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Aequalis Shoulder Fracture System & Aequalis Resurfacing Head:
Aequalis Range :
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
• Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• Revision surgery when other treatments or devices have failed. .
  Aequalis monobloc stem is for uncemented use only. The Aequalis press-Fit stem is for uncemented use only. The glenoid component is for cemented use only.
  Aequalis Fracture range:
• 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. - Revisions when other devices or treatments have failed.
  The Aequalis fracture stem is for cemented use only. The glenoid component is for cemented use only.
  Aequalis Resurfacing Head range:
  The resurfacing implant is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.
  The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head.
  The resurfacing implant is intended for uncemented use only. The glenoid component is for cemented use only.
  Aequalis Reversed Shoulder Prosthesis
  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 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 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 hemiprosthesis 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 hemiprosthesis 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.
  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 Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.

For the Aequalis Shoulder Fracture 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-lear associated to arthropathy and following massive cuff-lear 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 Acqualis 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 be used to relieve pain or significant disability following massive cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator nuscles 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 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 stemlike design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation. The Acqualis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
For the Aequalis Resurfacing Head:
The Aequalis Resurfacing Head is a humeral head resurfacing device. It requires less bone and cartilage removal, which makes it much more conservative than total joint implants. Revision or arthrodesis can be undertaken easily because the bone stock has been maintained with no loss of length. The main advantages of humeral head resurfacing are preservation of bone and the relatively simple surgical technique.
With the Aequalis Resurfacing Head the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury.
The present submission corresponds to the following modification:

• Addition of a new coating subcontractor (hydroxylapatite coating and titanium + hydroxylapatite coating): Eurocoating S.p.A on cobalt chromium and titanium components.
  All the prostheses of this application are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.

This document is a 510(k) Premarket Notification for orthopedic devices, specifically shoulder prostheses, and it details the substantial equivalence of a new coating subcontractor rather than presenting a study proving a device meets specific acceptance criteria based on performance. Therefore, the requested information, such as a table of accuracy metrics, sample sizes for test/training sets, expert qualifications, and human-in-the-loop study results, is not available in the provided text.

The core of this submission is to demonstrate that changing the coating subcontractor for existing, previously cleared devices (Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis, Aequalis Resurfacing Head) does not alter the safety or effectiveness of the devices.

Here's an analysis based on the information provided, focusing on what is available:

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

This document does not present quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic or therapeutic efficacy. Instead, it focuses on the performance of the coating from the new subcontractor meeting established standards.

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

No specific sample sizes for a "test set" in the context of device performance (e.g., clinical outcomes) are mentioned. The testing described (shear fatigue, static shear, static tensile, abrasion, and coating characterization) would have involved laboratory samples of the materials and coatings. The document does not specify the number of samples for these non-clinical tests, nor does it provide details on data provenance in terms of country of origin or retrospective/prospective nature, as it's a technical submission for material equivalence.

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 information is not applicable to the type of submission. Ground truth, in the context of diagnostic accuracy, is not relevant here. The "ground truth" for the coating tests would be the established material standards (ASTM, ISO) and the specifications set by the device manufacturer.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes. The non-clinical tests performed on the coating materials and their characterization are objective measurements against established standards.

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 submission is for orthopedic prostheses and relates to a material change (coating subcontractor), not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this submission are the established material and performance standards (e.g., ASTM F 1185 for hydroxylapatite coating, ISO 5832-3 for titanium alloy, ISO 5832-4 for cobalt-chromium alloy, ISO 5834-2 for UHMWPE) and the manufacturer's internal specifications for the coating properties (thickness, pore size, pore volume), which are stated to be "identical to the previously cleared devices."

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable.

Summary of the Study:

The study described is a non-clinical equivalency assessment. The purpose was to demonstrate that a new coating subcontractor (Eurocoating S.p.A) produces coatings that are substantially equivalent in terms of material properties and performance to the previously approved coatings from BioCoat Company.

• Objective: To show that the change in coating subcontractor does not introduce any new or higher risks and that the devices remain substantially equivalent to their predicates.
• Methodology:
  • Non-clinical testing: Shear fatigue strength, static shear strength test, static tensile strength, and abrasion tests were performed on the coating materials.
  • Coating characterization: Measurements of thickness, pore size, and pore volume were conducted.
  • Material Conformity: Verification that the materials used (titanium alloy, cobalt-chromium alloy, UHMWPE) and the coating (hydroxylapatite, titanium plasma spray) conform to relevant ISO and ASTM standards.
  • Comparison: The specifications and performance of Eurocoating S.p.A's coatings were compared to those previously requested from BioCoat Company.
• Conclusion (from the document): The results of the evaluation allowed the conclusion that the proposed new coating subcontractor Eurocoating S.p.A does not induce any new or higher risk compared to the predicate coating subcontractor BioCoat Company, and therefore both coating subcontractors are substantially equivalent. The indications for use, other technical characteristics (design, materials, manufacturing, sizing, method of fixation), and covered zones of the implants remain unchanged.

In essence, this document is a regulatory submission focused on proving the material equivalency of a component (the coating) from a different supplier, rather than a study on the clinical performance or diagnostic accuracy of the entire medical device.

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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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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 . - 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 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 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 hemiarthrosplasty to a total shoulder replacement. The present submission corresponds to the following modifications: - addition of two large glenoid components to the four existing sizes of glenoid both for the Aegualis shoulder Fracture System and the Aequalis shoulder System, - addition of a model of Fracture Stem covered with hydroxylapatite to the Aequalis shoulder Fracture -System, the new stem is strictly identical to the previously cleared device except for the coating.

The provided text is a summary of a 510(k) premarket notification for the Aequalis Shoulder Fracture System and Aequalis Shoulder System. It focuses on the device description, materials, indications for use, and regulatory classification.

There is no information in the provided document about:

• Acceptance criteria: The document does not specify any performance-based acceptance criteria for the device beyond the general goal of restoring the shoulder joint and reducing pain.
• Studies or performance data: The document states that the FDA determined the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide any specific studies, test results, or performance metrics (like sensitivity, specificity, accuracy, or effect size) for the Aequalis Shoulder systems themselves. The substantial equivalence determination is often based on design similarities, material biocompatibility, and similar indications for use to already approved devices, rather than new extensive clinical performance studies for 510(k) applications.

Therefore, I cannot populate the table or answer most of your detailed questions based on the input text.

Here's what I can extract and state explicitly about the lack of information:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Information (based on the lack of data in the provided document):

2. Sample size used for the test set and the data provenance: Not provided. The submission is a 510(k), which typically relies on substantial equivalence to predicate devices rather than new clinical outcome studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no specific test set or ground truth establishment is described for the Aequalis devices' performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no specific test set or ground truth establishment is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance studies are described. The regulatory approval is based on substantial equivalence to predicate devices for mechanical and material properties and intended use.
8. The sample size for the training set: Not applicable, as no development of an AI algorithm or similar data-driven model is described.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

• Device Name: Aequalis Shoulder Fracture System & Aequalis Shoulder System
• Predicate Devices: K952928, K041339, K043077 (Aequalis Shoulder system); K994392, K003728, K032679, K043077 (Aequalis Shoulder Fracture system)
• Regulatory Mechanism: 510(k) Premarket Notification based on substantial equivalence.
• Modifications in current submission: Addition of two large glenoid components and a fracture stem covered with hydroxylapatite (which is strictly identical to a previously cleared device except for the coating).
• Materials: Humeral implant: titanium alloy (Ti6Al4V) or chromium-cobalt alloy (CrCo). Glenoid component: ultra-high molecular weight polyethylene (UHMWPE). Hydroxylapatite coating.
• Indications for Use: Detailed for both the Aequalis Shoulder Range (except for Fracture) and Aequalis for Fracture, covering degenerative pathologies, necrosis, various humeral fractures, and revision surgeries.

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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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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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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 Aequalis Shoulder Fracture System is a typical 3 part system consisting of interchangeable humeral heads, a humeral stem and, if used as a total shoulder, a glenoid component.

The Aequalis Shoulder Open stem for Fracture is available in 3 diameters (6.5, 9 and 12), with the same length. The geometry of the meaphyseal part has been designed to allow the filling by bone graft and to improve the knitting of the bones. The goal of the metaphyseal shape is to make a "bony bridge" between the tuberosities. In order to allow extraction of the prosthesis in case of revision, two slits have been designed to break the bony bridge. Anterior-posterior fins extending from diaphyseal portion form a convex bearing area allowing adequate positioning and synthesis of the greater tuberosity. The stem is used cemented in the diaphyseal part.

Various heads may be assembled to the stem in different configurations thus accommodating large variations in patient size and anatomy. The head is fixed on the stem on a Morse taper. It is impacted onto the stem on an impacting support. Subsequent revisions may be accomplished if necessary by reoparetion and separation of the head and the stem. The taper fit heads may be rotated about the axis of the Morse taper. The reverse surface of the heads has series of holes drilled around the female Morse taper every 45°. Because the female Morse taper of the head is eccentric, rotation of the head before fully seating the male and female tapers produces eight possible offset combinations for the orientation of the humeral head radius. The rotational adjustability of the humeral articulating surface expands the surgical flexibility of the system. The articulating surface of each head is designed to mate with either the natural glenoid (hemi-shoulder applications) or the available glenoid implants (total shoulder applications).

The Aequalis glenoid components are pear-like in shape, to avoid friction with the deep surface of the rotator cuff.

Open Stem for fracture: 3 dia. (6.5. 9 and 12 mm) with 1 length

Humeral Heads:
37mm x 13.5mm
39mm x 14mm
41mm x 15mm
43mm x 16mm
46mm x 17
48mm x 18mm
50mm x 16mm
50mm x 19mm
52mm x 19mm
52mm x 23mm
54mm x 23mm
54mm x 27mm

Glenoid: 3 sizes (small, medium, large)

Each component of the system is individually part coded for ease identification. The offered combinations of stem, head and glenoid sizes accommodate a wide range of anatomical variations and circumstances.

The provided text describes a 510(k) Premarket Notification for the Aequalis Shoulder Fracture System. This document focuses on establishing substantial equivalence to a predicate device and safety and effectiveness, rather than providing specific acceptance criteria and performance data for a new device's functional attributes in the way a clinical trial for an AI/medical device might.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially for AI or software-based devices) are not applicable to this type of regulatory submission for a shoulder fracture system.

However, I can extract information related to the device's classification, general standards it complies with, and the regulatory process.

Here's a breakdown of what can be inferred or is directly stated, and what is not applicable:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than setting specific performance acceptance criteria for a new, innovative function and then reporting against them.

2. Sample size used for the test set and the data provenance:

Not applicable. This device is a shoulder implant, and the submission does not detail "test sets" or data provenance in the context of performance studies for an AI/software device. The submission relies on a comparison to a predicate device and compliance with established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment with experts is not mentioned as part of this type of regulatory submission for a physical implant.

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

Not applicable. Adjudication methods are not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical shoulder implant, not an AI-assisted diagnostic or treatment device, so MRMC studies are not relevant.

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

Not applicable, as this is a physical medical device.

7. The type of ground truth used:

Not applicable in the context of AI/software performance. For a physical implant, the "ground truth" would be related to clinical outcomes, biomechanical testing, and material properties, which are generally not detailed as "ground truth" in this manner within a 510(k) summary. The submission focuses on substantial equivalence based on design, materials, and intended use.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

General summary of what the document does address regarding "safety and effectiveness":

The document states:

• "This summary contains information upon which a determination of substantial equivalence could be based. Selected device testing demonstrates the functional equivalence of the Aequalis Shoulder Fracture System."
• It highlights compliance with various standards and regulations:
  • Tornier, S.A. Standard Operating Procedures (SOP)
  • Vendor certifications and qualification procedures
  • Quality System Regulations (QSR)
  • ISO9001 & EN46001 specifications
  • European CE Marking
  • FDA requirements for labeling (21 CFR 801 and 809.10)
  • Good Manufacturing Practice requirement (21 CFR Part 820)
• The sterilization method (gamma radiation, 2.5 Mrad, SAL of 10^-6) and its validation according to EN552 are described.
• The FDA letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the core "acceptance criteria" for a 510(k) submission. This determination is based on the information provided in the submission, including device description, intended use, and comparison to existing legally marketed devices.

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