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The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatic arthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function.

· Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is a tricompartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component. The product design incorporates a bone preserving approach for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. The joint restoring design provides for more natural kinematics by maintaining the patient specific femoral sagittal curves, preserving the patient specific femoral offset, preserving the medial and lateral joint lines and having a patient specific fit. It is intended for use in those patients whose condition cannot be appropriately or effectively addressed using a device that treats only one or two compartments of the knee (i.e. a unicompartmental, bicompartmental, or patellofemoral prosthesis).

Using patient imaging (CT scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of an uncemented metallic device designed from the patient's natural bone geometry. The femoral component is additively manufactured from a cobalt chromium molybdenum ("CoCrMo") alloy. The tibial tray is additively manufactured from titanium ("Ti-6Al-4V") alloy. The tibial inserts are manufactured and offered in either ultra-high molecular weight polyethylene (iPoly®) or highly crosslinked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly® XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly®) with a porous Ti6Al4V metal backing. The femoral, tibial, and patellar implants are additively manufactured using proprietary TIDAL Technology™ which allows biological fixation without the need for bone cement. The iTotal® ldentity™ CR 3DP Porous KRS is designed for press-fit use without cement, but may be used with a cemented technique if desired.

The iTotal® Identity™ CR 3DP Porous KRS is supplied with disposable, patient-specific instrumentation (ilig®) designed for use with the system. These patient-specific guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. Each set of instruments is designed for one-time use, specifically for one patient. The iJig® instrument set is manufactured from biocompatible nylon material and supplied sterile along with the implants.

The provided text describes a medical device, the "iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System," and its submission for FDA 510(k) clearance. However, it explicitly states that "No clinical testing was warranted for the subject device."

This means that the information you requested regarding acceptance criteria and the study that proves the device meets those criteria cannot be found in this document because a clinical study was not conducted or submitted for this particular clearance.

Therefore, I cannot provide the following information:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set.
4. Adjudication method for the test set: No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as no clinical study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical implant, not a software algorithm.
7. The type of ground truth used: No clinical ground truth established.
8. The sample size for the training set: No clinical training set.
9. How the ground truth for the training set was established: No clinical training set.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluation, which includes various biomechanical and material tests. These non-clinical tests are listed, but their specific acceptance criteria and detailed results are not provided in this summary.

Non-Clinical Performance Evaluation (as listed in the document):

• Patella static tensile test
• Patella static shear test
• Patella shear fatigue test
• Tibial tray fatigue test
• Femoral fatigue test
• Tibial micromotion
• Tibiofemoral constraint test
• Tibiofemoral contact area, stress and wear test
• Tibial interlock test
• Patellofemoral subluxation, contact area and stress test
• Particle characterization
• Porous coating testing per FDA guidance on modified metallic surfaces
• Biocompatibility assessment

Conclusion from the document: "The results of the testing demonstrate that the subject device iTotal® Identity™ CR 3DP Porous KRS is as safe and effective and is substantially equivalent to the cleared predicates... and the differences between the subject and predicates do not raise different questions of safety or effectiveness."

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The Kinos Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Total Ankle System is intended for cement use only.

The subject Kinos Total Ankle System consists of implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion- extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The subject line extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

This document is a 510(k) Summary for the Kinos Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML-driven device.

The Kinos Total Ankle System is a physical medical device (an ankle prosthesis), and the submission is for an expansion of indications for use. The performance testing section specifically states: "No performance testing was performed to establish substantial equivalence of the subject device to the predicates." Instead, a "dimensional analysis comparison of device components and a surgical technique comparison" was conducted.

Therefore, I cannot provide the requested information, as the provided text relates to a traditional medical device and its regulatory submission, not a study validating an AI/ML device's performance against specific acceptance criteria.

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