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The Eminent Spine 3D Titanium Pedicle Screw System is designed to provide immobilization and stabilization to the thoracic, lumbar and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 or 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.

The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps, and cross connectors with lock screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to 600mm in various increments. The radius of curvature of the pre-contoured rods is 154mm throughout the entire series. Cannulated polyaxial screws are available in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm diameters and in lengths ranging from 40mm to 60mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods.

All components are manufactured from Ti6Al4V ELI. The screw is made specifically from Ti6Al4V ELI per ASTM F3001 and the tulip, set cap, rod, and cross link systems are made specifically from Ti6Al4V ELI per ASTM F136. The devices are sold non-sterile.

The provided document is an FDA 510(k) clearance letter for a medical device, the "Eminent Spine 3D Titanium Pedicle Screw System." This letter is a regulatory document, not a clinical study report.

Therefore, none of the information requested about acceptance criteria and study proving device performance (points 1-9) can be found in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This equivalence is primarily demonstrated through mechanical testing (listed on page 6) and comparison of technological characteristics (page 6), rather than clinical performance studies involving human subjects or AI algorithms.

Specifically, the document mentions:

• Mechanical Testing:
  • Static torsion, static compression bending, and dynamic compression bending according to ASTM F1717
  • Torsional strength, driving torque, and axial pullout according to ASTM F543
  • Static cantilever bending according to ASTM F2193
  • Dynamic cantilever bending modified from ASTM F2193
• Conclusion: "The results support the substantial equivalence of the subject device compared to predicate devices."

This type of submission typically relies on non-clinical data (e.g., bench testing) to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device, and does not usually include the detailed clinical study data points requested (such as sample size for test/training sets, expert adjudication, MRMC studies, or AI algorithm performance).

In summary, the provided text does not contain the information necessary to address the specific questions about acceptance criteria and clinical study performance for human readers or AI, as it pertains to a mechanical medical device cleared through substantial equivalence based on bench testing.

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NEO Pedicle Screw System™

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO 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. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels (thoracic and lumbar T1 to L5) where the structural integrity of the spine is not severely compromised.

BonOs® Inject

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time 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. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. BonOs® Iniect

BonOs® Iniect is a radiopaque, iniectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

2. NEO Pedicle Screw System™

The NEO Pedicle Screw System™ has been optimized and consists of 27 pedicle and 8 iliac screws, rods and connectors which are available in different sizes. The system includes a reduced optimized trav of instruments providing options for open and MIS surgical techniques. The implants are all delivered sterile and ready to use. The relevant instruments are mainly delivered as single use, disposable and delivered sterile, just a few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. Screws and rods are made of titanium-alloy (Ti-6AI-4VELI) and comply with ISO 5832-3 or ASTM-F136. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy CoCrMo (ISO 5832-12, ASTM F1537) and delivered sterile, Connectors are made out of titanium alloy and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and 10.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 35 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The NEO Pedicle Screw System™ provides immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system can be used via an open or minimally invasive posterior approach. lliac screws shall be placed via Sacral Alar Iliac (SAI) and/or Posterior Superior Illiac Spine (PSIS) approach. The size and form of the device is adjusted to the morphology of the body and the surgical technique.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "NEO Pedicle Screw System™" and "BonOs® Inject Bone Cement." This document details the administrative information, device description, indications for use, and a summary of performance data to support substantial equivalence to a predicate device.

However, the document specifies that "No clinical studies were conducted." This means that the information requested regarding acceptance criteria for a study proving device performance (especially for AI/algorithm-based devices), sample size for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from this document.

The performance data mentioned in the document are limited to non-clinical testing, primarily focusing on mechanical performance, biological evaluation, and MRI compatibility. These types of tests are used to demonstrate that changes to the device (like new components or size extensions) do not negatively impact its existing, cleared performance characteristics, and that it is substantially equivalent to the predicate device.

Therefore, I cannot populate the requested table or answer the specific questions related to the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven device's performance study, as this submission is for a physical orthopedic implant system, not a software or AI product requiring such a study.

Here's what can be inferred from the document regarding "acceptance criteria" and "proof" in the context of this device:

The "acceptance criteria" for the modifications introduced in this 510(k) submission are implicitly met if the device demonstrates substantial equivalence to its predicate device. This is primarily demonstrated through:

• Mechanical Performance: Meeting the requirements for pedicle screw spinal systems according to relevant ASTM and ISO standards (e.g., ASTM F1717 for dynamic compression bending). The document states: "Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is substantially equivalent to its predicate devices."
• Biological Evaluation: Compliance with ISO 10993-1 series for the new components.
• MRI Compatibility: Meeting standards like ASTM F2052-15, ASTM F2182-11a, and ASTM F2119-07 (R2013).
• Functionality: Internal validation confirming new components function as intended.

Table of Acceptance Criteria (Implicit for a Mechanical Device) and Reported Performance:

Regarding the specific questions about an AI/algorithm performance study:

1. Sample size for the test set and data provenance: Not applicable. No clinical or external algorithm performance test set was used.
2. Number of experts used to establish the ground truth and qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
6. Type of ground truth used: Not applicable. Ground truth for a physical device is often demonstrated by meeting design specifications and performance under defined test conditions (e.g., material strength and fatigue testing).
7. Sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional mechanical medical device, not an AI/ML powered one. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML device evaluations, are not present in this submission. The "proof" for this device's acceptance rests on its demonstration of substantial equivalence to a predicate device through non-clinical laboratory testing.

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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.

The provided text is a 510(k) summary for the Reform Pedicle Screw System. This document focuses on the mechanical testing and equivalence of a medical device, specifically a pedicle screw system, rather than a diagnostic AI/ML device that would have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC).

Therefore, the typical acceptance criteria and study design elements you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) for an AI/ML device are not applicable to this submission.

Instead, the performance data provided is entirely about mechanical and material testing to demonstrate the physical characteristics and safety of the implanted device.

Here's a breakdown of the relevant information from the provided text, framed within the context of a traditional medical device submission, recognizing that it doesn't fit the AI/ML paradigm:

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

The document describes performance testing rather than specific acceptance criteria in a tabular format with quantitative metrics for a pass/fail. However, it states the following tests were conducted:

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

• Sample Size: Not specified in the summary. For mechanical testing, this would typically involve a specific number of test articles (e.g., screws, constructs) for each test.
• Data Provenance: The "study" is non-clinical mechanical bench testing performed according to ASTM standards. It's not human-centric data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

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

• Not applicable. Ground truth in this context is established by engineering specifications, standard ASTM testing methodologies, and objective mechanical measurements. It does not involve expert readers reviewing images or clinical data.

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

• Not applicable. Adjudication is relevant for subjective expert reviews, not for objective 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. This device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are used to evaluate the diagnostic performance of AI or imaging modalities.

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

• Not applicable. There is no algorithm or AI component in this device. The testing is entirely for the physical device's characteristics.

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

• The "ground truth" for this type of device is established by engineering standards and physical test methodologies (e.g., ASTM F1717 for spinal implant constructs). The performance is measured against these established standards and compared to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning; therefore, there is no training set.

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

• Not applicable. There is no training set for this type of device.

In summary, the provided document details the substantial equivalence of a physical medical implant through mechanical testing, not the performance claims or evaluation of an AI-powered diagnostic device.

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The MediRod Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar. and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the MediRod Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the MediRod Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MediRod Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws and rods manufactured from titanium alloy. All the components are available in a variety of sizes to match more closely the patient's anatomy.

This document is a 510(k) summary for the "MediRod Pedicle Screw System." It does not describe a study involving device performance metrics, accuracy, or human reader involvement in the context of AI or diagnostic systems. Instead, this document focuses on the mechanical performance testing of a physical medical device (pedicle screws) to demonstrate substantial equivalence to predicate devices for FDA clearance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, as typically applied to AI/diagnostic devices, is not available or applicable in this document.

The document states:

• Performance Testing: "Static and dynamic testing of the MediRod Pedicle Screw System was performed in accordance with ASTM F1717 (static and dynamic compression bending, and static torsion testing) and ASTM F1798 (static flexion-extension testing)."
• Conclusion: "Results of the testing demonstrate the substantially equivalent mechanical performance of the subject device."

This indicates that the acceptance criteria are based on meeting the standards set forth in ASTM F1717 and ASTM F1798 for mechanical properties, and the study "proves" the device meets these criteria by demonstrating substantial equivalence in mechanical performance to legally marketed predicate devices. However, no specific numerical acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the text.

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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 Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion

The subject system (Pitkar Spinal Pedicle Screw) attaches to the spine through screw, rod, and crosslink components. Furthermore, the system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. All implants are manufactured from Ti-alloy per ASTM F136.

This submission is for a medical device (Pitkar Spinal Pedicle Screw System), not a software or AI device. Therefore, the requested information on acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable and is not present in the provided text.

The document describes the regulatory review and clearance of a Pitkar Spinal Pedicle Screw System, a physical medical device. The clearance is based on its substantial equivalence to existing legally marketed predicate devices.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical and material testing, not clinical trials or AI/software performance studies.

Here's a breakdown of what is available in the document regarding how the device meets its "acceptance criteria" (which in this case are related to safety and performance through substantial equivalence):

Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this physical device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM standards for mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance
There is no specific table of "acceptance criteria" with numerical performance metrics provided in the document for the device itself. Instead, the performance is demonstrated by:

• Static Compression Bending Test
• Dynamic Compression Bending Test
• Static Torsion Test

"The submitted mechanical testing data demonstrates that the proposed device is substantially equivalent to that of the predicate device for the desired indications." |
| Material Composition | "All implants are manufactured from Ti-alloy per ASTM F136." |

2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a physical device, this would typically refer to the number of device samples tested in laboratory settings, not patient data sets. The provenance would be the testing facility.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable for this type of device submission. Ground truth here is established by engineering and materials science principles and adherence to standards.

4. Adjudication Method for the Test Set:
Not applicable for this type of device submission. Adjudication methods are typically for clinical data or expert reviews, not mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
Not applicable. This is a physical implant device, not a software algorithm.

7. Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:

• Mechanical Testing Results: Performance against established ASTM standards (ASTM F1717 for static compression bending, dynamic compression bending, and static torsion).
• Material Compatibility and Specifications: Conformance to ASTM F136 for Ti-alloy.
• Substantial Equivalence: Comparison of design features, intended use, indications for use, and function to existing cleared predicate devices.

8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no "training set" in the context of this physical device.

In summary, the provided document is a 510(k) clearance letter for a Class II spinal implant device. The "proof" it meets "acceptance criteria" lies in demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM mechanical testing standards.

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The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyhosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intents diagnosed with: spondylolisthesis / spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Eminent Spine Scoliosis Deformity Pedicle System consists of rods, polyaxial screws with set caps, and cross connectors with locking screws. Additionally, the system consists of rod connectors and iliac bolts with their respective locking screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to various increments. Cannulated polyaxial screws are available in 6.0mm to 12.5mm diameters and in lengths ranging from 40mm to 110mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods. Rod connectors are offered in 3 types and the iliac bolts are offered in 1 type. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy per ASTM F136.

The provided document describes a medical device, the "Eminent Spine Scoliosis Deformity Pedicle Screw System," and its 510(k) premarket notification. The document focuses on establishing substantial equivalence to predicate devices, primarily through technological characteristics and mechanical testing.

However, the provided text does not contain information directly related to the acceptance criteria and study proving device performance in the context of an AI/software-based medical device. The device described is a physical implant (pedicle screw system), and the studies mentioned are mechanical tests, not clinical performance studies involving a test set, ground truth, experts, or AI algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this information is not present in the provided text.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance for an AI/software component.
• Sample size and data provenance for a test set.
• Number and qualifications of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance metrics.
• Type of ground truth used (e.g., pathology, outcomes data) for an AI model.
• Sample size and ground truth establishment method for a training set.

The document solely focuses on mechanical testing of the physical pedicle screw system to demonstrate its substantial equivalence to previously cleared devices.

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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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· M.U.S.T. Fenestrated Pedicle Screw

The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in conjunction with Meta+ Spine cement, the M.U.S.T. 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 allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

· Meta+ Spine Cement

Meta+ Spine cement, when used in conjunction with the M.U.S.T. 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 allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The purpose of this submission is to gain the clearance for the Meta+ Spine Cement to be used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, a Medacta M.U.S.T. Pedicle Screws System line extension including the following screws:

• A. Poly-Axial Screws with standard screw head design, Ø 5, 6 mm (Dual Diameter) and 7mm (Single Diameter)
• B. Poly-Axial Screws with large screw head design, Ø 7, 8, 9, 10 mm (Dual Diameter)
• C. Mono-Axial Screws, Ø 5, 6, 7 mm (Dual Diameter)
• D. Long Tab (LT) Poly-axial screws Ø 4.5. 5. 6. 7. 8 mm (Single Diameter).

The Meta+ Spine Cement as well as the M.U.S.T. Fenestrated Pedicle Screws are provided individually packed, sterile and single-use.

The provided text describes a 510(k) premarket notification for a medical device (Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System) and outlines the testing conducted to support its substantial equivalence to predicate devices.

However, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance data against predicate devices, rather than establishing specific, quantitative acceptance criteria and proving the device meets those criteria. The "Performance Data" section lists various non-clinical tests performed, but it does not specify quantitative acceptance criteria or report specific device performance results against those criteria in a table format.

Therefore, many of the requested details about acceptance criteria, test set specifics (sample size, provenance, expert adjudication, ground truth), and training set details for an AI/ML-based device cannot be extracted from this document. This submission is for a traditional medical device (bone cement and pedicle screws), not an AI/ML diagnostic or therapeutic device. As such, concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training" are not applicable to this type of submission.

Based on the information provided, here's what can be gathered:

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

This information is not explicitly provided in the document as quantitative acceptance criteria with reported performance values in a table. The document states "testing activities were conducted to written protocols" and lists the types of tests. It asserts that "The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices with respect to the predicate devices." Implied acceptance is that the device performs equivalently to the predicate devices as per the listed tests.

Summary of Tests Performed (Implied Performance Goal: Substantial Equivalence to Predicate):

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

• Sample Size: Not specified in the provided text. The document refers to "cadaver specimen and PU foam" for the bone cement injection test, but no specific number of specimens/tests is given for any of the listed tests.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for non-clinical, in-vitro/ex-vivo biomechanical and material tests.

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

• Not applicable / Not specified. This document describes non-clinical performance testing of a physical medical device (bone cement and pedicle screws), not an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for these tests would be derived from the physical properties and mechanical behavior measured against established ASTM standards and comparable predicate device data, not expert consensus on images.

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

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers or AI output where subjective interpretation or consensus is needed (e.g., image reading). This is not relevant to the described biomechanical and material property tests.

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:

• No. An MRMC study is not mentioned, nor would it be relevant for this type of device. This device is a physical implant and bone cement, not an AI-assisted diagnostic tool.

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

• Not applicable. This pertains to AI/ML algorithms. No such algorithm is part of this submission.

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

• Not applicable in the AI/ML sense. For the non-clinical tests performed, the "ground truth" is based on the physical and mechanical properties of the materials and devices as measured using validated test methods (e.g., ASTM standards) and compared against established performance benchmarks or predicate device specifications.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm requiring a training set for this device submission.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture, dislocation, failed previous fusion (pseudoarthrosis), and/or tumor resection.

When used for posterior non-cervical screw fixation in pediatric patients, the Innovasis Vector Pedicle Screw System is indicated as an adjunct to freat adolescent idiopathic scoliosis (AIS). Additionally, the Innovasis Vector Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The Vector" Pedicle Screw System is a thoracolumbar system composed of polyaxial pedicle screws, rods, hooks, rod connectors, locking caps, lateral connectors, and transverse cross links. The system is designed with multiple options to address complex, multi-level deformity cases and accommodate various patient anatomies. The Vector Pedicle Screw System is also designed to facilitate percutaneous screw and rod placement via Minimally Invasive Surgery (MIS). The cannulated pedicle screws and extended reduction tabs allow for rod placement and minimal tissue disruption. The system was designed to minimize the number and complexity of procedural steps. Implants are manufactured from Titanium (Ti-6Al-4V ELI) per ASTM F136 or Cobalt Crome (CoCr) per ASTM F562.

This is a 510(k) summary for the Vector™ Pedicle Screw System. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does NOT describe a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Therefore, most of the requested information cannot be extracted directly from this document.

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

Information that can be extracted:

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

   • Acceptance Criteria (Mechanical Performance): The document states that "All testing performed demonstrated substantially equivalent mechanical performance to legally marketed predicate devices." This implies the acceptance criteria were to be substantially equivalent to the predicates in the tested mechanical properties.
   • Reported Device Performance:
     • Static and Dynamic Compression Bending per ASTM F1717
     • Static Torsion per ASTM F1717
     • Static Axial and Torsional Grip per ASTM F1798
     • The performance for these tests was deemed "substantially equivalent" to predicate devices. Specific quantitative values are not provided in this summary.

2. Sample sized for the test set and the data provenance: Not applicable. This document refers to mechanical testing of components, not clinical data from a test set of patients. The provenance would be the test labs where the mechanical tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical or diagnostic accuracy studies, which were not conducted or reported here.

4. Adjudication method for the test set: Not applicable.

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 device is a pedicle screw system, not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical tests, the ground truth was the established standards and performance of the predicate devices.

8. The sample size for the training set: Not applicable. This refers to mechanical testing, not a training set for an AI model.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document addresses vs. what it does not:

This FDA 510(k) summary is for a physical medical device (pedicle screw system), not an AI/software device. The "study" referenced is a series of non-clinical (mechanical) tests to establish substantial equivalence with predicate devices, as opposed to a clinical study demonstrating diagnostic accuracy or clinical effectiveness in patients.

Therefore, the detailed questions about ground truth, expert adjudication, test set/training set sizes, and MRMC studies related to human reader performance with or without AI are not applicable to this document. The document explicitly states: "N/A - no clinical data were necessary."

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