(135 days)
Total hip components are indicated for uncemented use in 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 theumatoid 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 osteomyelitits 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 MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.
The Smith & Nephew MIS Stem is a straight, tapered, proximally loading stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 1 through 9 and have modular neck options to address patient anatomy. The stems are manufactured from titanium alloy (Ti-6Al-4V) and the necks are manufactured from Cobalt Chrome. Each femoral stem is proximally coated with Smith & Nephew's Roughcoat porous coating.
The provided text is a 510(k) summary for the Smith & Nephew MIS Hip Stem. This submission establishes substantial equivalence to already-marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in the way a novel therapeutic or diagnostic device might.
In the context of a 510(k) for a medical implant like a hip stem, "acceptance criteria" are typically related to mechanical and biocompatibility testing, demonstrating that the new device performs as safely and effectively as previously cleared, substantially equivalent devices. There isn't usually a clinical study with patients and AI models as described in your prompt for this type of device.
Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, training ground truth) is not applicable to this 510(k) submission. These details are generally relevant for diagnostic devices, AI/ML-driven analyses, or novel therapeutic approaches where clinical performance metrics (sensitivity, specificity, accuracy, etc.) are directly evaluated against a ground truth.
However, I can extract information regarding the device's characteristics and the basis for its substantial equivalence, which serves as its "proof" of meeting regulatory requirements.
Here's the breakdown of what can be derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
For a 510(k) of a conventional implantable device, "acceptance criteria" are not reported as clinical performance metrics (like sensitivity/specificity) but rather as compliance with design, material, and performance standards demonstrated through bench testing and comparison to predicate devices. The "reported device performance" is essentially that it meets these standards and is substantially equivalent to existing devices.
| Acceptance Criteria (Implied by 510(k) Submission) | Reported Device Performance (Summary) |
|---|---|
| Material Composition: Use of established biocompatible materials. | Manufactured from titanium alloy (Ti-6Al-4V) for the stem, Cobalt Chrome for the necks. Proximal porous coating (Roughcoat). |
| Design Characteristics: Match geometry of femur, proportional sizing, modular neck options. | Straight, tapered, proximally loading stem designed to match femoral geometry. Sizes 1-9. Modular neck options. |
| Intended Use: For uncemented total hip arthroplasty in specified conditions. | Indicated for uncemented primary and revision surgery for various orthopedic conditions (trauma, inflammatory/degenerative joint disease, avascular necrosis, fractures, etc.). |
| Mechanical Performance: Implied by substantial equivalence to predicate devices which have undergone appropriate mechanical testing (e.g., fatigue strength, torsional stability, push-out strength for porous coatings, etc. - though not explicitly detailed in this summary). | Overall design is substantially equivalent to other cleared devices (Anthology Hip Stem, Profemur TL Hip Stem, Mayo Conservative Hip, Lateralized Taperloc Microplasty). |
| Biocompatibility: Implied by substantial equivalence to predicate devices and use of well-established medical-grade materials. | Uses Ti-6Al-4V and Cobalt Chrome, common materials in hip implants. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This 510(k) is for a medical implant where testing is primarily bench-top and comparison to predicate devices, not clinical studies in the way a diagnostic device would be evaluated. The "test set" would typically refer to the physical devices tested in a lab, but no sample sizes for such testing are mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in this context, would be established through engineering specifications, material standards, and clinical experience with predicate devices, rather than expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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:
- No. This is a medical implant, not an AI-driven diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Ground Truth: The "ground truth" for this device's approval is its substantial equivalence to legally marketed predicate devices. This means that the device's design, materials, manufacturing processes, and intended use are sufficiently similar to those of devices that have already been proven safe and effective. The safety and effectiveness of the predicate devices would have been established through a combination of engineering analysis, biocompatibility testing, mechanical testing, and clinical experience/outcomes data.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/ML device.
§ 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.