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510(k) Data Aggregation
(84 days)
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or coricocancellous bone graft, and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
The TranS1 Interbody Fusion System is used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. The devices are designed to be used in conjunction with supplemental spinal fixation instrumentation. The subject devices are multiple component systems comprised of single-use implants designed to treat the lumbar spine.
The TranS1 Interbody Fusion System lumbar implants are fabricated from PEEK (ASTM F2026) with Tantalum (ASTM F560) x-ray markers. The TranS1 Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
I am sorry, but the provided text only discusses the FDA's 510(k) clearance for the TranS1 Interbody Fusion System, which is a medical device used for spinal fusion procedures. It specifies the intended use, material composition, and references performance testing conducted according to ASTM standards for static and dynamic mechanical properties, as well as subsidence and expulsion.
However, the text does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity), or any study details proving an AI/ML device meets such criteria.
Therefore, I cannot fulfill your request for information about:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes and data provenance for a test set for an AI/ML device.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- MRMC study for an AI/ML device.
- Standalone performance for an AI/ML algorithm.
- Type of ground truth used for an AI/ML device.
- Sample size for the training set for an AI/ML device.
- How ground truth was established for the training set for an AI/ML device.
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(205 days)
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):
The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
Choice Spine Interbody Fusion System:
The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
This submission includes three lumbar implant families. The device description for each family is listed below.
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):
The Choice Spine Lumbar Spacer System consists of interbody fusion devices (specifically, SABRE, SHARK™, HORNET™ & HARPOON™ Lumbar Spacers) comprised of polyetheretherketone (PEEK - Optima®) with tantalum markers (ASTM F2026 and ASTM F560) or Ti-6AI-4V ELI (ASTM F136). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped anterior surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. These implants are delivered via a posterior or transforaminal approach.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine VEO™ Lateral Access & Interbody Fusion System is a multicomponent system including instrumentation made of stainless steel. Aluminum. and Radel R and implants made of tantalum (ASTM F560) and PEEK Optima® (ASTM F2026) or Ti-6Al-4V ELI (ASTM F136). The implants are delivered via lateral approach.
Choice Spine Interbody Fusion System:
The Choice Spine Interbody Fusion System is a family of implants intended to aid in spinal fixation of the lumbar spine. This system includes implants made of Zeniva ZA-500 PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136), which are delivered via anterior or anterolateral approach.
The provided document is a 510(k) summary for several intervertebral body fusion devices. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for a device's performance.
The document primarily focuses on:
- Indications for Use: What conditions the devices are intended to treat.
- Device Description: The materials and general design of the implants.
- Comparison to Predicate Devices: An assertion that the new devices are substantially equivalent to previously cleared devices.
- Non-Clinical Testing: A statement that "no new non-clinical testing is needed" due to the design being the same if manufactured from Titanium instead of PEEK.
In the context of a 510(k) submission for these types of devices, the "acceptance criteria" are typically related to demonstrating substantial equivalence through a comparison of technological characteristics and intended use, often supported by non-clinical performance data (e.g., mechanical testing to ASTM standards), rather than clinical performance metrics like sensitivity, specificity, or reader improvement with AI.
Therefore, I cannot extract the requested information from this document. The document specifically states: "no new non-clinical testing is needed," implying that the performance was considered sufficiently similar to the predicate devices based on design and material changes, and thus no new study specifically proving acceptance criteria for device performance was required or submitted as part of this 510(k).
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