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Cemented Aequalis Reversed prosthesis: It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Aequalis Reversed prosthesis: It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Note: Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification consists in the addition of glenoid sphere in Titanium.

This document describes a 510(k) premarket notification for the Aequalis Reversed Shoulder Prosthesis, specifically for a modification involving the addition of a titanium glenoid sphere. The FDA determined the device to be substantially equivalent to predicate devices.

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

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 does not specify the exact sample sizes (number of units tested) for each non-clinical test (pull-out, fatigue, wear). The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer, Tornier SAS, based in France. The studies are non-clinical, likely prospective in design, rather than retrospective or based on human subject data.

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)

This is a submission for a medical device (shoulder prosthesis) and involves non-clinical mechanical and material testing. Therefore, there are no "experts" in the context of clinical interpretation or ground truth establishment from patient data. The "ground truth" for these tests are objective, measurable physical properties and performance metrics established by engineering standards and testing protocols.

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

Not applicable. As described in point 3, this is non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader agreement on interpretations (e.g., radiology images), which is not relevant 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. This is a medical device (shoulder prosthesis) and not an AI/software device. No MRMC study was conducted.

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

Not applicable. This is a medical device (shoulder prosthesis) and not an AI/software device.

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

The "ground truth" for the non-clinical tests were the physical measurements and observations during standard engineering tests (pull-out strength, fatigue performance, wear rates). These are quantitative and objective metrics, not requiring expert consensus, pathology, or outcomes data in the traditional clinical sense.

8. The sample size for the training set

Not applicable. As described in point 3, this is non-clinical testing for a physical device, not an AI/software product requiring a training set.

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

Not applicable. As described in point 3, this is non-clinical testing for a physical device, not an AI/software product requiring a training set or its associated ground truth establishment.

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Cemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aegualis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to relieve pain. The reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification consists in the addition of glenoid base plates with central threaded post and a new coating.

Here's an analysis of the provided text regarding the Aequalis Reversed Shoulder Prosthesis, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) Premarket Notification summary for a modification to an already cleared device ("Aequalis Reversed II glenoid base plate"). Therefore, the studies are primarily aimed at demonstrating substantial equivalence of the new components to the previously cleared ones, rather than establishing de novo safety and effectiveness for a completely new device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission for a modification, the "acceptance criteria" are framed around demonstrating equivalence to previously cleared predicate devices, particularly concerns about the new glenoid base plate's anchorage.

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

• Pull-out Testing (E1586):
  • Sample Size: Not explicitly stated as a number. The text mentions "Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations." This implies a comparative test with multiple specimens/configurations for both the new and cleared devices.
  • Data Provenance: The study was "conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate." This indicates controlled laboratory testing, not human patient data.
• Cadaver Testing:
  • Sample Size: Not explicitly stated (e.g., number of cadavers).
  • Data Provenance: "Cadaver testing was performed." This is prospective testing on biological tissue from cadavers, likely conducted in a laboratory or simulated surgical environment.

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

For the engineering tests (pull-out) and cadaver testing described, "ground truth" is typically established by objective physical measurements (e.g., force required for pull-out, visual inspection for fractures/complications) rather than expert consensus on interpretive data.

• No information is provided about the number or qualifications of experts for establishing ground truth in these non-clinical tests. This type of testing relies on engineering and biomechanical principles, not clinical interpretation.

4. Adjudication Method for the Test Set

Given the non-clinical, objective nature of the tests (pull-out force, observational findings during cadaver surgery), formal adjudication methods like 2+1 or 3+1 (common in diagnostic imaging studies) are not applicable or described. The results would be based on direct measurement and observation by the testing personnel.

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 submission pertains to a medical implant (shoulder prosthesis modification), not a diagnostic device or a system involving human interpretation of data. Therefore, the concept of human readers or AI assistance in the context of an MRMC study does not apply here.

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

• No, a standalone algorithm-only performance study was not done.
• This is an implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Pull-out Testing: The ground truth used was objective physical measurement of the force required to pull out the glenoid base plate from a foam block. The "truth" was the measured load/resistance.
• Cadaver Testing: The ground truth was based on direct observation and qualitative assessment of surgical outcomes, specifically whether "primary fixation has been achieved without scapular fracture or other major peri-operative complications." This involved visual inspection, palpation, and potentially other assessments during and after the simulated surgical procedure.

8. The Sample Size for the Training Set

• Not applicable. This is a medical implant, not a machine learning algorithm. There is no concept of a "training set" in this context. The device's design is based on engineering principles and previous device iterations, not data-driven machine learning.

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

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

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Cemented Acqualis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Acqualis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability . following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists of:

• the addition of humeral stems with hydroxylapatite coating,
• the addition of 2 sizes of metaphyses with hydroxylapatite coating, •
• the update of the Aequalis Reversed Shoulder Prosthesis indications for use. .

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for the "Aequalis Reversed Shoulder Prosthesis," a traditional medical device (implantable shoulder prosthesis). It focuses on demonstrating substantial equivalence to predicate devices, not on evaluating the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information, which includes:

1. Acceptance criteria table
2. Sample size and data provenance for test sets
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for training set
9. Ground truth establishment for training set

Ask a specific question about this device

The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to recuce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in :

• addition of glenoid baseplates and glenoid spheres, .
• addition of polyethylene inserts.

The provided text is a 510(k) premarket notification letter and a summary of safety and effectiveness information for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen in performance studies for diagnostic or AI-based devices.

The document describes the device, its indications for use, materials, and classification within the FDA's regulatory framework. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices. This type of submission does not usually include detailed performance studies with acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, I cannot provide the requested information based on the given text.

To address the specific points you asked for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. The document is for a physical orthopedic implant, not a diagnostic device that uses a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method for the test set: Not applicable/not present.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used: Not applicable. For an orthopedic implant, "ground truth" in the context of device performance usually refers to clinical outcomes, wear testing, mechanical properties, etc., which are not detailed in this summary.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the dettoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition And to reduce or eliminate pain. The Aegualis Reversed Shoulder Prosthesis is intended to accomplish these goals. Is reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in the following changes:

1ª change: addition of components in order to have the possibility to use multidirectional screws with the glenoid baseplate

2 types of components are added to the components of the Aequalis Reversed Shoulder prosthesis:

• Multidirectional screws in various length, l
• Specific glenoid baseplate for multidirectional screws.
• 244 change: addition of "fish-scales" on the peg of the humeral insert
• 314 change: modification of packaging of polyethylene components

The indications for use already covered by the previous 510(k) clearance are not modified.

The provided document is a 510(k) premarket notification for the "AEQUALIS Reversed Shoulder Prosthesis". This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance evaluation in the typical sense of a clinical trial or performance study for a new, novel device.

Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available within this type of regulatory submission.

Here's why and what information is present:

• 510(k) Premarket Notification: This is a regulatory pathway used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The primary goal is to show that the device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
• Focus on Equivalence: The document lists the predicate devices (K030941, K041873, K952928, K991585, K021478) and outlines modifications to an already cleared device (addition of multidirectional screws, "fish-scales" on the humeral insert peg, and packaging modifications). The safety and effectiveness are largely inferred from the predicate devices and the nature of the minor modifications.
• Lack of Performance Study Details: A 510(k) submission typically does not include extensive clinical studies or performance data comparing the device against specific acceptance criteria for efficacy or diagnostic performance, especially for modifications to an existing, cleared device like this one. Such studies are more common for novel devices or those requiring a PMA (Premarket Approval).

Information that CAN be extracted:

1. Device Name: AEQUALIS Reversed Shoulder Prosthesis
2. Regulatory Pathway: Special 510(k)
3. Indications for Use: For patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with massive and non-repairable rotator cuff-tear, and for prosthetic revisions with massive and non-repairable rotator cuff-tear.
4. Device Description (Changes):
   • Addition of components for multidirectional screws with the glenoid baseplate.
   • Addition of "fish-scales" on the peg of the humeral insert.
   • Modification of polyethylene component packaging.
5. Materials: UHMWPE, Titanium alloy.

Conclusion:

Based on the provided document, which is a 510(k) Summary of Safety and Effectiveness for a medical device (specifically an orthopedic implant modification), the requested information regarding acceptance criteria, specific performance studies, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies is not present. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than presenting de novo clinical or performance study data against defined acceptance criteria.

Ask a specific question about this device

The Aequalis Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid muscle, as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosities humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glonoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of a Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Reversed prosthesis in to an anatomical non reversed hemiprosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres pinor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to mcdialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in the addition of components to the Aequalis Reversed Soulder prosibesis in order to have the possibility to transform the Aequalis Reversed Soulder Prosthesis in a standard hemi or total prosthesis in some clinical cases encountered during the surgical procedure.

The present Device Modification submission corresponds to the addition of 3 components of the Aequalis Reversed Shoulder prosthesis:

• Hemi-prosthesis adaptor diameter 36 mm, -
• Hemi-prosthesis adaptor diameter 42 mm, -
• Adaptor metaphysis union screw.

The provided document is a 510(k) premarket notification for a medical device, specifically the AEQUALIS Reversed Shoulder Prosthesis, and does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

This document describes:

• The device name, classification, and submitter information.
• A description of the device and its intended use.
• Materials used in its construction.
• Indications for use for the original device and the added components.
• A letter from the FDA determining substantial equivalence to predicate devices, thus allowing the device to be marketed.

Since the document provided is a 510(k) submission, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results. The content is primarily descriptive and regulatory in nature. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from this particular text.

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The Aegualis Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid I ho requare to rever sou box replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aegualis Reversed Shoulder Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The humeral component:

The humeral part is made of 3 parts consisting of interchangeable stems, metaphysis , and inserts, that may be assembled in different configurations thus accommodating a large variation in patient size and anatomy.

The metaphyseal parts are fixed to the stem by a screwing fixation secured by a polyethylene breaking system. A lateralization spacer can be added to the humeral metaphysis in order to vary the lateralization.

The inserts are impacted on to the conic shape of the metaphysis. A polyethylene peg guides it in the correct position.

The stems are made of cobalt-chrome in 4 diameters The metaphyseal parts are manufactured from cobalt-chrome, in 2 sizes. The inserts are available in polyethylene in 6 sizes. The lateralization spacers are made of cobalt-chrome and are available in 2 sizes.

The glenoid component:

The glenoid part is composed of a base made of titanium alloy, on which is impacted a sphere of chrome cobalt. The assembly is secured by a central and internal screw. The sphere is available in two diameters congruent with the humeral insert.

The metallic base of the glenoid is fixed to the bone by using 4 compression screws for fixation.

The provided text is a 510(k) summary for the Tornier S.A. Aequalis Reversed Shoulder Prosthesis. It describes the device, its intended use, materials, and provides a substantial equivalence determination from the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication in the context of proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would fall under the categories requested in your prompt. The "Standards / Testing" section only lists material and sterilization standards, not performance criteria for the device's clinical efficacy or safety beyond material biocompatibility.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions (like a PMA) that are not part of this 510(k) summary.

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