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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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The CarboClear® Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® II Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® and CarboClear® II Pedicle Screw Systems are 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 implants include pedicle screws, rods, locking elements and transverse connectors. 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, and includes a small tantalum marker.

The implants are supplied sterile, and are intended for single use.

This document is a 510(k) Premarket Notification and does not describe acceptance criteria for a device's performance based on clinical study data, nor does it detail a study proving such performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing rather than clinical outcomes or diagnostic accuracy.

Therefore, many of the requested elements (e.g., sample size for test sets, expert adjudication, MRMC studies, ground truth for training/test sets) are not applicable or findable within this document, as they relate to clinical or AI/diagnostic performance studies, which were not the basis for this specific device clearance.

The "device" in this context is a CarboClear® Pedicle Screw System and CarboClear® II Pedicle Screw System, which are medical implants. The "performance" being evaluated here is primarily mechanical performance, not diagnostic accuracy or human-in-the-loop improvement for complex medical tasks often associated with AI/diagnostic devices.

Here's an attempt to answer the questions based on the provided document, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in the way one might for a diagnostic device (e.g., minimum sensitivity/specificity). Instead, it states that the performance characteristics (mechanical) were evaluated against standards, and the results were comparable to predicate devices. This implies the acceptance criterion was "comparable mechanical performance" as demonstrated by meeting specified ASTM standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify mechanical test sample sizes. Mechanical testing typically involves a set number of samples per test condition (e.g., n=6 for fatigue testing). These are in vitro tests, not patient data.
• Data Provenance: Not applicable for a mechanical performance study. The tests were performed in vitro to ASTM standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth and expert review are relevant for diagnostic or AI performance studies involving interpretation of medical data. This document describes mechanical testing of an orthopedic implant.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies. This is a mechanical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No. An MRMC study is relevant for diagnostic performance, evaluating how human readers perform with or without AI assistance on medical cases. This document covers mechanical testing of a pedicle screw system.

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

Not applicable. This is not an AI/algorithm-based diagnostic device. The performance refers to the physical mechanical properties of the implant itself.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic "ground truth." For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM F1717, F1798, F2193, F543) and demonstrable equivalence to predicate devices under these test conditions.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of why requested information is largely absent:

The provided text is a 510(k) summary for a pedicle screw system, which is an implantable medical device. The clearance is based on substantial equivalence to existing predicate devices, primarily demonstrated through mechanical performance testing (in vitro engineering tests) rather than clinical studies or diagnostic accuracy evaluations. Many of the questions posed directly relate to the methodology of AI/diagnostic device studies (e.g., human reader performance, training/test sets, expert ground truth, MRMC studies), which are not performed for this type of device clearance.

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The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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, locking elements and transverse connectors. 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, and includes a small tantalum marker.

The implants are supplied sterile, and are intended for single use.

This document is a 510(k) premarket notification for a medical device called the CarboClear® Pedicle Screw System. It is primarily concerned with establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information about clinical studies, expert-established ground truth, and specific performance metrics for an AI device is not applicable or available within this document.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not present:

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

This document does not provide a table of acceptance criteria in the context of device performance in a clinical setting (e.g., accuracy, sensitivity, specificity for an AI device). Instead, it focuses on demonstrating substantial equivalence to a predicate device through mechanical and material testing. The "acceptance criteria" in this context are implicitly met if the test results are "comparable to those of the predicate device."

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. This submission relies on mechanical and material testing, not a test set of patient data.

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. This submission does not involve clinical data or ground truth established by medical experts for a test set.

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

Not applicable. This submission does not involve adjudication 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

Not applicable. This document describes a medical implant, not an AI device, and therefore no MRMC study was conducted or reported.

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

Not applicable. This document describes a medical implant, not an AI device.

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

Not applicable. The "ground truth" in this context relates to the mechanical and material properties of the device, which are evaluated against established engineering standards (ASTM) and compared to the predicate device, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This submission deals with a physical medical device and its mechanical testing, not a machine learning model with a training set.

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

Not applicable. There is no training set for a machine learning model.

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The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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 are supplied sterile, and are intended for single use.

I am sorry, but based on the provided document, I cannot extract the specific details about the acceptance criteria, the study that proves the device meets the acceptance criteria, or most of the other requested information (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).

This document is a 510(k) summary for a medical device (CarboClear® Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results in the format you've requested.

Here's what I can tell you from the document:

• Device: CarboClear® Pedicle Screw System
• Purpose: To restore the integrity of the spinal column in patients with advanced-stage tumors involving the thoracic and lumbar spine.
• Performance Data: "Performance characteristics included static and dynamic tests according to ASTM F 1717, and tests according to ASTM F 1798, ASTM F 2193, ASTM F 543; as well as fatigue lateral bending-axial rotation test and rod creep test. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use."
• Clinical Data: "Clinical data for the CarboClear System was presented for the target population specified in the indications for use statement, and supports the safety and effectiveness of the device."

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance (this is a hardware device, not an AI algorithm).
7. The type of ground truth used (beyond general "clinical data").
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This type of information would typically be found in a more detailed clinical study report, which is not part of this 510(k) summary.

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