(227 days)
· 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, atthritis 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.
The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
The REDAPT Anteverted Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the REDAPT Anteverted Cemented Liner, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit, quantitative acceptance criteria for novel performance. However, it does mention various mechanical tests and their successful completion, which imply meeting internal or industry-standard acceptance criteria.
| Acceptance Criterion (Implicit/General) | Reported Device Performance (as stated or implied) |
|---|---|
| Withstanding expected in vivo loading | "A review of the mechanical data indicates that the REDAPT Anteverted Liners are capable of withstanding expected in vivo loading without failure." (Page 4) |
| Fatigue performance | Performed, implied success for substantial equivalence. (Page 4) |
| Push out, Lever Out, Torque-to-Failure | Performed, implied success for substantial equivalence. (Page 4) |
| Range of Motion | Performed, implied success for substantial equivalence. (Page 4) |
| Impingement | Performed, implied success for substantial equivalence. (Page 4) |
| Wear performance | "Wear performance of the cross-linked polyethylene liners are substantially equivalent to the REDAPT 0-Degree Liners in K150790 and the REFLECTION Liners in K002747." (Page 4) |
| Sterility/Endotoxin | "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance..." (Page 4) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for the mechanical tests. For medical devices like hip liners, samples often refer to the number of devices tested. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are in vitro mechanical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a mechanical implant, and the "ground truth" for its performance is established through objective engineering standards and mechanical testing, not expert clinical consensus or interpretation of images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints. Mechanical tests have pass/fail criteria based on engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a hip implant, not an AI diagnostic device. An MRMC study is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. Its performance is assessed through its physical properties and mechanical behavior.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through established engineering principles, material specifications (e.g., ASTM F648 for highly cross-linked polyethylene), and industry-standard mechanical testing protocols. These tests simulate in vivo conditions to assess properties like fatigue, push-out strength, lever-out resistance, torque-to-failure, range of motion, impingement, and wear. The success criteria are typically defined by these standards or comparative data from predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.