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

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

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

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

The Trigon Ti Stand-Alone Wedge Fixation System is a family of additively manufactured titanium wedges used for angular correction of small bones of the foot. The wedges incorporate an organized lattice structure and two screw-receiving holes. The system rectangular and kidney shaped wedges may or may not include a window for containing 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 screws are designed in lengths of 10 to 20mm.

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. Windowless wedge designs that do not allow for graft placement should only be used with ancillary plating.

The provided text describes a medical device, the Trigon™ Ti Stand-Alone Wedge Fixation System, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.

The document primarily focuses on:

• Regulatory review: The FDA's substantial equivalence determination for the device.
• Device description: Physical characteristics, materials, and intended use of the bone wedge system.
• Predicate devices: Identification of similar devices already on the market.
• Non-clinical testing: Mechanical testing (compression, compression shear, expulsion, screw strength/pullout) to demonstrate substantial equivalence to predicates.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as it relates to AI/ML performance, because that information is not present in the provided text.

Specifically, the document does not mention or provide data for any of the following:

• AI/ML algorithm performance.
• Test sets, training sets, or data provenance.
• Experts establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies.
• Standalone algorithm performance.
• Types of ground truth (beyond mechanical test results for a physical device).

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HEDRON™ Lumbar Spacers (HEDRON A™, HEDRON L™, HEDRON T™, HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T -T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be sketcally mature and have had at least six (6) months of non-operative treatment. HEDRON™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). HEDRON IATM Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

HEDRON™ Lumbar Spacers are lumbar interbody fusion devices used to provide structural stability following discectomy. Each HEDRON™ spacer has a different shape to accommodate various surgical approaches to the spine, including anterior, anterolateral, lateral, posterior or transforaminal approaches. All approaches are used in the lumbar spine; only anterior, anterolateral, or lateral approaches are used in the thoracic spine.

HEDRON™ Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability following discectomy. They are used with screws and/or anchors.

All HEDRON™ Lumbar Spacers are additively manufactured from titanium powder per ASTM F3001. The mating screws and anchors are manufactured from titanium alloy, per ASTM F135 and F1295, and/or cobalt chrome alloy, per ASTM F1537. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating, per ASTM F1185.

The provided document is a 510(k) premarket notification for the HEDRON™ Lumbar Spacers. It describes the device, its indications for use, and the basis for its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to a diagnostic or AI-driven performance metric.

The "performance data" section explicitly states: "Mechanical testing (static and dynamic compression and compression-shear, subsidence, and expulsion) was conducted in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device,' June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."

This indicates that the performance criteria and studies are related to the mechanical and biological safety of the physical implant device, not to the performance of a diagnostic algorithm or device with specific performance metrics like sensitivity, specificity, or AUC which would typically be associated with the questions asked.

Therefore, I cannot provide the requested information because:

1. Acceptance criteria and reported device performance (Table): The document does not describe acceptance criteria in terms of diagnostic performance metrics for an AI or imaging device. It focuses on mechanical and biological safety for a physical implant.
2. Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth type, training set sample size, ground truth for training set: These questions are all relevant to the evaluation of an AI or diagnostic device's performance, which is not the subject of this 510(k) submission. This submission is for a physical medical implant device.

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HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When the HEDRON IC™ Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON™ Cervical Spacers (HEDRON CTM and HEDRON ICT™) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRON ICT™ Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON ICT™ Plate-Spacer, a stand-alone cervical interbody fusion device. HEDRON™ Spacers are additively manufactured from titanium alloy, as specified in ASTM F3001.

The provided document is a 510(k) summary for a medical device (HEDRON™ Cervical Spacers), which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data. It does not describe an AI medical device or a clinical study that establishes acceptance criteria and proves the device meets those criteria from an AI performance perspective.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance for an AI model, as this document is not about an AI medical device.

The document discusses:

• Device Name: HEDRON™ Cervical Spacers
• Intended Use: Interbody fusion devices for cervical spine
• Mechanical Testing: Static and dynamic compression, torsion, compression-shear, subsidence, and expulsion in accordance with specific ASTM standards and FDA guidance.
• Basis of Substantial Equivalence: Similar technological characteristics (design, intended use, material composition, sizes) to predicate devices.

However, none of this relates to AI performance metrics, ground truth establishment, expert adjudication, or MRMC studies for AI devices.

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