Search Results
Found 6 results
510(k) Data Aggregation
(217 days)
The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.
This is a 510(k) summary for a medical device (an ankle replacement system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not applicable in the context of AI/ML performance evaluation.
However, I can extract the information that is present regarding the non-clinical performance and a general conclusion of equivalency:
Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
1. A table of acceptance criteria and the reported device performance
The document lists "Applicable Standard" for various non-clinical performance bench tests. The specific acceptance criteria (e.g., minimum tensile strength value) are not explicitly stated within this summary, nor are the reported performance values. The study concludes that the device performs "at least as well as the predicate devices," implying it met the standards.
| Non-clinical performance bench testing | Applicable Standard | Reported Device Performance |
|---|---|---|
| Tensile Properties | ASTM F648 | Met (Implied) |
| Percent Crystallinity | ASTM F2625 | Met (Implied) |
| Impact Resistance | ASTM F648 | Met (Implied) |
| Cross-Link Density | ASTM F2214 | Met (Implied) |
| Oxidation Characterization | ASTM F2102 | Met (Implied) |
| Density Characterization | ASTM D1505 | Met (Implied) |
| Fatigue Crack Growth Rate | ASTM E647 | Met (Implied) |
| Free Radical Concentration | No ASTM or ISO standard governing free radical concentration evaluation or acceptance in this submission | Met (Implied) |
| Wear Performance | ISO/DIS 22622 | Met (Implied) |
| Lock Detail Testing | ASTM F2665 | Met (Implied) |
| Articular Shear Stability | ASTM F2665 | Met (Implied) |
| Endotoxin ( |
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(90 days)
INFINITY Total Ankle System, INBONE Total Ankle System
The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.
This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.
Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Chemical Analysis | Demonstrated equivalence to predicate devices |
| Compressive Strength | Demonstrated equivalence to predicate devices |
| Shear and Tensile Strength | Demonstrated equivalence to predicate devices |
| MRI Safety Analysis | Minimal risk to patients in an MR environment (MR Conditional) |
| Direct Metal Laser Sintering (DMLS) Process Validation | Demonstrated equivalence to predicate devices (Performance Qualification, Mechanical validation, Microstructure, Powder Bed Position Validation) |
| Endotoxin ( |
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(57 days)
INFINITY Total Ankle System
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The tibial tray is manufactured using additive manufacturing technology.
The provided document is a 510(k) summary for the INFINITY Total Ankle System. It focuses on demonstrating substantial equivalence to predicate devices and outlines non-clinical bench testing. It explicitly states that "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices." Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on clinical data.
Based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document discusses non-clinical bench testing for a medical device (Total Ankle System) rather than an AI/ML-driven device with clinical performance metrics. The listed non-clinical tests (e.g., Chemical Analysis, Abrasion Resistance, Fatigue Testing) are intended to show substantial equivalence to predicate devices, not to meet specific clinical performance acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used as clinical studies were not required. The document refers to non-clinical bench testing.
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. No clinical test set or human expert review for ground truth was involved since clinical studies were not required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process was involved.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices." This device is a total ankle system, not an AI/ML diagnostic tool for which MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical implant (Total Ankle System), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Since no clinical studies were performed and clinical performance was not assessed in this submission, there is no discussion of ground truth based on clinical data. The "ground truth" for the non-clinical tests would be defined by engineering specifications and material standards, which are not detailed in this summary.
8. The sample size for the training set
Not applicable. This document pertains to a physical medical device. There is no mention of a training set as would be relevant for an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned for an AI/ML device, the establishment of ground truth for a training set is not discussed.
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(237 days)
INFINITY Total Ankle System
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The talar dome is manufactured using additive manufacturing technology.
The provided text is a 510(k) premarket notification for the INFINITY Total Ankle System. It outlines the regulatory review process and the basis for the FDA's substantial equivalence determination. However, it does not contain information about acceptance criteria for a device's performance (e.g., accuracy, sensitivity, specificity, or other performance metrics) nor details of a study proving the device meets those criteria, especially in the context of an AI/ML-based device.
The document states:
- "(b)(1). Substantial Equivalence- Non-Clinical Evidence" lists various bench performance tests (e.g., Chemical Analysis, Abrasion Resistance, Fatigue Testing, MRI Safety Analysis, DMLS Process Validation). These are engineering tests for the physical properties and manufacturing of the implant, not performance metrics of an AI/ML system.
- "(b)(2). Substantial Equivalence- Clinical Evidence" explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices."
Therefore, I cannot provide the requested information as it is not present in the given text. The device described (an ankle prosthesis) is a physical implant, not a software device or an AI/ML-based system that would typically have performance criteria related to classification, diagnosis, or prediction, and associated test sets, ground truth establishment, or MRMC studies.
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(31 days)
INFINITY TOTAL ANKLE SYSTEM
The INFINITY™ Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications for Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INFINITY™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The INFINITY® Total Ankle System is a fixed-bearing, bone-sparing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial tray, tibial insert, and talar dome) that are assembled together to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.
This document describes a 510(k) premarket notification for the WMT INFINITY® Total Ankle System. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable or not provided in the given text.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics. The core "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document states that "Through mechanical analysis the subject devices do not represent a new worst-case. Therefore, no additional mechanical testing was performed to support the subject devices." This implies that the performance is considered to be equivalent to the predicate device, which is presumably already proven safe and effective.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | No new worst-case mechanical behavior compared to predicate. | No new worst-case identified through mechanical analysis. |
| Material Composition | Same materials as predicate. | Composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium (same as predicate). |
| Design Features | Clinically relevant design features maintained; differences do not raise new safety/effectiveness questions. | Maintains clinically relevant design features. Differences are an anterior-posterior (AP) tray length and neutral posterior curvature, which do not raise new safety/effectiveness questions. |
| Intended Use/Indications | Intended use and indications are substantially equivalent to predicate. | Intended use and indications are equivalent to the predicate. |
2. Sample Size for Test Set and Data Provenance: Not applicable. This submission relies on a comparison to a predicate device and mechanical analysis, not a clinical trial with a test set of data.
3. Number of Experts and Qualifications for Ground Truth for Test Set: Not applicable. Ground truth as typically defined for algorithm performance in AI/ML is not established here. The "ground truth" is the established safety and effectiveness of the predicate device.
4. Adjudication Method for Test Set: Not applicable. No test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study: Not applicable. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used: The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate device (K123954 INFINITY® Total Ankle System).
8. Sample Size for Training Set: Not applicable. This document describes a medical device, not an AI/ML algorithm that requires a training set. The "training" in a regulatory sense would refer to the historical data and experience with the predicate device.
9. How Ground Truth for Training Set was Established: Not applicable. As above, this is a medical device, not an AI/ML algorithm. The safety and effectiveness of the predicate device would have been established through its own regulatory pathway, which may have included clinical data, mechanical testing, and biocompatibility assessments.
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(101 days)
INFINITY TOTAL ANKLE SYSTEM
Intended Use: The INFINITY™ Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications For Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The INFINITY ™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.
The provided text is a 510(k) summary for the INFINITY™ Total Ankle System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the medical device is at least as safe and effective as a legally marketed device (predicate device).
However, the information provided does not contain details about acceptance criteria, a study proving device performance against those criteria, or any of the specific reader study methodologies requested.
The document primarily focuses on:
- Device Description: What the INFINITY™ Total Ankle System is made of and how it functions.
- Intended Use and Indications for Use: For whom and under what conditions the device is designed to be used.
- Technological Characteristics Comparison: A high-level statement that its features are similar to predicate devices.
- Non-Clinical Evidence: A list of types of non-clinical analyses performed (Bone interface stability, Component stability, Fatigue testing, Contact area/stress testing) and a conclusion that these results show the device performs "at least as well as" predicate devices. No specific performance metrics, acceptance criteria, or detailed study results are given.
- Clinical Evidence: Explicitly states "N/A", meaning no clinical evidence was presented for this 510(k) submission.
- Substantial Equivalence Conclusion: A general statement of safety and effectiveness based on non-clinical evidence and comparison to predicate devices.
Therefore, I cannot populate the requested table and answer the specific questions because the necessary data is not present in the provided text. The document aims to demonstrate substantial equivalence to existing devices through non-clinical testing and design comparison, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/software device.
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