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The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Anatomic Shoulder Prosthesis is a modular system intended to be used for anatomical shoulder arthroplasty.

The Medacta Anatomic Shoulder Prosthesis is composed of the following components:

• Standard Humeral Diaphysis - Cementless (sizes 6 to 16)
• Standard Humeral Diaphysis Cemented (sizes 6 to 16)
• Humeral Anatomical Metaphysis Cementless (128°, 135° and 142° inclinations, sizes 6 to 16)
• Humeral Anatomical Metaphysis Cemented (128°, 135° and 142° inclinations, sizes 6 to 16)
• Double Eccenter
• Cobalt-Chromium Humeral Head (10 sizes, Ø 40 mm to Ø 58 mm)
• Highcross PE Pegged Glenoid (10 sizes, Ø 40 mm to Ø 58 mm)
• Humeral Stem Screw

The Standard Humeral Diaphysis and the Humeral Anatomical Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Humeral Stem Screw. The Double Eccenter is also connected to the Humeral Anatomical Metaphysis by means of a press-fit cylinder and a securing screw. The Cobalt-Chromium Humeral Head is coupled to a Double Eccenter by means of a taper Morse connection.

The Glenoid Anatomical Implant is composed of the Highcross PE Pegged Glenoid only, which is cemented into the glenoid bone.

The Medacta Anatomic Shoulder Prosthesis components are single-use only, are provided sterile via gamma irradiation or ethylene oxide, and are packaged individually.

The standard humeral diaphysis, humeral anatomical metaphysis, double eccenter, and humeral stem screw are manufactured from titanium alloy. The humeral head is manufactured from CoCr, and the highcross glenoid is manufactured from polyethylene.

The provided text describes the "Medacta Anatomic Shoulder Prosthesis" and its regulatory clearance. However, it does not contain information about acceptance criteria for device performance related to a diagnostic or AI-driven system, nor does it detail a study proving such criteria are met.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The performance data presented focuses on the mechanical, material, and sterilization aspects of the physical implant, NOT on the performance of an AI or diagnostic system.

Therefore, I cannot provide the requested information in the format specified because the input document does not contain the relevant data for an AI/diagnostic device.

To answer your request, the input document would need to describe a study evaluating the performance of an AI or diagnostic device, including its acceptance criteria and the results of that evaluation.

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

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

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

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

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

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

1. Table of acceptance criteria and the reported device performance

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

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

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

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical testing is based on:

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

8. The sample size for the training set

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

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

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

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

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

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

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

The reason for this is that the submission states:

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

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

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

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

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

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

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

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

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

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

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

The present device modification submission consists in :

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

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

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

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

To address the specific points you asked for:

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

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

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

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

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

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

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

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

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

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

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

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

The document does NOT contain:

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

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

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