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The CarboClear® Pedicle Screw System is intended to provide rigid immobilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, 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. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone graff.

The CarboClear® Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants include tantalum markers. The implants are supplied sterile, and are intended for single use.

The provided text describes the CarboClear® Pedicle Screw System, a medical device for spinal stabilization, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as might be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and study methodology for proving device performance through such studies is not available in this document.

However, based on the provided text, here's what can be extracted regarding performance and substantiation:

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

The document does not explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

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

The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Instead, it refers to "Performance data" and "Clinical data."

• Performance Data (Mechanical Testing): The sample size for mechanical tests (e.g., number of screws, rods tested) is not provided. The data provenance is laboratory testing conducted according to ASTM standards. Country of origin not specified, but the applicant is based in Israel.
• Clinical Data: The sample size for clinical data (e.g., number of patients) is not provided. The provenance (country of origin, retrospective/prospective) is also not specified.

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)

This information is not applicable to the type of submission described. The document does not describe a study involving expert-established ground truth for a test set, as would be relevant for an AI/ML device.

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

This information is not applicable. There is no mention of an adjudication method as it relates to expert review of a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a physical pedicle screw system, not an AI/ML-driven diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

For the mechanical performance, the "ground truth" is established by adherence to recognized ASTM standards and comparison to predicate device performance. For clinical performance, the "ground truth" would likely be patient outcomes, but the specific type of clinical ground truth (e.g., imaging follow-up, functional scores, fusion rates) is not detailed.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML model that requires a training set.

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

This information is not applicable. The device is not an AI/ML model that requires a training set with established ground truth.

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CarboClear Cervical Plate System is intended for anterior fixation of the cervical spine.

The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following:

Degenerative disc disease (DDD) (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis and tumors, deformity (e.g., scoliosis, kyphosis, lordosis), pseudoarthrosis, failed previous fusions.

The CarboClear Cervical Plate System comprises implants (plates and screws) in different dimensions, and instruments.

The CarboClear cervical plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and may incorporate tantalum markers. The screws are made of titanium alloy.

This is a 510(k) premarket notification for a medical device, specifically the CarboClear® Cervical Plate System. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, the provided document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML powered diagnostic or prognostic device.

The document discusses the following:

• Device Name: CarboClear® Cervical Plate System
• Intended Use: Anterior fixation of the cervical spine for temporary stabilization during fusion development in patients with various spinal conditions.
• Materials: Carbon fiber reinforced PEEK for plates, titanium alloy for screws.
• Predicate Devices: Several predicate devices are listed, including Spider® Cervical Plating System and Anterior CSLP System.
• Substantial Equivalence: The submission claims substantial equivalence based on intended use, design, materials, technological characteristics, principles of operation, and mechanical performance.
• Performance Testing: Static and dynamic compression bending, static torsion (per ASTM F1717), and static screw pushout testing were conducted, and the results were found to be comparable to predicate devices. Bacterial endotoxin evaluation was also performed.

To answer your specific questions, based only on the provided text, I must state that the requested information is not present:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Performance characteristics... are comparable to those of predicate devices," but no specific acceptance criteria or quantitative performance data are given.
2. Sample size used for the test set and the data provenance: Not applicable or provided. This is physical device testing, not a data-driven AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would likely refer to engineering specifications and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
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 not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not directly specified in terms of "ground truth" for a diagnostic study. Mechanical performance is compared against predicate devices and ASTM standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.

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The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.

CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.

Patients should have at least six months of non-operative treatment prior to surgery.

CarboClear® Lumbar Cage System is composed of implants of various sizes, and instruments.

The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.

Unfortunately, the provided text does not contain the specific information required to answer your request about acceptance criteria for an AI/ML powered medical device and the study that proves it meets those criteria.

The document is a 510(k) summary for the "CarboClear® Lumbar Cage System," which is an intervertebral body fusion device made of carbon fiber-reinforced PEEK and titanium alloy. This is a physical implant, not an AI/ML powered device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Details about sample size, data provenance, expert qualifications for test set ground truth, or adjudication methods for an AI/ML study.
3. Information on MRMC studies or effect sizes of AI assistance.
4. Details on standalone algorithm performance.
5. Type of ground truth used for AI/ML.
6. Sample size and ground truth establishment for an AI/ML training set.

The document does mention performance data for the CarboClear® Lumbar Cage System, which includes mechanical tests like static and dynamic axial compression, compression-shear, wear evaluation, subsidence, expulsion, and endplate shear tests. These are standard tests for spinal implants, demonstrating the physical device's mechanical integrity and similarity to predicate devices. However, this is not related to AI/ML performance.

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The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

The CarboClear VBR System comprises implants (spacers) in different dimensions, and instruments. The CarboClear VBR spacers are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

The provided document is a 510(k) summary for the CarboClear® VBR System, a medical device for spinal intervertebral body fixation. It does not describe an AI/ML powered device, nor does it detail a study proving device performance against acceptance criteria in the manner requested (e.g., with specific metrics like sensitivity, specificity, or human reader improvement with AI assistance).

The document focuses on demonstrating substantial equivalence of the CarboClear® VBR System to predicate devices through an assessment of its intended use, design, materials, technological characteristics, principles of operation, and mechanical performance characteristics.

Therefore, I cannot extract the information required for an AI/ML powered device study from this document. The sections you requested (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) are deeply specific to the evaluation of AI/ML models, not for a physical implant device like the CarboClear® VBR System.

The closest relevant information concerning "performance" in this document refers to mechanical testing standards for an implant:

• Performance characteristics included static and dynamic axial compression and torsion testing per ASTM F 2077, expulsion testing, and endplate shear strength testing.
• Performance characteristics are comparable to those of predicate devices (as applicable), thus demonstrating that the device is substantially equivalent to the predicates.

This indicates that the "acceptance criteria" were likely defined by meeting or exceeding the mechanical performance standards established in ASTM F 2077 and demonstrating comparability to predicate devices for these physical attributes. However, specific numerical acceptance criteria (e.g., a minimum axial compression strength) and reported performance values are not provided in this summary for confidentiality reasons, as this is a 510(k) summary, not the full submission. Similarly, the "study" proving this performance would be the mechanical testing described, not a clinical study involving human outcomes or an AI algorithm's performance.

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