(29 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 and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; 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 Hip System components are designed for single use only.
The Smith & Nephew Hip System is comprised of cross-linked UHMWPE acetabular liners and cobalt chrome femoral heads. The acetabular liners are designed to mate to previously cleared Smith & Nephew Reflection metal acetabular shells. The cobalt chrome femoral heads are designed to function with the subject acetabular liners and to mate with Smith & Nephew femoral hip stems identified in this Special 510(k) Premarket Notification. The intended use, type of interface, and design features of the components comprising the Smith & Nephew Hip System are identical to other Smith & Nephew predicate devices identified in this submission.
The provided document pertains to a 510(k) premarket notification for the Smith & Nephew Hip System, specifically focusing on cross-linked UHMWPE acetabular liner components and cobalt chrome femoral heads.
Based on the information provided in this 510(k) summary, the device is a medical implant, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, human reader performance, ground truth, and training sets that are typically applicable to AI/ML powered medical devices are not relevant for this submission.
The "study" that proves the device meets acceptance criteria for this type of medical device is typically a demonstration of substantial equivalence to a predicate device, supported by "test data, material information, and substantial equivalence information."
Here's an interpretation based on the provided text, modified to fit the context of a non-AI/ML device:
Acceptance Criteria and Study for Smith & Nephew Hip System (Non-AI/ML Device)
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Material Composition Equivalence: Materials used are comparable to those in legally marketed predicate devices. | The Smith & Nephew Hip System is comprised of cross-linked UHMWPE acetabular liners and cobalt chrome femoral heads. The components are similar to predicate devices manufactured by Smith & Nephew and previously cleared for market. The "material" (and design features) are identical to the predicate devices identified in this submission. |
| Design Feature Equivalence: Design features are comparable to those in legally marketed predicate devices. | The acetabular liners are designed to mate to previously cleared Smith & Nephew Reflection metal acetabular shells. The cobalt chrome femoral heads are designed to function with the subject acetabular liners and to mate with Smith & Nephew femoral hip stems. The "design features" of the components are identical to other Smith & Nephew predicate devices identified in this submission. |
| Intended Use Equivalence: The intended use is comparable to that of legally marketed predicate devices. | The intended use is identical to other Smith & Nephew predicate devices identified in this submission. The indications for use are clearly stated for primary and revision surgery for various hip conditions. |
| Performance (Mechanical/Biocompatibility) Equivalence: Device performance (e.g., wear, strength, biocompatibility) is comparable to predicate devices and meets relevant standards. | "The safety and effectiveness for the subject devices are adequately supported by test data, material information, and substantial equivalence information provided in this Special 510(k) Premarket Notification." "Tests results indicate that the subject devices meet the requirements of the applicable guidance documents." (Specific tests or standards are not detailed in this summary, but this statement confirms their completion and positive outcome). |
2. Sample size used for the test set and the data provenance
The document indicates that "test data" was used. For mechanical and material testing of orthopedic implants, a "test set" typically refers to the number of physical samples of the device and its components subjected to various biomechanical tests (e.g., fatigue, wear, strength, corrosion) and material characterization tests. The specific sample size for these tests is not specified in the provided 510(k) summary.
Data Provenance: The data would be derived from laboratory bench testing (e.g., in vitro mechanical testing) and material characterization performed according to established standards. The summary does not specify the country of origin for the testing, but it would presumably be in compliance with FDA requirements for medical devices marketed in the USA. Given the nature of mechanical testing, it is prospective in the sense that new samples are tested to demonstrate performance.
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 as the device is a physical implant, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation to establish a "ground truth" for a test set of data. "Ground truth" for this device would be established through engineering specifications, material standards, and biomechanical performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases of diagnostic disagreement for image-based or clinical data. For an orthopedic implant, performance is assessed against predefined engineering and material standards, not through adjudication of expert opinions on a "test set."
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 physical orthopedic implant and does not involve AI assistance, human readers, or image interpretation. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical implant, the "ground truth" is fundamentally based on:
- Engineering Specifications and Standards: Compliance with recognized international and national standards for orthopedic implants (e.g., ISO, ASTM for materials, mechanical properties, wear resistance).
- Biocompatibility Standards: Demonstration that materials are safe for implantation in the human body.
- Predicate Device Performance: The primary "ground truth" for a 510(k) submission is often the established safety and effectiveness of a legally marketed predicate device. The new device must perform comparably.
8. The sample size for the training set
This question is not applicable as there is no "training set" in the context of an AI/ML algorithm for this physical orthopedic implant.
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" for an AI/ML algorithm.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.