(147 days)
The SL-PLUS® MIA Stem and the SL-PLUS® MIA Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:
Indications Standard Stem
The SL-PLUS MIA Hip Stem is 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.
Indications Lateral Stem
The SL-PLUS MIA Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
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; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS™ Stem and the SL-PLUS™ Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for:
Indications Standard Stem
The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head
Indications Lateral Stem
The SL-PLUS Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
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; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS® MIA Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ MIA Femoral Stem cleared via K122296. The subject stems are made from forged titanium alloy, Ti-6AI-7Nb, with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating form Medicoat AG is substantially equivalent to the Ti/HA coating on the SL-PLUS® MIA Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K122296.
The SL-PLUS® Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ Femoral Stem cleared via K120211. The subject stems are made from forged titanium alloy, Ti-6Al-7Nb, with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating form Medicoat AG is substantially equivalent to the Ti/HA coating on the SL-PLUS™ Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K120211.
This document describes the Smith & Nephew SL-PLUS™ MIA and SL-PLUS Femoral Stem with Ti/HA, which are hip joint femoral components. The provided text primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria. Therefore, much of the requested information cannot be extracted directly.
However, based on the available information, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "A review of the mechanical data indicates that the SL-PLUS™ MIA and SL-PLUS Femoral Stem with Ti/HA is capable of withstanding expected in vivo loading without failure." However, specific numerical acceptance criteria for mechanical data (e.g., maximum load, fatigue life, wear rates) and the corresponding reported performance values are not provided in this document.
| Acceptance Criteria (Example - Not explicitly stated in document) | Reported Device Performance (Implied) |
|---|---|
| Mechanical stability under expected in vivo loading | Capable of withstanding expected in vivo loading without failure. |
| Coating characteristics (physical, chemical, mechanical) | Substantially equivalent to predicate devices; discussed in Ti/HA Coating Master File MAF-2541. |
2. Sample size used for the test set and the data provenance:
The document refers to "mechanical data" and "HA powder and coating characterization X All tests which are in relation to the surface characterization (physical, chemical or mechanical)". It does not specify a "test set" in the context of clinical data or human subjects. The tests mentioned are laboratory-based mechanical and material characterization tests.
- Sample size: Not explicitly stated for specific tests.
- Data provenance: Laboratory testing (implied by "mechanical data" and "coating characterization"). This is not retrospective or prospective in the sense of clinical data from patients or countries of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a medical implant, and the assessment here is based on mechanical and material properties, not on diagnostic accuracy requiring expert interpretation of images or clinical outcomes. The "ground truth" for these tests would be the established engineering standards and material science specifications.
4. Adjudication method for the test set:
Not applicable, as this is related to expert consensus on clinical data, which is not the type of data presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images. This document pertains to a hip implant's mechanical and material equivalence.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not an algorithm or AI.
7. The type of ground truth used:
The ground truth used for demonstrating substantial equivalence and device performance appears to be based on:
- Established engineering specifications and test standards for mechanical integrity of orthopedic implants.
- Material science specifications for the titanium alloy and Ti/HA coating.
- Comparison to the properties and performance of legally marketed predicate devices, specifically the SL-PLUS™ MIA Standard and Lateral Femoral Stems with Ti/HA (K122296) and the SL-PLUS™ Standard and Lateral Femoral Stems with Ti/HA (K120211).
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of a physical medical implant whose assessment is based on mechanical and material testing.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set. The "ground truth" for the assessment of this device is based on scientific and engineering principles applied to mechanical and material testing, and comparison to predicate devices, as overseen by regulatory bodies like the FDA.
§ 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.