(129 days)
The Corin BIOLOX delta Modular Femoral Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHMWPE) acetabular cup liners to reinstate function following the degenerative effects of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity and
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin BIOLOX delta Modular Femoral Heads are intended for single use only.
BIOLOX delta material is an aluminum oxide / zirconia ceramic composite composed of approximately 75% aluminum oxide and approximately 25% zirconia.
The Corin BIOLOX delta Modular Femoral Heads are available in 28mm and 32mm diameters. The 28mm heads are available with short (-3.5mm), medium (0mm) and long (+3.5mm) offsets. The 32mm heads are available with short (-4.0mm), medium (0mm), long (+4mm) and extra long (+7mm) offsets.
The Corin Biolox Delta heads are compatible with Corin titanium stems (i.e. Tri-Fit, Metafix and MiniHip femoral stems having a 12/14 taper trunnion) and the Trinity acetabular system.
The provided text describes the regulatory clearance for the Corin BIOLOX delta Modular Femoral Heads. This is a medical device application, and the "acceptance criteria" here refers to the requirements for demonstrating substantial equivalence to predicate devices, rather than performance metrics for an AI algorithm. Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, effect size, standalone performance) are not applicable in this context.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrating Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use/Indications: Same as predicate devices | The Corin BIOLOX delta Modular Femoral Heads have the same types of indications and intended uses as the predicates (Non-inflammatory degenerative joint disease, Rheumatoid arthritis, Correction of functional deformity, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)). |
| Technological Characteristics: Same as predicate devices | The BIOLOX delta material is an aluminum oxide/zirconia ceramic composite (75% aluminum oxide, 25% zirconia). The heads are available in 28mm and 32mm diameters with various offsets. They are compatible with Corin titanium stems and the Trinity acetabular system. The document states "The technological characteristics are the same as the predicates." |
| Performance (Non-Clinical Testing): Meet suggested values in "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" and be within the range of legally marketed predicates. | Burst Strength Testing: Performed on 28mm-12/14L and 32mm-12/14XL Biolox delta heads on Corin titanium taper trunnion (worst case construct). Fatigue Testing: Performed on the worst case construct. Post-Fatigue Burst Testing: Performed on the worst case construct. Pull-off Testing: Performed on the worst case construct. Results: "The results of the ceramic head testing meet the suggested values in the 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems.' The results of the preclinical data provided indicate that the subject system is within the range of legally marketed predicates." |
| Clinical Testing: Not necessary if substantial equivalence can be demonstrated through other means. | "Clinical testing was not necessary to determine substantial equivalence between the Corin BIOLOX delta Modular Femoral Heads and the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the described study is non-clinical testing of a hip implant device, not a diagnostic AI device requiring a clinical test set from human subjects. The testing involved physical ceramic heads and trunnions.
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 applicable. The "ground truth" for this device's performance is based on established engineering standards and material properties, not expert interpretation of medical images or patient outcomes in a clinical trial setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple human readers, which is not the case 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
This information is not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was based on established engineering standards, material specifications, and the performance characteristics of legally marketed predicate devices. The "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" provides the benchmark values.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/machine learning device.
Summary of the Study:
The study proving the device meets acceptance criteria was a series of non-clinical mechanical tests designed to assess the durability and structural integrity of the Corin BIOLOX delta Modular Femoral Heads.
- Tests Performed: Burst strength testing, fatigue testing, post-fatigue burst testing, and pull-off testing.
- Test Setup: The tests were performed on the ceramic heads in combination with Corin titanium taper trunnions, specifically focusing on "worst case constructs" (28mm-12/14L and 32mm-12/14XL Biolox delta heads).
- Acceptance Criteria: The results of these tests were compared against "suggested values in the 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'" and demonstrated that the subject system performed within the range of legally marketed predicate devices.
- Ground Truth: The "ground truth" for these tests was derived from these established guidance documents and the performance of existing, legally marketed hip implant devices.
- Clinical Testing: No clinical testing was deemed necessary as substantial equivalence was established through the non-clinical mechanical testing and comparison of material, geometric, and intended use characteristics with predicate devices.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.