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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 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 as 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-TI) 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® Lumbar Spacers (HEDRON A™, HEDRON P®, 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 sketally 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 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, anterior plate systems, 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 indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy), 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and or anchors which accompany the implants. These devices are with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when

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

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 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 or without screws and/or anchors.

All HEDRON® Lumbar Spacers are additively manufactured from titanium powder. The mating screws and anchors are manufactured from titanium alloy and/or cobalt chrome alloy. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating.

The SABLE® Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

SABLE® Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with ExcelsiusGPS® and may be used for a freehand navigated surgical procedure.

The provided text describes a 510(k) premarket notification for several spinal implant devices (HEDRON® Cervical Spacers, HEDRON® Lumbar Spacers, SABLE® Expandable Spacer, and ExcelsiusGPS® Instruments). However, it does not contain information about an AI/ML-based device.

Therefore, I cannot provide the detailed information requested regarding machine learning acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on the substantial equivalence of the new devices to existing predicate devices based on:

• Mechanical testing: Dynamic compression-shear testing was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, and ASTM F2077.
• Technological Characteristics: The subject implants are stated to have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• Basis of Substantial Equivalence: The information provided within the premarket notification supports substantial equivalence of the subject spacers to the predicate devices with respect to technical characteristics, performance, and intended use.

In summary, the document addresses the regulatory requirements for hardware medical devices and does not involve AI/ML components or related performance studies.

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SABLE™ Expandable Spacer is an interbody fusion device 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). The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.

The SABLE™ Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

SABLE™ Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.

The provided text is a 510(k) summary for a medical device called the "SABLE™ Expandable Spacer," which is an intervertebral body fusion device.

It's crucial to understand that this document describes the regulatory clearance process for a physical medical device (an implantable spacer), not an AI/software-based medical device.

Therefore, the information requested in your prompt (acceptance criteria for an AI/software device, sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, etc.) is not applicable to this document.

The document discusses mechanical testing and bacterial endotoxin testing to demonstrate substantial equivalence to predicate devices, which are standard procedures for physical implants. It does not involve any AI algorithms, image analysis, or diagnostic performance evaluation that would necessitate the metrics you've asked for.

Here's a breakdown of why your questions cannot be answered by this document:

• No AI/Software Component: The SABLE™ Expandable Spacer is a physical implant. There's no AI or software involved in its function or regulatory clearance as described.
• Performance Data for a Physical Device: The "Performance Data" section specifically mentions mechanical testing (static and dynamic compression, compression-shear, subsidence) per ASTM standards and bacterial endotoxin testing. These are physical product tests, not software performance evaluations.
• Ground Truth: For a physical device, "ground truth" relates to material properties, strength, biocompatibility, etc., not to diagnostic accuracy against expert consensus or pathology, as would be the case for AI.
• Sample Size for Test/Training Sets (AI): These concepts are irrelevant as there is no AI model to train or test.
• Experts for Ground Truth/Adjudication (AI): No human experts are used to establish ground truth for a physical implant's performance in the way they would for medical image analysis AI.
• MRMC Study/Standalone Performance (AI): These are methodologies for evaluating AI diagnostic performance and are not applicable to an implantable device.

In summary, the provided document describes a different type of medical device and regulatory process than what your questions anticipate.

Ask a specific question about this device