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The SiNAPTIC Osteotomy Wedge System is intended to be used for internal bone fixation for fractures or osteotomies in the ankle and foot, such as:

1. Opening wedge osteotomies of the bones of the foot, including osteotomies for Hallux Valgus
2. Opening wedge of the medial cuneiform or Cotton osteotomies.
3. Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z-Osteotomy)
4. Metatarsal Cuneiform osteotomies
5. Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
6. Hindfoot osteotomies such as Ankle fusion and Subtalar fusion

The Osteotomy Wedge System MTP Wedges are intended to be used for internal fixation of metatarsal bones that have been surgically prepared (osteotomy) for correction of deformity.

The Osteotomy Wedge System is indicated for use with supplemental fixation.

The Osteotomy Wedge System is not indicated for use in the spine.

The Osteotomy Wedge System devices are a sterile, single use Silicon Nitride (Si₃N₄) implants. The wedges are designed in a variety of shapes, each available in multiple footprints and thickness. The Osteotomy Wedge System is intended to be used for internal bone fixation for opening or lengthening osteotomies in the foot and ankle. The wedges contain an insertion feature as well as a central, open area for packing graft material or insertion of supplemental fixation.

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The Auxano® Wedge Fixation System is intended to be used as internal bone fixation for bone fractures or osteotomies in the ankle and foot. Specific indications include:

• Cotton (opening wedge) osteotomies of the medial cuneiform
• Evans lengthening osteotomies

The Auxano® Wedge Fixation System is indicated for use with ancillary plating fixation.

The Auxano® Wedge Fixation System is not intended for spinal use.

The Auxano® Wedge Fixation System (WFS) is a titanium implant that is designed to be used for internal bone fixation and angular correction of foot geometry. The implants are offered in different length x width profiles (16x11, 20x14, 18x18, 20x20, and 22x22 mm) and heights (4.50, 5.50, 6.50, 8, 10, and 12 mm) to address different anatomic locations and size variations. All implants are made from Ti-6AL-4V ELI Titanium alloy per ASTM F3001. The Auxano® Wedge Fixation System includes implants, the instruments necessary to implant them, and the tray system for transport, storage and sterilization.

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OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include:

• Opening wedge osteotomies of the foot (including osteotomies for Hallux Valgus).
• Opening wedge of Medial Cuneiform or Cotton osteotomies.
• Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy).
• Metatarsal/Cuneiform arthrodesis.

OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine

The OsteoSinter® EVANS and COTTON wedges are sterile, single use porous titanium implantable wedges, available in varied footprints and heights, intended to be used for correction of foot deformities.

The provided text does not contain information about acceptance criteria for a medical device or a study proving that the device meets such criteria within the typical context of a diagnostic AI/ML device.

This document is a 510(k) Premarket Notification for a physical medical device, the "OsteoSinter® EVANS and COTTON wedges and related accessories," which are sterile, single-use porous titanium implantable wedges used for internal bone fixation.

The discussion focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and material comparisons, not AI/ML performance metrics.

Therefore, I cannot provide the requested information from the given text as it pertains to AI/ML device acceptance criteria and studies. The document only describes traditional medical device equivalence testing.

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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 TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.

The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.

Here's a breakdown of the acceptance criteria and the study details for the TITAN 3-D Wedge System, based on the provided text. Please note that the document is a 510(k) summary for a medical device (an implant for bone fixation), not an AI/software device. Therefore, many of the requested categories related to AI performance, such as expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Device Name: TITAN 3-D® Wedge System

Device Type: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (Implantable device)

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an implantable device, the acceptance criteria are not for diagnostic performance (like sensitivity/specificity) but rather for safety and mechanical performance. The document describes performance testing related to MR Safety and mechanical properties.

Note: "Pass" implies that the device met the specified requirements of the respective ASTM standards or verified that the changes did not negatively impact safety or effectiveness.

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

The document does not specify a "test set" in the context of patient data or images. Instead, the testing involves physical samples of the device for mechanical and MR safety testing.

• Sample Size for Testing: Not explicitly stated as a number of devices, but implies testing was performed on representative samples for each test (e.g., multiple wedges for mechanical testing, a representative wedge for MR testing).
• Data Provenance: Not applicable as this refers to physical device testing, not clinical data or images from specific countries.

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

Not applicable. This device is an implant, not a diagnostic AI/software tool. Ground truth for its performance is established through standardized laboratory testing (e.g., ASTM standards) conducted by qualified engineers and technicians, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Laboratory test results are typically objective measurements against a standard, not subject to subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is an implantable medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is an implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on established engineering principles, material science, and performance standards (e.g., ASTM standards for mechanical properties and MR compatibility). It's scientific measurement and verification against defined criteria, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic study.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/software product that requires a training set.

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

Not applicable. See explanation for #8.

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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 restor3d Utility Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:

• · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform or Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• · Metatarsal Cuneiform osteotomies
• · Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
• · Hindfoot osteotomies such as Ankle fusion and Subtalar fusion

The restor3d Utility Wedges are intended for use with supplemental fixation. The restor 3d Utility Wedges are not intended for use in the spine.

The proposed Utility Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for opening and lengthening osteotomy procedures of the foot, including Lapidus and Subtalar.

The provided text is a 510(k) Summary for the restor3d Utility Wedge. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by benchtop performance testing. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding acceptance criteria and study details that would typically be found in a clinical study report or a more comprehensive validation summary for a device involving AI or human interpretation.

Based on the provided text, here's what can be extracted and what information is missing:

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

The document mentions three benchtop performance tests:

• Static Compressive Strength
• Dynamic Compressive Strength
• Expulsion

It states, "No new questions of safety or effectiveness were identified during device testing." However, specific acceptance criteria (e.g., minimum compressive strength in Newtons, or maximum displacement under dynamic load) and the reported device performance against these criteria are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The summary refers to "benchtop performance tests" rather than tests involving patient data.

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)

This information is not applicable as the summary describes benchtop tests, not tests involving expert interpretation or medical imaging.

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

This information is not applicable as the summary describes benchtop tests, not tests involving expert interpretation or medical imaging.

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

There is no mention of a multi-reader multi-case (MRMC) study, AI assistance, or human readers. This device is a physical implant, not an AI-enabled diagnostic tool.

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

This information is not applicable as this is a physical medical device (an osteotomy wedge), not an algorithm or AI system.

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

For the benchtop tests, the "ground truth" would be the engineering specifications and relevant testing standards (e.g., ASTM or ISO standards for mechanical testing of implants), but these specific standards or criteria are not detailed in this summary.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI model.

In summary: The provided document is an FDA 510(k) summary for a physical orthopedic implant. It outlines the device's indications for use and states that substantial equivalence was supported by benchtop mechanical testing. However, it does not provide the detailed acceptance criteria, specific performance results, or study methodologies that would be relevant for an AI/software device or a clinical study involving human interpretation. The questions regarding AI, human readers, ground truth establishment for training/test sets, and expert qualifications are not applicable to the information contained within this specific 510(k) summary.

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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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