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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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