(28 days)
The SL PLUS® MIA Stem with and without Ti/HA 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.
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.
The SL PLUS° MIA Stem with and without Ti/HA is for single use only and is intended to be implanted without bone cement.
The SL-PLUS MIA Femoral Stem with Ti/HA is based on the uncoated design of SL-PLUS MIA Femoral Stem cleared via K082371. 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 Ti/HA coating is identical to the Ti/HA coating on the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K120211.
The document provided is a 510(k) premarket notification for a medical device (SL-PLUS® MIA Femoral Stem with Ti/HA) and not a study describing the performance of an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this submission.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through a comparison of technological characteristics and, in the case of implantable devices, mechanical testing to ensure the device can withstand expected in vivo loading. It does not involve a clinical study as would be performed for a novel AI/ML algorithm.
However, I can extract the relevant information that is present in the document.
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the nature of this 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and withstanding mechanical stresses. The "reported device performance" is not a quantitative clinical outcome here, but rather a successful demonstration of mechanical integrity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Demonstrated through comparison of design, materials, and indications for use. |
| Capability to withstand expected in vivo loading without failure | Indicated by successful Stem Fatigue Testing and Neck Fatigue Testing. |
Study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is described as a set of mechanical tests and a substantive equivalence comparison with predicate devices.
- Mechanism of Proof: The 510(k) submission relies on demonstrating substantial equivalence to previously cleared predicate devices and performing specific mechanical tests to ensure the device's structural integrity.
- Tests Performed:
- Stem Fatigue Testing
- Neck Fatigue Testing
- Surface characterization (physical, chemical, or mechanical) are discussed in the Ti/HA Coating Master File MAF - 1762, Amendment 1 (though not detailed in this specific dossier).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: This is not applicable in the context of this 510(k) submission for a hip implant. The "test set" would refer to the mechanical test specimens. The document does not specify the number of specimens used for fatigue testing.
- Data Provenance: Not applicable in the context of an AI/ML study. The data provenance here would be standard engineering test data, likely generated in a lab setting by the manufacturer.
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 AI/ML sense, is not established for this type of device submission. The "ground truth" for mechanical testing is primarily objective measurements against engineering standards.
4. Adjudication method for the test set:
- Not applicable. This concept applies to human expert review in diagnostic studies, not mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an AI algorithm.
7. The type of ground truth used:
- Ground Truth (for mechanical testing): The "ground truth" here is the physical integrity and durability of the implant as measured by engineering standards (e.g., fatigue life, strength). The test results are compared against established industry standards or internal specifications that ensure the device can function as intended in the body.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm, so there is no training set or ground truth to establish 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.