(29 days)
Bencox Mirabo Cup System of Benox Total Hip System is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
The Bencox Mirabo Cup System is a Cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. This submission consists of the following components:
- Acetabular Cup Bencox Mirabo Cup
- Acetabular Liner Bencox Mirabo PE Liner
Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 44 mm.
Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liners with head size, 28/35 & 32/39 mm.
Bencox Hip Replacement System Instrumentation (Non Sterile)
Bencox Hip Replacement System Instrumentation is a set of accessories to be used with Bencox Hip Implants. The parts of the instruments are made of stainless steel and/or polymers and/or silicon and cleared for use in previous premarket notifications of Corentec. Bencox Hip System Instrumentation to be used with Bencox Mirabo Cup System is same with Instrumentation cleared under K162127 and K150007 & K120924 along with the inclusion of instruments specific to Bencox Mirabo Cup System components included in this submission.
This document is a 510(k) summary for the Bencox Mirabo Cup System, a hip acetabular system. The information provided outlines the system's specifications, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not describe any acceptance criteria for "device performance" in terms of clinical outcomes or human-in-the-loop performance. Instead, it focuses on laboratory testing to ensure the device materials and design meet established engineering standards for orthopedic implants.
Therefore, many of the requested sections (acceptance criteria related to clinical performance, clinical study details, expert input, MRMC studies, standalone algorithm performance, and training set details) cannot be extracted from this document as it is focused on a medical device clearance based on substantial equivalence through material and mechanical testing, not a digital health or AI-based device's diagnostic performance.
Based on the provided text, here is what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Satisfied) |
|---|---|
| Wear Testing (ISO 14242-1) | Satisfied |
| Liner Torsion (ASTM F1820 Torque Out Disassembly) | Satisfied |
| Pull out Testing (ASTM F1820 Offset Pull out disassembly) | Satisfied |
| Push out (ASTM F1820 Axial Disassembly) | Satisfied |
| Impingement Testing (ASTM F2582) | Satisfied |
| Range of Motion Testing (ISO 21535) | Satisfied |
| Endotoxin Testing (ANSI/AAMI ST72) | Satisfied |
| Risk Management (ISO 14971) | Satisfied |
| Shelf life validation (5 years) for sterile barrier packaging (ASTM F1980) for metal component | Validated |
| Sterilization validation (SAL of 10-8) for metal component (ISO 11137-1 & 2) | Ensured |
| Shelf life validation (5 years) for sterile barrier packaging (ASTM F1980) for UHMWPE component | Validated |
| Sterilization validation (SAL of 10-6) for UHMWPE component (ISO 11135-1) | Ensured |
| EtO Residuals within limits (ISO 10993-7) | Within limits |
Note: The document explicitly states "The results of this testing/analysis showed that the subject devices are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices." This implies that the device met the acceptance criteria defined by these standards, even if specific numerical thresholds aren't provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "testing protocols" and "series of testing," which are typically laboratory-based mechanical and material tests for medical implants. These do not usually involve "test sets" in the same way clinical or AI performance studies do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable to the type of testing described (mechanical and material performance of an orthopedic implant).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to the type of testing described.
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
This is not applicable as the device described is a hip arthroplasty system, not an AI-based diagnostic tool or system that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device described is a hip arthroplasty system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data, the "ground truth" is established by adherence to recognized international and ASTM standards (e.g., ISO 14242-1, ASTM F1820, ISO 11137-1). For a medical implant, this means that the materials behave as expected under specified mechanical loads, wear conditions, and sterilization processes, demonstrating substantial equivalence to previously cleared devices.
8. The sample size for the training set
This information is not provided and is not applicable to the type of testing described (mechanical and material performance of an orthopedic implant), which does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
§ 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.