(21 days)
The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are for ) 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 using other techniques; and 5) Revision procedures where other treatments or devices have failed.
The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are the same as their predicate, except for a modified profile on two of the sizes and the addition of Hydroxyapatite Coating.
The provided document is a 510(k) premarket notification for a medical device, specifically a hip implant. It primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria.
Therefore, many of the requested fields regarding acceptance criteria, study design, and performance metrics are not applicable or not provided in this type of regulatory submission. This document aims to show the new device is as safe and effective as an already legally marketed device, and typically relies on non-clinical testing for equivalence.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance Study Information
| Information Category | Details from Document |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Not Applicable/Not Provided. The document states: "Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems presented no new risks and were, therefore, substantially equivalent to the predicate device." This indicates that the acceptance criteria revolved around demonstrating mechanical equivalence and no new risks compared to the predicate device (Modular Reach™ Hip- 510(k) K994038), rather than performance against pre-defined clinical or analytical thresholds. Specific numerical performance metrics for the device are not reported in this summary. The "performance" is implicitly deemed equivalent to the predicate. |
| 2. Sample size used for the test set and data provenance | Not Applicable. No clinical test set was used. Mechanical testing was performed, but details on the sample size for that testing are not provided in this summary. The data provenance is "Non-Clinical Testing" which suggests laboratory testing rather than data from human subjects. |
| 3. Number of experts used to establish ground truth for test set and qualifications | Not Applicable. No clinical test set with ground truth established by experts was used. The substantial equivalence was based on mechanical testing and engineering justification. |
| 4. Adjudication method for the test set | Not Applicable. No clinical test set requiring adjudication was used. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study information | Not Applicable. This is a medical device (hip implant) 510(k) submission, not an AI/imaging diagnostic device. Therefore, no MRMC study, human reader improvement statistics, or AI assistance calculations are relevant or provided. |
| 6. Standalone (algorithm only without human-in-the-loop performance) study information | Not Applicable. This is a physical medical device (hip implant) and not an algorithm or AI system. Its function is not "standalone" in the computational sense. |
| 7. Type of ground truth used | Not Applicable. In the context of this 510(k), "ground truth" was established through "Mechanical Testing with an Engineering Justification" to demonstrate that the device "presented no new risks and were, therefore, substantially equivalent to the predicate device." It's based on engineering principles and comparison to the predicate's established performance, rather than clinical outcomes or pathology data for this specific device. |
| 8. Sample size for the training set | Not Applicable. No training set, in the sense of machine learning, was used. The development and testing were based on mechanical engineering principles. |
| 9. How ground truth for the training set was established | Not Applicable. As no training set was used, no ground truth needed to be established for it. The device design and testing are based on established biomechanical and materials science principles, and comparison to the predicate device's design and previous testing results (implicitly the "ground truth" for what constitutes a safe and effective hip implant of this type). |
§ 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.