(89 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 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; 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 SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.
The Smith & Nephew SMF® Stem, previously marketed by Smith & Nephew as the MIS Hip Stem, is a straight, tapered, proximally loaded stem designed to match the geometry of the subject monobloc SMP femoral stem line additions are offered in sizes -1 and 0. The subject devices have fixed, non-modular necks with a 12/14 neck taper to accept currently available Smith & Nephew femoral heads, and are available in standard and high offset. The SMP monobloc femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.
The provided text describes a 510(k) premarket notification for a hip stem device (Smith & Nephew SMF® Hip Stem line additions). This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than conducting a full clinical study with specific acceptance criteria and detailed performance data like those typically found for novel devices or AI/software-as-a-medical-device.
Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) are not applicable to this type of submission.
Here's a breakdown of what can be extracted and how it relates to the request:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) of this nature, the "acceptance criteria" revolve around demonstrating that the new device (SMF Hip Stem line additions - sizes -1 and 0) is substantially equivalent to predicate devices (SMF Hip Stem cleared in K080625 and Anthology Hip Stem cleared in K052792). The "performance" is demonstrated through a comparison of features and review of non-clinical testing.
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance (Comparison) |
|---|---|
| Similar Indications for Use | ✓ (Subject device has similar indications for use to predicates) |
| Similar Stem Material | Ti-6Al-4V (Same as predicates) |
| Similar Tapered Stem Geometry | ✓ (Same as predicates) |
| Similar Medial Grit-Blasted Surface Finish | ✓ (Same as predicates) |
| Similar Proximal Porous Coating | ✓ (Same as predicates) |
| Similar Glass Bead Distal Tip | ✓ (Same as predicates) |
| Similar Neck Taper | 12/14 (Same as predicates) |
| Similar Standard and High Offset Options | ✓ (Same as predicates) |
| Similar Polished Neck Area | ✓ (Same as predicates) |
| Review of Performance Testing | "Fatigue strength testing has also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." Specific thresholds or numerical results are not provided in this summary. |
| No significant changes in overall design philosophy, intended use, and material choices | "Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission relies on demonstrating substantial equivalence through a comparison of device features and non-clinical performance testing (e.g., fatigue strength), not clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth from experts on clinical data is mentioned as this is a device modification based on substantial equivalence and non-clinical testing. The "experts" would likely be the engineers and regulatory personnel involved in the design and testing, and the FDA reviewers.
4. Adjudication method for the test set
- Not Applicable. No clinical 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
- Not Applicable. This is a physical medical device (hip stem), not an AI/software device.
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/AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is the established performance and safety of the predicate devices and the results of non-clinical engineering tests (e.g., fatigue strength). The expectation is that because the new device is structurally and functionally equivalent to the predicate (with only minor changes to size offerings and neck type), it will perform safely and effectively in the same manner. This is based on engineering testing standards and comparison to legally marketed devices.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this physical device submission.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this submission type.
In summary: The provided document is a 510(k) submission for substantial equivalence. It is not an AI/software or novel device submission that would typically involve the detailed clinical study and performance metrics you've asked for. The "acceptance criteria" and "proof" are fulfilled by demonstrating that the new device is essentially the same as already cleared devices, supported by review of standard non-clinical performance data.
§ 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.