(81 days)
The Bencox Hip System is intended for cementless use in total or partial 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
Bencox II Stem cleared under K103431 is modified at the proximal neck region. The other aspects of design / material / specification / manufacturing & sterilization / packaging are not altered and remain the same as discussed in K103431. The component is manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.
Bencox Metal Head is cleared under K103431 & K112019 with the neck lengths of small, medium and large. This submission includes extra large (XL) neck length as an inclusion to the existing specification. The other aspects of design / material / specification / manufacturing & sterilization/packaging are not altered and remain the same as discussed in K103431 & K112019. The component is manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.
Here's an analysis of the acceptance criteria and supporting study for the Bencox II Stem & Bencox Metal Head, based on the provided text:
Important Note: This document describes a modification to an existing medical device (hip prosthesis components). The acceptance criteria and performance data provided relate to demonstrating that the modified device performs similarly or better than the previously cleared predicate devices, particularly regarding fatigue strength and range of motion. This is a common approach for 510(k) submissions for device modifications, focusing on demonstrating equivalence rather than establishing de novo clinical performance benchmarks.
Acceptance Criteria and Study Details for Bencox II Stem & Bencox Metal Head (K122099)
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not specify explicit numerical acceptance criteria in the typical sense for a diagnostic device (e.g., accuracy thresholds). Instead, for this orthopedic implant modification, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices through performance testing. The reported performance is comparative.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Fatigue Strength: Must be equivalent or superior to predicate devices. | The Bencox II Stem neck change and Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019 when subjected to testing protocols for fatigue strength as described in ISO 7206-4 and ISO 7206-6. |
| Range of Motion: Must be equivalent or superior to predicate devices. | The Bencox II Stem neck change and Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019 when subjected to testing protocols for range of motion as described in ISO 21535. |
| Sterility Assurance Level (SAL): Components must be sterilizable to an SAL of 10^-6. | Sterilization validation as per ISO 11137 - 1 & 2 (Radiation) ensures sterility of the components for an SAL of 10^-6. This is consistent with the predicate devices. |
| Shelf Life for Sterility: Packaging must maintain sterility for a specified shelf life. | Packaging was subjected to sterile barrier testing to validate a shelf life of 5 years for both components. This is consistent with the predicate devices. |
| Biocompatibility/Material Safety: Materials must conform to recognized standards (implicit for substantial equivalence). | The components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and Co-Cr-Mo alloy conforming to ASTM F1537, which are standard materials for surgical implants and are the same as used in the predicate devices. This implies continued meeting of biocompatibility standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for the mechanical and sterilization tests, but refers to "a series of testing protocols." For such device modifications, testing typically involves a sufficient number of samples to statistically demonstrate compliance with standards and equivalence, but specific numbers are not provided.
- Data Provenance: The data is generated from laboratory testing (mechanical, sterilization, packaging) of the modified Bencox II Stem & Bencox Metal Head and comparison with the predicate devices. This is not patient-derived data. The manufacturing country is South Korea (Corentec Co., Ltd.). The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable: For this type of submission involving mechanical and sterilization testing of an orthopedic implant component, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and established engineering principles, rather than expert clinical consensus on patient data. There is no mention of clinical experts being involved in establishing "ground truth" for these specific performance tests.
4. Adjudication Method for the Test Set:
- Not Applicable: As the "test set" consists of physical devices undergoing laboratory performance testing against engineering standards, there is no need for an adjudication method involving multiple human readers/experts. The tests produce quantifiable results compared to standard requirements and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not done. This 510(k) submission pertains to physical modifications of an orthopedic implant system and its mechanical and sterilization performance, not a diagnostic device requiring human-in-the-loop performance evaluation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, not done. This product is a physical hip prosthesis component, not an algorithm or AI software. Therefore, an "algorithm only" performance study is not applicable.
7. Type of Ground Truth Used:
- Engineering Standards and Predicate Device Performance: The "ground truth" for the performance evaluation is based on established international engineering standards for orthopedic implants (ISO 7206-4, ISO 7206-6, ISO 21535, ISO 11137-1 & 2) and the demonstrated performance of the previously cleared predicate devices (K103431 & K112019). The goal is to demonstrate that the modified device meets or exceeds these established benchmarks.
8. Sample Size for the Training Set:
- Not Applicable: As this is a physical medical device (hip prosthesis components) and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device designs, but not through data-driven 'training' in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The performance evaluation is based on direct physical testing and comparison to engineering standards and predicate device performance.
§ 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.