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The Succession™ Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Succession™ AFN System is comprised of a set of straight 10mm, 11mm, and 12 mm diameter cannulated nails, 12.5mm diameter end caps, 5mm and 6mm diameter cortical screws, and accessory instrumentation. All implants are composed of Titanium (Ti-6Al-4V ELI) and provided to the user sterile packed with a combination of both sterile and non-sterile accessory instrumentation to assist in implantation. Each of the accessory instruments provided with the subject device contain substantially equivalent materials to the Oxford™ Ankle Fusion Nail System predicate device instrumentation, including stainless steel (ASTM F899 and ASTM F138 / ISO 5832-1) and Fluorinated Ethylene Propylene direct contacting materials.

During the procedure, following preparation of the tibial intramedullary canal (using the device accessory instrumentation) and placement of the intramedullary fixation nail, the provided 5mm screws are inserted into the medial to lateral (M/L) slots of the implant, allowing for fixation in the tibia, talus, and calcaneus. In both the talus and calcaneus, dynamic compression slots are included in the nail and are to be used with the internal and/or external methods of compression across the tibiotalar and subtalar joints. In addition, a 6mm screw is placed through the only angled posterior to anterior (P/A) slot located at the distal end of the nail implant, allowing for additional fixation between the calcaneus and talus. Following the placement of all screws, the end caps are implanted to add stability to the distal end of the nail and prevent excess bony ingrowth from occurring within the nail cannulation. Overall, the Succession™ Ankle Fusion Nail is intended to effectively fuse the tibiotalar and subtalar joints together, providing stability in the hindfoot region to facilitate tibiotalocalcaneal arthrodesis.

Based on the provided FDA 510(k) Clearance Letter, the Succession™ AFN System is an intramedullary fixation rod, and the clearance is primarily based on substantial equivalence to predicate devices. This means the device is demonstrated to be as safe and effective as a legally marketed device, not necessarily by proving it meets specific quantitative performance acceptance criteria for an AI/machine learning device.

The document provided does not contain information about an AI/ML-driven device's acceptance criteria or a study proving its performance. The "Non-Clinical and/or Clinical Tests Summary" in the document describes mechanical testing of the physical device (nails, screws, and accessories) for properties like torsional yield strength, driving torque, pullout strength, self-tapping force, cyclic fatigue, bending strength, torsional strength, and corrosion resistance.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The provided text is solely about the substantial equivalence of a physical orthopedic implant.

If this were a document about an AI/ML device, the sections you requested would typically be found in a "Performance Benchmarking" or "Clinical Study" section, detailing the AI's accuracy, sensitivity, specificity, or impact on human performance, along with the study methodology.

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The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.

The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.

This document is a 510(k) premarket notification for the COGNITION™ Staple System, a medical device for bone fixation. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information related to an AI/ML-driven device or an AI performance study. The document describes a traditional medical device (a staple system) and its mechanical and non-clinical testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets the acceptance criteria in the context of an AI/ML system, as this information is not present in the provided text.

The document discusses:

• Device Name: COGNITION™ Staple System
• Intended Use: Hand and foot bone fragments, osteotomy, fixation, and joint arthrodesis. Not for spinal use.
• Device Description: Comprised of implantable metallic (Superelastic NiTi Alloy) staples and accessory instrumentation.
• Predicate Device: K111678 Ortho Solutions Extremity Fixation Implants for Osteosynthesis.
• Technological Comparison: The new device is stated to have the same materials, chemical composition, manufacturing methods, austenite finish temperature, similar size range, and sterilization methods as the predicate.
• Non-Clinical Tests: Mechanical testing per ASTM F564 Annex A1 and A4, and corrosion testing per ASTM F2129-19a.
• Conclusions: The COGNITION device was found to be superior in static bending strength, constant amplitude bending resistance, and corrosion resistance compared to the predicate.

The document does not contain any details about:

• AI/ML algorithms
• Test sets, training sets, or data provenance for AI models
• Expert involvement for establishing ground truth in an AI context
• Adjudication methods for AI performance
• MRMC comparative effectiveness studies (AI vs. human)
• Standalone AI algorithm performance
• Types of ground truth for AI
• Sample sizes for training or test sets in an AI context
• Ground truth establishment for training sets in an AI context

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The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.

In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Volition Plating System is a set of implantable metallic (Titanium Alloy) bone plates consisting of a series of tubular plates of varying lengths as well as anatomically contoured plates. The Volition Plating System plates are provided with locking and non-locking in Ø2.7mm, Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.

This is a 510(k) premarket notification for the Volition Plating System, a metallic bone fixation device. The document states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes a medical device called the "Volition Plating System" which is a metallic bone fixation device. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In such submissions, explicit "acceptance criteria" and "reported device performance" are typically framed in terms of equivalence to the predicate device through various tests and analyses.

Therefore, the "acceptance criteria" here is that the Volition Plating System demonstrates substantial equivalence to the predicate devices in terms of material, geometry, design, indications for use, and mechanical performance. The "reported device performance" is the conclusion that this equivalence has been demonstrated.

Since this is a substantial equivalence determination and not a performance claim against specific quantitative thresholds for a new function, a typical acceptance criteria table with numerical performance metrics isn't directly applicable in the same way it would be for, say, an AI diagnostic tool.

However, based on the "Performance Analysis" and "Conclusion" sections of the 510(k) summary, we can infer the following:

2. Sample size used for the test set and the data provenance

The document describes an engineering analysis and comparison to predicate devices. It does not describe a clinical study involving human subjects or a test set of data with a specified sample size. The provenance of such a "test set" is therefore not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, this is a 510(k) submission based on engineering analysis and comparison to predicate devices, not a study involving a "test set" with ground truth established by experts.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set or adjudication process.

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 MRMC comparative effectiveness study was done. This device is a bone fixation system, not an AI-powered diagnostic tool, so such a study is not relevant.

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

Not applicable. This device is a physical bone fixation system, not an algorithm.

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

Not applicable. As this is not a diagnostic device or a study requiring ground truth establishment, this information is not relevant to this 510(k) submission. The "ground truth" in this context is the performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" in this context would be the design and testing of the device to meet engineering specifications and ensure equivalence to predicates.

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

Not applicable. As there is no training set discussed, this question is not relevant.

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The Ortho Solutions Plating System is indicated for use in stabilization of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.

In addition, the non-locking screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Ortho Solutions Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of tubular plates of varying lengths as well as anatomically contoured plates. Locking and non-locking screws are provided in Ø2.7mm, Ø3.5mm, & Ø4.0mm in various lengths and are compatible with all plates. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the "Ortho Solutions Plating System." As such, it does not contain the information requested about acceptance criteria for an AI/device performance study. The document is about a bone fixation device, not an AI or diagnostic tool.

The requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

None of this information is available in the provided text because the device is a physical bone plating system, not a software or AI-driven diagnostic device.

The "Performance Analysis" section on page 3 simply states:
"Performance testing per ASTM F382, engineering analysis and rationale was completed for the plates to demonstrate substantial equivalence for static and fatigue bending strength. Performance testing was completed for the screws per ASTM F543 to demonstrate substantial equivalence with respect to torsional strength, insertion torque, and pullout strength."

This refers to mechanical engineering tests for physical product performance, not clinical or algorithmic performance, and it does not describe study methodologies relevant to AI/software.

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