(147 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 MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
The MDF Revision Hip System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete MDF Revision Hip System construct. The Extra Small (XSM) Modular Sleeve line additions mate with similar size femoral stems in the MDF Revision Hip System and lock onto the proximal end of the stem. The XSM Modular Sleeves are manufactured from titanium alloy (Ti-6Al-4V). The XSM MDF Modular Sleeve line additions are grit-blasted and contain a threaded surface with a hydroxylapatite (HA) coating applied by a plasma spray technique.
This document describes a 510(k) premarket notification for the "Smith & Nephew MDF Modular Sleeve" hip implant component, a medical device. The information provided heavily focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and results against those criteria in the way one might expect for a novel AI device or a device with new functional claims.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this type of regulatory submission. The "performance data" section refers to non-clinical (mechanical) testing, not clinical performance or AI/software performance.
Here's an attempt to answer based on the provided text, noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence of a medical device (hip implant component) and not an AI or software-driven device, the "acceptance criteria" and "reported device performance" are primarily related to mechanical and material characteristics and adherence to established guidance documents for non-clinical testing, rather than metrics like sensitivity, specificity, or accuracy against a ground truth. The acceptance criteria are implicitly met by demonstrating compliance with the referenced guidance documents and by showing that the new device's design, materials, and intended use are comparable to predicate devices.
| Acceptance Criteria (Implied by Guidance) | Reported Device Performance (as stated in submission) |
|---|---|
| Compliance with "Non-Clinical Information for Femoral Stem Prostheses" (2007) | "Performance testing has been conducted for the subject devices in accordance with the following guidance documents..." (including this one) |
| Compliance with "Draft Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components" (1995) | "...Performance testing has been conducted for the subject devices in accordance with the following guidance documents..." (including this one) |
| Compliance with "Calcium Phosphate (Ca-P) Coating Draft Guidance Document..." (1997) | "...Performance testing has been conducted for the subject devices in accordance with the following guidance documents..." (including this one) |
| Absence of new issues related to safety or effectiveness post-testing | "A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." |
| Substantial equivalence in overall design, intended use, and material choices to predicate devices | "The overall design... is substantially equivalent to the modular sleeves that currently exist as part of the MDF Revision Hip System cleared via K081124. The XSM Modular Sleeves utilize an HA coating on a grit blasted surface... and are substantially equivalent to the Synergy Press Fit Stem (K970337)... no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices." |
| Materials (Substrate, Roughened Coating, HA Coating) matching predicate or accepted standards | Subject K100481: |
- Substrate: Ti-6Al-4V per ASTM F1472
- Roughened Coating: N/A; substrate is grit-blasted
- HA Coating: HA Coated per ASTM F1185
(These align with or are found in predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document describes non-clinical performance testing (e.g., corrosion fatigue, dissociation testing of mechanical components), not a clinical study involving patients or a test set of data for an AI algorithm. The "test set" would refer to the physical devices subjected to mechanical testing. The specific number of devices tested is not provided in this summary but would be detailed in the underlying test protocols and reports.
- Data Provenance: Not applicable. This refers to non-clinical laboratory testing of hip implant components. No human patient data is discussed.
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 context of AI or diagnostic studies, is not relevant here. The "ground truth" for mechanical performance is implicitly defined by the physical properties of the materials and the engineering standards (ASTM, guidance documents) against which the device is tested.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study assessing human reader performance or diagnostic accuracy.
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-driven device or study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-driven device or study.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is established by engineering standards and guidance documents (e.g., ASTM standards for materials, FDA guidance for non-clinical testing of femoral stems and modular components). The performance data (e.g., environmental corrosion fatigue, pre-fatigue dissociation, post-fatigue dissociation) is evaluated against the requirements set forth in these documents to ensure safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI-driven device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set for this type of medical device submission.
§ 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.