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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 and/or myelopathy 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 as an anterior cervical plate or posterior cervical fixation.

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, lordosis, 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 implant. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON C-MIS™ Spacer is an integrated interbody fusion device indicated 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, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are intended to be used with or without two screws and/or anchors which accompany the implants. When used with two screws, these devices are intended for stand-alone use at one or two levels. When used with one or more anchors, these devices are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation, such as an anterior cervical plate or posterior cervical screw fixation. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws or anchors.

HEDRON™ Cervical Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

HEDRON™ Cervical Spacers (HEDRON C™, HEDRON IC™, and HEDRON C-MIS™) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRON IC™ Spacer may be assembled to the COALITION AGX™ Plate to create the HEDRON IC™ Plate-Spacer, a stand-alone cervical interbody fusion device. HEDRON C-MIS™ Spacer is a cervical interbody fusion device that may be used with screws and/or anchors. HEDRON C-MIS™ is a stand-alone device when used with screws only. HEDRON™ Cervical Spacers are additively manufactured from titanium alloy powder. The mating screws and anchors are manufactured from titanium alloy.

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The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two levels. DDD is defined as discogenic 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) weeks of non-operative treatment. The SPINELINC Cervical Spacer Body and Anterior Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with three SpineLinc screws per assembly.

The SpineLinc Anterior Cervical Implant system consists of a cervical interbody fusion device, cervical plate, screws, and a locking clip, which may be implanted in various configurations to accommodate patient anatomy. The SpineLinc Anterior Cervical implant devices are offered manufactured from titanium alloy per ASTM F136 or ASTM F3001. Instrumentation is provided with the SpineLinc Anterior Cervical Implant system to facilitate implantation. Instruments are manufactured from medical grade stainless steel per ASTM F899. All subject implants and instruments are provided sterile via gamma irradiation and are provided as single use kits.

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The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.

The provided text is a 510(k) summary for the Hammerdesis™ Interphalangeal Fusion System, a medical device. This document focuses on demonstrating the substantial equivalence of the device to existing predicate devices, primarily through mechanical performance testing.

It does not contain information about an AI/ML-driven device or diagnostic study. Therefore, I cannot provide a response addressing acceptance criteria and study details related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document describes the device, its indications for use, technological characteristics, and performance data related to its mechanical properties. The performance data section states:

"The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459)."

This indicates that the acceptance criteria for this device are based on its mechanical equivalence or superiority to the specified predicate device in these specific tests, rather than diagnostic accuracy metrics.

To answer your request, the provided document would need to be about a diagnostic AI/ML device, which it is not.

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The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.

The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.

The DOLOMITE Anterior Cervical Stabilization System are implants developed for the stabilization of the cervical column. The spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a locking mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient in machined Titanium alloy. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates to allow bone growth.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding the Astura Medical, LLC's "DOLOMITE Anterior Cervical Stabilization System." This document is a regulatory notice of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered medical device, which is what the prompt is asking for.

The document explicitly states under "Clinical Test Summary" that "No clinical studies were performed." and under "Non-clinical Test Summary" that "The following analyses were conducted: Dynamic Compression Static Compression Dynamic Torsion Static Torsion. The results of these evaluations indicate that the Dolomite implants are equivalent to predicate devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, specifically in the context of an AI/ML powered medical device, based on the provided text. The text describes a conventional medical device (an intervertebral body fusion device) and its regulatory clearance process, which relies on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than performance against specific acceptance criteria in a clinical study of an AI/ML product.

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