Search Results

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

The subject Kinos Axiom Total Ankle System is an implant and instrument system 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 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 device is intended to be used with bone cement. The subject Kinos Axiom 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 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 tibial-talar joint. The subject line extension tibial implant is additively manufactured from Ti-6A1-4V (ASTM F2924) and features a modified stem for fixation into the tibia.

The provided text is a 510(k) Summary for the Kinos Axiom Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

Specifically, the document lists "Performance Testing" with bullet points for:

• Strength Testing per ASTM F2665
• Bone Stability Testing
• Porous Surface Characterization
• Biocompatibility per ISO 10993-1:2018

However, it does not provide:

• A table of acceptance criteria and reported device performance. It only lists the types of tests conducted.
• Sample sizes used for any test sets.
• Data provenance for any test sets.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Information on standalone algorithm performance.
• Type of ground truth used.
• Sample size for any training set.
• How ground truth for a training set was established.

Therefore, I cannot fulfill your request for this information based on the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed report of clinical or performance study results.

Ask a specific question about this device

The Axiom PSR System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Axiom PSR System is intended for use with the Kinos Axiom Total Ankle System and its cleared indications for use.

restor3d's Axiom PSR System is an ankle surgical guide system, designed for an individual patient from the patient's CT imaging scans. The subject Axiom PSR System is intended to aid in the placement of Kinos Axiom Total Ankle System (K192778) implant components when used in conjunction with the Kinos Axiom standard, reusable instruments. The Axiom PSR System includes preoperative plans developed with and approved by the operative surgeon, tibia and talus resection guides, manufactured from implant grade titanium, bone models manufactured from biocompatible polymer for use with the Kinos Axiom Total Ankle System.

The restor3d Axiom PSR System is a patient-specific surgical planning and instrumentation system designed to assist in the positioning of total ankle replacement components intraoperatively and in guiding bone cutting. The information provided does not include specific acceptance criteria with numerical thresholds. However, the study conducted aims to demonstrate that the Axiom PSR System is at least as accurate as, or more accurate than, the previously cleared Kinos Axiom Total Ankle System standard instruments alone, with respect to implant placement relative to the pre-operative plan in six degrees of freedom.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific numerical acceptance criteria. Instead, it states a comparative performance objective.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document mentions "cadaver testing" but does not specify the number of cadavers or individual surgical procedures performed.
• Data Provenance: Retrospective or Prospective is not explicitly stated, but "cadaver testing" implies a controlled, experimental setting, likely
  prospective for the purpose of the study. The origin (country/region) of the cadavers is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The ground truth ("pre-operative plans") is established as a digital design workflow, which is later compared to post-operative CT scans. The experts involved in creating these pre-operative plans and evaluating the post-operative scans are not specified.

4. Adjudication Method for the Test Set:

The document mentions that post-operative CT scans were obtained, and the final implant positions were evaluated in 3D space about six degrees of freedom and then compared to the pre-operative plans. It does not describe any specific multi-reviewer adjudication method (e.g., 2+1, 3+1). The evaluation method appears to be a direct comparison of physical outcomes (post-operative CT) to digital plans.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated or described. The study compared the device's performance to the standard method rather than comparing human readers with and without AI assistance. The "AI" aspect is in the patient-specific surgical planning and guiding, not in assisting human readers in diagnosis or interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

This aspect is not directly applicable in the typical sense of standalone AI performance for diagnostic algorithms. The Axiom PSR System is a surgical guidance system, and its "performance" is inherently tied to its use in a surgical setting. The digital design workflow is an algorithmic process that creates the patient-specific guides and plans, but the "standalone" performance isn't measured in isolation from the surgical act. The evaluation "compared to the pre-operative plans" could be considered an evaluation of the system's output (the guides) against its intended design.

7. Type of Ground Truth Used:

The ground truth for comparison was the "pre-operative plans." These plans are a digital design output, established through a digital design workflow. The "final implant positions" from post-operative CT scans were then compared against these pre-operative plans.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. The Axiom PSR System is a patient-specific device based on individual patient CT scans, not a machine learning model that requires a separate training set for algorithm development in the traditional sense. The "digital design workflow" is likely based on established biomechanical and engineering principles rather than supervised machine learning requiring a training dataset.

9. How the Ground Truth for the Training Set Was Established:

Since there is no mention of a training set or a machine learning model requiring such a set, this information is not applicable based on the provided document. The device's functionality is based on individual patient imaging and a digital design workflow to create custom surgical guides and plans, not on learning from a large labeled training dataset.

Ask a specific question about this device