(208 days)
The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.
The BiPolar-i is intended for use in the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement,
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
- Revision of failed partial hip replacements in which the acetabulum does not require replacement
The BiPolar-i is indicated for cementless use only.
The BiPolar-i is a preassembled bipolar head comprised of an ultra-high molecular weight polyethylene (UHMWPE) liner and a highly polished cobalt-chromium alloy (CoCr) outer shell. The BiPolar-i is used in combination with a 22mm or 28mm CoCr modular head (dependent on the BiPolar i size) and compatible hip stem, both supplied separately. When assembled, the modular head is maintained captive and articulates within the UHMWPE liner. The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. The BiPolar-i is intended for use with a Corin femoral head and hip stem prosthesis with a compatible 12/14 taper connection and is designed to articulate in the patient's natural acetabulum.
The provided document is a 510(k) summary for the Corin BiPolar-i, a hip joint femoral (hemi-hip) metal/polymer prosthesis. This document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, intended use, and non-clinical testing. It explicitly states that clinical testing was not necessary for this particular submission.
Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not available within this document because a clinical study of the device's performance against pre-defined acceptance criteria was not conducted or reported for this 510(k) submission.
This type of submission relies heavily on non-clinical testing to demonstrate that the new device performs as safely and effectively as legally marketed predicate devices, rather than establishing numerical performance metrics against acceptance criteria from a clinical trial.
However, I can provide the non-clinical testing information that was conducted:
1. Acceptance Criteria and Device Performance (from non-clinical testing):
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ASTM F1820-13 (Pull-out & Lever-out Force) | Results show substantial equivalence to the predicate device. |
| Assembly Testing | Results show substantial equivalence to the predicate device. |
| ISO 21535:2007/Amd1:2016 (Range of Motion) | Results show substantial equivalence to the predicate device. |
| Evaluation of Impingement & Wear | Results show substantial equivalence to the predicate device. |
| Bacterial Endotoxin Testing (BET) | Conducted on finished, sterilized product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology (results not numerically detailed but assumed to meet standards for sterility). |
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical human test set was used. This refers to non-clinical laboratory testing. The document does not specify the sample sizes used for each non-clinical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical human test set requiring expert ground truth was used.
4. Adjudication method for the test set: Not applicable, as no clinical human test set 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 device is a physical hip prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip prosthesis, not an algorithm.
7. The type of ground truth used: For the non-clinical testing, the "ground truth" is defined by the requirements and test methodologies outlined in the referenced ASTM and ISO standards, and the performance of the predicate device. For BET, it's the absence of bacterial endotoxins.
8. The sample size for the training set: Not applicable, as no training set for an algorithm was used.
9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm was used.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.