(177 days)
The SL-PLUS° Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SL-PLUS* Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).
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 Standard and Lateral Stems with Ti/HA are based on the uncoated design of SL-PLUS® Standard and Lateral Femoral Stems cleared via K072852. The subject stems are made from forged titanium alloy Ti-6Al-4Nb with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.
The provided document is a 510(k) summary for the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical effectiveness studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement with AI.
Therefore, many of the requested elements (sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types and establishment methods) are not applicable or not explicitly stated in this document as it pertains to a medical device clearance process for a hip implant, not an AI/algorithm-based diagnostic device.
However, I can extract the information relevant to the substantial equivalence determination for this device, which serves as its "acceptance criteria" in the context of this 510(k) submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome | Reported Device Performance (Summary of Study Results) |
|---|---|---|
| Material & Design | Overall design, materials, and indications for use substantially equivalent to predicate. | "Based on the similarities to the predicate components..." |
| Mechanical Strength | Capable of withstanding expected in vivo loading without failure. | "A review of the mechanical data indicates that the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure." |
| Specific tests performed: Stem Fatigue Testing, Neck Fatigue Testing. | ||
| Surface Characterization | Physical, chemical, or mechanical properties of the Ti/HA coating meet established standards. | "...discussed in detail in the Ti/HA Coating Master File MAF – 1762, Amendment 1 and are not included in this dossier." (Implies satisfactory data exists in the master file). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes a mechanical device (femoral stem). The "test set" in this context refers to the physical devices subjected to mechanical testing, not a dataset of patient samples or images for an AI/diagnostic algorithm. The document does not specify the number of stems tested, only the types of tests performed.
- Data Provenance: The tests are likely laboratory-based mechanical tests conducted at Smith & Nephew Orthopaedics AG or a contracted lab. Country of origin for the data is not specified but implicitly related to the manufacturing/testing location of Smith & Nephew (stated as Cordova, Tennessee, and Smith & Nephew Orthopaedics AG, which suggests global operations).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No experts (e.g., radiologists) were used to establish "ground truth" in the context of a diagnostic test set, as this is a hip implant. The "ground truth" for a mechanical device is its ability to meet engineering specifications and withstand forces, which is assessed through standardized mechanical testing, not expert consensus.
4. Adjudication method for the test set:
- Not Applicable. As there's no expert consensus or diagnostic test set, an adjudication method is not relevant. Mechanical test results are typically evaluated against pre-defined engineering standards.
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 medical device (hip implant), not an AI diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- Engineering Specifications and Industry Standards: For the mechanical aspects (fatigue testing), the "ground truth" is adherence to established engineering specifications and industry standards for orthopedic implants, ensuring the device can withstand in vivo loading.
- Predicate Device Characteristics: For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the legally marketed predicate devices (SL-PLUS® Standard and Lateral Femoral Stems K072852, and POLARCUP® Dual Mobility System K110135). The new device is compared directly to these.
8. The sample size for the training set:
- Not Applicable. No training set exists as this is a mechanical device, not an AI algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth established for it.
§ 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.