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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 mon-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 designed for use with supplemental fixation and with autogenous and/or

allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft 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 autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. Choice Spine Interbody Fusion System (Harrier™):

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 and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Choice Spine Vertebral Body Replacement System (Hawkeye™):

The Choice Spine Vertebral Body Replacement (VBR) System is in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Vertebral Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion

The implant components are available in two material varieties, Materials: polyetheretherketone (PEEK-OPTIMA® LT1, Invibio® or Zeniva® PEEK, Solvay) as described by ASTM F2026 with integral radiopaque markers manufactured from tantalum as described by ASTM F560. The second implant variety is Titanium alloy (Ti-6Al-4V ELI) which conforms to ASTM F136. All chosen materials are commonly used in medical devices. The implants will be provided non-sterile, but will be steam sterilized before use.

This document is a 510(k) premarket notification from the FDA for several spinal interbody fusion devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on regulatory clearance, device descriptions, and comparison to predicate devices, but lacks the specific details requested in your prompt regarding performance studies.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that because the designs of the implants are similar between material types (PEEK or Titanium Alloy) and have been previously cleared, and the Titanium implants are expected to be stronger, "no new non-clinical testing is needed." This explicitly indicates that no new performance studies (which would involve acceptance criteria and test sets) were conducted for this specific submission.

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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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When used as an intervertebral body fusion device, Choice Spine lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L 2 - S 1 , in skeletally mature patients who have had six months of nonoperative 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 systems such as (ORIA Claris, ORIA Spinal Clip System, etc.).

When used as a vertebral body replacement device, Choice Spine lumbar Spacers are 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 turnor or traumatic injury. The device system is designed for use with supplemental fixation (ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft bone to facilitate fusion.

The 9mm width spacer system (SABRE, SHARK, HORNET, HARPOON) has a rectangular shape, a hollow center for placement of autograft bone, and a smooth anterior surface (nose). It is available in a variety of heights, length, and lordosis combinations with and without medial-lateral curvature to accommodate many different anatomic requirements.

The provided text describes the Choice Spine Lumbar Spacer System, which is a medical device. The information details the device's indications for use, materials, and a declaration of substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, many of the requested categories are not applicable to the provided document. The document describes a traditional medical device (spinal spacer), not an AI or algorithm-based device.

Here's a breakdown based on the information provided, highlighting what is and isn't available:

Acceptance Criteria and Study for Choice Spine Lumbar Spacer System

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. The document describes mechanical performance testing of the physical device (spinal spacer) rather than a test set for an AI/algorithm. The "test set" in this context would refer to the physical spacers subjected to the performance tests. The specific number of devices tested is not provided, but the testing was conducted by an "independent laboratory."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical device, and "ground truth" for mechanical performance is established by standardized testing methods, not expert consensus interpretation of data.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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:

• Not Applicable. This device is a physical implant; it does not involve human readers or AI assistance.

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

• Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• For the performance testing, the ground truth is established by physical measurement against the requirements of the ASTM standards (ASTM F2077-11 and ASTM F2267-04) and comparison to the performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/algorithm requiring a training set.

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

• Not Applicable. See point 8.

Summary of the Study:

The "study" described in the provided text is a series of mechanical performance tests conducted on the Choice Spine Lumbar Spacer System. These tests were performed by an independent laboratory according to established ASTM standards (ASTM F2077-11 and ASTM F2267-04). The tests covered static axial compression bending, static torsion, dynamic axial compression bending, and dynamic torsion.

The overall conclusion of these tests was that the device's performance was "substantially equivalent to those of the predicate devices." This "substantial equivalence" is the basis for the FDA 510(k) clearance, indicating that the device is as safe and effective as legally marketed predicate devices. The document does not provide raw data, specific pass/fail values, or detailed performance metrics beyond stating substantial equivalence.

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