(119 days)
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 or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, 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.
Subject of this Abbreviated 510(k) premarket notification is the Modular Proximally Fluted Hip Stem. The subject device is a line addition to the MDF Revision Hip System cleared via premarket notification K081124. The Modular Proximally Fluted Hip Stem is a straight, tapered, distally fixed stem with a modular female 12/14 neck taper. The subject device is manufactured from titanium alloy (Ti-6Al-4V) and has a grit-blast finish. The stems will be available in lengths of 240mm and 300mm in sizes 12-27. The subject devices will mate with the cobalt chrome modular necks cleared with the MDF Revision Hip Stems in premarket notification K081124, but are not designed to utilize the modular sleeves included as part of the MDF Revision Hip System.
The provided text describes the Smith & Nephew Modular Proximally Fluted Hip Stem, an orthopedic implant. However, it does not contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria in the context of an AI/ML device.
The document discusses performance data related to the mechanical integrity of the hip stem, not an AI or software-based medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, AI multi-reader multi-case studies, ground truth for training) are not applicable to the content provided.
Here's a breakdown of the information that can be extracted, and where the requested information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical fatigue (e.g., environmental corrosion fatigue, fatigue strength) | "A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." Specific quantitative raw values for resistance to fatigue are not provided, only a general statement of satisfactory performance. |
| Post-fatigue pull-off strength | "A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." Specific quantitative raw values are not provided. |
| Range of Motion | "The range of motion of the subject device was also evaluated." Specific quantitative raw values are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Performance testing has been conducted," but does not mention the number of units tested.
- Data Provenance: Not applicable in the context of patient data for an AI/ML device. For the mechanical tests, the data was generated internally by Smith & Nephew.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This is a mechanical device, and "ground truth" in the AI/ML sense (e.g., expert consensus on images) is not relevant. The "review of the testing and analysis" would have been performed by engineers or scientists familiar with the test methods and device specifications.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. This refers to consensus building among experts for labeling data, which is not relevant for mechanical testing of a hip stem.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. The document explicitly states "Clinical data was not needed to support the safety and effectiveness of the subject devices." MRMC studies are relevant for evaluating diagnostic software where human readers are involved.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- Not applicable. This device is not an algorithm.
7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the mechanical performance of the device would be the physical properties and behavior of the tested samples as measured against predetermined engineering specifications and industry standards (e.g., ISO standards for implants, though not explicitly cited, the guidance documents imply this). This is not "expert consensus" or "pathology" in the medical sense.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
Summary of what the document does provide regarding performance and equivalence:
- Guidance Documents: Performance testing was conducted in accordance with:
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant Components, dated May 1995
- Tests Performed: Environmental corrosion fatigue, post-fatigue pull-off, fatigue strength testing, and range of motion evaluation.
- Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to the predicate device (MDF Revision Hip Stem, K081124) by showing similarities in materials (Ti-6AL-4V), intended/indications for use, sterilization, overall design philosophy, and performance, despite minor modifications (e.g., size offerings, absence of modular sleeves). The "Conclusion" explicitly states this.
- Clinical Data: No clinical data was required or used to support the safety and effectiveness of this device.
§ 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.