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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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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. . Primary and secondary necrosis of the humeral head
• Displaced 4-part upper humeral fracture i
• Humeral head fracture
• Humeral head fracture
  Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are i not acceptable ·
• Revision surgery when other treatments or devices have failed. i

Aequalis monobloc stem is for use with cemented applications and is labeled as such. Aequalis Inditionio stem is for uncemented applications and is labeled as such.
Aequalis Press-Fit stem is for uncemented applications and is labels as such. Aequalis Fress-Fit sich is for uncemented applications ad is labeled as such.

Aequalis for Fracture:
Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral frequres Traumatic or pathologic concilibilis of the since as and displaced 3-or 4-part proximal humeral fractures.
joint, including humeral head fracture and displaced 3-or 4-part pr Revision surgery when other treatments or devices have failed.

Aequalis fracture stem is for cemented use.

Aequalis Reversed Shoulder Prosthesis:
Acqualis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid The Aequalis Reversed Shoulder Frosthesis is the relief of panin and significant disability
muscle as a total shoulder replacement for the relief off paint and significant Th following arthropathy associated to massive and non repairshe rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rolator colfis also indicated for the prosilent revisions whiles. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

the bone with 4 screws and is for non-cention interest to be insufficient to bear When during the primary surgery the gions one accure occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw be adapted to the humeral
procedures, the hemi-prosthesis adaptor and the union screw cases in the humeral procedures, the nemi-prosthesis adaptor and the amon before and on reversed hemi-prosthesis.

hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears When, in case of revision of a Aequalis Reverse of Aequalis Reversed range again, the to be insufficient to implant a baseptate and the union screw allows for the transformation of the use of the hemi-prosthesis adaptor and the amon serow and is to the morder to avoid the revision of the humeral components.

Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:

• in case of 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, or
• in case of bone defect in proximal humerus. ।

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

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 hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed Fracture Shoulder 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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aegualis Reversed Fracture Shoulder humeral stem is for cemented use only.

For the Aequalis Fracture Shoulder System:
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or 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 hemi-arthroplasty to a total shoulder replacement.

For the Aequalis Reversed Shoulder Prosthesis:
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 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.

For the Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive 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 surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture 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 and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.

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

The present submission corresponds to the following modification:

• Addition of a new coating subcontractor (hydroxyapatite coating): APS Materials, Inc. on . titanium components (stem and baseplate).
  All the prostheses of this file are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.

I am sorry, but the provided text from the FDA 510(k) Premarket Notification for the Aequalis Shoulder Fracture System and related prostheses does not include information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The document is a clearance letter and a summary of safety and effectiveness for a physical medical device (shoulder prostheses). It discusses:

• Device Names: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis.
• Regulatory Information: Regulation number, regulation name, product codes, regulatory class (Class II).
• Indications for Use: Detailed descriptions of the medical conditions for which each type of shoulder prosthesis is intended.
• Device Description: Information on the components, their function, and the surgical goals.
• Materials: Specifically mentions titanium alloy (Ti6Al4V) and hydroxyapatite coating, and a new coating subcontractor (APS Materials, Inc.).
• Predicate Devices: Lists previously cleared devices to which the current devices are compared for substantial equivalence.

There is no mention of:

• AI/Machine Learning: No algorithm, software, or AI component is described.
• Acceptance Criteria for AI Performance: No metrics like sensitivity, specificity, AUC, or other performance thresholds are stipulated.
• Clinical Study for AI Validation: No details of a study with a test set, ground truth establishment, expert adjudication, or MRMC studies are present.
• Training Data: No information on training sets for an AI model.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/SaMD device meets them based on the provided text. The document pertains to the clearance of traditional orthopedic implants.

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The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint :

• in case of 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, or
• in case of bone defect in proximal humerus. .

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

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 hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed Fracture Shoulder humeral stem, 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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.

The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive 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 surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture 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 and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.

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

This document is a 510(k) premarket notification for the "Aequalis Reversed Fracture Shoulder Prosthesis." It outlines the device's indications for use, materials, and provides a comparative analysis to predicate devices to establish substantial equivalence.

Based on the provided text, here's a breakdown of the requested information:

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

This document describes a medical device (Aequalis Reversed Fracture Shoulder Prosthesis) and its substantial equivalence to predicate devices, rather than an AI/software device. Therefore, the concept of "acceptance criteria" as typically applied to performance metrics like sensitivity, specificity, or accuracy for an AI system is not directly applicable here.

Instead, the "acceptance criteria" implicitly referred to are the regulatory requirements for showing substantial equivalence to legally marketed predicate devices, as defined by the FDA's 510(k) process. This involves demonstrating that the new device is as safe and effective as the predicate device(s). The document indicates that the device meets these criteria as the FDA issued a "substantially equivalent letter."

The "reported device performance" is not quantified in terms of clinical outcomes or performance metrics in this document, but rather in terms of its design, materials, and intended use being comparable to existing devices already deemed safe and effective.

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

This document is a regulatory submission for a medical implant (a shoulder prosthesis), not a study evaluating an AI device's performance. Therefore, there is no test set, sample size, or data provenance information related to an AI algorithm's evaluation. The evaluation is based on a comparison to predicate devices, materials testing, and design specifications.

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 medical device submission, not an AI study requiring expert ground truth for a test set.

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

Not applicable, as this is a medical device submission.

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 medical device submission, not an AI or software device that would involve human readers or AI assistance.

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

Not applicable, as this is a medical device submission, not an AI or software device.

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

For this medical device, the "ground truth" for regulatory clearance is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence by showing similar technological characteristics, materials, and intended use, supported by engineering testing and clinical experience with similar devices, rather than a specific "ground truth" derived from patient data in the context of an AI algorithm validation.

8. The sample size for the training set

Not applicable, as this is a physical medical device submission, not an AI/machine learning model that requires a training set.

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

Not applicable, as this is a physical medical device submission.

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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 Delta CTA™ Humeral Cups, as part of the DePuy Delta CTA™ Total Shoulder are intended for use in patients with non-functional rotator cuffs with or without bone cement.

The Delta CTA™ Total Shoulder Prosthesis is indicated for use in grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.

The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

The Delta CTA™ Humeral Cups proposed in this submission are a line extension to the humeral cup system components cleared in the DePuy Delta CTA™ Shoulder submission (cleared as DePuy Delta Shoulder under K021478, November 18, 2003). The additional humeral cups are made of polyethylene and will be available in four sizes: 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness.

This 510(k) premarket notification for the Delta CTA™ Humeral Cups does not describe a study involving acceptance criteria or device performance.

Instead, this submission is centered on demonstrating substantial equivalence to a previously cleared device (DePuy Delta CTA™ Shoulder, K021478). The "study" described, therefore, is a comparison to the predicate device, not a performance study against specific acceptance criteria.

Here's why and what information is available:

1. Acceptance Criteria and Reported Device Performance:

• Not Applicable: The submission does not define specific acceptance criteria related to clinical performance (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the Humeral Cups. The "performance" being evaluated is the similarity of the new device to the predicate.

2. Sample Size and Data Provenance:

• Not Applicable: No clinical or in-vitro study data with a "test set" and a defined sample size are provided. The basis for substantial equivalence is the design, material, and manufacturing method.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable: Since no clinical performance study was conducted to establish ground truth, there were no experts employed for this purpose in this submission.

4. Adjudication Method:

• Not Applicable: No adjudication method was used as there was no study requiring one.

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

• No: An MRMC comparative effectiveness study was not performed. This type of study investigates the impact of an AI device on human reader performance, which is not relevant to a medical implant that is not an AI-enabled diagnostic or therapeutic device.

6. Standalone Performance Study:

• No: A standalone (algorithm-only) performance study was not performed. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Not Applicable: No "ground truth" in the context of a diagnostic or therapeutic study was established or used. The "ground truth" for substantial equivalence is the existing predicate device and its established safety and effectiveness.

8. Sample Size for the Training Set:

• Not Applicable: The device is a physical implant, not an AI model, so there is no "training set."

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

• Not Applicable: As above, there is no training set for this device.

Summary of the Basis for Substantial Equivalence (from the provided text):

The submission argues for substantial equivalence based on the following:

• Identical Design, Material, and Manufacturing Method: The Humeral Cups proposed are identical in these aspects to those cleared in the predicate device (Delta CTA™ Total Shoulder Prosthesis, K021478).
• Line Extension/Increased Sizes: The current submission only introduces additional sizes (36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness) to the existing range of humeral cups, which were already cleared in 36mm diameters in +0mm and +6mm thicknesses, and 42mm diameters in +0mm and +6mm thicknesses.

Therefore, the "study" demonstrating the device meets "acceptance criteria" here is the presented rationale that the new sizes of humeral cups do not introduce new questions of safety or effectiveness compared to the already cleared predicate device, given the identical design, materials, and manufacturing processes. The FDA's letter (sections 2 and 3) indicates their agreement with this assessment, leading to the clearance of the device.

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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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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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