(104 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 and structurally 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 and 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.
Comprehensive Nano Stemless Shoulder System
- Primary total shoulder arthroplasty.
- Non-inflammatory degenerative joint disease including
Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications.
The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.
The Identity Shoulder System is previously cleared (K213856/K240876) as 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 is cleared for hemi-arthroplasty and conventional total shoulder replacement in both the anatomic and reverse configurations. The current submission is for the anatomic configuration.
The subject Comprehensive Humeral Head Adapter (CHHA) is a line extension to the Identity Shoulder System (K213856) cleared for the hemi-arthroplasty configuration and anatomic Total Shoulder Configuration.
The new CHHA (PN SAHHA002) allows additional compatibility with the previously cleared Identity Humeral Heads (K213856) and the Comprehensive humeral components, excluding fracture stems, as noted below:
Based on the provided FDA 510(k) clearance letter for the "Identity Shoulder System" (K250848), here's an analysis of the acceptance criteria and the study that proves the device meets them:
Crucial Observation: The provided document is a 510(k) clearance letter for a medical device that does not appear to be software or an AI/ML enabled device. It is for an orthopedic implant (shoulder system). Therefore, several of the requested points related to AI/ML (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of traditional medical device submission.
The "acceptance criteria" for this device are generally based on non-clinical performance testing to demonstrate the device's physical and mechanical properties meet established standards and are substantially equivalent to predicate devices. There are no "reported device performance" metrics in the sense of clinical performance (like sensitivity/specificity for AI, diagnostic accuracy, etc.) because it's a physical implant, not a diagnostic or AI-driven system.
Acceptance Criteria and Study Details (Based on the provided document)
Since the document provided is for a physical orthopedic implant, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a traditional medical device, primarily through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|---|---|
| Mechanical Performance | Fatigue Verification | Device withstands specified cyclic loading without failure, demonstrating durability comparable to predicates. | Non-clinical verification successfully performed. |
| Fretting Corrosion Verification | Device components resist fretting corrosion under specified conditions, comparable to predicates. | Non-clinical verification successfully performed. | |
| Fixation Stability Verification | Device maintains stable fixation under simulated physiological loads, comparable to predicates. | Non-clinical verification successfully performed. | |
| Static Modular Junction Strength Verification | Modular junctions maintain integrity and strength under static loads, comparable to predicates. | Non-clinical verification successfully performed. | |
| Compatibility | ROM Verification | Device allows for intended range of motion when implanted, comparable to predicates. | Non-clinical verification successfully performed. |
| Imaging Compatibility | MRI Verification | Device is compatible with MRI (e.g., minimal artifact, no excessive heating), comparable to predicates. | Non-clinical verification successfully performed. |
| Material Equivalence | Materials composition | Identical to legally marketed predicate devices. | "Identical to predicates" |
| Design Equivalence | Design Features | Similar to legally marketed predicate devices, with any differences not raising new safety/effectiveness concerns. | "Similar to predicates" |
| Packaging Equivalence | Packaging | Identical to legally marketed predicate devices, ensuring sterility and protection. | "Identical to predicates" |
| Sterilization Equivalence | Sterilization Method | Identical to legally marketed predicate devices, ensuring sterility. | "Identical to predicates" |
| Intended Use Equivalence | Intended Use | Identical to legally marketed predicate devices. | "Identical to predicates" |
| Indications for Use Equivalence | Indications for Use | Identical to legally marketed predicate devices. | "Identical to predicates" |
Note: For traditional orthopedic implants, specific numerical values for acceptance criteria and device performance (e.g., "Fatigue life > X cycles at Y load") are typically contained within the full 510(k) submission and are not usually detailed in the public clearance letter. The letter only states that these verifications were "successfully performed" and support the conclusion of substantial equivalence.
AI/ML Specific Questions (Answered as "Not Applicable" for this device)
Given that this is a 510(k) for a physical orthopedic implant and not an AI/ML device, the following points are not applicable (N/A):
- Sample sizes used for the test set and the data provenance: N/A. This device does not have a "test set" of patient data in the typical sense for AI/ML validation involving images or clinical parameters. Its evaluation involves mechanical testing of physical samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts for clinical data is not relevant for this device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. This applies to review of clinical data, not mechanical testing.
- 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: N/A. MRMC studies are for evaluating human reader performance, typically with diagnostic images, in conjunction with AI. This is not a diagnostic or AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device's performance is derived from standardized mechanical testing methods and compliance with material specifications.
- The sample size for the training set: N/A. This device does not use a "training set" as it's not an AI/ML model.
- How the ground truth for the training set was established: N/A.
Summary of the Study:
The "study" that proves the device meets the acceptance criteria is described as a series of non-clinical verifications. These tests are designed to objectively assess the physical and mechanical properties of the Comprehensive Humeral Head Adapter (CHHA) and its compatibility within the Identity Shoulder System, thereby demonstrating its substantial equivalence to previously cleared predicate devices.
The specific non-clinical tests performed include:
- Fatigue Verification: Assesses the device's ability to withstand repeated stress without failure, simulating long-term use.
- Fretting Corrosion Verification: Evaluates the device's resistance to material degradation caused by small-amplitude oscillatory motion between contacting surfaces.
- Fixation Stability Verification: Confirms the secure attachment and stability of components under load.
- Static Modular Junction Strength Verification: Measures the strength of the connections between modular parts under static loading conditions.
- ROM Verification: Ensures the device allows for the intended range of motion within the joint.
- MRI Verification: Confirms the device's safety and compatibility when exposed to magnetic resonance imaging environments.
The results of these tests, along with the asserted identicality of intended use, indications for use, materials, packaging, and sterilization, and similarity in design features, were deemed sufficient by the FDA to conclude that:
- any differences do not raise different questions of safety and effectiveness; and
- the proposed device is as safe and effective as the legally marketed predicate device.
This conclusion of substantial equivalence is the basis for the 510(k) clearance for the Identity Shoulder System's new line extension, the Comprehensive Humeral Head Adapter.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”