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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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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 stability and to relieve pain. The Aequalis Fx2 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
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints 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
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains.

The reversed insert is permitted to be used in the transformation to reverse Aequalis Fx2 without the removal of 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 glenohumeral articulation.

The Aequalis Fx2 consists of:
in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads ; Or

• in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants.
  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 document is a 510(k) premarket notification for a medical device called Aequalis Fx2, a shoulder prosthesis. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and proving performance through a clinical study with a test set, ground truth, and expert evaluation as would be common for AI/ML-based devices.

Therefore, the specific information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable to this type of regulatory submission for a traditional medical device (implant) like the Aequalis Fx2.

Instead, the document details physical and mechanical testing and a comparison of materials, design, and intended use to existing, cleared devices.

Here's a breakdown of what is provided, and why the requested information isn't present:

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

• Not Applicable in the traditional sense. For this device, "acceptance criteria" are related to mechanical and material properties meeting established standards and demonstrating equivalence to predicate devices, not diagnostic performance metrics (like sensitivity, specificity, accuracy).
• What is provided: Table 1 on page 6 compares "Main features or system characteristics" of the Aequalis Fx2 to several predicate devices, including materials, standards, stem fixation, stem length, and diameter of reversed insert. This comparison aims to show technological equivalence.
• Device Performance: The document states:
  • "The results of these tests [pull out, torque, and fatigue testing] demonstrate the equivalence between the Aequalis Fx2 and the predicate devices." (Page 7)
  • This implies that the Aequalis Fx2 performed comparably to the predicate devices in these mechanical tests, thus meeting the "acceptance criteria" for demonstrating substantial equivalence on a technical level. Specific numerical performance values are not provided as they would be for a software device.

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

• Not Applicable. This device is a physical implant, not an AI/ML diagnostic or therapeutic device that would use a test set of data (e.g., images, patient records). The testing described (pull-out, torque, fatigue) are physical tests on the device itself.
• What is provided: The document mentions "pull out, torque testing, and fatigue testing were performed." (Page 7). The sample size for these engineering tests is not specified in this summary.

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

• Not Applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive correct answer established by experts or other definitive means. This concept does not apply to the mechanical testing of a physical implant.

4. Adjudication method for the test set:

• Not Applicable. As no test set of data is used in the AI/ML sense, there is no need for an adjudication method.

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. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI) on human performance (e.g., radiologists reading images). This device is a surgical implant and does not involve human readers interpreting data.

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

• Not Applicable. This device is solely a physical implant. There is no algorithm to evaluate in a standalone manner.

7. The type of ground truth used:

• Not Applicable. As explained in point 3, the concept of "ground truth" for diagnostic evaluation is not relevant here. The "truth" for this device lies in its physical properties and mechanical performance meeting established engineering standards and showing equivalence to legally marketed devices.

8. The sample size for the training set:

• Not Applicable. This device does not involve machine learning; therefore, there is no "training set."

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

• Not Applicable. As there is no training set for machine learning, this question is not relevant.

In summary: The provided document is a 510(k) submission for a non-AI medical device (a shoulder prosthesis). It demonstrates "substantial equivalence" to predicate devices through comparisons of design, materials, and mechanical testing results (pull-out, torque, and fatigue). The requested information primarily pertains to the evaluation of AI/ML-based diagnostic devices and is therefore not found within this type of regulatory submission.

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