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The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.

The subject restor3d 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 restor3d 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 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 additively manufactured r3 talar dome and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) r3 bearing component, subject of this 510(k), are compatible with:

• All Kinos Axiom Total Ankle System Tibial Tray Components and associated . instrumentation cleared via K192778
• All Kinos Axiom Total Ankle System X-Stem Tibial Components and associated . instrumentation cleared via K232595

This document is a 510(k) Summary for the restor3d Kinos Axiom Total Ankle System, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. The performance testing mentioned (ASTM F2665, engineering analyses) pertains to the mechanical and physical properties of the ankle implant, not to the performance of a software algorithm.

Therefore, most of the requested information (e.g., acceptance criteria for AI performance, sample size for test set/training set, ground truth establishment for AI, expert consensus, MRMC studies) is not applicable to this document.

The document discusses:

• Device Name: restor3d Kinos Axiom Total Ankle System
• Regulation Number: 21 CFR 888.3110 (Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: HSN
• Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, or failed previous ankle surgery. Intended for cement use only.
• Predicate Devices: Primarily INFINITY Total Ankle System (K123954) and SALTO TALARIS Total Ankle Prosthesis (K182878).
• Device Description: An implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. It's a fixed bearing and semi-constrained implant construct, consisting of a tibial implant, a bearing implant (Vitamin E, cross-linked UHMWPE), and a talar implant (additively manufactured r3 talar dome).
• Performance Testing:
  • Contact Area Testing per ASTM F2665
  • Constraint Testing per ASTM F2665
  • Range of Motion Testing per ASTM F2665
  • Locking Mechanism Fatigue Strength Analysis per ASTM F2665
  • Implant Strength Engineering Analysis per ASTM F2665
  • Wear Engineering Analysis per ASTM F2665
• Conclusion: The device is substantially equivalent to predicate devices, and changes (additively manufactured talar component, Vitamin E cross-linked UHMWPE bearing component, design/size changes) do not raise new safety or effectiveness concerns.

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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 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. 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 comprises three implant components – a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and 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 tibial-talar joint.

This document describes a medical device submission (K192778) for the Kinos Axiom Total Ankle System. It does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of an Artificial Intelligence (AI) or machine learning device.

The Kinos Axiom Total Ankle System is a physical implant, not a software or AI-driven diagnostic/prognostic device, so the usual metrics associated with AI device performance (like sensitivity, specificity, AUC) and relevant study designs (like MRMC studies) are not applicable here.

The "studies" mentioned are non-clinical analyses of the physical implant's mechanical properties, material safety, and biocompatibility, which are standard for orthopedic implants.

Here's a breakdown of the requested information based only on the provided text, acknowledging that many categories will be N/A due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: The document states that the non-clinical analysis shows the device "can be expected to perform at least as well as the legally marketed predicates referenced above." The specific quantitative acceptance criteria (e.g., minimum fatigue life, maximum wear rate) from the ASTM and ISO standards would be detailed in the full submission, but are not provided in this summary.
   • Reported Device Performance: The summary indicates that the "results of this analysis show that the subject Kinos Axiom Total Ankle System can be expected to perform at least as well as the legally marketed predicates referenced above." No specific quantitative performance metrics are provided in this summary.

   Acceptance Criteria (General)	Reported Device Performance (General)
   Performed at least as well as predicate devices	Performed at least as well as predicate devices based on non-clinical analyses (Fatigue, Constraint, Contact Area, Strength, Wear, Range of Motion, Biocompatibility, Pyrogenicity)

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: Not applicable in the context of an observational/clinical test set for AI. The "test set" here refers to physical samples of the implant undergoing mechanical and biological testing. The specific number of implant samples for each test (e.g., how many underwent fatigue testing) is not specified.
   • Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering and laboratory testing of the device itself.

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)

   • Not applicable. Ground truth for an AI device involves expert consensus on medical images or clinical outcomes. For this physical implant, performance is assessed against engineering standards and material properties, not clinical expert readings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This is relevant for clinical outcome adjudication or image interpretation, not for mechanical testing of a physical device.

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

   • No. Not applicable, as this is a physical implant, not an AI-assisted diagnostic tool. No clinical study or MRMC study was required for its 510(k) clearance ("n/a – no clinical evidence was required to determine substantial equivalence").

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards (e.g., ASTM F2665 for fatigue and wear, ISO 10993-1 for biocompatibility). The device's performance is compared against the requirements and benchmarks set by these standards and against the performance of predicate devices.

8. The sample size for the training set

   • Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable.

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