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The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.

The provided text is for a 510(k) summary for a medical device (Scient'X Anterior Buttress Plate), which falls under the category of spinal implants. These summaries are typically for demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than clinical studies with human subjects or AI performance metrics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI standalone performance, training set size) are not applicable to this type of regulatory submission and information will not be found in the provided document.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. The submission focuses on substantial equivalence based on mechanical testing and comparison to predicate devices, not on a clinical test set with human data as would be relevant for AI/diagnostic devices. The document does not specify sample sizes for mechanical tests, nor details about data provenance in the context of clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, in the sense of expert consensus for diagnostic accuracy, is not relevant to this type of device submission. The primary "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of results (e.g., imaging). This is a mechanical device submission.

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 is a medical device (spinal implant), not an AI or diagnostic tool where MRMC studies would be conducted.

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

• Not Applicable. This is a physical spinal implant, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this submission is the performance characteristics and safety profiles of the legally marketed predicate devices. Substantial equivalence means the new device is as safe and effective as existing devices. This would be established through mechanical testing results compared to the predicate, and possibly design comparisons.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set.

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

• Not Applicable. This is not an AI or machine learning device.

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The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, 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 Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care.

The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.

The Tribeca™ Cage involves lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Tribeca™ Cage is manufactured from PEEK-OPTIMA polymer and is provided nonsterile.

This 510(k) summary describes a spinal intervertebral fusion device, the Scient'x Tribeca™ Cage, and its substantial equivalence to a predicate device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostics.

The document primarily focuses on:

• Device description (Tribeca™ Cage made of PEEK-OPTIMA polymer)
• Intended use and indications for use (intervertebral body fusion in the lumbosacral spine for degenerative disc disease)
• Predicate device (Abbott Spine Ardis Spacer K073202)
• Performance standards met: ASTM F2077 and F2267. These are mechanical testing standards for intervertebral body fusion devices, not clinical performance metrics or acceptance criteria for an AI algorithm.
• FDA's substantial equivalence determination.

Therefore, most of the requested fields are not applicable or cannot be extracted from the provided text.

Here is a summary of what can be inferred or stated as N/A:

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

   Acceptance Criteria	Reported Device Performance
   Compliance with ASTM F2077 (static and dynamic shear)	Testing indicates substantial equivalence to predicate device.
   Compliance with ASTM F2267 (fatigue testing)	Testing indicates substantial equivalence to predicate device.
   No specific numeric clinical acceptance criteria or performance metrics are provided in the document.

2. Sample size used for the test set and the data provenance: N/A. This document pertains to a physical implant and its mechanical testing, not a digital algorithm evaluated on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth as typically understood for AI models is not relevant here. The "ground truth" for this device's performance would be derived from mechanical testing results against ISO/ASTM standards.

4. Adjudication method for the test set: N/A.

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: N/A. This is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical implant.

7. The type of ground truth used: For the mechanical performance, the "ground truth" would be the specifications and performance characteristics defined by ASTM F2077 and F2267, and the comparative performance of the predicate device.

8. The sample size for the training set: N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established: N/A. This is not an AI/ML device.

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Davantis/Antelys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The DAVANTIS/ANTELYS Vertebral Body Replacements are oval shaped. The interior of the spacers has three compartments to provide space for bone graft. The implanted in the vertical position. These components are available in various heights (9mm-75mm). The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation. The body has a multitude of holes to allow additional impaction of bone graft.

The DAVANTIS!ANTELYS components are fabricated from pure poly(ether ether ketone) (PEEK). This material closely matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

This document is a 510(k) summary for the DAVANTIS/ANTELYS Vertebral Body Replacement device, which describes its intended use, design, and equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on comparison to a predicate device and often involves bench testing, rather than clinical studies with quantifiable performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information from the provided text, as it describes a regulatory submission (510(k)) that focuses on substantial equivalence, not on studies proving specific acceptance criteria.

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The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/iliac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.

Indications for use include:

• degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• spondylolisthesis
• trauma (i.e., fracture or dislocation)
• spinal stenosis
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• tumor
• pseudoarthrosis
• failed previous fusion

The ISOBAR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOBAR Spine System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

As a pedicle screw system the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws (K990118, K013447 and K020245) rods, nuts and cross link members. It can be used for single or multiple level fixation. It also included single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/illiac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.

All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is the EASYS Transverse Connection. Its purpose is to provide rigidity to the spinal construct similar to the crosslink cleared on K990118. It consists of a cross bar and two self locking jumper consists of a clamp and tightening screw.

The EASYS Transverse Connection is a component intended to provide rigidity to a spinal construct, similar to a previously cleared crosslink for the ISOBAR Spinal System.

The device's acceptance criteria and the study proving it meets these criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The study involved a comparison of mechanical properties, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study was a non-clinical mechanical test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The study was a non-clinical mechanical test.

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 is a mechanical device, not an AI or imaging device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used: The ground truth was based on the mechanical strength of the predicate device's crosslink as measured by ASTM 1717.

8. The sample size for the training set: Not applicable. This is a non-clinical mechanical test, not a machine learning study with a training set.

9. How the ground truth for the training set was established: Not applicable.

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