(21 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 osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Total Hip 12/14 Taper Femoral Heads are designed for single use only.
The Total Hip 12/14 Taper Femoral Heads are designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
The provided text describes a 510(k) premarket notification for a medical device, specifically Smith & Nephew, Inc. Total Hip Femoral Heads, 12/14 taper. This document focuses on demonstrating substantial equivalence to existing devices, primarily through mechanical testing and comparison of indications for use.
Crucially, this type of submission does not involve clinical studies with human participants in the way typically required for AI/algorithm-based devices, which usually involve evaluation of diagnostic performance (e.g., sensitivity, specificity). Therefore, many of the requested elements for an AI/algorithm study (such as sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) are not applicable to this device and its submission.
The "study" described here is a mechanical test data review rather than a clinical study evaluating diagnostic or predictive performance.
Here's a breakdown of the information that is applicable and why other parts are not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Capable of withstanding expected in vivo loading without failure, and equivalent to devices currently on the market. | "A review of the mechanical test data indicated that the Total Hip 12/14 Taper Femoral Heads are equivalent to devices currently on the market and capable of withstanding expected in vivo loading without failure." |
| Indications for Use Equivalence: Similar indications for total hip replacement as legally marketed predicate devices (Smith & Nephew CoCr alloy and yttria-stabilized zirconia femoral heads). | "The Total Hip 12/14 Taper Femoral Heads are similar to the femoral heads currently distributed by Smith & Nephew, Inc. All heads are indicated for total hip replacement and are similar to Smith & Nephew CoCr alloy and yttria-stabilized zirconia femoral heads." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is based on mechanical testing (simulating in vivo loading) and a comparison of product specifications and indications for use, not a clinical study involving a "test set" of patient data.
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)
- Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for mechanical equivalence would be the established engineering standards and performance of predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Not a clinical study.
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 is not an AI/algorithmic device, nor a diagnostic device that would involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical orthopedic implant (femoral head), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" or basis for acceptance in this context is the established mechanical performance standards and regulatory requirements for hip joint prostheses, along with the demonstrated performance of legally marketed predicate devices. This is based on engineering principles and material science, not clinical outcomes data for this specific new device, as it's a 510(k) for substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is not an AI/algorithmic device that uses a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/algorithmic device that uses a "training set."
In summary: The K021673 submission for the Smith & Nephew Total Hip Femoral Heads is a premarket notification (510(k)) that demonstrates substantial equivalence to legally marketed predicate devices. The "study" referenced is a review of mechanical test data demonstrating the device's ability to withstand in vivo loading and its equivalence to market comparators, along with a comparison of its intended uses. It does not involve a clinical study with patients or an AI algorithm, and therefore most of the requested fields related to such studies are not applicable.
§ 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.