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The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

• · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
• · Evans Lengthening Osteotomies
• · Subtalar Arthrodesis
• · First Metatarsal-Cuneiform Lengthening Arthrodesis
• · Calcaneocuboid Arthrodesis
• · Calcaneal Z Lengthening Osteotomies
• · MTP Lengthening Arthrodesis
• · Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
• · Navicular-Cuneiform Arthrodesis
• · Talonavicular Arthrodesis

The Trigon HA wedges are intended for use with ancillary fixation.

The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate an inserter-receiving hole and/or two screw-receiving holes and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, MTP, Lesser Metatarsal, and Midfoot Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.

This document is a 510(k) premarket notification for the Trigon PEEK HA Wedges, which are part of the Trigon HA Stand-Alone Wedge Fixation System. This is a notification for a medical device and not a study involving AI/ML software. Therefore, it does not contain the requested information about acceptance criteria, device performance from a clinical study, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details, as these are typically associated with AI/ML software evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on engineering analysis, materials, intended use, and processes, rather than a clinical performance study with defined acceptance criteria and statistical outcomes against a ground truth.

Specifically, the document states:

• "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
• "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
• "The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested information from the provided text.

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The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

• · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
• · Evans Lengthening Osteotomies
• · Subtalar Fusion
• · First Metatarsal-Cuneiform Lengthening Arthrodesis
• · Calcaneocuboid Arthrodesis
• · Z-Calcaneal Lengthening Osteotomies
• · MTP Lengthening Arthrodesis

The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, and MTP Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.

This FDA 510(k) clearance letter and summary describe a medical device, the Trigon HA Stand-Alone Wedge Fixation System, and its substantial equivalence to previously cleared predicate devices. However, it does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.

Specifically, the document states:

• "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
• The "SUMMARY OF NON-CLINICAL TESTING" section indicates that "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)" was performed.
• The conclusion is based on "comparison of device characteristics," "similar indications for use, technological characteristics, and performance characteristics" to predicate devices.

Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating substantial equivalence to predicate devices through engineering analysis and comparison, rather than an independent study with defined acceptance criteria for the new device's performance.

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The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

• · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
• · Evans Lengthening Osteotomies
• · Subtalar Fusion
• · First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis

The Trigon HA wedges are intended for use with ancillary fixation.

The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular oval and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus and Calcaneocuboid Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.

This submission describes a medical device, the Trigon™ HA Stand-Alone Wedge Fixation System, and its claim of substantial equivalence to predicate devices. However, the provided document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on demonstrating performance against specific clinical acceptance criteria through new clinical studies.

Therefore, I cannot provide the requested information for points 1 through 9.

Summary of missing information specifically related to acceptance criteria and performance studies:

• No acceptance criteria tables: The document does not specify any quantitative acceptance criteria for device performance.
• No reported device performance data: While there is a mention of "Engineer analysis comparing device characteristics," no specific performance metrics or data are provided.
• No clinical study details: There is no mention of a test set, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth types and their establishment.
• No training set details: Information on training set size or how ground truth was established for a training set is not present.

The document focuses on comparing the proposed device's characteristics (materials, intended use, processes) to those of previously cleared predicate devices to establish substantial equivalence. It explicitly states, "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System." and "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)". This indicates a non-clinical, comparative assessment rather than a clinical performance study against defined acceptance criteria.

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The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

• Cotton (opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Ssteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis

The Trigon HA wedges are intended for use with ancillary fixation.

The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular and oval shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Trigon HA Wedge Fixation System." This document primarily focuses on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for AI performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document. This type of information is typically found in clinical trial reports or performance validation studies for devices that rely on algorithms or AI for diagnostic or prognostic purposes.

The document states:

• "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
• "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)."
• "The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices."

This indicates that the "study" demonstrating the device meets requirements was an engineering analysis to show equivalence to existing devices, not a performance study as would be done for an AI-powered diagnostic tool. The device is a physical implant, not a software-driven diagnostic or treatment planning system that would require the kind of performance metrics you've asked about.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The Vector Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.00mm, Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria, as it relates to performance metrics of a device, particularly an AI/imaging device. The document is an FDA 510(k) clearance letter for a medical device called the "Vector® Hammertoe Correction System," which is a bone fixation system, not an imaging or AI-driven diagnostic device.

Therefore, I cannot provide the requested information from the given text.

The document discusses:

• Device Name: Vector® Hammertoe Correction System
• Regulation Number: 21 CFR 888.3040 (Smooth Or Threaded Metallic Bone Fixation Fastener)
• Regulatory Class: Class II
• Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
• Device Description: Sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device, K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
• Predicate Devices: K201850 (Nvision Biomedical's Vector Hammertoe Correction System), K183055 (Nvision Biomedical's Vector Hammertoe Correction System), and K193645 (Nvision Biomedical's nva, nvt).
• Non-Clinical Testing: Primarily engineering analysis comparing device characteristics (materials, intended use, cleaning, sterilization) to predicate devices. It states no FDA performance standards have been established for this device and that the results indicate substantial equivalence. The key modification mentioned is the addition of steam sterilization as an alternative method.

None of the information required for explaining acceptance criteria for an AI/imaging device, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, is present in this regulatory document.

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The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

• Cotton (opening wedge) osteotomies of the medial cuneiform
• . Evans lengthening osteotomies
  The Trigon HA wedges are intended for use with ancillary fixation.
  The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.

The provided text describes a 510(k) premarket notification for the "Trigon HA Stand-Alone Wedge Fixation System" but does not contain information about acceptance criteria or a study proving that the device meets those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis comparing device characteristics (materials, intended use, processes) and the addition of steam sterilization as an alternative method.

Therefore, for aspects related to acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, the requested information is not provided in the given text.

The text does mention:

• Summary of Non-Clinical Testing: An engineering analysis was performed comparing device characteristics including materials, intended use, and processes (cleaning and sterilization methods). No FDA performance standards have been established for this device.
• Conclusion: Based on the comparison of device characteristics, the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics are assessed to be substantially equivalent.

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