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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; 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 for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable. The humeral component can be implanted either cemented or press-fit while the glenoid component is designed for cemented use only.

The Bigliani/Flatow 56mm Offset Humeral Heads are a line extension to the Bigliani/Flatow Shoulder system. The proposed devices are larger diameters of offset humeral heads.

This is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the format requested.

Based on the provided document, here's an analysis of the requested information:

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

This information is not provided in the document as it is a 510(k) submission. A 510(k) submission for a line extension primarily focuses on demonstrating that the new device (Bigliani/Flatow 56mm Offset Humeral Heads) is substantially equivalent to a legally marketed predicate device (Bigliani/Flatow The Complete Shoulder Solution, K982981).

The document states:

• "The proposed device is identical to the predicate device in: intended use/indications for use, material specifications, mode of assembly, surface specifications, manufacturing processing, shelf life and sterilization method."
• "The proposed device is a larger size of the predicate device."
• "Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing and/or engineering analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing and/or analyses included: Magnetic Resonance Imaging (MRI) Compatibility testing, and Engineering Analysis of proposed offset humeral heads' effect on humeral stem stresses."

Therefore, the "acceptance criteria" appear to be meeting the safety and effectiveness standards of the predicate device, demonstrated through non-clinical testing. Specific quantitative acceptance criteria or detailed performance reports are not included.

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 for clinical data, as the document explicitly states, "Clinical data and conclusions were not needed for this device." For non-clinical testing (MRI compatibility and engineering analysis), specific sample sizes are not provided, but these would typically involve a small number of physical samples for testing and/or computational models.
• Data provenance: Not applicable for clinical data. For non-clinical testing, it would be laboratory-based data, presumably from the manufacturer (Zimmer, Inc., USA).

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. No clinical test set or ground truth established by experts is mentioned, as clinical data was not required. The "ground truth" for substantial equivalence is based on the characteristics and performance of the predicate device.

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

• Not applicable. No clinical test set requiring adjudication is mentioned.

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 shoulder prosthesis, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this 510(k) submission is primarily the performance and safety profile of the predicate device (Bigliani/Flatow The Complete Shoulder Solution, K982981). The new device is deemed substantially equivalent because it performs identically in key aspects and any differences (larger size) were assessed via engineering analysis to ensure no new questions of safety or effectiveness.

8. The sample size for the training set

• Not applicable. This refers to a physical device, 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 for a machine learning model is involved.

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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, 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 cemented in place in the USA.

This new implant device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The resulting implant, the Trabecular Metal Glenoid, is designed to interface & articulate with Zimmer B/F humeral components. The subject device is available in one thickness option of 5 mm, and the same outer profile options as the B/F all-polyethylene glenoid. The range of outer profile options include 40, 46, and 52 mm round shapes, and 40 by 46 mm, 46 by 52 mm, and 52 by 56 mm oval shapes.

The provided text is a 510(k) Summary for a medical device called "The Trabecular Metal Glenoid." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a report of a study proving the device meets specific acceptance criteria through clinical trials or performance evaluations against a set threshold.

Therefore, much of the requested information cannot be found in this type of document. Specifically:

• Acceptance criteria and reported device performance: This document asserts "substantial equivalence" based on "similarity in technological characteristics and indications for use" to predicate devices. It does not provide specific acceptance criteria (e.g., a required accuracy, sensitivity, or precision) or report performance metrics against such criteria.
• Sample size and data provenance for a test set: No test set is described. The approval is based on a comparison to existing predicate devices.
• Number of experts and qualifications for ground truth: Not applicable as there is no test set with ground truth established by experts.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or required for a 510(k) submission of this nature.
• Standalone algorithm performance: Not applicable; this is a physical implant, not an algorithm.
• Type of ground truth used: Not applicable as there is no test set for performance evaluation.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document states:

• "Performance data for the UHMPWE and Hedrocel Trabecular Metal interface can be found in Implex MAF #920, and for the articulating surface geometry in K982981." This implies that prior performance data exists for the materials and articulating surface geometry of components similar to those used in the device, likely from studies supporting those specific material clearances or prior device approvals. However, these are references to other documents and not performance data explicitly reported or re-evaluated for this specific 510(k) submission as a study proving acceptance criteria for the whole device.

In summary, this 510(k) is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting a study with specific acceptance criteria, test sets, or ground truth as would be found for a new diagnostic device or AI algorithm.

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