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The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels 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 nonoperative treatment.

The CarboClear® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The CarboClear® Hybrid 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® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy set screw, and with CarboClear CFR-PEEK rods. The implants may include tantalum markers. CarboClear titanium alloy rod is also offered.

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

The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

This document is a 510(k) premarket notification decision letter from the FDA regarding the CarboClear® Hybrid Pedicle Screw System. It declares the device substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document focuses on the mechanical and material properties of a surgical implant (pedicle screw system), not a software device or an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert information, adjudication, MRMC, standalone performance, ground truth, training set details) from this document as it pertains to a different type of medical device and regulatory review process.

The document covers:

• Device Name: CarboClear® Hybrid Pedicle Screw System
• Regulation Name: Thoracolumbosacral Pedicle Screw System (21 CFR 888.3070)
• Regulatory Class: Class II
• Purpose of Submission: Expansion of indications for use (specifically, longer rods).
• Performance Data Mentioned: Previously conducted static and dynamic tests according to ASTM F1717 and ASTM F1798, showing comparability to predicate devices.
• Conclusion: Substantial equivalence to predicate devices based on intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance.

It explicitly states: "No new performance testing was necessary to support the current submission." This further confirms that no new clinical or AI/ML performance study was conducted for this specific submission.

To answer your request, you would need a document related to an AI/ML medical device submission, typically found in a "Clinical Performance" or "Software Validation" section of a 510(k) summary or a similar regulatory filing for AI/ML products.

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The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels 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® X Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The CarboClear® X 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 implants include pedicle screws, rods, and a locking element (set screw). They 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 may include tantalum markers. Titanium alloy rod is also available.

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

The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

The provided text describes the 510(k) premarket notification for the CarboClear® X Pedicle Screw System. This document is a regulatory submission for a medical device, specifically spinal implants. It focuses on demonstrating that the new device is substantially equivalent to existing predicate devices already on the market.

Crucially, this document does not describe studies proving device meets acceptance criteria related to AI/software performance or diagnostic accuracy. It primarily discusses the mechanical performance and material equivalence of a physical implant system (pedicle screws) to predicate devices, and an expansion of its indications for use.

Therefore, many of the requested items related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained within this regulatory submission.

However, I can extract information relevant to the device's performance as understood in the context of this specific regulatory submission for a physical medical device:

Acceptance Criteria and Device Performance (Mechanical/Physical)

For this type of medical device (pedicle screws), "acceptance criteria" and "performance" relate to mechanical and material characteristics rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document mentions "Performance Data" from mechanical tests (ASTM F1717, ASTM F1798). It does not specify the sample size for these tests (e.g., number of constructs tested, number of screws).
• The data provenance is not explicitly stated beyond being part of this 510(k) submission by CarboFix Orthopedics Ltd. (Israel-based company). It's scientific laboratory data gathered for regulatory purposes, typically conducted in a controlled lab environment. It is prospective testing for the submission, not retrospective data.

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

• This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM standards) and the physical measurements obtained from those tests, not by expert human 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable as this is not an AI/software device.

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

• Not applicable as this is not an AI/software device.

7. The type of ground truth used:

• The "ground truth" for this device's performance relies on objective physical measurements derived from standardized mechanical testing (e.g., load-displacement curves, fatigue life) compared against established performance benchmarks within the specific ASTM standards for spinal implants and demonstrating comparability to predicate devices.

8. The sample size for the training set:

• Not applicable as this is not an AI/software device.

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

• Not applicable as this is not an AI/software device.

Summary regarding the provided document:

The provided document (a 510(k) clearance letter and summary) is for a physical medical device (pedicle screw system), not an AI/software device. As such, the "acceptance criteria" and "performance studies" described are entirely focused on the mechanical and material properties of the implant, demonstrating its substantial equivalence to already cleared devices. The detailed questions about AI, ground truth, experts, and MRMC studies are not relevant to the content of this specific regulatory submission.

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CarboClear® Hybrid Pedicle Screw System (Oncological)
The CarboClear® Hybrid 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.

CarboClear® Hybrid Pedicle Screw System (DDD)
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization 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® Hybrid 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 graft.

CarboClear® Hybrid Navigated Instruments
CarboClear® Hybrid Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Hybrid Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Hybrid Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CarboClear® Hybrid Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® Hybrid Fenestrated 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® Hybrid Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used without cement, the CarboClear® Hybrid Fenestrated Pedicle Screws are intended: (a) 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.

(b) to provide rigid immobilization and stabilization 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® Hybrid 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 graft.

High V+® Bone Cement
When used in conjunction with the CarboClear® Hybrid Fenestrated Pedicle Screw System, High V +® Bone Cement 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. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

CarboClear® X Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® X Fenestrated 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® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used without cement, the CarboClear® X Fenestrated Pedicle Screw System is intended: (a) 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.

(b) to provide rigid immobilization and stabilization 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® X 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 graft.

High V+® Bone Cement
When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement 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. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

The CarboClear® Hybrid 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® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy locking element, and with CarboClear X CFR-PEEK rods and trans-connectors. The implants may include tantalum markers. CarboClear X titanium alloy rod is also offered.

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

The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

The CarboClear® Hybrid Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® Hybrid pedicle screws, respectively, during spinal surgery.

The CarboClear® Hybrid Fenestrated Pedicle Screws and CarboClear® X Fenestrated Pedicle Screws are cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body in oncological patients.

These implants may also serve as traditional cannulated pedicle screws when used without bone cement.

The High V+ Bone Cement is a self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzoyl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.

This document is a 510(k) Pre-market Notification from the FDA, confirming substantial equivalence for several CarboFix Orthopedics Ltd. devices. It does not describe any acceptance criteria or studies performed to prove the device meets acceptance criteria in the context of device performance or clinical endpoints.

Instead, it primarily addresses the substantial equivalence of the new devices to existing predicate devices based on:

• Intended Use & Indications for Use: These are compared to ensure they align, indicating what the devices are designed for.
• Technological Characteristics: Materials, design, and operating principles are compared. The key difference noted for the hybrid system is the screw tulip and locking element material.
• Performance Data (Bench Testing): This section specifically mentions mechanical performance characteristics evaluated through bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of clinical performance or diagnostic accuracy, as this document does not contain such details. The studies mentioned are engineering/mechanical tests.

However, I can extract the available information regarding the performance data.

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

Based on the provided document, the "acceptance criteria" are implied by the comparison to predicate devices, and the "reported device performance" refers to mechanical test results. The document states:

"Performance characteristics included static and dynamic compression bending tests according to ASTM F1717, as well as static flexion-extension test, axial gripping capacity test, and torsional gripping capacity test according to ASTM F1798. The results of the tests are comparable to those of the predicate devices, demonstrating substantially equivalent performance of the subject and predicate devices."

Table: Acceptance Criteria (Implied) and Reported Device Performance

2. Sample size 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 the sample size for the mechanical performance tests, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests, not clinical studies involving 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. The performance data discussed are from mechanical bench tests of the physical medical device components, not from studies involving human interpretation or clinical ground truth.

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

Not applicable. This is not a clinical or diagnostic study involving adjudication of human assessments.

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 does not describe studies involving AI or human readers.

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

Not applicable. This document does not describe studies involving algorithms or software performance in a diagnostic context. The "Navigated Instruments" are physical instruments used with a navigation system, not a standalone diagnostic algorithm.

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

Not applicable. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F1717, ASTM F1798) and the performance of the predicate devices. It is not clinical or diagnostic ground truth.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, as there is no training set for an AI/ML model mentioned in this document.

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The CarboClear® Posterior Cervical 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® Posterior Cervical Screw System ("CarboClear® 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® System is a posterior, cervical screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients.

The CarboClear® System implants include posterior screws, rods and locking elements (set screw). The implants are made mainly of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion and the spherical head of the screw are encased within a thin titanium shell, and may include a tantalum marker.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a 510(k) clearance letter from the FDA for a CarboClear® Posterior Cervical Screw System, which is a physical implant, not a software or AI/ML device.

The document discusses:

• Device Name: CarboClear® Posterior Cervical Screw System
• Regulation Number: 21 CFR 888.3075 (Posterior Cervical Screw System)
• Regulatory Class: Class II
• Product Code: NKG
• Indications for Use: Restoring spinal column integrity in patients with advanced stage tumors involving the cervical spine for a limited time.
• Device Description: Implants (screws, rods, locking elements) made of carbon fiber-reinforced PEEK, with titanium shells and tantalum markers, and associated instruments.
• Substantial Equivalence: Comparison to predicate devices (Synapse OCT System, Mesa Mini Spinal System, CarboClear® X Pedicle Screw System) based on indications for use, design, materials, technological characteristics, principles of operation, and performance characteristics (static and dynamic tests according to ASTM standards).

There is no mention of an AI/ML component, algorithm performance, ground truth establishment, expert review, or any of the specific criteria related to an AI/ML performance study as requested in your prompt.

Therefore, I cannot extract the information required to populate the table or answer the questions related to acceptance criteria and study proving device meets acceptance criteria for an AI/ML device from this document.

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The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with deqenerative 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® X 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 graft.

CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The CarboClear® X 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 implants include pedicle screws, rods, and a locking element (set screw). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants may include tantalum markers. Titanium alloy rod is also available.

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

The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

The CarboClear® X Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of AI/ML or medical imaging performance. The document is an FDA 510(k) clearance letter for the CarboClear® X Pedicle Screw System and CarboClear® X Navigated Instruments, which are physical medical devices (implants and surgical instruments) for spinal surgery.

The performance data mentioned relates to mechanical testing of the pedicle screw system (e.g., static and dynamic bending, torsion) according to ASTM standards, not to the performance of an AI algorithm or a diagnostic imaging system. Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML model performance, ground truth, expert consensus, or MRMC studies.

Ask a specific question about this device

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® X 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.

CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

When used in conjunction with High V+ ® Bone Cement, the CarboClear® X Fenestrated 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® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement 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. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

The CarboClear® X 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 implants for minimally invasive surgical procedures include pedicle screws, rods, and a set screw (locking element). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. Implants may include tantalum markers. The implants are supplied sterile, and are intended for single use.

CarboClear® X Navigated Instruments are manually operated, instruments intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery.

The CarboClear® X Fenestrated Pedicle Screw System consists of cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near the screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body. The Screws are implanted with the components of the CarboClear® X Pedicle Screw System. The CarboClear® X Fenestrated Screw System is made of carbon fiberreinforced polyetheretherketone (CFR-PEEK). The threaded portion of the screws is encased within a thin titanium shell, and includes a small tantalum marker. The CarboClear® X Fenestrated Screw System is supplied sterile, and is intended for single use.

High V+® Bone Cement is self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzovl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.

The provided document is a 510(k) summary for the CarboClear® X Pedicle Screw System and related components. It does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through design validation, including engineering analyses and testing. The purpose of this submission is to add a minimally invasive surgery approach option to previously cleared devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This document doesn't provide performance metrics against specific acceptance thresholds for an AI/algorithm.
• Sample size and data provenance for a test set: Not applicable, as there's no mention of an algorithm test set.
• Number of experts and their qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
• Standalone algorithm performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document describes a typical 510(k) submission for a physical medical device (pedicle screw system), where substantial equivalence is demonstrated through material properties, design specifications, and mechanical testing, rather than clinical performance of an AI algorithm.

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The CarboClear® X 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.

CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The CarboClear X 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 implants include pedicle screws, rods, a set screw and transverse connectors. They 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.

CarboClear® X Navigated Instruments are reusable, manually operated, instruments, including probes, bone taps and a screwdriver. These instruments are intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X Pedicle Screws during spinal surgery.

The provided document is a 510(k) premarket notification summary for the CarboClear® X Pedicle Screw System and CarboClear® X Navigated Instruments. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a clinical study.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way requested by the prompt for a typical AI/medical device performance evaluation.

The "Performance Data and Substantial Equivalence" section describes the types of tests conducted:

• For CarboClear® X Pedicle Screw System: Tests according to ASTM F1717 and ASTM F1798. These are standards for mechanical testing of spinal implants and pedicle screw systems, respectively.
• For CarboClear® X Navigated Instruments: Engineering analysis - comparative dimensional measurements.

These tests are designed to show that the new device performs similarly to previously cleared predicate devices, not to set and individually meet new "acceptance criteria" for a novel device performance claim.

Therefore, I cannot populate the requested table and sections as the information is not present in the provided text. The document describes a substantial equivalence pathway, where the performance is compared to predicates rather than against newly established acceptance criteria based on clinical outcomes or specific performance metrics.

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The CarboClear® X 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 X 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 implants include pedicle screws, rods, locking components (a set screw and a nut) 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) summary for the CarboClear® X Pedicle Screw System, a medical device. It does not present acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria.

Instead, it provides:

• Device Name: CarboClear® X Pedicle Screw System
• Intended Use/Indications for Use: To restore the integrity of the spinal column (even in the absence of fusion for a limited time) in patients with advanced stage thoracic and lumbar spine tumors who have insufficient life expectancy to permit fusion.
• Regulation Number and Device Class: 21 CFR §888.3070; Class II
• Product Code: NKB
• Predicate Devices: CarboClear® Pedicle Screw System (K173487, K182377, K201926) as the primary predicate, and several additional predicate devices from other manufacturers.
• Performance Data: Static and dynamic tests were performed according to ASTM F1717 and ASTM F1798.
• Conclusion: The device is substantially equivalent to its predicate devices based on intended use, design, material, dimensions, technological characteristics, and principles of operation, and its performance test results are comparable.

Therefore, since the provided text relates to a traditional medical device (pedicle screw system) and not an AI/ML powered device, I cannot extract the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

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The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.

For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.

The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.

The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.

The provided text is a 510(k) summary for a medical device (Piccolo Composite Proximal Tibia Plate System) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about studies involving human readers, AI, or diagnostic performance metrics typically associated with acceptance criteria for such studies.

Therefore, many of the requested sections about acceptance criteria, human reader performance, AI, and ground truth establishment cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what cannot:

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)

This information is not provided in the document. The performance testing described is mechanical, not clinical, and thus terms like "test set" for human or AI performance or "data provenance" in this context are not applicable.

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 provided. The "ground truth" in this context refers to engineering standards and comparisons to predicate devices, not expert human interpretation.

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

This information is not provided. Arbitration methods are typically used for clinical studies with human observers, which is not the type of study described.

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

There is no indication that an MRMC comparative effectiveness study was done. This document describes the mechanical testing of a bone plate system, not a diagnostic or AI-assisted device. Therefore, no information on AI assistance or human reader improvement is available.

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

There is no indication that a standalone algorithm performance study was done. The device is a physical bone plate system, not an algorithm.

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

The "ground truth" for the mechanical performance testing appears to be established engineering standards (ASTM F 382) and performance data from legally marketed predicate devices.

8. The sample size for the training set

This information is not provided. The concept of a "training set" is not applicable to the mechanical performance testing described for this physical device.

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

This information is not provided. The concept of a "training set" and its ground truth is not applicable to the mechanical performance testing described for this physical device.

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