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510(k) Data Aggregation
(247 days)
CarboClear**®** X Pedicle Screw System
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:
| Acceptance Criteria Category | Specific Test Standard | Performance/Result | Notes |
|---|---|---|---|
| Mechanical Stability | ASTM F1717 | Results comparable to predicate devices. | Includes static and dynamic tests for spinal implant constructs. |
| Axial Gripping Capacity | ASTM F1798 | Results comparable to predicate devices. | Relates to the ability of the screws to grip the bone. |
| Torsional Gripping Capacity | ASTM F1798 | Results comparable to predicate devices. | Relates to the rotational stability of the screws in the bone. |
| Static Flexion-Extension | ASTM F1798 | Results comparable to predicate devices. | Simulates spinal movement. |
| Material Equivalence | Not explicit standard, but inferred | Components (pedicle screws, rods, locking elements) made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). Threaded portion of screws encased in thin titanium shell. Tantalum markers may be included. Titanium alloy rod also available. | Compared to predicate devices, especially the primary predicate, the subject device's implant components are "the same." |
| Geometric Equivalence | Not explicit standard, but inferred | Subject device includes "longer rods" compared to primary predicate. Otherwise, implant components are "the same." | This is the basis for the "expansion of indications for use." |
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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(27 days)
CarboClear**®** X Pedicle Screw System; CarboClear® X Navigated Instruments
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.
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(61 days)
CarboClear**®** X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle
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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