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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuffshoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.

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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The Reverse Shoulder Prosthesis Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The Humeral Eccentric Reverse Metaphysis is a line extension to the Medacta Shoulder Reverse System (K170452) and it is compatible with the other Medacta cleared products: Humeral Reverse PE Liner (K170452), Humeral Diaphysis (K170452), Short Humeral Diaphysis (K180089), Long Humeral Diaphysis (K192967).

The Humeral Eccentric Reverse Metaphysis implant subject of this submission is comprised of the following size: Diameter= Ø37.5mm Offset= 3mm.

The Humeral Eccentric Reverse Metaphysis implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:

• Humeral Diaphysis Cemented; ●
• Humeral Diaphysis Cementless; ●
• Humeral Reverse Metaphysis; ●
• Humeral Reverse HC Liner (also referred to as PE Liner); ●
• Glenoid Baseplate - Pegged;
• Glenoid Baseplate - Threaded;
• . Glenosphere;
• . Lateralized Glenosphere
• Glenoid Polyaxial Locking Screw;
• Glenoid Polyaxial Non-Locking Screw; ●
• Reverse Metaphysis Screw; and ●
• Glenosphere Screw.

The Humeral Diaphysis and the Humeral Reverse Metaphysis (standard or eccentric) are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis (standard or eccentric).

The purpose of the current submission is to gain clearance for the Humeral Eccentric Reverse Metaphysis.

The main body of Humeral Eccentric Reverse Metaphysis is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

The screw of the Reverse Metaphysis (standard or eccentric), packaged with main body, is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy, enhanced with Type-II anodization.

The document provided is a 510(k) premarket notification for a medical device (Humeral Eccentric Reverse Metaphysis). It concerns the regulatory approval process for a new medical device, demonstrating its substantial equivalence to existing devices. Therefore, it does not describe acceptance criteria for, or the results of, a study proving device performance in the way a clinical trial or AI/ML performance study would.

Instead, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements for demonstrating substantial equivalence to a predicate device. This is primarily done through non-clinical performance testing and comparison of technological characteristics.

Here's how to interpret the provided information based on the request:

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

The document doesn't provide a direct table of "acceptance criteria" and "reported device performance" in a quantitative sense as might be seen for diagnostic accuracy or clinical outcomes. Instead, the acceptance criteria are implicitly that the device performs mechanically and biologically comparably to the predicate devices and meets relevant mechanical standards.

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

• Sample Size for Test Set: For non-clinical (mechanical) testing, sample sizes are not explicitly stated in the summary, but such tests typically involve a specific number of components or assemblies required by the test standard (e.g., ISO, ASTM). The document refers to "written protocols with acceptance criteria that were based on standards," implying standard-mandated sample sizes were used.
• Data Provenance: Not applicable in the context of clinical data for this device submission. The data is from non-clinical laboratory mechanical and material tests performed to specific standards (e.g., ISO 5832-3:2016, European Pharmacopoeia §2.6.14, USP chapter ).

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 question is not applicable for this type of submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices or those involving interpretation of medical images/data. This device is a shoulder prosthesis, and its evaluation for regulatory clearance relies on engineering, material science, and mechanical testing, not expert consensus on clinical diagnoses or interpretations.

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

• This question is not applicable. Adjudication methods (like 2+1 physician review) are used in clinical studies, particularly for endpoints that require expert consensus or evaluation. This submission relies on non-clinical engineering and material testing, where the "ground truth" is determined by physical measurements and adherence to technical specifications and standards, not human consensus on clinical findings.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI/ML assistance for human readers (e.g., radiologists interpreting images). This device is a shoulder prosthesis, not a diagnostic tool, and its submission did not involve such studies.

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

• No, this is not applicable. A standalone performance evaluation (algorithm only) is relevant for AI/ML-driven diagnostic or analytical devices. This device is a mechanical implant; there is no algorithm involved in its direct function or evaluation for regulatory clearance.

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

• The "ground truth" for the non-clinical tests is based on engineering specifications, material standards, and benchmarked mechanical performance against established predicate devices and relevant ISO/USP standards. For example, the ground truth for a static torsion test is whether the device withstands specified forces without failure, as per the test protocol and standard acceptance criteria. For material composition, the ground truth is adherence to the chemical specifications of Ti-6Al-4V.

8. The sample size for the training set

• This question is not applicable. "Training set" refers to data used to train AI/ML models. This submission is for a mechanical orthopedic implant and does not involve AI/ML.

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

• This question is not applicable for the same reasons as #8.

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