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The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

The Humelock II Reversible Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without a stabilization screw, 135/145° humeral cups, standard humeral cups and a 135/145° adaptor. These components are intended for use with the previously cleared Humelock II Cemented Humeral Stems and the Humelock II Cementless Humeral Stems. The design of the Humelock II Reversible Shoulder allows conversion from an anatomic shoulder configuration to a reverse shoulder configuration either intraoperatively or during revision of an anatomic shoulder with a well fixed humeral stem.

The glenoid baseplate, standard and locking screws, baseplate post extensions, glenosphere screws and 135/145° reverse adapters are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxylapatite coating. The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The 135/145° Humeral Cups and standard Humeral Cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2.

Based on the provided text, the device described is the Humelock II Reversible Shoulder System, which is a medical implant, not an AI/software device. Therefore, the questions related to acceptance criteria, study design for AI devices, and performance metrics for AI models are not applicable to this document.

The document is a 510(k) premarket notification summary for a medical device (a shoulder prosthesis), which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

However, I can extract information related to the physical device's "performance" as described in the "Non-Clinical Testing" section, which might be interpreted as "acceptance criteria" for a medical implant, and then address why other points are not applicable.

Here's a breakdown of the requested information based on the provided text, indicating where it's not applicable to this medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/Software specific questions:

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

• Not Applicable. This is a physical medical implant device, not an AI/software product, so there is no "test set" in the context of AI model evaluation. The "tests" mentioned are non-clinical biomechanical and material tests.

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. This is a physical medical implant device. Ground truth, in the AI context of expert consensus, is not relevant here. The "ground truth" for the non-clinical tests would be the established engineering standards and biomechanical principles.

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

• Not Applicable. As there's no "test set" for an AI model, adjudication methods are irrelevant.

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 physical medical implant device. MRMC studies are for evaluating diagnostic performance with or without AI assistance, which doesn't apply to a shoulder prosthesis.

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

• Not Applicable. This is a physical medical implant device. There is no algorithm or standalone AI performance to evaluate.

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

• Not Applicable in the AI context. For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and biomechanical stability benchmarks typically verified through laboratory testing against established standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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