(83 days)
Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomvelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Biolox Delta Ceramic femoral heads are for single use only.
The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction and articulates against a Smith & Nephew polyethylene acetabular liner. The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 respectively.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Biolox Delta Ceramic Femoral Heads:
This document is a 510(k) Premarket Notification Summary for Substantial Equivalence, not a clinical study report with detailed acceptance criteria and performance metrics. Therefore, it primarily focuses on demonstrating that the new device (Biolox Delta Ceramic Femoral Heads) is substantially equivalent to legally marketed predicate devices, rather than establishing de novo performance against specific acceptance criteria through a dedicated study.
Because of this, many of the requested data points (sample sizes, ground truth details, expert qualifications, MRMC studies, standalone performance) are not applicable or not provided in this type of regulatory submission. The primary "study" is a review of mechanical data for equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Withstand expected in vivo loading without failure. | "A review of the mechanical data indicated that the Smith & Nephew Biolox Delta Ceramic femoral heads are equivalent to devices currently cleared for market and are capable of withstanding expected in vivo loading without failure." | The specific acceptance criteria (e.g., force, cycles, fracture strength) are not explicitly stated, but the conclusion of equivalence and capability is affirmed. This is based on mechanical data review, not a clinical trial. |
| Material Equivalence | Similar material composition and properties to predicate devices. | The device uses "Biolox Delta Ceramic" which is stated to be similar in design and material to cleared "Biolox Forte Alumina Ceramic" and "Zimmer Biolox Delta Ceramic" predicate devices. | The document implies that the material choice of Biolox Delta Ceramic itself is part of the substantial equivalence claim, having been previously cleared in other devices. |
| Device Design/Function | Similar overall design and function to predicate devices. | "The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems... The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads..." | Emphasizes similarity to previously cleared devices. |
| Indications for Use | Match or be a subset of the Indications for Use of the predicate devices. | The Indications for Use for the Biolox Delta Ceramic femoral heads are identical to the comprehensive list provided for total hip components, which are presumably the same as the predicate devices. | The provided text explicitly lists the indications, implying these are consistent with legally marketed devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on mechanical data analysis and comparison to predicate devices, not a clinical test set with human subjects or patient data.
- Data Provenance: The "mechanical data" originates from the manufacturer's testing or engineering analysis. The document does not specify country of origin for the data, nor does it refer to patient data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the sense of clinical interpretations or diagnoses by experts is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols. The "experts" involved would be engineering and materials specialists within Smith & Nephew, or independent testing labs, whose qualifications are not detailed in this summary.
4. Adjudication method for the test set
- Not applicable. There was no "test set" in the clinical sense requiring expert adjudication.
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 ceramic femoral head (a physical implant), not a diagnostic AI/software device. MRMC studies are for evaluating reader performance in interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the mechanical testing: The "ground truth" would be established by engineering standards and validated mechanical testing protocols (e.g., fatigue testing, fracture testing, static and dynamic loading tests), and comparison against the performance of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/machine learning model. For mechanical testing, the "sample size" would refer to the number of femoral heads subjected to various mechanical tests. This is not specified in the summary but would be sufficient to meet relevant ISO or ASTM standards for medical device testing.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set in the AI sense. For mechanical testing, the performance characteristics of the device itself and the predicate devices, under specified loading conditions defined by engineering standards, serve as the "ground truth" for comparison.
§ 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.