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In an anatomic shoulder configuration, the FX V135 Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• a severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
• 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).

In a reverse shoulder configuration, the FX V135 Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with massive and non-repairable rotator cuff tear.

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

The humeral stem of the FX V135 Cementless Shoulder is intended for cementless use only. The glenoid components of the FX V135 Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The FX V135 Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an anatomic or a reversed shoulder construct. The new components of this system include the FX V135 cementless humeral stems, the new Humeral Cup 135/145° and a new humeral spacer on the reverse configuration, and on the anatomic configuration, the new humeral stem and new humeral heads.

The Humeral Stem of the FX V135 Shoulder Prosthesis is manufactured from Ti-6AI-4V ELI alloy conforming to ISO 5832-3 and is available in diameters of 10-20mm in the diaphysis dependent upon the epiphyseal size 32, 36, or 40mm. All have a length of 70mm. The distal end of the humeral stem is quadrangular and bead blasted. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating.

The FX V135 Humeral Stems incorporate a female taper for attachment of compatible components.

The new FX V135 Humeral Head is available in two versions and are manufactured from CoCrMo alloy conforming to ISO 5832-12. The new FX V135 Humeral Cup 135/145° is available in three sizes, Ø32, Ø36 and Ø40mm. Each size is available in two versions, standard and stability. Each version is available in three heights: +3mm, +6mm; and is compatible with all sizes of FX V135 Humeral Stems. The FX V135 Humeral Cup 135/145º is pre-assembled, one-piece component manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO5834-2 and Ti-6AI-4V ELI alloy conforming to ISO 5832-3. The new Humeral Cup 135/145° may be used with the new Humeral Spacer +9mm to increase the cup offset.

The FX V135 Humeral Stems can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.

For reverse configuration, the FX V135 Humeral Stem can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate (with or without a central screw), optional post extensions and standard (compression) or locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups or the subject Humeral Cup 135/145° mate with the FX V135 Humeral Stem to complete the reverse configuration.

The provided text does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.

The document is a 510(k) premarket notification for a FX V135 Shoulder Prosthesis, which is a medical implant (a shoulder replacement system), not an AI/ML powered device. The document details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Specifically, under the heading "Non-Clinical Testing", it states:
"Range of motion analysis demonstrated substantial equivalence to predicate device. Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135 Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device."

And under "Clinical Testing":
"Clinical testing was not necessary to determine substantial equivalence of the FX V135 to the predicate device."

This indicates that the evaluation was based on non-clinical (mechanical) testing for a physical implant, not an AI/ML algorithm. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device from this document.

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