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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, with optional cortical bone screws for the longer stems. 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 the system included in this submission are the FX V135™ Additional Humeral Stems that are added to the system as a line extension of the cementless humeral stems.
The FX V135™ Shoulder Prosthesis is manufactured from Ti-6l-4V ELI alloy conforming to ISO 5832-3 and are available in diameters of 8-16mm in the diaphysis dependent upon the epiphyseal size 32, 36, and 40mm. The longer stems added to the system are available in lengths 120mm, 180mm and 200mm. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating. The distal end of the humeral stem is cylindrical and bead blasted with unthreaded screw holes oriented in the medial / lateral direction for optional fixation using cortical bone screws.
The FX V135™ Shoulder Prosthesis incorporates a female taper for attachment of compatible components.
The FX V135™ Shoulder Prosthesis 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 anatomic shoulder configuration.
For reverse configuration, the FX V135™ Shoulder Prosthesis can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a qlenoid baseplate (with or without a central screw), optional post extensions and standard (compression) and locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups mate with the FX V135™ Additional Humeral Stems to complete the reverse configuration.

The provided text is a 510(k) summary for the FX V135™ Shoulder Prosthesis, which is a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing independent performance against a specific set of acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies is not available in this document because the device's clearance relied on non-clinical testing and comparison to existing devices, not a new clinical study with performance benchmarks.

Here's an breakdown of why the requested information cannot be fully provided based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable: The document does not define specific "acceptance criteria" for clinical performance. Instead, it states that "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." This refers to non-clinical mechanical testing, not clinical outcomes.

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

• Not Applicable (for clinical data): The document explicitly states: "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device." Therefore, there is no clinical "test set" with associated sample size or data provenance in this submission. For the non-clinical fatigue testing, specific sample sizes are not provided in this summary.

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

• Not Applicable: No clinical ground truth was established for a test set, as no clinical study was deemed necessary.

4. Adjudication method for the test set:

• Not Applicable: No clinical test set and thus no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No: The document states that clinical testing was not necessary. Therefore, an MRMC study was not conducted.

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

• Not Applicable: This device is a physical medical implant (shoulder prosthesis), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used:

• Not Applicable (for clinical ground truth): As no clinical study was conducted, there's no clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the non-clinical testing would be the engineering specifications and performance standards met by the predicate device and reproduced by the subject device.

8. The sample size for the training set:

• Not Applicable: This is a physical medical device, not an AI model, so there is no "training set."

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

• Not Applicable: As above, no training set.

Summary based on the provided text:

The device, FX V135™ Shoulder Prosthesis, obtained 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (FX V135™ Shoulder Prosthesis (K213117), Humelock Reversed® Shoulder (K162455), and Encore Humeral Shoulder Stem (K141990)).

The primary evidence provided in this summary to support this claim comes from non-clinical testing:

• "Range of motion analysis demonstrated comparability to the predicate device."
• "Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed."

The conclusion is that these non-clinical tests indicate the performance is "adequate for its intended use and substantially equivalent to the predicate device." The document explicitly states, "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device."

Therefore, the device meets its "acceptance criteria" (which are performance benchmarks derived from the predicate device and established through non-clinical testing) by demonstrating comparable range of motion and successful completion of fatigue testing without failures or loosening. This approach leverages the pre-existing FDA clearance of the predicate devices.

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