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510(k) Data Aggregation
(274 days)
The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to:
· non-inflammatory degenerative joint disease including osteoarthritis;
• revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);
· glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).
The SMR Stemless Anatomic is intended for uncemented use.
The SMR Stemless Anatomic is a modular system comprised of a stemless core and humeral head adaptor taper. The modular components are available in various sizes and are interchangeable allowing for independent sizing and positioning. The SMR humeral heads were previously cleared (K161476, K100858), and the SMR Stemless Anatomic is compatible with the previously cleared Cemented SMR metal back Glenoid Components (K113254, K133349, K143256), Cemented SMR all polyethylene glenoid components (K100858, K130642, K153722), and SMR TT Hybrid Glenoid System (K163397).
This document is a 510(k) clearance letter from the FDA for a medical device called the "SMR Stemless Anatomic." It's not a study report of an AI/ML powered medical device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML product.
The document discusses performance testing for a mechanical orthopedic implant, specifically a shoulder joint prosthesis, covering aspects like fatigue, micromotion, and pull-out strength. It also mentions "Clinical Data" related to the device's success in patients, comparing it to a predicate device. This is a traditional medical device clearance, not an AI/ML software as a medical device (SaMD) or AI-powered medical device.
Therefore, I cannot extract the requested information (table of acceptance criteria with AI performance, sample sizes for AI test sets, expert details for AI ground truth, MRMC studies, etc.) from this document. The concepts and methodologies described in the prompt are specific to the evaluation and clearance of AI/ML-driven medical devices, which this document does not concern.
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(249 days)
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
The Arthrex Eclipse Shoulder Prosthesis is a stemless humeral joint (hemi-shoulder) prosthesis that is designed as a humeral head replacement device. It consists of a humeral head; a trunnion; and a hollow screw. The Arthrex Eclipse Shoulder Prosthesis System replaces the proximal humeral bone, including surface, using an anatomical reconstruction surgical technique. The Eclipse fixates to the humeral bone by a hollow screw that is torqued into place.
The humeral head is manufactured from Cobalt Chromium (CoCr) and is offered in 10 sizes (39-55mm) with varying offsets of 16-23mm. The trunnion is manufactured from Titanium alloy (Ti6Al4V) with a titanium plasma spray (TPS) Calcium Phosphate (CaP) coating and is available in 10 sizes (37-55mm). The hollow screw is manufactured from Titanium alloy (Ti6Al4V) and is offered in 4 sizes (30-45mm).
Here's an analysis of the provided text to fulfill your request regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Arthrex Eclipse Shoulder Prosthesis System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Composite Endpoint) | Reported Device Performance (Eclipse Group) |
|---|---|
| Clinical Success: An improvement in Adjusted Constant Score from baseline to Month 24 that is ≥10 points AND a final Adjusted Constant Score ≥54. | 97.1% of Eclipse subjects experienced a clinically meaningful improvement (≥10 point increase and score value ≥54) at Month 24. |
| Radiographic Success: Absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3-month time point), glenoid migration/subsidence (relative to 3-month time point), device disassembly or fracture, and/or periprosthetic fracture. | Eclipse patients did not experience any radiographic failures. The majority had no glenoid radiolucencies (Grade 0) or minor radiolucencies (Grades 1, 2) at Month 24. A very small percentage had Grade 3 glenoid radiolucencies, but no Grade 4 or 5. |
| No Reoperation, Removal, or Modification of any study component up to the subject's completion of the study. | The rate of subsequent surgical intervention (reoperation) for Eclipse subjects was 3.6% through 24 months. (This criterion defines "success" as no reoperation, so a 3.6% reoperation rate contributes to the overall failure rate for the composite endpoint.) |
| No Serious Device-Related Complications up to the subject's completion of the study. | The rate of device-related events was 1.4% for Eclipse subjects. (This criterion defines "success" as no serious device-related complications, so a 1.4% complication rate contributes to the overall failure rate for the composite endpoint.) |
| Overall Composite Clinical Success Rate (Non-Inferiority to Univers II) | The success rate for the Eclipse group was 92.3%. The difference between Eclipse and Univers II (89.7%) was 2.6%. The lower-bound of the 1-sided 95% confidence interval for the group difference was -4.5%. The lower-bound of the 1-sided 98.131% confidence interval was -6.4%. Both are greater than the -10% non-inferiority margin, demonstrating non-inferiority. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Pivotal Study (Test Set):
- Eclipse Group: Population Size = 143, Sample Size for Composite Success Rate = 132
- Univers II Group (Control): Population Size = 68, Sample Size for Composite Success Rate = 61
- Data Provenance: Prospective, randomized, multi-center study conducted in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For radiographic criteria, it mentions "clinically significant," and the "radiographic protocol," but doesn't detail the review process or who performed it. For the Constant Score, it is an objective scoring system, but its application would generally be by trained medical professionals (e.g., orthopedic surgeons, physical therapists) involved in patient assessment.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes a "pivotal study" and "composite clinical success criteria" which would involve collecting various data points (clinical scores, radiographic findings, reoperations, complications) and comparing them against predefined thresholds to determine individual subject success. The determination of "clinically significant" radiolucency implies some level of expert interpretation, but the process is not detailed.
5. 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 evaluating the performance of a medical device (shoulder prosthesis) directly, not an AI algorithm assisting human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The device is a surgical implant, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the pivotal study's primary composite endpoint was established using a combination of objective clinical outcomes and expert interpretation of radiographic findings and events:
- Objective Outcomes Data: Adjusted Constant Score (quantitative assessment of pain, function, range of motion).
- Clinical Outcomes Data: Occurrence of reoperation, removal, or modification of components, and serious device-related complications.
- Radiographic Interpretation: Assessment of humeral radiolucency, migration/subsidence, device integrity, and periprosthetic fracture. While the document doesn't detail the "experts," these assessments are typically made by trained radiologists or orthopedic surgeons.
8. The Sample Size for the Training Set
The document describes a pivotal clinical study and a literature review. There is no mention of a training set in the context of an AI/algorithm-based device, as this device is a physical shoulder prosthesis. The "training set" concept is not applicable here.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned for this physical device, this question is not applicable.
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