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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 cuff shoulder joint with severe arthropathy failed joint replacement with a grossly rotator cuff deficient 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 Lateralized Glenosphere are line extensions to the Medacta Shoulder Reverse System (K170452) and are compatible with the other Medacta cleared products Threaded Glenoid Baseplate (K171058), Glenoid Polyaxial Non-Locking Screws (K181826) and the Short Humeral Stem (K180089).

The Lateralized Glenosphere implants subject of this submission are comprised of the following products (9 sizes):

• Size Ø 32: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5mm
• Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm
• Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm
• Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm

The Lateralized Glenosphere 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;
• Glenoid Polyaxial Locking Screw;
• Glenoid Polyaxial Non-Locking Screw;
• Reverse Metaphysis Screw; and
• Glenosphere Screw.

The glenosphere is attached to the glenoid baseplate and secured by means of a taper connection and a fastening screw.

The purpose of the current submission is to gain clearance for the Lateralized Glenospheres, whose center is more lateralized respect to Medacta predicate device Glenosphere (Medacta Shoulder Reverse System - K170452).

The new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy.

The Lateralized Glenosphere is made of CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6A1-4V), enhanced with Type-II anodization, according to ISO 5832-3:2016 Implants For Surgery -Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

The provided text describes a 510(k) premarket notification for a medical device called the "Lateralized Glenosphere." This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or predictive AI device.

Therefore, the requested information cannot be fully extracted as there is no study that proves the device meets specific acceptance criteria in the context of a diagnostic AI product, because this is a physical implant. The performance data section refers to mechanical tests on the implant itself, not a study of a diagnostic algorithm.

Here's an analysis of what information can be provided based on the input:

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

Based on the document, there isn't a table of acceptance criteria and reported device performance in the way one would describe for a diagnostic AI device (e.g., sensitivity, specificity, accuracy). Instead, there are mechanical tests performed with acceptance criteria based on established standards for shoulder prostheses.

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic accuracy. The "test set" here refers to the physical samples of the medical device (Lateralized Glenosphere and associated components) that underwent mechanical testing. The exact number of physical devices or components tested for each mechanical study is not specified in this summary.
• Data Provenance: The mechanical tests were conducted in a laboratory setting according to written protocols. There's no information about the country of origin or whether it was retrospective/prospective as it relates to patient data.

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

• Not applicable. This device is a physical implant, not a diagnostic AI device requiring expert-established ground truth for a test set. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM, ISO, European Pharmacopoeia, USP) and the physical properties observed during testing.

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

• Not applicable. Adjudication methods like 2+1 are used for establishing ground truth in diagnostic studies, not for mechanical testing of physical implants. The "adjudication" for mechanical tests is agreement with the predefined acceptance criteria of the 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 is not an AI diagnostic device. No human reader studies (MRMC) were conducted as the device is a physical implant.

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

• Not applicable. This is not an AI algorithm. The performance data refers to the mechanical integrity and biological safety of the physical medical device itself.

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

• The "ground truth" for the performance data is based on recognized engineering standards (ASTM F2028-17, ASTM F1378-17), pharmacopoeia guidelines (European Pharmacopoeia §2.6.14, USP , USP ), and design validation reports for the mechanical and biocompatibility aspects of the implant.

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not an AI model that requires a training set.

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "performance data" refer to mechanical and biocompatibility testing against established engineering and medical device standards, not to the performance of a diagnostic or AI-driven system. Therefore, most of the requested information, which is typically relevant for AI/diagnostic device evaluation, is not applicable or provided in this context.

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