(458 days)
The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR):
- Non inflammatory or rheumatoid arthritis;
- Osteonecrosis of femoral head;
- Hip deformity affecting its function;
- Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques;
- Revision of previous hip surgery;
- Dislocation risks (e.g., ASA score ≥ 3)
The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
The TREGOR® Dual Mobility Acetabular System includes the acetabular components of a total hip prosthesis. Its design is based on the original 1976 Dual Mobility design developed by Prof. Bousquet: it uses two distinct articulating surfaces. The TREGOR® Dual Mobility Acetabular System is composed of a metal acetabular cup/shell and a dual mobility polyethylene insert. The articulating surfaces are: between the cup and the dual mobility insert, and between the dual mobility insert and the femoral head. The acetabular cup is made of wrought high nitrogen stainless steel (M30NW) for the cemented cup design (TREGOR® Medial Cup) and of Cobalt/Chromium alloy for all other cementless cup designs that are intended for a press-fit application. When used with cement, an acetabular reinforcement accessory with screws may also be used. When used without cement, the cup may include additional fixation aids (screws, pegs, blades) and includes a non-porous double coating. The plasma spray coating is made of pure titanium and hydroxyapatite (Ti/HA). The insert is made of ultra-high-molecular-weight polyethylene (UHMWPE).
There are five configurations of acetabular cups covering a wide range of sizes with dual mobility inserts compatible with 28 mm prosthetic femoral heads made of CrCo or ceramic:
- TREGOR® Standard (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application.
- TREGOR® 3 Blades (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades provide additional fixation.
- TREGOR® + (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades and screws provide additional fixation.
- TREGOR® Tripod (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Pegs and screw provide additional fixation.
- TREGOR® Medial Cup (5 sizes from 52 to 60 mm outer diameter): for cemented use only. An optional acetabular reinforcement cross is for cemented use only.
The device is single use and provided sterile.
This premarket notification does not include the femoral components. The TREGOR® Dual Mobility Acetabular System is compatible with FDA cleared StelKast femoral components: Provident, Protract and Progeny femoral stems with the femoral heads made of cobalt-chromium and ceramics, listed below. The femoral heads fully cover the morse taper of the femoral stem neck and the stems all have a polished, highly polished or electro-polished neck:
- Prosthetic head made of Cobalt-Chromium: 28 mm (StelKast reference SC1151: -5 mm, -3.5 mm, standard and +3.5 mm offset)
- Biolox Delta Femoral head: 28 mm (StelKast reference SC3347, -3.5 mm, standard and +3.5 mm offset)
The provided text describes a 510(k) summary for the TREGOR Dual Mobility Acetabular System, which is a hip prosthesis. The information focuses on demonstrating substantial equivalence to predicate devices and presents results from pre-clinical performance testing.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "All acceptance criteria were met" for a series of pre-clinical tests. However, it does not provide specific numerical acceptance criteria for each test, nor does it present specific measured performance values for the device. Instead, it offers a list of tests conducted.
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional and sizes analysis | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Static test of dual mobility insert dislocation pull-out | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Static test of dual mobility insert dislocation lever out | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Static and fatigue loading testing of the acetabular cup | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Range of motion analysis | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Jump distance analysis | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Holding of cemented cup under flexion and torsion loading | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Axial holding of tripod peg under loading | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Wear of polyethylene of dual mobility insert | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
| Dual Titanium and Hydroxyapatite coating characterization | Not specified (implied to meet predetermined specifications) | "All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Pre-clinical performance testing was conducted in accordance with various international standards and FDA guidance documents." However, it does not specify the sample size used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Given the nature of pre-clinical testing for medical implants, the "data provenance" would typically be a laboratory setting rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation relies on pre-clinical, mechanical, and material testing rather than expert-derived ground truth from clinical images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on pre-clinical, mechanical, and material testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data were not required for this device." This implies that the device's equivalence and safety/effectiveness were demonstrated through pre-clinical testing and comparison to predicate devices, without human-in-the-loop performance studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this device. The TREGOR® Dual Mobility Acetabular System is a physical medical device (hip prosthesis), not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" doesn't apply.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering specifications and established international standards for implantable medical devices. Rather than expert consensus, pathology, or outcomes data (which would be clinical), the performance is evaluated against predefined parameters for mechanical strength, wear, dimensions, material properties, and stability.
8. The Sample Size for the Training Set
This information is not applicable. The TREGOR® Dual Mobility Acetabular System is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, the device is not an AI/ML model and therefore does not have a "training set."
§ 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.