(29 days)
Cemented or non-cemented total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed.
The Indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
All devices are metallic, hemispherical, modular acetabular shell components. All shells have Regenerex™ (porous Ti-6Al-4V) applied to the exterior fixation surface. Each shell utilizes a modular polyethylene liner and a modular femoral head component that is a taper fit onto a femoral stem intra-operatively.
This Biomet Regenerex™ RingLoc® + Modular Acetabular Shell 510(k) submission (K070369) is for a hip replacement component. This type of device relies on substantial equivalence to a predicate device rather than performance against specific analytical or clinical acceptance criteria in the same way an AI/ML device would.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can still extract relevant information, and indicate "Not Applicable" where appropriate.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not applicable for this device type) | Reported Device Performance |
|---|---|
| Substantial Equivalence to a predicate device. | The device is geometrically similar or identical to the predicate device (Porous Coated Acetabular Components, 510(k) K050124). Non-clinical testing (design verification bench tests and validation activities) was performed, and the results did not raise new issues of safety and effectiveness. |
| Intended Use: Cemented or non-cemented total hip replacement in cases of: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; 5. Revision procedures where other treatment or devices have failed. | |
| Indications for Constrained Liners: General use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not Applicable. This submission relies on substantial equivalence to a predicate device and non-clinical bench testing, not a traditional "test set" of patient data for performance evaluation in the context of AI/ML or diagnostic devices.
- Data provenance: Not Applicable. No patient data was used for performance testing described in this submission. The "data" refers to the results of bench tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No patient-specific ground truth was established, as there was no clinical study involving patient data for performance evaluation.
4. Adjudication method for the test set
- Not Applicable. No clinical test set requiring adjudication was used.
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 medical device for hip replacement, not an AI/ML 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. This is a physical medical implant, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this type of submission is primarily established through engineering principles, material science, and consistency with the performance characteristics of an already legally marketed predicate device. The non-clinical bench testing aims to demonstrate that the new device performs as expected according to established standards for mechanical and material properties relevant to hip implants, similar to the predicate.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/ML model for this medical device submission.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth for this device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. 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. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.