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NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, and intervertebral disc space). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during process. When used in intervertebral disc space, NovaBone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

NovaBone Putty - Bioactive Synthetic Bone Graft is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is provided in a PETG tray, disposable plastic syringe, or a prefilled cartridge delivery system (MIS delivery system).

The provided text is a 510(k) summary for the NovaBone Putty - Bioactive Synthetic Bone Graft. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, innovative device that requires extensive clinical validation. Therefore, many of the requested elements for describing acceptance criteria and proving device performance through a study (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods) are not explicitly detailed in this type of regulatory submission.

However, based on the information provided, here's what can be inferred and stated regarding the device's acceptance criteria and the "study" (or rather, the justification for substantial equivalence):

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

The document doesn't provide a table of precise quantitative acceptance criteria in the format typically seen for a new device's efficacy or safety trial. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is essentially the claim that the NovaBone Putty exhibits functional characteristics similar to the predicate devices and meets general safety and efficacy requirements for this class of device.

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

The document does not describe a "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it relies on:

• Prior functional animal model performance: This data provenance is mentioned to address differences in material composition. The specific sample size for this animal model is not provided.
• Previously cleared devices (K240404, K082672): Data for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and bench performance are leveraged from these reference devices. The original sample sizes for these tests are not provided in this summary.
• Prior posterolateral spine fusion studies: Mentioned to support performance in the intervertebral body space. No specific sample size or provenance for these studies is given.

Given this is a 510(k) submission, the data is likely a combination of pre-clinical (animal) data, bench testing, and potentially existing clinical data from predicate or reference devices, rather than a new, large-scale prospective clinical study specifically for this submission. The provenance (country of origin, retrospective/prospective) is not detailed for these underlying studies.

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

This information is not provided. Since no new clinical "test set" requiring expert ground truth establishment is described for this submission, these details are absent. The FDA's review process inherently involves experts, but not in the context of establishing ground truth for a discrete test set for the device's performance in this document.

4. Adjudication method for the test set:

Not applicable, as no described new clinical test set requiring adjudication is presented in this document.

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. The NovaBone Putty is a medical implant (bone graft) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.

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

Not applicable. The NovaBone Putty is a medical implant, not an algorithm.

7. The type of ground truth used:

For this 510(k) submission, the "ground truth" for the device's substantial equivalence is established by regulatory standards and existing data on the predicate devices. The safety and effectiveness claims are based on:

• Functional animal model performance data: This would typically involve histological analysis, biomechanical testing, and potentially imaging to assess bone regeneration.
• Previous characterization, bench performance, and biocompatibility studies: These tests follow recognized standards and guidance documents (e.g., ISO standards for biocompatibility (pathology), ASTM standards for material properties (bench data)).
• Clinical experience with predicate and reference devices: The FDA considers the established safety and efficacy profile of the legally marketed predicate device as part of the ground truth for substantial equivalence.

8. The sample size for the training set:

Not applicable. The NovaBone Putty is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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The COSINE™ Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The COSINE™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

This device is 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 anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

COSINE™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

COSINE™ Spacers are manufactured from titanium alloy per ASTM F136 or ASTM F1295. The endplates are additively manufactured from titanium powder, as specified in ASTM F3001, and an internal component is manufactured from radiolucent PEEK polymer.

This document pertains to the 510(k) premarket notification for the COSINE™ Spacer, an intervertebral body fusion device. Regulatory information for the device is provided in the document. However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document states that:

• Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.
• The subject implants have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• The subject interbody devices have been found substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.

To answer your request, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions mechanical testing was performed in accordance with standards, but it does not list specific acceptance criteria (e.g., minimum compression strength, subsidence limits) or the actual performance values achieved by the COSINE™ Spacer.
2. Sample size used for the test set and the data provenance: This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the "ground truth" for mechanical testing is typically defined by engineering standards, not expert interpretation.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is not applicable as the device is a physical implant, not an AI or imaging system requiring human reader interaction.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ASTM standards and FDA guidance. Specific quantitative values are not given.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA communication confirms the clearance of the COSINE™ Spacer based on its substantial equivalence to predicate devices through mechanical testing. However, it does not detail the specific acceptance criteria, test results, or methodology (beyond mentioning adherence to standards) that would allow for a complete answer to your request.

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ADIRATM Lateral Plate System

The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or failed previous spinal surgery.

The ADIRA™ 1-Hole Plate is intended to stabilize allograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications.

ADIRA™ Plate-Spacer Assemblies

ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON® L, TransContinental®, RISE®-L, Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON® L, TransContinental®, or RISE®-L Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When ADIRA™ Plates are assembled to Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers, the plate-spacer assembly takes on the indications of the interbody device.

ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when

The ADIRA™ Lateral Plate System consists of 4-, 2- and 1-hole thoracolumbar plates of various sizes to accommodate varying patient anatomy and surgical needs. The ADIRA™ plates are used with bone screws to attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine. ADIRA™ plates may also be attached to certain lateral lumbar interbody fusion devices (HEDRON L™, TransContinental™, RISE-L™, Modulus® XLIF, Cohere® XLIF, or CoRoent®) with an alignment screw. The plate-spacer assembly is used with bone screws and/or lateral anchors.

The provided text describes a medical device called the ADIRA™ Lateral Plate System and its clearance by the FDA based on substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based devices with performance metrics like accuracy, sensitivity, specificity, etc.

Instead, the document focuses on regulatory approval for a physical medical implant (thoracolumbar plate system) based on material, design, and mechanical performance. The "Performance Data" section in the document refers to mechanical testing for physical device characteristics, not clinical performance or diagnostic accuracy.

Therefore, many of the requested fields regarding AI/ML device performance metrics, study design, expert adjudication, and ground truth establishment cannot be populated from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided in the requested format. The document describes mechanical testing (static and dynamic compression bending, static torsion, expulsion testing) against ASTM standards and FDA guidance for spinal systems. It states: "Performance data demonstrate substantial equivalence to the predicate devices." It does not list specific numerical acceptance criteria (e.g., "accuracy > 90%") or reported performance values (e.g., "accuracy = 92%") for AI/ML-related performance.

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

• Not applicable/Not mentioned. This information is typically for clinical or AI/ML performance studies. The testing mentioned is mechanical testing of physical implants, not data-driven 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/Not mentioned. This is for AI/ML performance studies.

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

• Not applicable/Not mentioned. This is for AI/ML performance studies.

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

• No. An MRMC study was not done as this is not an AI-assisted device.

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

• No. Not an AI algorithm.

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

• Not applicable/Not mentioned. The "ground truth" for mechanical testing would be the physical properties and structural integrity measured against engineering standards.

8. The sample size for the training set

• Not applicable/Not mentioned. Not an AI/ML device requiring a training set.

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

• Not applicable/Not mentioned. Not an AI/ML device.

Summary regarding the acceptance criteria and study as requested for AI/ML devices:

The provided FDA 510(k) clearance letter for the ADIRA™ Lateral Plate System does not contain information typically found for AI/ML-based medical devices regarding acceptance criteria, study design for performance evaluation (e.g., accuracy, sensitivity, specificity), sample sizes for test/training sets, expert adjudication, or ground truth establishment.

The device is a physical thoracolumbar plate system, and the "Performance Data" section solely refers to mechanical testing against engineering standards (ASTM F1717) and FDA guidance documents for spinal implant systems, demonstrating "substantial equivalence to the predicate devices."

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The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. These devices are intended to be used with bone screws, anchoring blades, or a combination of the two. When used with Modulus ALIF bone screws, the Modulus ALIF System 10° 20° lordotic cages may be used as a standalone system. When used with Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.q., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (e.g., radiographs, CT scan, MRI scan). The Modulus ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolistheses and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by FDA for use in the lumbar spine in addition to the integrated screws/anchoring blades.

The subject NuVasive Modulus ALIF System interbody implants are manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. When used with the Modulus ALIF bone screws, the Modulus ALIF Interfixated System 10°- 20° lordotic cages may be used as a standalone system. When used with the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25°- 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine.

The purpose of this submission is to introduce the Modulus ALIF anchoring blades (blades), which are a new in-line fixation option, provided sterile and non-sterile, for the NuVasive Modulus ALIF System.

The provided text is a 510(k) summary for the NuVasive Modulus ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, material composition, function, and range of sizes, supported by mechanical performance testing.

Therefore, it does not contain the specific information requested regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, or the results of a multi-reader multi-case (MRMC) study. The NuVasive Modulus ALIF System is an intervertebral body fusion device and is not an AI/ML powered medical device.

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