(42 days)
Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.
This device is a single use implant intended for cemented application.
Biomet's 150mm CoCr BiMetric Head/Neck Replacement Hip Stem – Color Buff Finish Prosthesis is indicated for use in noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
This device is a single use implant intended for cemented application only.
The device is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.
Proximally, the stem is designed to replace the proximal portion of the femur in cases of severe bone loss. The medial portion is built up to compensate for bone deficiencies. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsional forces.
There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanter osteotomy has been performed.
The platform inside the collar is bead blasted; the stem outside the collar distally has a highly polished surface with a mirror-like appearance (according to Biomet's Color Buff Finish spec Q00999). This surface finish allows for some subsidence of the stem within the cement mantle and decrease the incidence of stem loosening.
A proximal to distal taper of the femoral stem parallels the shape of the femur to follow the natural contours of the canal. The tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. The employment of a PMMA distal stem positioner centralizes the stem within the canal.
The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery. The modular heads are manufactured from wrought cobalt-chromemolybdenum conforming to ASTM F-1537. The stem trunions are identical to Biomet's Type I Tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687. There is a 4 degree included angle on the trunion.
The provided text is a 510(k) summary for a medical device (Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem), which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial acceptance criteria and performance data for a novel device. As such, the document does NOT contain the detailed information necessary to fully answer all aspects of your request.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
- Cannot be provided. The document does not describe specific acceptance criteria (e.g., specific thresholds for wear rates, fatigue life, or clinical outcomes) or quantitative performance metrics from a study in the format typically used for medical device approval based on novel data. The 510(k) process relies on demonstrating equivalence to an already approved device.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. This document is not a clinical study report. It does not mention any test set, sample sizes for human subjects, or data provenance (country of origin, retrospective/prospective) for a study proving acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. This information pertains to a study's methodology for establishing ground truth, which is not present in this 510(k) submission.
4. Adjudication method for the test set:
- Cannot be provided. Adjudication methods are relevant to clinical studies, which are not detailed here.
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:
- Cannot be provided. An MRMC study is completely irrelevant here. This is a hip implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This question is also irrelevant as the device is a physical hip implant and not an algorithm.
7. The type of ground truth used:
- Cannot be fully provided in the context of a "study proving acceptance criteria." For mechanical aspects, the "ground truth" would be engineering specifications and testing (e.g., fatigue testing, wear testing against standards), but specific data or thresholds are not in this summary. For clinical outcomes, the "ground truth" for the 510(k) is the established performance and safety of the predicate devices to which it is deemed substantially equivalent, as there's no new clinical trial data presented to establish independent ground truth for this specific device.
8. The sample size for the training set:
- Cannot be provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Cannot be provided. As above, no training set.
What the document DOES tell us about "acceptance criteria" in the context of a 510(k):
In a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This means the new device shares the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to a legally marketed predicate device.
The document states:
- Intended Use: Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.
- Substantial Equivalence: "In function and overall design Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem Prosthesis is equivalent to other commercially available hip prosthesis currently on the market." (Specifically listing HNR, Solution, Modular Calcar, and Biomet's own Grit Blast Finish model).
- Technological Characteristics: The document describes the materials (CoCr, Stainless Steel, UHMWPE), design features (collar, keel, polished surface, tapered geometry, modular head, specific taper angle), and manufacturing processes that are comparable to existing devices.
- Potential Risks: The document explicitly states, "The potential risks associated with this device are the same as with any joint replacement device." This implies that the device does not introduce new or unmanageable risks beyond what is already accepted for hip replacements.
Therefore, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which primarily relies on comparison to predicate devices and adherence to established engineering and material standards for such implants, rather than a novel clinical trial with specific performance metrics for this particular device. The FDA's letter (K983710) confirms that based on the submission, the device is considered "substantially equivalent" and therefore meets the regulatory "acceptance criteria" for market entry.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.