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Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The devices are a line extension of the Comprehensive Reverse Shoulder System and consists of new 36mm and 40mm tray and liner locking mechanism designs as well a a new 40mm glenosphere. The highly cross-linked ultrahigh molecular weight (HXPE) polyethylene liners are offered either in Prolong® (Standard) or Vivacit-E (Vitamin E). The tray taper geometry as well as the material (Ti-6AL-4V and Co-28Cr-6Mo) and thickness offerings are identical (standard, +5mm, +10mm) to the predicate. The trays will still be offered with a centric (standard) taper as well as two other offset tapers (+3 and +6) to provide more offerings to the surgeon.

The provided document is a 510(k) summary for the Zimmer Comprehensive Reverse Shoulder System, which describes a medical device rather than an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device performance (like experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study (non-clinical testing) that proves it meets those criteria.

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

The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. Instead, it states that non-clinical testing "demonstrated that the proposed devices meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy." The listed tests are the means by which this performance was evaluated.

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

The document lists "Non-Clinical Tests," which typically involve physical models, simulations, or benchtop experiments rather than patient data. No sample sizes are specified for these non-clinical tests. Data provenance in terms of country of origin or retrospective/prospective is not applicable or provided.

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, as this is a mechanical device evaluation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation of patient data.

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

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation of medical data, which is not the case 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

Not applicable, as this is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable, as standalone performance refers to AI algorithm performance without human intervention, which is irrelevant to a shoulder implant.

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

The "ground truth" for this device would be established by engineering standards, validated testing methodologies, and comparison to the predicate device's established performance. It's based on objective physical and mechanical properties and behaviors, not clinical interpretations or pathological findings in the context of an AI/ML algorithm.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device testing in the context of this 510(k) submission.

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

Not applicable, as there is no training set mentioned or implied.

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Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.

The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating.

This document is a 510(k) Summary for the Zimmer Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, and Comprehensive Mini Baseplate. It describes the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of a medical device submission for substantial equivalence to predicates, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.

The acceptance criteria and device performance are described in terms of engineering and material characteristics for orthopedic implants.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the non-clinical tests performed to demonstrate substantial equivalence. These are not performance metrics in the sense of accuracy, sensitivity, or specificity as would be the case for AI/ML models, but rather engineering and material properties.

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

This is an orthopedic implant 510(k) submission, not a study of an AI/ML device. Therefore, the concept of a "test set" in the machine learning sense, or data provenance in terms of patient data origin and retrospectivity/prospectivity, is not applicable. The documentation refers to mechanical and material testing, which would have specific sample sizes for engineering tests (e.g., number of specimens tested for shear strength, porosity), but these details are not provided in this summary document.

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

Not applicable. This is not an AI/ML device that requires human expert review for establishing ground truth on image data or similar. The "ground truth" here refers to established engineering standards and material specifications.

4. Adjudication Method for the Test Set

Not applicable. Ground truth establishment for AI/ML model test sets.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI/ML device where human readers interact with AI assistance.

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

Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to:

• Engineering Standards and Material Specifications: The device's performance against established industry standards for orthopedic implants, including mechanical strength, durability, material composition (e.g., PPS and HA/TCP coating properties), and resistance to loosening/disassociation.
• Predicate Device Performance: The comparison of the proposed device's characteristics to those of legally marketed predicate devices, demonstrating that any differences "do not raise new questions of safety and effectiveness."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Device and Performance Aspects from the Document:

• Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
• Purpose: Manufacturing of alternate versions of existing Comprehensive Standard and Mini Baseplates with a different porous plasma spray (PPS) coating vendor and the addition of Zimmer's Calcicoat coating. Also includes a new Comprehensive Reverse Augmented Baseplate with an augmented backside.
• Basis for Substantial Equivalence:
  • Intended Use & Indications for Use: Identical to predicate devices.
  • Materials: Substrate and porous coating are the same as the predicate; Calcicoat® coating has been previously cleared.
  • Design Features: Identical or similar to predicates.
  • Sterilization: Identical assurance level and validation methods to predicate (new vendor).
• Performance Data Provided: Non-clinical tests were conducted. These included assessments of PPS and HA/TCP Coating Pore Size and Porosity, Glenoid Loosening/Disassociation Test Method, and Shear testing justification. No clinical tests were provided.
• Conclusion: The proposed devices are deemed substantially equivalent because they have the same intended use and indications for use, similar technological characteristics, and the differences do not raise new questions of safety and effectiveness, meaning they are at least as safe and effective as the legally marketed predicate devices.

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The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty are as follows:

• · Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• · Congenital abnormalities in the skeletally mature
• · Primary and secondary necrosis of the humeral head.
• · Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• · Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
• · To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

The Exactech Equinoxe Preserve Stem is a line extension to the range of humeral stems marketed by Exactech under the Equinoxe brand name. The subject device is intended to provide surgeons with a short-stem, distal bone preserving option that is compatible with minimally invasive surgical techniques. The proposed device is manufactured from Ti-6Al-4V and has Titanium Plasma Spray, grit blasted, and polished regions. The stems are available in 10 sizes, with distal stem diameters between 6mm and length of 70mm.

This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe® Preserve Stem, a humeral stem for shoulder replacement surgery. It establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies in the way you've outlined, as this document pertains to a physical orthopedic implant and its regulatory clearance process based on substantial equivalence, not an AI/software as a medical device.

The document discusses:

• Indications for Use: What the device is intended for.
• Technological Characteristics: How the device is similar to predicate devices (materials, design, dimensions, sterilization).
• Non-Clinical Testing: Engineering analyses performed to demonstrate performance (Fatigue Testing, Subsidence and Pull-out Testing, Pyrogen testing).

It does not contain information about:

1. A table of acceptance criteria and reported device performance (in terms of AI metrics).
2. Sample size for a test set, data provenance, or ground truth.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or therapeutic device that would require the specific types of studies and acceptance criteria you're asking about.

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The ReUnion RSA Shoulder System is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).

• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis
• Proximal humeral fracture
• Revision of previously failed shoulder joint replacement
• Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The humeral stem components are intended for both cemented and cementless use.

The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a Humeral Cup, Humeral Insert, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws. The ReUnion RSA Shoulder System components are indicated for primary reverse shoulder or revision reverse shoulder replacement procedures having gross rotator cuff deficiency.

The provided document is a 510(k) premarket notification for the ReUnion RSA Shoulder System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria in terms of clinical performance or algorithm accuracy.

Therefore, the requested information, which is typically associated with studies demonstrating the performance of diagnostic algorithms or standalone software, cannot be found in this document.

Specifically, the document states:

• "Clinical Testing: Clinical testing was not required for this submission." (Page 5)

This means there is no study presented in this 510(k) that evaluates the device's clinical performance against specific acceptance criteria in the manner requested. The document primarily focuses on non-clinical testing (e.g., fatigue strength, micromotion) to demonstrate substantial equivalence in design and materials to predicate devices.

As such, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This information is simply not part of a 510(k) for a physical implantable device like a shoulder system, especially when clinical testing is explicitly stated as not required.

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The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the Macro Bond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The device is a single-use implant.

The Titanium Alloy Glenosphere Prosthesis consists of a series of various sized modular glenospheres with variable offset between 0.5mm and 4.5 mm. Titanium alloy material has been selected to provide the surgeon with an alternate material to treat patients with nickel allergies. Each modular glenosphere consists of a "head" and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Reverse Shoulder System or Biomet's BioModular® Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device, specifically the Comprehensive® Reverse Shoulder - Titanium Glenosphere. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving that the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics (like sample size for test sets, expert ground truth, effect size, etc.) are not applicable or not provided in this type of regulatory submission. The document explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."

However, I can extract the relevant information that is present:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The performance reported here is primarily related to non-clinical bench testing.

Detailed Study Information (Not applicable/Not provided in this document type):

As noted, this document is a 510(k) summary demonstrating substantial equivalence, not a clinical study report with detailed performance data against specific acceptance criteria. Therefore, the following information is not present:

2. Sample sizes used for the test set and the data provenance: Not provided for this type of submission which relies on non-clinical testing for substantial equivalence. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set requiring expert ground truth for this submission.
4. Adjudication method for the test set: Not applicable, as there was no clinical test set.
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 an orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "No clinical data submitted." For non-clinical tests (like torsional separation), the "ground truth" would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device is an orthopedic implant, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

This document describes a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - Mini Baseplate" device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Comprehensive® Reverse Shoulder, 510(k) K080642), rather than establishing new acceptance criteria for a novel device. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML or diagnostic device is not directly applicable here.

However, I can extract the relevant information regarding the performance data section and how substantial equivalence was demonstrated for this medical device, which serves a similar purpose of proving the device's safety and effectiveness compared to an existing standard.

Here's a breakdown of the available information structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission for a medical implant, "acceptance criteria" refers to demonstrating that the new device (Mini Baseplate) performs equivalently to the predicate device in terms of mechanical properties and materials, ensuring it is safe and effective for its intended use. The table below summarizes the comparison to the predicate device. Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in this summary but are implied by the statement "performed within the intended use" and "did not raise any new safety and efficacy issues."

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

• Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., n=5 or n=6 per group for certain tests), but the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical (mechanical bench testing). Therefore, there is no "country of origin of the data" in the human data sense, nor is it retrospective or prospective. The data is generated in a laboratory setting.

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

This information is not applicable to this type of submission. "Ground truth" in this context would refer to the physical and mechanical properties of the materials and device components. The "truth" is established by standard engineering principles and validated testing methods according to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert judgment in clinical or diagnostic studies. This submission relies on objective mechanical testing.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a surgical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone algorithm performance study was not done. This point is relevant for AI/ML diagnostic tools.

7. Type of Ground Truth Used

The "ground truth" for non-clinical performance data for an orthopedic implant like this is based on:

• Material specifications: Compliance of the Ti-6Al-4V material to established standards (e.g., ASTM F136).
• Design specifications: The dimensions and geometric features of the components.
• Mechanical properties: The measured strength, stiffness, fixation integrity, and separation resistance against established performance benchmarks or comparisons to the predicate device, as determined by standardized mechanical testing methods.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set."

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in this manner.

In summary: The submission demonstrates substantial equivalence of the "Comprehensive® Reverse Shoulder - Mini Baseplate" to its predicate device through non-clinical performance testing (e.g., compressed shear load, baseplate fixation, axial separation, torsional separation). The results of these tests confirmed that the modified device "performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices." This is the primary "proof" for regulatory acceptance for this type of medical device.

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