(88 days)
The Tigran TM Hip Prosthesis for total hip arthoplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The Tigran TM Hip Prosthesis is designed for implantation into the human femur in total or hip replacement and is indicated for the following:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
- Patients suffering from disability due to previous fusion;
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity:
- Patients with acute femoral neck fractures.
The Tigran™ Femoral Prosthesis for hip arthroplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The femoral stem is made from Titanium Ti-6A1-4V Alloy, a high fatigue strength material with a long history of clinical use and exceptional The surface of the femoral stem is prepared with a surface finish and biocompatibility. pattern to provide optimal initial and lasting fixation in bone. The femoral stem has a collar and is modular in design, incorporating a Morse-type tapered neck and utilizing modular femoral heads. The Femoral stem is straight and with a rectangular crosssectional shape to provide optimal, rotational stability. The Tigran™ Prosthesis Femoral Stem is available in four neck sizes (short, medium, long and extra long).
The femoral head is fabricated from Cobalt-Chromium-Molybdenum Alloy and comes in three neck configurations (short, medium and long) and in one head diameter (28mm). The various neck lengths provided allow this prosthesis to fit different variations found in the human femora.
The titanium and chrome-cobalt alloy components can be used together, although they are made from dissimilar alloys. In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys are coupled.
Special instruments are available to assist in mating, disassembling, and the accurate installation of the implant components.
The Tigran™ Femoral Prosthesis (femoral stem and head) may be used with any acetabular prosthesis with an articulating surface made of ultra high molecular weight polyethylene (UHMWP) and designed to be used with a 28 mm CoCrMo Alloy femoral head.
The provided text describes a 510(k) summary for the Tigran™ Hip Prosthesis. However, it does not include detailed information regarding specific acceptance criteria, studies proving device performance against those criteria, sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for ground truth, which would typically be found in a more comprehensive clinical trial report or a detailed premarket approval (PMA) submission.
The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than providing detailed performance data against specific acceptance criteria.
Here's an analysis of what information is available related to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document implies the acceptance criteria are met if the device demonstrates "substantial equivalence" to predicate devices and passes "appropriate testing standards / requirements" for mechanical testing, and shows "safety and performance" through clinical testing. No specific performance thresholds, such as a minimum tensile strength, fatigue life, or clinical success rate, are provided.
- Reported Device Performance:
- Non-Clinical (Mechanical): "Non-clinical mechanical testing was performed to demonstrate that the femoral stem met or exceed the appropriate testing standards / requirements." No specific quantitative results (e.g., actual fatigue life, material properties) are reported.
- Clinical: "Long-term clinical testing was performed and reported on to demonstrate the safety and performance of the Tigran™ Hip Prosthesis." Again, no specific quantitative outcomes (e.g., revision rates, pain scores, functional outcome measures) are reported.
- Electrochemical Corrosion: "In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys are coupled." This is a qualitative statement of performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K964769, K915594) | "The Tigran ™ Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594)." This is the primary regulatory acceptance criterion for a 510(k). The document further states differences between the proposed device and predicate devices are not significant. |
| Compliance with appropriate mechanical testing standards/requirements for femoral stem | "Non-clinical mechanical testing was performed to demonstrate that the femoral stem met or exceed the appropriate testing standards / requirements." (Specific standards or results not provided). |
| Safety and performance shown through clinical testing | "Long-term clinical testing was performed and reported on to demonstrate the safety and performance of the Tigran™ Hip Prosthesis." (Specific outcomes or results not provided). |
| No detrimental electrochemical changes between dissimilar alloys | "In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys [titanium and chrome-cobalt alloy] are coupled." (Specific study details not provided). |
| Compliance with general controls provisions of the Act (e.g., annual registration, listing, GMP, labeling) | The FDA letter (page 3) confirms the device can be marketed subject to these provisions, indicating that the submission was deemed compliant in principle. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions "Long-term clinical testing was performed and reported on," but provides no details about the study design, number of patients, or geographic location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable as the document does not describe a study involving expert review for establishing ground truth, such as in image analysis or diagnostic AI. Instead, it refers to clinical testing for a physical orthopedic implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the document does not describe a study involving expert review for establishing ground truth.
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
- This question is not applicable. The device is a hip implant, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical testing, the "ground truth" would likely be based on patient outcomes data, considering the nature of a hip prosthesis. This would typically involve measures like revision rates, pain relief, functional scores, and radiographic evidence of proper fixation and absence of complications over time. However, the document only states that the testing demonstrated "safety and performance" without detailing the specific outcome measures or the "ground truth" criteria.
- For mechanical testing, the "ground truth" would be established by engineering standards and specifications (e.g., ISO standards for orthopedic implants), which define acceptable performance limits for properties like fatigue strength, wear, and corrosion resistance.
8. The sample size for the training set
- This question is not applicable. The device is a physical hip implant. The concept of a "training set" is typically associated with machine learning or AI models, which is not relevant here.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
In summary, the provided 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" to predicate devices, rather than a detailed scientific publication outlining specific performance criteria and comprehensive study results. Many of the questions about detailed study design, sample sizes, and ground truth establishment are not addressed in this type of document.
§ 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.