(78 days)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NiDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Subject of this Traditional Premarket Notification are Biolox Delta Ceramic Femoral Head line additions. The subject devices are ceramic femoral head components which are intended to be used in conjunction with existing Smith & Nephew 12/14 taper hip stems, and they are intended to articulate against appropriately sized, existing XLPE acetabular liners. The Biolox Delta Ceramic Femoral Heads are manufactured from Biolox delta ceramic material and will be offered in sizes 40 and 44mm with offsets of 0, +4, and +8mm.
Biolox Detta Ceramic Femoral Heads in smaller sizes (28, 32, and 36mm) have previously been cleared for market via premarket notification K083762. The only difference between the subject Biolox Delta Ceramic Femoral Heads and those cleared via K083762 is the size offering: the subject devices are offered with a larger diameter than the predicate devices. All other design features, including material choice, taper design, and articular surface finish, are identical. Additionally, Biolox Delta Ceramic Femoral Heads in the same size range have previously been cleared for market via K082844.
Here's an analysis of the provided text regarding the Biolox Delta Ceramic Femoral Heads, structured to address your specific questions.
It's important to note that this document is a 510(k) Premarket Notification summary for a medical device (femoral heads), not an AI/ML medical device. Therefore, many of the questions related to AI/ML specific concepts (like multi-reader multi-case studies, ground truth establishment for a training set, sample sizes for test/training sets in an AI context) are not applicable. The device's "performance" in this context refers to its mechanical and material properties, not diagnostic accuracy or predictive power.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Range of Motion | Evaluated |
| Femoral Head Burst | Evaluated |
| Femoral Head Fatigue | Evaluated |
| Wear Performance | Evaluated |
| Assembly/Disassembly Strength | Evaluated |
| Head/Stem Construct Fatigue | Evaluated |
Note: The document explicitly states: "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This implicitly means the device met the acceptance criteria derived from the referenced guidance documents. Specific numerical acceptance criteria or detailed test results are not provided in this summary, which is typical for a 510(k) summary. The acceptance criteria would be defined within the full test reports, per the cited FDA guidance documents.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "Performance testing has been conducted" and evaluates various mechanical properties (burst, fatigue, wear, etc.). These tests typically involve a specific number of samples for each test type, based on engineering standards and statistical power requirements, but these numbers are not disclosed in this summary.
- Data Provenance: The data is from in-vitro mechanical and material performance testing conducted by Smith & Nephew, Inc. at their facilities, or by contract labs following established test methods. This is not patient data; it's device performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this type of device and study. "Ground truth" in the context of this device refers to the physical and mechanical properties being measured, compared against established engineering standards and predicate device performance. It doesn't involve expert consensus on diagnoses or interpretations of medical images. The "experts" would be the engineers and technicians performing and reviewing the materials and mechanical testing.
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, typically for evaluating diagnostic accuracy or clinical outcomes. This document describes mechanical performance testing, not a clinical trial or expert review of clinical cases.
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 question is not applicable. This device is a ceramic femoral head (joint implant), not an AI/ML software device for diagnostic assistance. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This device is a physical implant, not an algorithm or software. "Standalone performance" in this context would refer to the device's mechanical integrity under simulated physiological conditions, which is what the performance testing ("femoral head burst, femoral head fatigue, wear performance," etc.) evaluated.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on accepted engineering standards, material specifications, and the performance of legally marketed predicate devices.
- Expert Consensus: Not in the sense of clinical experts, but rather consensus within the engineering community on test methods and material properties.
- Pathology: Not applicable.
- Outcomes Data: Not directly used as "ground truth" for the device performance tests described (which are primarily mechanical). Clinical outcomes would be observed post-market or in clinical trials, but this 510(k) relies on non-clinical performance data and substantial equivalence to predicates.
8. The sample size for the training set
- This question is not applicable. The device is a physical product, not an AI/ML model that requires a "training set" of data.
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as point 8.
§ 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.