(33 days)
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
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- Tumor resections.
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- Revision of previously failed total joint arthroplasty.
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- Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
- Trauma.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
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- Tumor resections.
- Revision of previously failed total joint arthroplasty.
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- Trauma.
The Compress Segmental Humeral Replacement System components are intended use.
- Trauma.
The Compress and Mini Compress Anti-Rotation Spindles are components of the Compress Segmental Femoral Replacement System and Compress Segmental Humeral Replacement System. The Anti-Rotation Spindles attach to an anchor plug and a proximal/distal femoral/humeral component to serve as a method of fixing a segmental joint replacement to a patient's host bone. The Anti-Rotation Spindles contain several conical washers which allow a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. The Anti-Rotation Spindles also include a series of holes around the spindle collar to allow placement of pins to prevent rotation of the component. The purpose of this submission is the update of the surgical techniques associated with the Compress and Mini Compress Anti-Rotation Spindles to revise the recommended pin selection range for use with the Anti-Rotation Spindles.
This FDA 510(k) premarket notification for the "Compress and Mini Compress Anti-Rotation Spindles" describes a device that is essentially an updated component of existing segmental replacement systems. The submission centers around an update to surgical techniques and therefore does not rely on extensive clinical or performance studies in the way a novel device might.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this submission is for an update to surgical techniques for components of an existing device, and not for a new device itself, the typical "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, accuracy) are not applicable. Instead, the acceptance is based on demonstrating that the updated surgical technique does not adversely affect the device or its intended use, and that the devices remain substantially equivalent to predicates.
The "acceptance criteria" here implicitly relate to ensuring functional compatibility and non-inferiority in terms of mechanical properties and surgical application.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Compatibility / Non-Adverse Impact of Surgical Technique Update | Geometric evaluation conducted, demonstrating the necessity for revisions to clarify Anti-Rotation Pin usage. |
| Substantial Equivalence to Predicate Devices | The subject surgical technique modifications are implemented per the results of the geometric evaluation, leading to a conclusion of substantial equivalence. |
| Absence of New Safety/Efficacy Concerns | The updates to the surgical techniques do not impact indications, materials, design features or dimensions, packaging or sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of typical performance testing. The "test set" in this case appears to be a geometric evaluation of the components in relation to the revised surgical technique.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The geometric evaluation would be internal to the manufacturer (Biomet Inc.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable as this was a geometric evaluation, not a clinical study requiring expert ground truth for interpretation. The "ground truth" would be the engineering specifications and physical properties of the device components.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical study with a test set requiring adjudication in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the subject devices." This type of study investigates human reader performance, which is not relevant for this engineering-focused submission about surgical technique updates.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI component or human-in-the-loop study was involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone (algorithm only) performance study was not done. This device is a mechanical implant, not an algorithm or software.
7. Type of Ground Truth Used
- The implicit "ground truth" for this submission is engineering specifications and verification/validation data related to the geometric fit and function of the Anti-Rotation Spindles with the revised surgical technique, as determined by the "geometric evaluation." There is no clinical or pathology-based ground truth mentioned.
8. Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing of the device components would follow standard engineering and quality control processes.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no training set in this context.
§ 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.”