(207 days)
The REDAPT Augments are indicated for:
· Hip components are 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 (NIDID) 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; 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,
REDAPT Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface.
Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.
Smith & Nephew has developed the subject REDAPT Blade Augments as a modification to the previously marketed and cleared REDAPT Augments (S.E. K171073 (S.E. 11/21/2017)). Both the subject REDAPT Blade Augments and the existing REDAPT Augments are porous acetabular augments used to fill bone voids (superior/posterior) where significant bone loss is present and a cup alone cannot fill the void. The subject REDAPT Blade Augments are made of titanium alloy (Ti-6A1-4V) using the same additive manufacturing methods and materials as the predicate REDAPT Augments.
The purpose of this 510(k) submission is to add additional geometry augments to the Smith & Nephew REDAPT family of Total Hip System implants.
The provided text describes a 510(k) premarket notification for the REDAPT Blade Augments, a medical device for hip replacement surgery. The submission claims substantial equivalence to a previously cleared device, the REDAPT Augments (K171073).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Strength | The subject REDAPT Blade Augment devices met the pre-determined acceptance criteria for each intended output. |
| Post-Fatigue Lever-out | The subject REDAPT Blade Augment devices met the pre-determined acceptance criteria for each intended output. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set (e.g., number of specific augments tested). It mentions mechanical verification testing/analysis was conducted. The data provenance is "mechanical verification testing/analysis" performed by Smith & Nephew, Inc. No information regarding country of origin or retrospective/prospective nature is provided for the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study described is mechanical verification testing, not an assessment requiring expert clinical or imaging review.
4. Adjudication method for the test set
This information is not applicable and therefore not provided, as the study involves mechanical testing against pre-determined acceptance criteria, not expert adjudication of clinical outcomes or imaging.
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
There is no mention of an MRMC comparative effectiveness study, human readers, or AI in the provided text. This device is a physical hip implant component, and the testing described is mechanical verification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the mechanical testing was the pre-determined acceptance criteria for fatigue strength and post-fatigue lever-out.
8. The sample size for the training set
This information is not provided and is not applicable to the type of device and testing described. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable. The device is not an AI/ML algorithm.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.