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The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, and, when used for total shoulder replacement, a glenoid component.

The humeral stem is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral head.

The double taper connector is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads.

The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm in centered and offset styles. A female taper allows attachment to the double taper connector, which connects to the humeral stem.

The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, and large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The current submission adds bone graft cutting and manipulating instruments and graft trials to the Humelock II Shoulder System.

Bone graft cutting and manipulating instruments and graft trials may be used to cut bone graft from the humeral head and position it around the humeral stem. The bone graft can be used to help position and consolidate the tuberosities in cases with proximal bone loss.

The provided document, K140071, describes a 510(k) premarket notification for the Humelock II Cemented Shoulder System. It explicitly states that "Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study proving the device meets those criteria, as no clinical testing was performed for substantial equivalence.

The document details the device's components, materials, intended use, and a comparison to predicate devices, but lacks any description of a performance study involving a test set, expert readers, ground truth, or statistical analysis.

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The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
   The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stern, a humeral head, a double taper connector and, when used for total shoulder replacement, a glenoid component.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The distal end of the humeral stern is cylindrical with a polished surface. The proximal portion of the humeral stem has a grit blasted surface.
The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral head.
The double taper connector is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the taper.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, large and extra large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The provided document is a 510(k) summary for the Humelock II Cemented Shoulder System, which is a medical device for shoulder replacement. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, this document does not contain information related to software or AI-based devices, and therefore, it does not include acceptance criteria for algorithm performance or a study demonstrating such performance.

The "Non-Clinical Testing" section mentions mechanical testing conducted to demonstrate the stability of the modular connection and characterization data for the UHMWPE. The "Clinical Testing" section explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI/software device based on the provided text. The questions are not applicable to the content of this 510(k) summary.

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