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510(k) Data Aggregation
(29 days)
Arthrex Eclipse Shoulder Prosthesis System
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 proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr) and will be offered with a 16mm offset. The proposed size 37 trunnion is manufactured from Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray (TPS) coating. The trunnion will be offered in a slotted design. The Size 37 Head and Trunnion will be used with the existing hollow screws cleared under the predicate.
This FDA 510(k) summary describes a modification (a new size) to an existing shoulder prosthesis system, the Arthrex Eclipse Shoulder Prosthesis System. It does not involve an AI/ML powered device, and therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample sizes for test and training sets, expert adjudication, MRMC studies) are not applicable.
The core of this submission is to demonstrate substantial equivalence of a new component (size 37 Humeral Head and Trunnion) to a previously cleared device. The acceptance criteria and "study" are primarily focused on mechanical performance and ensuring the new component maintains the same safety and effectiveness profile as the existing predicate device.
Here's an attempt to populate the requested table and information based on the provided text, indicating "Not Applicable" (N/A) where the information is absent or irrelevant for this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What needs to be demonstrated) | Reported Device Performance (How the device meets the criteria) |
|---|---|
| Mechanical Strength & Fatigue Resilience: The new size 37 Humeral Head and Trunnion must withstand physiological loads and demonstrate fatigue resilience comparable to the predicate device. | Leveraged Predicate Data: "Static and dynamic compression testing presented in the predicate 510(k) clearance is leveraged to demonstrate the fatigue resilience of the proposed Arthrex Eclipse Shoulder Prosthesis." This implies that the design and materials of the new component are sufficiently similar to the predicate that the previously performed tests are considered valid for the new size, or that engineering analysis confirms mechanical equivalence. |
| Material Composition: New components must be made of materials suitable for surgical implantation and consistent with predicate. | Specified Materials: "The proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr)... The proposed size 37 trunnion is manufactured from Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray (TPS) coating." These materials are standard for orthopedic implants and consistent with predicate devices. |
| Intended Use: The modified device must maintain the same intended use as the predicate device. | Identical Indications for Use: The "Indications for Use" section for K201542 is identical to the one provided in the general information, stating: "The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis." This confirms the intended use remains unchanged. |
| Fundamental Scientific Technology: The new component must not introduce any new fundamental scientific technology or principles of operation. | Same Fundamental Scientific Technology: "The Arthrex Eclipse Size 37 has the same intended use and the same fundamental scientific technology as the Arthrex Eclipse Shoulder Prosthesis System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable for this type of mechanical device submission in the context of an AI/ML device. The "test" here refers to mechanical testing of physical samples, not a dataset for an algorithm. The exact number of physical samples tested is not specified in the summary, but typically involves a statistically relevant number for mechanical evaluations.
- Data provenance: Not specified in the summary. For mechanical testing, this would typically involve samples manufactured under controlled conditions, often within the company's facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a mechanical device, not an AI/ML algorithm requiring expert interpretation of outputs or ground truth for a test set. Ground truth for mechanical properties is established through standardized engineering tests, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is a mechanical device. Adjudication methods are relevant for subjective interpretations of data, such as medical image analysis by multiple experts.
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
- Not Applicable. This is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm discussed or included in this device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing Standards & Engineering Specifications: The "ground truth" for this device's performance is established by adhering to recognized mechanical testing standards (e.g., ISO, ASTM for orthopedic implants) for properties like fatigue strength, compressive strength, and material biocompatibility. The predicate device's cleared performance against these standards serves as the benchmark.
8. The sample size for the training set
- Not Applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an algorithm is involved.
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(249 days)
Arthrex Eclipse Shoulder Prosthesis System
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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