(127 days)
The Taper 2™ Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• Revision of previously failed femoral head resurfacing component.
Taper 2™ Porous Femoral Stems are intended for uncemented use only.
The Taper 2™ Porous Femoral Stem is a short, tapered stem, designed to provide Device Description: The Tapel 2 - Porous Femoral Seem of Children Station of Services of Services of Services
This 510(k) pertains to a medical device, specifically a femoral stem for hip replacement, and thus the acceptance criteria are not related to diagnostic performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Technologies & Non-Clinical Testing) |
|---|---|
| Same Intended Use | Taper 2™ Porous Femoral Stems are indicated for non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, treatment of non-union/fractures, and revision of failed resurfacing components. This aligns with or is sufficiently similar to the predicate devices. |
| Similar Technological Characteristics | "The Taper 2™ Porous Femoral Stem is a short, tapered stem, designed to provide similar patient benefits to the predicate devices." (Implicitly, materials, design principles, and manufacturing are similar). |
| Performance Data Demonstrating Equivalence | "Testing utilized the same manufacturing, packaging and the predicate stems." |
| "Reference literature and performance data demonstrate that the Taper 2™ Porous Femoral Stems are equivalent to the predicate femoral hip stems." (This refers to non-clinical testing, likely mechanical and material properties). |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the context of clinical performance data using patient data. For medical devices like prosthetic implants, validation primarily relies on non-clinical testing (e.g., mechanical, material, and sometimes in-vitro studies) to demonstrate safety and effectiveness and substantial equivalence to existing devices.
- Sample Size: The document does not specify exact sample sizes for non-clinical tests. It refers to "testing" and "performance data," which would typically involve multiple samples of the device and predicate devices for mechanical and material characterization.
- Data Provenance: Not applicable in the context of patient data. The "provenance" here is in-house testing by the manufacturer and reference to existing scientific literature ("Reference literature" mentioned).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study that establishes ground truth through expert review of patient data. The ground truth for device performance is established through engineering and scientific testing standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring adjudication by experts in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a prosthetic implant and does not involve human-in-the-loop diagnostic tasks. Therefore, no effect size of human readers' improvement with AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is not an algorithm or AI system. It is a physical medical implant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Engineering Standards and Specifications: The device is designed and tested to meet specific mechanical strength, fatigue life, and material composition standards relevant to orthopedic implants.
- Biocompatibility Standards: Materials are tested to ensure they are biocompatible and do not elicit adverse reactions in the body.
- Comparison to Predicate Devices: Performance is measured against established predicate devices, which have a known history of safe and effective use. The "performance data" and "reference literature" mentioned likely refer to these types of evaluations.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of medical device submission. The device is designed, manufactured, and tested, not "trained" like a machine learning 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.
§ 888.3350 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.