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Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

• Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head
• -Displaced 4-part upper humeral fracture
• Humeral head fracture -
  Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
  Revision surgery when other treatments or devices have failed.
  The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.

The Aequalis Shoulder System is intended to restore the shoulder joint to its best working condition and to reduce or eliminate pain. It consists in a humeral stem and a humeral head. With these systems the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Acqualis Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement. The present device modification submission consists in the addition of a new glenoid system, named Tornier Glenoid, to the current cleared model. The Tornier Glenoid system is a comprehensive offering that includes a variety of anchorage options such as a keel, standard peg and Cortil oct 14 peg available in a variety of sizes. The Tornier Glenoid has been designed to be compatible with the Aequalis, Affiniti and Ascend humeral head systems in certain combinations. The new Tomier Glenoid completes the Tornier range of glenoid implants. Tornier Glenoid component is intended for cemented use only.

This document is a 510(k) premarket notification for a medical device modification, specifically the addition of a new glenoid system ("Tornier Glenoid") to the existing Aequalis Shoulder System. The primary purpose of this submission is to demonstrate "substantial equivalence" of the modified device to legally marketed predicate devices, not to establish new performance criteria through a study with the modified device.

Therefore, the document does not contain acceptance criteria and a study demonstrating the device meets these criteria in the typical sense of a novel device demonstrating efficacy or performance through clinical trials. Instead, it argues for equivalence based on similar design, materials, indications for use, and a limited set of non-clinical bench tests confirming that the modifications do not introduce new risks.

Here's a breakdown of the requested information based on the provided text, with explanations where direct answers are not available due to the nature of a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

This document does not present a table of specific numerical acceptance criteria (e.g., minimum tensile strength, maximum wear rate) and corresponding reported performance values for the new Tornier Glenoid. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, focusing on similarity rather than novel quantitative metrics.

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 the test set: Not explicitly stated as a "test set" in the context of a clinical study. The "test set" refers to the new Tornier Glenoid components that underwent non-clinical bench testing. The specific number of components tested for each bench test is not provided in this summary.
• Data provenance: The non-clinical testing was performed by Tornier S.A.S. in France. This is implied by the company's address and the nature of manufacturing and R&D activities. The data is prospective, generated specifically for this submission.

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 510(k) submission for a device modification, "ground truth" in the sense of clinical disease diagnosis or outcome for a test set of patients (as would be established by medical experts) is not part of the submission criteria. The "ground truth" here is adherence to design specifications, material standards, and performance in bench tests against established engineering principles, which would be managed by product development engineers and quality assurance personnel.

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

Not applicable. This is not a study involving human interpretation or clinical outcomes that would require an adjudication method among experts.

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 submission for a physical medical device (shoulder prosthesis) modification, not an AI or imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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 the non-clinical testing is based on:

• Established engineering standards and design specifications for prosthetic implants (implied by the bench testing, e.g., acceptable range of motion, pull-out strength).
• Material standards (e.g., ISO 5834-2 for UHMWPE, ISO 5832-7 for CoCr alloy).
• Performance of predicate devices, used as a basis for comparison to ensure the modified device performs similarly and safely in simulated conditions.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of machine learning. If "training set" is being reinterpreted as the data or knowledge base used to design and develop the device, it would encompass all prior design data, material science knowledge, and manufacturing experience for the Aequalis system and similar prostheses. However, this is not quantified in the document.

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

Not applicable. There is no "training set" in the machine learning sense. The design and validation of the device rely on established engineering principles, material science, and regulatory standards for medical device safety and performance. Manufacturing quality controls ensure that each produced device conforms to these established specifications.

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Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head Displaced 4-part upper humeral fracture Humeral head fracture Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable Revision surgery when other treatments or devices have failed. Aequalis Shoulder Fracture System Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems. The Affiniti pegged glenoid components are available in sizes 40 - 56.

The provided text is a 510(k) summary for a medical device (Aequalis Shoulder System and Fracture System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or even a standalone technical performance study.

Therefore, the document does not contain the information requested about acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance.

The reason for this is that the submission states:

"The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously."

This indicates that the submission is for a minor modification (compatibility with new glenoid components) to an already cleared device, relying on the substantial equivalence principle rather than new performance testing.

However, I can extract the following information based on the provided text:

• Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System
• Device Type: Total shoulder prosthesis (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
• Classification: Class II
• Product Codes: 87 KWS
• Predicate Devices: K994392, K003728, K012212, K032679, K060209 (for Fracture System) and K952928, K980244, K012212, K041339, K043077, K060209, K060988 (for Shoulder System).

In summary, there is no information in the provided document to answer the questions about acceptance criteria and device performance studies because the submission is based on substantial equivalence to predicate devices, not new performance data.

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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.

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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 a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in some additions and changes for metaphyseal screw, glenoid baseplate, glenoid sphere and insert.

Metaphyseal inserts are made of ultra high molecular weight polyethylene (UHMWPE). The base of the glenoid implant is manufactured from Titanium alloy. The sphere is manufactured from Cobalt-Chromium alloy and the screw is manufactured from Titanium alloy.

The hydroxylapatite coating conforms to the ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.

This is a 510(k) premarket notification for a medical device (Aequalis Reversed Shoulder Prosthesis), not a study report detailing acceptance criteria and performance data. Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) is not available in the provided document.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics for the novel device itself.

Here's what can be inferred from the document regarding the device and its regulatory status:

• Device Name: Aequalis Reversed Shoulder Prosthesis
• Intended Use: Restore shoulder joint function and relieve pain for patients with functional deltoid muscle, suffering from arthropathy associated with massive and non-repairable rotator cuff-tear, and for prosthetic revisions with massive and non-repairable rotator cuff-tear. It can also be adapted into a non-reversed hemi-prosthesis if glenoid bone stock is insufficient during primary surgery or revision.
• Predicate Devices: Aequalis Reversed Shoulder Prosthesis (K030941, K041873, K050316), Aequalis Shoulder System (K952928, K012212, K041339, K060209), Delta Shoulder (K021478). This indicates the device is considered substantially equivalent to these devices.
• Regulatory Clearance: The FDA has issued a substantial equivalence determination (K061439) for this device on July 20, 2006, allowing it to be marketed.

The document does NOT contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance for a study proving acceptance criteria.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How the ground truth for a training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a clinical trial report.

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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.

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AEQUALIS Shoulder Range (except AEQUALIS for Fracture): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. i Primary and secondary necrosis of the humeral head - Displaced 4-part upper humera! fracture । - Humeral head fracture । - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other treatments or devices have failed. - AEQUALIS for Fracture: Traumatic or pathologic conditions of the shoulder resulting in fracture of the Fraumatio of painting of joing humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

Total-Shoulder System and Hemi-Shoulder System. Shoulder joint metal/polymer semi-constrained cemented prosthesis.

This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System, AEQUALIS Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/software as a medical device.

The provided text is a regulatory filing for a physical medical device (shoulder prosthesis), focusing on establishing substantial equivalence to previously marketed predicate devices. It lists indications for use, device classification, and administrative details for FDA approval.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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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Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3-or 4-part proximal humeral fractures.

The usual goal of total shoulder replacement is to relieve or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid is replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthroplasty to a total shoulder replacement. The present Device Modification submission consists in the addition of a long stem to each diameter of the previous range.

This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System), not a study report. Therefore, it does not contain the information required to describe acceptance criteria and a study proving the device meets those criteria.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the regulatory requirements for marketing, but it does not involve a specific clinical study with acceptance criteria and a detailed performance evaluation as would be found in a clinical trial report.

Here's why the requested information cannot be extracted from the provided text:

1. Acceptance criteria and reported device performance: This document does not detail specific acceptance criteria for performance metrics (e.g., success rates, complication rates, range of motion improvements) or report any performance data from a study.
2. Sample size, data provenance: No study is described, so no sample size or data origin is mentioned.
3. Number of experts, qualifications, adjudication method: These pertain to establishing ground truth in a clinical or imaging study, which is not present here.
4. MRMC comparative effectiveness study: No such study is mentioned or implied.
5. Standalone (algorithm only) performance: This is a physical implant, not an algorithm.
6. Type of ground truth: Ground truth is not relevant in this context, as no performance data based on ground truth is being presented.
7. Training set sample size/ground truth: This pertains to machine learning models, which is not what this document is about.

In summary, the provided text is a regulatory filing for marketing clearance, not a scientific or clinical study report.

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