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510(k) Data Aggregation
(279 days)
Hemiarthoplasty/Conventional Total Application:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Correction of functional deformity.
- · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
· Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.
This FDA 510(k) summary for the "Identity Shoulder System" does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The document is a premarket notification for a medical device seeking substantial equivalence to previously cleared devices. It primarily focuses on:
- Indications for Use: What the device is intended for (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures).
- Device Description: A high-level overview of the components and configurations (hemiarthroplasty, total shoulder replacement, reverse configuration).
- Technological Characteristics: How the device is similar to predicate devices in terms of intended use, indications for use, materials, design features, and sterilization.
- Non-Clinical Tests/Justifications: A list of non-clinical tests performed (e.g., FEA, Axial Pull Off, Fatigue, Corrosion) to support substantial equivalence, but no results or acceptance criteria are provided for these tests in this summary document.
- Clinical Tests: Explicitly states "None provided."
Therefore, based solely on the provided text, I cannot answer the requested questions regarding acceptance criteria and studies proving the device meets them because this information is not present. This type of detail is typically found in the full 510(k) submission, not in the public summary.
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(270 days)
General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
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- Primary and secondary osteoarthritis
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- Rheumatoid arthritis
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- Correction of functional deformities
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- Avascular necrosis
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- Femoral neck fractures
- Revision after implant loosening dependent on bone mass and quality
The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.
The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.
Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.
Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.
| Test Type | Objective / "Acceptance Criteria" (Implied) | Reported Performance / Conclusion |
|---|---|---|
| Disassembly Testing (Axial push-out, offset pullout, and torsional tests according to ASTM F1820 for liner/shell assembly) | Demonstrate mechanical integrity and resistance to disassembly, comparable to predicate devices. | Results indicate the device performs adequately and maintains mechanical integrity as expected for an acetabular cup system. The device is shown to be as safe and effective as the predicate device. |
| Wear Test (according to ISO 14242-1 and particle analysis per ISO 17853 and ASTM F1877) | Demonstrate wear rates and particle generation comparable to predicate devices and acceptable for clinical use. | Wear rates were compared to those of the Stelkast Exp highly crosslinked Vitamin E UHMWPE acetabular shell liners (a reference device), suggesting comparable or acceptable wear performance. |
| Wear Testing under Adverse Conditions and Particle Analysis | Demonstrate performance under more challenging conditions, comparable to predicate devices. | Results imply acceptable wear performance under adverse conditions, consistent with predicate devices. |
| Range of Motion (according to ISO 21535) | Demonstrate an appropriate range of motion. | Results indicate the device allows for a range of motion comparable to predicate devices and clinically acceptable. |
| Endotoxin Testing | Confirm biocompatibility and sterility. | Results indicate compliance with endotoxin limits, supporting the safety of the device. |
| Impingement Testing (per ASTM F2582) | Demonstrate resistance to impingement and associated wear/damage. | Results indicate acceptable performance in impingement tests, comparable to predicate devices. |
| Coating Characterization (microstructural analysis, mechanical testing, metallurgical analysis per FDA Guidance) | Demonstrate coating integrity, adhesion, and material properties consistent with established standards and predicate devices. | Results demonstrate the coatings meet established standards and are comparable to those of predicate devices, ensuring long-term performance. |
| PE Characterization (material characterization, HXL characterization and aging study, biocompatibility testing per ISO 10993) | Demonstrate material properties, stability, and biocompatibility of the UHMWPE liners consistent with established standards and predicate devices. | Results indicate the PE materials conform to FDA guidance for UHMWPE, including HXL characterization, aging study, and biocompatibility, thereby supporting the safety and effectiveness of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering standards.
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
- MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
- Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device.
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