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510(k) Data Aggregation
(37 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 Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The proposed Eclipse Titanium humeral head is manufactured from Ti-6Al-4V ELI per ASTM F136 and is offered in sizes ranging from 37-55mm with varying offsets of 16-23mm. The humeral head is placed on a trunnion, which is fixated to the proximal humerus by a hollow screw. The Titanium humeral heads are used with the existing trunnions and hollow screws cleared under the predicate.
This FDA 510(k) summary describes a medical device, the Arthrex Eclipse Titanium Humeral Head, which is a shoulder prosthesis. However, it does not contain information about the acceptance criteria and study proving a software or AI-based device's performance.
The document pertains to a physical orthopedic implant. The "Performance Data" section discusses:
- Fatigue testing and Pull Off testing: Evaluates the mechanical properties of the humeral head.
- Engineering analysis: Compares hardness, adhesion, surface roughness, scratch resistance, and Young's modulus to the predicate device.
- Bacterial endotoxin testing: Ensures pyrogen limits are met.
- MRI compatibility engineering analysis: Addresses MRI force, torque, and image artifact.
These are all standard tests for physical medical implants and not for software or AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device (as in, a software or AI device) meets critical performance measures from the provided text.
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(29 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 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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