedure. The B/F humeral heads are used with existing UHMWPE B/F glenoids and TM glenoids manufactured from Trabecular Metal and UHMWPE. AS cemented humeral stems are manufactured from Protasul -1 (Co-Cr-Mo); the uncemented and fracture stems from Protasul-100 (titanium alloy). The B/F heads are manufactured from Zimaloy® (Co-Cr-Mo). Collectively, these components are identified as the Anatomical Shoulder Combined System.

The Adaptor features two taper interfaces, one connecting to the Anatomical Shoulder humeral stems and the other connecting to the Bigliani/Flatow humeral heads. The proximal taper of the adaptor (connecting to the Bigliani/Flatow heads) is identical to the male taper geometry from the predicate Bigliani/Flatow humeral stems. The distal taper of the adaptor (connecting to the Anatomical Shoulder humeral stem) is a male oval taper, identical to the oval taper of the predicate Anatomical Shoulder Ball-Taper component. Both the AS B/F Adaptor and the predicate AS Ball-Taper component are manufactured from Protasul-100, a forged titanium alloy.

The Zimmer Anatomical Shoulder™ Combined System is a medical device and, as such, the "acceptance criteria" and "device performance" are typically assessed through non-clinical (laboratory) testing to demonstrate substantial equivalence to predicate devices, rather than through sensitivity, specificity, or AUC as might be seen for diagnostic AI/ML devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: For medical devices like shoulder prostheses, "acceptance criteria" are usually based on meeting established engineering standards and demonstrating equivalent or superior performance to existing predicate devices through various mechanical and material tests. The specific numerical acceptance criteria for each test (e.g., minimum load for fatigue, maximum corrosion rate) are not detailed in this summary but are implied to have been met.

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

• Sample Size for Test Set: This device underwent non-clinical (lab) performance testing and/or analyses. The document does not specify a "sample size" in the context of a clinical test set with patient data. Instead, it refers to mechanical and material tests performed on various components of the device. The "sample size" would relate to the number of physical components tested for each specific non-clinical test (e.g., number of stems tested for fatigue, number of adaptors for strength testing). These specific numbers are not provided in this summary.
• Data Provenance: The data is from non-clinical (lab) performance testing. No country of origin for this testing is explicitly stated, but the sponsor is Zimmer GmbH in Switzerland, and the contact person is in Indiana, USA. This is not retrospective or prospective patient data, but rather engineering test data.

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

• Not applicable. This is a mechanical device, and "ground truth" for a test set typically refers to clinical diagnosis or outcome, which is not relevant here. Ground truth would be defined by engineering standards and specifications.

4. Adjudication Method for the Test Set

• Not applicable. This refers to consensus among clinical experts for diagnostic decisions, not for mechanical device testing.

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 conducted. Such studies are typically for diagnostic devices or AI/ML tools where human readers interpret medical images.
• Effect size of human reader improvement: Not applicable.

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

• Not applicable. This device is a shoulder prosthesis, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established through industry-standard engineering specifications, material properties, and biomechanical principles. Performance is benchmarked against the known characteristics and successful clinical history of the predicate devices. This includes adherence to standards for loading conditions, fatigue life, fretting corrosion resistance, and assembly strength.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and prior successful device designs (predicates).

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

• Not applicable, as there is no "training set" for this type of medical device.

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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatic disease of the glenohumeral joint; un-united 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 for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.

The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface composed of direct compression molded polyethylene (UHMWPE). The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449.

This document is a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Glenoid. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for device performance or a study that proves the device meets such criteria.

Instead, this is a regulatory submission focused on demonstrating that the new device's technological characteristics, materials, and intended use are similar enough to previously cleared devices that it can be marketed without undergoing a new premarket approval process. The information provided is primarily for regulatory clearance rather than a performance study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria or report device performance against them.
2. Sample size used for the test set and the data provenance: There is no mention of a clinical or ex-vivo test set used to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses "documentation" that was provided to demonstrate substantial equivalence, focusing on:

• Intended use/indications for use
• Materials (Trabecular Metal and UHMWPE, similar to numerous other cleared Zimmer devices)
• Technological characteristics (same external articulating geometry, dimensions, minimum polyethylene thickness, sizing options as predicate).
• Basic principles of operation.

It also highlights that modifications were made to:

• Increase interfacial area for attachment between Trabecular Metal and UHMWPE.
• Increase interfacial area between UHMWPE and bone cement mantle.
• Decrease likelihood of center pilot post damage during impaction/insertion.
• Increase overall fatigue and static strength of the Trabecular Metal base.

These points describe design improvements and comparisons to predicate devices, but they do not constitute a performance study with acceptance criteria and measured outcomes. For a 510(k) submission like this, the "study" is often a comparison of technical specifications, materials, and intended use to a legally marketed predicate device, rather than a clinical trial demonstrating specific performance metrics against an acceptance threshold.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.

The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.

The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.

The provided document is a 510(k) summary for the Biomet Orthopedics, Inc. Modular Hybrid Glenoid device. It describes the device, its indications for use, and a comparison to predicate devices, but does not contain information about studies proving the device meets acceptance criteria in the way a diagnostic AI/ML device would be evaluated.

This document pertains to a medical device, not an AI/ML diagnostic algorithm. Therefore, the specific criteria for evaluating AI/ML algorithms (such as sensitivity, specificity, AUC, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this submission.

Instead, the acceptance criteria for this type of medical device are generally based on non-clinical mechanical testing and establishing substantial equivalence to existing legally marketed devices.

Here's how the provided information relates to acceptance criteria for this specific medical device:

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

Since this is a mechanical orthopedic implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the document states:

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

• Sample Size for Test Set: Not applicable. The "testing" here refers to mechanical engineering tests of the device itself, not a clinical study on patients or an evaluation of an algorithm on a dataset.
• Data Provenance: Not applicable for clinical data. The mechanical tests would have been performed in a laboratory setting.

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

• Not applicable. "Ground truth" in the context of an AI/ML algorithm evaluation (e.g., radiologist diagnoses) is not relevant for this device's mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.

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

• Not applicable. This refers to consensus methods for interpreting medical images or data, which is not relevant for mechanical device 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:

• No. This type of study is specifically for evaluating diagnostic AI/ML algorithms used in conjunction with human readers. This document explicitly states: "Clinical Testing: None provided."

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

• Not applicable. This refers to the performance of an AI/ML algorithm by itself.

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

• Not applicable in the context of clinical "ground truth." For mechanical tests, the "ground truth" is derived from established engineering principles, material science, and testing methodology to ensure the device meets specified strength, fatigue, and other performance parameters.

8. The sample size for the training set:

• Not applicable. The concept of a "training set" is for AI/ML models. This is a physical medical device.

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

• Not applicable. (See #8)

Summary regarding AI/ML evaluation:

The provided document details a 510(k) submission for an orthopedic implant. It specifically states "Clinical Testing: None provided." The acceptance criteria and "study" are based on non-clinical mechanical testing and a demonstration of substantial equivalence to predicate devices, which is a different regulatory pathway and set of evaluation criteria than those used for AI/ML diagnostic devices.

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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united 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 for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.

The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same outer geometry and dimensions as the B/F glenoids cleared in K022377 and K031449.

The provided 510(k) summary describes a medical device, the "Trabecular Metal Glenoid," but it does not contain information about acceptance criteria or a study proving the device meets said criteria.

This 510(k) clearance is for a change in manufacturing technique to increase the interfacial area between UHMWPE and the Trabecular Metal glenoid base. The primary basis for substantial equivalence is that the device has the same external geometry, dimensions, articulation geometry, minimum polyethylene thickness, and size options as predicate devices.

The document states:

• "An engineering analysis showed that the increased area of polyethylene infiltration does not adversely affect device strength and increases the area of attachment between the UHMWPE and the Trabecular Metal glenoid base." This is the entire extent of the "performance data" mentioned.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the document, and what cannot:

Acceptance Criteria and Study Details for the Trabecular Metal Glenoid (Based on provided 510(k) Summary K043061)

1. Table of Acceptance Criteria and Reported Device Performance

Note: These are inferred "acceptance criteria" based on the described engineering analysis. The document does not explicitly list quantitative acceptance criteria values.

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

• Not provided. The document refers to an "engineering analysis," which typically involves bench testing, but no details on sample size, methodology, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.

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

• Not applicable / Not provided. The "engineering analysis" likely refers to mechanical testing or simulation, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

• Not applicable / Not provided. This typically applies to clinical studies or image interpretation, which are not described here.

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, an MRMC study was not done. This device is a shoulder implant, not an AI-powered diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used

• Not applicable. The "engineering analysis" likely relied on physical measurements, material properties, and mechanical stress/strain calculations, rather than a "ground truth" derived from clinical outcomes or expert consensus.

8. The sample size for the training set

• Not applicable / Not provided. This project involves a medical device (implant) and an engineering analysis, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set or machine learning model is involved.

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