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The Simpliciti™ Shoulder System is intended for use in Total Shoulder Arthroplasty of the shoulder (TSA) application. As a Total shoulder, the system consists of a metaphyseal metal humeral component, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. Glenoid components are labeled "for cemented use only" and are indicated only for use with bone cement. The metaphyseal humeral components are indicated and labeled for press-fit un-cemented use.

The materials used in the manufacture of the Simpliciti™ Shoulder System implants are as follows:

Metaphyseal humeral component is made of titanium alloy (Ti-6AL-4V) in accordance to ASTM standard F136 with a sintered titanium (CP Ti) bead coating conforming to ASTM F-1580.
. The humeral heads are made off cobalt-chromium- alloy (CoCr) according to ASTM standard F1537.
The glenoid components are made of ultrahigh molecular weight polyethylene (UHMWPE) according to ASTM standard F648 or ISO 5834-2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Simpliciti™ Shoulder System, based on the provided document:

Acceptance Criteria and Device Performance

Validation and / or Verification Method	Acceptance Value / Criteria	Verification and Validation Results
CAD study to ensure acceptable geometry	Head geometry is comparable to the Aequalis humeral heads	Acceptable
Mechanical testing (fatigue)	The nucleus shall survive a prescribed number of cycles at a prescribed load without fatigue, fracture, yielding, loosening	Acceptable
Mechanical testing (lever out)	Qualitative Comparison to Aequalis Resurfacing Shoulder	Acceptable
Mechanical testing (pull out)	Qualitative Comparison to Aequalis Resurfacing Shoulder	Acceptable
Mechanical testing (torque out)	Qualitative Comparison to Aequalis Resurfacing Shoulder	Acceptable
Mechanical testing (taper disassociation testing)	The Simpliciti Shoulder taper is equivalent to the taper of the Affiniti Shoulder System	Acceptable
X-ray overlay validation	No impingement of the fin geometry on the inner cortex of the metaphysis	Acceptable
Clinical Study Primary Endpoint	Percentage of subjects meeting all four criteria > 75% (historical control) + 10% (non-inferiority margin)	88.74% (lower one-sided 95% confidence bound of 83.59%)
	(Criteria: no continuous radiolucent line, adjusted Constant score > 85, no revision surgery, no system-related serious adverse event at 24 months)
Clinical Study Secondary Objectives	Patient improvement in Quality of Life (QOL), range of motion, strength	All secondary QOL objectives, on average, reported patient improvement.
Clinical Study Radiographic Assessment	No instances of radiolucency, device migration, osteolysis, or subsidence of the glenoid component or nucleus	Third-party radiologists determined no instances of these issues.
Clinical Study Safety (Adverse Events)	Acceptable incidence of expected complications for total shoulder arthroplasty; no Unanticipated Adverse Device Effects (UADEs)	No UADEs reported. System or procedure related events considered expected.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 157 subjects were enrolled (out of 181 consented and screened).
- Data Provenance: Prospective, multi-center study conducted at 14 sites in the US.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Third-party radiologists" were involved. The exact number is not specified.
- Qualifications of Experts: General radiologists. Specific experience level (e.g., "10 years of experience") is not provided.
Adjudication method for the test set:
- The document primarily mentions "third-party radiologists" determining radiographic outcomes, implying a form of expert review for these specific criteria. For other criteria like Constant score, revision surgery, and adverse events, the primary endpoint suggests a direct assessment based on defined objective measures. No specific "adjudication method" like 2+1 or 3+1 is explicitly stated for the overall primary endpoint success.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a medical device (shoulder system), not an AI algorithm, and therefore the concept of "human readers improve with AI" does not apply. The clinical study compared the device to a historical control group.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This study evaluates a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical study was established through a combination of:
  - Outcome Data: Adjusted Constant score (> 85), instance of revision surgery, and system-related serious adverse events.
  - Expert Radiographic Review: Radiographic assessment by "third-party radiologists" for criteria like continuous radiolucent line, device migration, osteolysis, and subsidence.
The sample size for the training set:
- This study is about a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of AI. The "training set" for the device's design and manufacturing would be the iterative design and testing process, but not in the sense of data used to train an algorithm.
How the ground truth for the training set was established:
- Again, this is not applicable as it refers to a device, not an AI model. The "ground truth" for the device's development would be established through engineering principles, materials science, biomechanical testing standards (like ASTM and ISO mentioned), and clinical understanding of shoulder anatomy and biomechanics. The clinical study served as the primary validation of the device's performance against predefined endpoints.

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