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The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis AscendTM Modular Reverse Shoulder System K110599.

The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.

The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:

• Uncoated,
• Hydroxylapatite (HAP) coated,
• HAP over titanium plasma spray (HAP/Ti PS) coated.

The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120):

The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.

The provided text from the FDA 510(k) summary (K141029) describes a medical device, the Aequalis Adjustable Reversed Shoulder System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document discusses:

• Device: Aequalis Adjustable Reversed Shoulder System (a shoulder joint prosthesis).
• Predicate Device: Tornier Aequalis Adjustable Reverse Shoulder System, K120739.
• Purpose of this 510(k): To add an additional stem configuration (without HAP Coating, with plasma titanium spray coating on a portion, and a fluted surface on a portion) and validate an alternate plasma titanium spray coating supplier.
• Non-clinical Tests: Performed to evaluate device performance per design requirements and risk analysis. These included:
  • Demonstration of design equivalence
  • Fatigue testing
  • Shear fatigue strength
  • Static shear strength per ASTM F1044
  • Static tensile strength per ASTM F1147
  • Abrasion resistance per ASTM F1978
  • Thickness per ASTM F1854
  • Mean void intercept length per ASTM F1854
  • Mean volume percent of void per ASTM F1854
• Conclusion: "All testing results met pre-established acceptance criteria." and "the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device."

Based on the provided text, I cannot answer your questions because the document describes a mechanical orthopedic implant, not an AI or algorithm-based medical device. Your questions are tailored for evaluating the performance of an AI/algorithm.

Therefore, for each of your specific questions, the answer is that the information is not available in the provided document.

Here's why:

1. AI/Algorithm Focus: The core of your questions (e.g., test set, ground truth, experts, MRMC studies, standalone performance, training set) directly pertains to the evaluation of AI/machine learning algorithms. The Aequalis Adjustable Reversed Shoulder System is a physical implant, and its evaluation focuses on mechanical and material properties.

I can only extract information that is present in the document.

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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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The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder System (K100142, K081059). The Aequalis Adjustable Reverse Shoulder system is supplied in separate, sterile packages which will be assembled in the operating room. The components provided will be: Metaphysis, Stem Spacers, Stems, Assembly Screw, Securitization System: Securitization Bracket and Screw. The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599. The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty. The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options: Uncoated, Hydroxylapatite (HAP) coated, HAP over titanium plasma spray (HAP/Ti PS) coated. The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120).

The provided document is a 510(k) premarket notification for a medical device (Aequalis Adjustable Reverse Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic accuracy.

The document discusses the substantial equivalence of this new device to previously marketed predicate devices based on material, design, sizing, indications for use, and non-clinical mechanical testing (e.g., fatigue, fretting corrosion). It's a regulatory submission for a physical orthopedic implant, not a software-driven diagnostic or prognostic tool.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance using the details from this document, as those types of studies and criteria are not applicable to the content provided.

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Cemented Acqualis Reversed prosthesis:

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

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

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

Uncemented Acqualis Reversed prosthesis:

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

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

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

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

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

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

The present device modification submission consists of:

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

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

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

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

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

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