(260 days)
The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System is intended for cementless applications.
The Renovis Tesera Trabecular Technology (T3) Acetabular Shell System ("T" Acetabular Shell System") acetabular shells ("T" shells") are modifications of the Renovis A400 Surgical Hip Replacement System acetabular shells cleared through premarket notification K112897. This submission proposes the following design change: The proposed T shells will be manufactured from the same titanium alloy using an additive manufacturing process to fabricate the implant and porous structure concurrently, and have a thicker solid substrate and porous layer. The T shells are to be used with polyethylene liners, femoral components, acetabular shell trials, and other system specific instruments originally cleared in the Renovis A400 Surgical Hip System (K112897). The T shell is available in multiple configurations (no hole shell; cluster hole shell) and sizes (44 - 66 mm diameter). The liners attach to the shells under impaction with a snap lock mechanism.
Here's a summary of the acceptance criteria and the study information for the Renovis Tesera Trabecular Technology (T3) Acetabular Shell System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|---|
| Shear Testing of Coatings | ASTM F1044-05 (2011) | Successfully conducted |
| Shear and Bending Fatigue Testing of Coatings | ASTM F1160-05 (2011) | Successfully conducted |
| Tension Testing of Coatings | ASTM F1147-05 (2011) | Successfully conducted |
| Stereological Evaluation of Porous Coatings (Volume Porosity, Average Pore Size, Interconnecting Porosity, Porous Coating Thickness) | ASTM F1854-09 (compliance with 21 CFR 888.3358 requirements) | Demonstrates compliance with reqs. |
| Abrasion Resistance of Metallic Thermal Spray Coatings | ASTM F1978-12 | Successfully conducted |
| Acetabular Shell Fatigue Testing | Renovis protocol and ASTM F1820-97 (compared to a predicate device) | Successfully conducted |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided document. The performance tests (e.g., ASTM standards) imply defined sample sizes as per the respective standard protocols, but these specifics are not detailed here.
- Data Provenance: The document describes bench (laboratory) testing of the device. This is a controlled environment, not human-patient data. Therefore, notions of country of origin or retrospective/prospective study design are not applicable in the human clinical sense.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Not Applicable. The ground truth for this device's performance is established by engineering tests against recognized industry standards (ASTM standards) and regulatory requirements (21 CFR 888.3358). There's no mention of human experts establishing ground truth for the test set in the context of diagnostic interpretation.
4. Adjudication Method (Test Set)
- Not Applicable. As the tests are based on objective engineering measurements against defined standards, an adjudication method for human interpretations is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document describes a traditional 510(k) submission for a medical implant (acetabular shell system), which focuses on demonstrating substantial equivalence to predicate devices primarily through design comparison, material standards, and bench performance testing. It does not involve diagnostic imaging or human interpretation, and thus, an MRMC study is not relevant or reported.
6. Standalone Performance Study (Algorithm Only)
- Not Applicable. This is a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance listed in the table relates to the physical and mechanical properties of the implant itself.
7. Type of Ground Truth Used
- Engineering Standards and Regulatory Compliance: The ground truth for the device's performance is established by demonstrating compliance with established ASTM (American Society for Testing and Materials) standards for material properties, coating performance, and fatigue resistance, as well as adherence to specific regulatory requirements outlined in 21 CFR 888.3358 for porous coating characteristics.
8. Sample Size for the Training Set
- Not Applicable. This device is a manufactured physical implant. The concept of a "training set" typically applies to machine learning algorithms. Design, material selection, and manufacturing processes for this device are based on established engineering principles and materials science, not on a machine learning training set.
9. How Ground Truth for Training Set Was Established
- Not Applicable. As there is no "training set" in the context of a machine learning algorithm, there is no corresponding method for establishing its ground truth. The design and manufacturing are based on established validated engineering and materials science principles and previous regulatory clearances (predicate devices).
§ 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.