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Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Software: Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).

Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.

Software: Blueprint® is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid components when appropriate.

The provided text is a 510(k) premarket notification for the BLUEPRINT™ Patient Specific Instrumentation, which includes both hardware (Glenoid Guides) and software (Blueprint®). While it describes the device, its intended use, and comparison to predicate devices, it does not contain the detailed performance data or acceptance criteria typically found in a study report.

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study details. The document states that "Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation." However, it does not present the results or specific criteria of these activities.

In the absence of a detailed study report within the provided text, I can only state that the document asserts that:

• Differences in design specifications do not raise different questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
• The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness.
• Differences in technological characteristics have been addressed by software verification and validation activities.

To answer your request, a more detailed study report or validation protocol would be necessary.

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Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
• Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).

The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.

The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."

The non-clinical testing performed includes:

• Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
• Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
• Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
• Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Identical to previously cleared devices.
• Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
• Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
• MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
• Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.

These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.

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The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Revision where other devices or treatments have failed.
• · Correction of functional deformity.
• · Fracture of the humeral head
• · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.

The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).

The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.

The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.

The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

The provided FDA 510(k) document is for the Ignite Anatomic Shoulder System, a medical device. This document describes the device itself and its equivalence to previously cleared devices. It does not contain information about an AI/ML powered device or a study involving acceptance criteria for such a device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices." This indicates that the regulatory clearance was based on non-clinical testing and comparison to predicate devices, not on a clinical study evaluating its performance against specific acceptance criteria in patient populations.

The "Non-Clinical Testing" section lists various mechanical and material-related tests (e.g., Range of Motion, Biocompatibility, Wear Testing, Fatigue Testing) conducted to demonstrate the device's substantial equivalence to predicate devices, but these are for the physical implant itself, not an AI/ML component.

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The DELTA XTEND Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cemented or cementless use.
All other metallic components are intended for cemented use only.

The DELTA XTEND Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws used for reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

This document is a 510(k) Premarket Notification for the DELTA XTEND™ Reverse Shoulder System, a medical device (shoulder prosthesis). It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" refers to engineering and material performance tests, not a study involving human-in-the-loop AI or diagnostic performance.

Here's an analysis of the provided text in relation to your questions, framed for a medical device rather than an AI/diagnostic system:

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values for the device. Instead, it lists the types of non-clinical tests performed to demonstrate safety and efficacy and asserts that the device was "determined as substantially equivalent."

Here's what can be inferred/extracted:

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

• Sample Sizes: The document does not specify the sample sizes (e.g., number of implants or test specimens) used for each non-clinical test (Fatigue Analysis, Biocompatibility, etc.).
• Data Provenance: The data provenance is from non-clinical laboratory testing of the device components. The specific country of origin of these tests is not stated, but the manufacturer "DePuy (Ireland)" is based in Ireland. These are prospective tests performed on newly manufactured devices or components to demonstrate performance characteristics.

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

This question is not applicable to this type of device submission.

• Ground Truth: For a shoulder prosthesis, "ground truth" for performance is established through engineering principles, material science, and regulatory standards (e.g., ISO, ASTM standards for implant testing). It's based on objective measurements rather than expert consensus on individual cases.
• Experts: While engineers, material scientists, and regulatory experts would have designed and overseen these tests, the document does not specify their number or qualifications as it would for, say, a clinical diagnostic study.

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

This question is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers (e.g., radiologists) interpret images and their interpretations need to be reconciled for ground truth establishment. For mechanical device testing, results are objective measurements from laboratory equipment and are compared against predetermined engineering specifications.

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

This question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where the performance of human readers, potentially aided by AI, is being evaluated. This submission is for a mechanical medical implant, not a diagnostic imaging device or AI.

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

This question is not applicable. There is no algorithm in this medical device. The "standalone performance" for this device would be its mechanical performance in a laboratory setting, which is what the non-clinical tests assessed.

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

The "ground truth" for this medical device's performance is based on:

• Engineering and material science principles: Adherence to established mechanical, physical, and chemical properties required for an implantable device.
• Regulatory standards: Compliance with international and national standards for implantable medical devices (e.g., for fatigue, biocompatibility, endotoxin levels).
• Comparison to predicate devices: The "ground truth" of performance is largely the established safe and effective performance of previously cleared, substantially equivalent devices.

8. The sample size for the training set

This question is not applicable. This device is a mechanical implant; there is no "training set" in the context of machine learning or AI.

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

This question is not applicable, as there is no "training set."

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The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Univers Revers Shoulder Prosthesis System is indicated for primary total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency.

(Humeral) Stems are intended for cementless applications for use with Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers Apex Humeral Stems are Titanium humeral stems with a Calcium Phosphate coating designed to articulate with the Arthrex Univers Revers Shoulder Prosthesis System. The stem will be offered sterile in 10 sizes (Size 6-15). The primary differences between the Arthrex Univers Revers Apex Humeral Stem and the predicate device are that the proposed device is shorter in superior to inferior length and contains two suture holes.

The provided document describes Arthrex Univers Revers Apex Humeral Stems, a medical device, and its 510(k) summary. This document focuses on the performance data provided to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, as might be found for AI/ML devices. As such, the responses below are tailored to the type of information available for this specific product.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify general "test sets" or "data provenance" in the way one would for diagnostic algorithms. Instead, it describes engineering and biological tests conducted on the device components.

• Sample Size: The document does not explicitly state the number of samples (e.g., number of stems) tested for dynamic fatigue or bacterial endotoxin. For dynamic fatigue, it refers to "all constructs," implying that multiple samples were tested, but the exact number isn't given.
• Data Provenance: Not applicable in the context of device performance testing of physical components (e.g., not patient data). The testing was conducted by Arthrex Inc. as part of their premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for mechanical and biological performance is based on established engineering standards and test methods, not expert consensus on diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This device underwent performance testing against engineering standards, not expert adjudication of diagnostic outcomes.

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

No. This document describes a mechanical orthopedic implant, not an AI/ML diagnostic tool. Therefore, an MRMC comparative effectiveness study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

No. This is a physical medical device (humeral stem), not a software algorithm.

7. Type of Ground Truth Used

• For dynamic fatigue testing: The ground truth is the established mechanical failure criteria (e.g., fracture, loosening) after a specified number of cycles. The criteria are likely derived from industry standards for orthopedic implants.
• For bacterial endotoxin testing: The ground truth is the established pyrogen limit as defined by pharmacopeia standards (EP 2.6.14/USP ).
• For stem fixation: The ground truth is likely based on biomechanical principles and potentially industry standards for implant stability.

8. 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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IN ANATOMIC:

The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Aequalis Ex2 is indicated for use 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 proximal humerus except for size 50mm(1)
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains except for size 50mm(1)

IN REVERSE:

The Aequalis Fx2 is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)

• Correction of functional deformity

• Fractures of the proximal humerus except for size 50mm(1

• Traumatic arthritis

• Revision of the devices if sufficient bone stock remains except for size 50mm( ).. The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the gleno-humeral articulation.

The Aequalis Fx2 consists of:

• in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads (K122698 ; K140082);

or

• in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants (K081059; K140478).

The Aequalis Fx2 is intended for use as:

• 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,

• in case of bone defect in the proximal part of the humerus,

• a replacement of shoulder joints in primary anatomic or in primary reverse,

• a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

This submission corresponds to the design modification related to the Aequalis Fx2 assembly zone (humeral stems and reversed inserts) compatible only with each other. This design modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The pending humeral stems are compatible with the cleared Flex Shoulder humeral heads and the pending reversed inserts are compatible with the cleared Aequalis Reversed II glenoid implants. There is no change regarding the material of the pending Aequalis Fx2 humeral stems. The design change related to the pending Aequalis Fx2 reversed inserts does not include a titanium locking ring in contrast to the previously cleared Aequalis Fx2 reversed inserts.

Here's a breakdown of the acceptance criteria and the study information for the Aequalis Fx2 device based on the provided document:

This document is a 510(k) premarket notification for a medical device (Aequalis Fx2), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study on human-in-the-loop performance or diagnostic accuracy. Therefore, many of your requested points related to AI/algorithm performance (standalone performance, MRMC studies, ground truth establishment for training/test sets, expert qualifications) are not applicable to this type of submission.

The "study" described here consists of various engineering and physical tests to demonstrate that the modified device's performance is acceptable and comparable to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size in terms of units tested for each validation method. It refers to "the design modification" and "the pending Aequalis Fx2 humeral stem and reversed insert," implying that these tests were conducted on representative samples of the device components.
• Data Provenance: The tests are described as physical/bench tests conducted by the manufacturer, Tornier S.A.S., which is based in Montbonnot Saint-Martin, France. This is not patient-derived data; it's engineering test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The "ground truth" for these engineering tests is established by industry standards, engineering specifications, and predicate device performance, not by medical experts interpreting data like in a diagnostic study.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant to the physical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This document is for a shoulder prosthesis and does not involve AI or human reader performance.

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

This information is not applicable. This document is for a physical medical device (shoulder prosthesis) and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is based on:

• Engineering Specifications and Design Requirements: For dimensional comparisons, assembly methods, and convertibility.
• Predicate Device Performance: For tests like Pull-out and Torque testing, where the modified device's performance is compared for equivalence to previously cleared devices (K030941 and K141345).
• Failure Criteria: For fatigue testing ("No failure after the test").

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an engineering evaluation for a mechanical implant.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as above.

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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 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 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 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 Aegualis 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 relieve pain. The 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 consists in the addition of glenoid base plates with central threaded post and a new coating.

Here's an analysis of the provided text regarding the Aequalis Reversed Shoulder Prosthesis, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) Premarket Notification summary for a modification to an already cleared device ("Aequalis Reversed II glenoid base plate"). Therefore, the studies are primarily aimed at demonstrating substantial equivalence of the new components to the previously cleared ones, rather than establishing de novo safety and effectiveness for a completely new device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission for a modification, the "acceptance criteria" are framed around demonstrating equivalence to previously cleared predicate devices, particularly concerns about the new glenoid base plate's anchorage.

2. Sample Size Used for the Test Set and Data Provenance

• Pull-out Testing (E1586):
  • Sample Size: Not explicitly stated as a number. The text mentions "Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations." This implies a comparative test with multiple specimens/configurations for both the new and cleared devices.
  • Data Provenance: The study was "conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate." This indicates controlled laboratory testing, not human patient data.
• Cadaver Testing:
  • Sample Size: Not explicitly stated (e.g., number of cadavers).
  • Data Provenance: "Cadaver testing was performed." This is prospective testing on biological tissue from cadavers, likely conducted in a laboratory or simulated surgical environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the engineering tests (pull-out) and cadaver testing described, "ground truth" is typically established by objective physical measurements (e.g., force required for pull-out, visual inspection for fractures/complications) rather than expert consensus on interpretive data.

• No information is provided about the number or qualifications of experts for establishing ground truth in these non-clinical tests. This type of testing relies on engineering and biomechanical principles, not clinical interpretation.

4. Adjudication Method for the Test Set

Given the non-clinical, objective nature of the tests (pull-out force, observational findings during cadaver surgery), formal adjudication methods like 2+1 or 3+1 (common in diagnostic imaging studies) are not applicable or described. The results would be based on direct measurement and observation by the testing personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This submission pertains to a medical implant (shoulder prosthesis modification), not a diagnostic device or a system involving human interpretation of data. Therefore, the concept of human readers or AI assistance in the context of an MRMC study does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm-only performance study was not done.
• This is an implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Pull-out Testing: The ground truth used was objective physical measurement of the force required to pull out the glenoid base plate from a foam block. The "truth" was the measured load/resistance.
• Cadaver Testing: The ground truth was based on direct observation and qualitative assessment of surgical outcomes, specifically whether "primary fixation has been achieved without scapular fracture or other major peri-operative complications." This involved visual inspection, palpation, and potentially other assessments during and after the simulated surgical procedure.

8. The Sample Size for the Training Set

• Not applicable. This is a medical implant, not a machine learning algorithm. There is no concept of a "training set" in this context. The device's design is based on engineering principles and previous device iterations, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this type of device.

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