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510(k) Data Aggregation
(148 days)
GLOBAL ICON Stemless Shoulder System
The Stemless Shoulder System is comprised of modular humeral heads to be used in total shoulder arthroplasty.
The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The Stemless humeral components are intended for press-fit fixation without the use of bone cements are intended only for use with bone cement.
The GLOBAL ICON Stemless Shoulder System includes cobalt-chromium alloy humeral heads that mate with titanium alloy anchor plates. The anchor plates include four grooved peripheral legs which are seated in the proximal humerus, and hydroxyapatite coating on all bone- contacting surfaces.
The document describes the GLOBAL ICON Stemless Shoulder System, a medical device for total shoulder arthroplasty. It details the device's indications for use, technological characteristics, and a summary of non-clinical and clinical tests conducted to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GLOBAL ICON Stemless Shoulder System were based on a composite success endpoint at 24 months post-operative in a clinical study. The criteria and reported performance are summarized in the table below:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Composite Success Endpoint (all criteria met at 24 months): | Overall Composite Success at 24 months: The study data were successful in meeting the protocol-specified primary endpoint. |
| a. Radiographs indicate no continuous radiolucent line around the GLOBAL ICON Stemless Shoulder System humeral component. | "There were no radiological signs of loosening or continuous radiolucent lines observed." |
| b. The adjusted Constant-Murley score is greater than 85. | "At 24-months the adjusted Constant-Murley Score was greater than 85 in 85.1% of Subjects." The mean adjusted Constant-Murley Score improved by 60.4 points at 24 months. |
| c. No GLOBAL ICON Stemless Shoulder System has been removed for any reason. | "There were no humeral components removed in 98.7% of Subjects." "Kaplan-Meier Survivorship estimate at 2.18 years is 98.72%." |
| d. No device-related serious adverse events. | "There were no device-related serious adverse events." "There were no device-related serious adverse events in 98.7% of Subjects." "There were no UADEs reported." (UADEs likely refers to Unexpected Adverse Device Effects, though not explicitly defined in the provided text). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The clinical study included 128 subjects for the 24-month interim data analysis.
- Data Provenance: The document does not explicitly state the country of origin for the data. However, it is a submission to the U.S. Food & Drug Administration (FDA), indicating the device is intended for the U.S. market. The study is described as having "interim 24-month data," which suggests it is a prospective study (following subjects forward in time).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Radiographs indicate" and "adjusted Constant-Murley score," suggesting these assessments were made by healthcare professionals, but specific qualifications (e.g., radiologist with X years of experience) or the number of such experts are not specified.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or radiological assessments in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document presents a clinical study evaluating the device's performance directly, not a comparative effectiveness study involving human readers with and without AI assistance for interpretation. The device itself is a physical medical implant, not an AI diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
No. The device is a surgical implant (GLOBAL ICON Stemless Shoulder System), not an algorithm or AI software. Therefore, a standalone (algorithm only) performance study is not applicable. The clinical study evaluates the performance of the implanted device in human subjects.
7. Type of Ground Truth Used
The ground truth for the clinical study was established using a combination of:
- Radiological assessment: To determine the presence or absence of continuous radiolucent lines around the humeral component.
- Clinical outcome scores: Specifically, the adjusted Constant-Murley score, which is a functional assessment used in shoulder arthroplasty.
- Device integrity/removal data: Tracking whether the humeral component was removed for any reason.
- Adverse event reporting: Documentation of device-related serious adverse events.
8. Sample Size for the Training Set
The document describes a clinical study for device approval, not an algorithm's development. Therefore, there is no mention of a "training set" in the context of machine learning. The 128 subjects are part of the clinical evaluation for the device's performance.
9. How the Ground Truth for the Training Set Was Established
As this is not a study involving an AI algorithm that requires training data, the concept of establishing ground truth for a "training set" is not applicable to this document. The clinical study evaluated the device's performance in patients.
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