(118 days)
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
- Previously failed hip surgery.
- Proximal femoral neck fractures or dislocation.
- Idiopathic avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Treatment of fractures that are unmanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.
Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating. The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.
This document describes the Entrada™ Hip Stem, a hip arthroplasty device, and its acceptance criteria for substantial equivalence to legally marketed predicate devices. The information provided is from a 510(k) Premarket Notification to the FDA.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance
Unfortunately, the provided document does not explicitly state specific numerical acceptance criteria for the mechanical tests. It only lists the types of tests performed and generally concludes that the device "met the predetermined acceptance criteria" and that "The mechanical test results demonstrate that Entrada™ hip stem is safe and effective."
| Test Type | Acceptance Criteria (Not explicitly stated with numerical values) | Reported Device Performance |
|---|---|---|
| Proximal fatigue | Implied to meet safety and effectiveness standards | Met predetermined criteria |
| Distal fatigue | Implied to meet safety and effectiveness standards | Met predetermined criteria |
| Range of motion | Implied to meet safety and effectiveness standards | Met predetermined criteria |
| Bacterial endotoxin | Met predetermined acceptance criteria (LAL pyrogen testing) | Met predetermined criteria |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states that mechanical tests were "conducted on the worst-case configurations of Entrada™ hip stem." However, it does not specify the numerical sample size for these tests (e.g., number of stems tested for fatigue).
- Data Provenance: This was a non-clinical study involving mechanical testing of the device itself. Therefore, concepts like country of origin for patient data or retrospective/prospective clinical data do not apply. The data was generated in a laboratory setting.
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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 question is not applicable as the studies performed were non-clinical mechanical tests, not clinical studies requiring expert ground truth for interpretation of patient data. The "ground truth" for mechanical testing is adherence to established engineering standards and performance targets.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there were no clinical studies or human interpretation of diagnostic data that would require an adjudication method.
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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
This question is not applicable. No clinical studies, and specifically no MRMC studies involving human readers or AI assistance, were performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical hip stem, not an algorithm or AI software. Therefore, there is no standalone algorithm performance to evaluate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the "ground truth" is based on established engineering standards, biomechanical principles, and the performance characteristics of predicate devices. The tests aim to demonstrate that the Entrada™ Hip Stem meets performance criteria consistent with devices already on the market and considered safe and effective.
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The sample size for the training set
This question is not applicable. As this device is a physical hip stem and the studies were non-clinical mechanical tests, there is no concept of a "training set" like there would be for an AI algorithm.
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How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
§ 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.