(112 days)
The SLR-PLUS Hip Stem is 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; old, remote osteomyelitis 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 Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.
Subject of this Traditional 510(k) premarket notification is the SLR-PLUS Standard and Lateral Femoral Stems. The subject devices are intended for primary hip arthroplasties and to replace previously failed femoral hip arthroplasties. The SLR-PLUS Standard Femoral Stems are designed for prosthetic arthroplasty in primary and revision surgery. The SLR-PLUS Lateral stem has been designed to optimize the lateralization of the femur (offset) in hip arthroplasty surgery. Both stems are manufactured from Ti-6Al-7Nb titanium alloy.
The provided document is a 510(k) summary for a medical device (femoral stems), and it does not describe an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device evaluations, such as ground truth, sample sizes for training/test sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable.
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing.
Here's an attempt to answer the questions based solely on the provided text, recognizing the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance | Comments |
|---|---|---|
| Neck fatigue testing per ASTM F 2068-03 | Implied to meet or exceed. | "A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure." |
| Neck fatigue testing per ISO 7206-6 | Implied to meet or exceed. | "A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure." |
| Distal fatigue testing per ISO 7206-4/8 | Implied to meet or exceed. | "A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure." |
| Range of Motion per EN ISO 21535 | Implied to meet or exceed. | (See above) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical tests. The data provenance is not mentioned, but it would typically be from laboratory testing rather than clinical data for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable for a mechanical device. The "ground truth" for mechanical testing is established by compliance with the specified international standards (ASTM and ISO). No human experts are used to interpret the "ground truth" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Mechanical tests have objective outputs that are compared directly to standard specifications, not adjudicated by human experts.
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 device is a physical hip stem, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical hip stem, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of this device is adherence to mechanical performance standards (ASTM F 2068-03, ISO 7206-6, ISO 7206-4/8, EN ISO 21535). The performance is assessed against the requirements and specifications defined in these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.