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The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.

The VCFix Spinal System is a cannulated screw-shaped implant with an expandable plate structure and is available in multiple sizes to accommodate varying patient anatomy. A pair of implants are inserted into the pedicles and manipulated with the toolset, resulting in the expansion of the device to restore the vertebral height. The implant is made of titanium alloy (Ti6Al4V ELI). During the procedure, the surgeon inserts the implants bilaterally through each pedicle of the fractured vertebra and adjusts the height and angle of the device (to correct local kyphosis) based on the unique vertebral fracture of the patient.
The VCFix Spinal System includes sterile, single-use implantation kits and a preparation kit. The kits include a pair of implants and all tools necessary for preparing the implant site and vertebral body expansion. The positioning and expansion of the implant must imperatively be followed by the injection of Teknimed F20 bone cement (K103433) to fixate the restored vertebral body. The bone cement and its delivery system are sold separately.

The provided text is a 510(k) clearance letter and summary for a medical device (VCFix Spinal System). It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance testing.

Crucially, this document describes performance testing for a medical implant (a physical device), not an AI/ML medical device. The questions you've asked are specific to AI/ML device studies, particularly concerning acceptance criteria based on metrics like sensitivity, specificity, or F1 score, and elements like ground truth establishment and expert adjudication.

Because the VCFix Spinal System is a physical implant and not an AI/ML device, the detailed information requested about AI/ML specific study design (e.g., sample size for test set/training set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) is not applicable and therefore not present in this document.

The "Performance Testing Summary" section describes the mechanical and functional testing conducted for the implant. These tests are designed to ensure the physical device meets its engineering specifications and safety requirements, not to evaluate the diagnostic or predictive performance of an AI algorithm.

Here's a breakdown of the relevant information provided and an explanation of why other requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical implant, "acceptance criteria" here refers to engineering specifications and mechanical performance standards, not statistical performance metrics for an AI algorithm. The document states that "All necessary testing has been performed for the worst-case configuration of the VCFix Spinal System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended."

Information Not Applicable / Not Available for this Type of Device (Physical Implant):

The following points are specific to AI/ML device studies and are not found in this document because the VCFix Spinal System is a physical implant, not an AI/ML software device.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for implants involves physical specimens or in-vitro/in-vivo models, not image or clinical text data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML typically refers to expert labels on data. For an implant, "ground truth" relates to objective measurements from mechanical tests or clinical outcomes from trials (which are not detailed here beyond safety and equivalence).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to how expert disagreements are resolved for data labeling in AI/ML studies.
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. MRMC studies are for evaluating AI's impact on human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be the objective results of the specified mechanical and biological tests, demonstrating it meets engineering specifications and safety requirements.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) pertains to a physical medical device (spinal implant) and its clearances are based on comprehensive engineering, mechanical, and biological testing, demonstrating substantial equivalence to existing predicate devices. Therefore, the specific details and study design elements common to AI/ML medical device evaluations are not present in this documentation.

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The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.

The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).

The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.

The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.

The SLK Ortho LLC Injection Pin (K221697) is a fenestrated screw made of Titanium alloy (Ti 6Al 4V) intended for use in combination with PMMA bone cement (Teknimed F20®) to treat fractures in the thoracic/lumbar spine (T9-L5) caused by severe osteoporosis, trauma, or tumors. The device's substantial equivalence to the predicate device, Hyprevention SAS V-STRUT© (K191709), was established through various performance tests.

Here's an analysis of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a numerical or pass/fail format for the Injection Pin device. However, the performance data presented is used to demonstrate substantial equivalence to the predicate device, V-STRUT©. The implicit acceptance criterion is that the Injection Pin exhibits substantially equivalent safety, effectiveness, and performance to the predicate device.

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

• Test Set (Biomechanical and Biocompatibility): The document does not specify a numerical sample size for the mechanical testing or in silico simulations beyond mentioning "worst-case loading scenario" and "4 different scenarios." For biocompatibility, it states "Injection Pin was tested" indicating that testing was performed on representative samples of the device.
• Data Provenance:
  • Biomechanical: Testing was conducted at the Polytechnic University of Milan, Dept. of Structural Engineering. In silico simulations were conducted in Labs of Politecnico di Milano.
  • Biocompatibility: Testing performed on the Injection Pin device, likely in a laboratory setting.
• Retrospective or Prospective: The testing described appears to be prospective, specifically designed to evaluate the performance of the Injection Pin device for this submission.

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

This type of information is generally not applicable to the non-clinical performance studies (biomechanical, biocompatibility, sterility, shelf-life) used for the Injection Pin. These studies evaluate the physical and biological characteristics of the device itself rather than interpretation of clinical images or patient data by human experts. The "ground truth" for these tests is based on established scientific principles, engineering standards (e.g., ISO, ASTM), and laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable, as this refers to adjudication by experts for clinical data interpretation, which is not described here. The evaluation involves laboratory testing against established specifications and comparison to a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance data (biomechanical, biocompatibility, sterility, shelf-life) in comparison to a predicate device, rather than a clinical trial involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies conducted (biomechanical, biocompatibility, sterility, shelf-life) are essentially "standalone" in nature, as they evaluate the device itself and its intrinsic properties without human-in-the-loop performance in a clinical setting. The in silico simulations are also a form of standalone evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies is:

• Biomechanical: Defined by established engineering principles, material science properties, mechanical loads, and the performance characteristics of the legally marketed predicate device (V-STRUT©).
• Biocompatibility: Based on established international standards (ISO 10993-1 parts 5 and ETO/ECH residual limits) and comparisons to a marketed device (Miniars Screws K143596).
• Sterility: Defined by a Sterility Assurance Level (SAL) of 10-6 and adherence to ISO 11135-1.
• Shelf-life: Defined by compliance with packaging and aging standards (e.g., UNI EN ISO 11607, ASTM F 1980-07).

8. The Sample Size for the Training Set

Not applicable. There is no information about a "training set" as this device assessment relies on non-clinical performance testing and in silico simulation for substantial equivalence, not machine learning or AI algorithm development that would involve training data.

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

Not applicable, as there is no training set described in the provided document.

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V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.

V-STRUT© Vertebral Implant is part of V-STRUT© Transpedicular Vertebral System. V-STRUT© Transpedicular Vertebral System is composed of :

• V-STRUT© Vertebral Implant,
• -V-STRUT© Guide Wire,
• -V-STRUT© Instrumentation Kit.
  V-STRUT© Vertebral Implant is a medical device to be placed in the vertebrae through a minimally invasive procedure. Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior vertebral body wall.
  The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers made of tantalum (as per ASTM F560).
  V-STRUT© Vertebral Implant exists in 2 different diameters and 5 different lengths to accommodate individual patient's anatomy of thoracic and/or lumbar vertebrae from T9 to L5.
  V-STRUT© Vertebral Implant is provided sterile and is not reusable.
  V-STRUT© Vertebral Implanted using specific instrumentation provided with the implant and is combined in situ with a Polymethylmethacrylate (PMMA) bone cement, F20® manufactured by Teknimed SA (K103433).

This document is a 510(k) summary for the V-STRUT© Vertebral Implant, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a complex clinical trial with specific acceptance criteria for AI performance as would be seen for an AI/ML medical device.

Therefore, the requested information about acceptance criteria and the study proving the device meets them, particularly in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC studies, standalone performance), is not applicable to this 510(k) submission.

This document describes a traditional medical device (an implant) and its substantial equivalence is demonstrated through:

• Biomechanical Performance Testing: Static and dynamic mechanical testing.
• Biocompatibility Testing: According to ISO 10993-1, 10993-5, and USP 42-NF 37.
• Sterility Testing: According to ISO 11137-1 and 11137-2.
• Shelf-Life Testing: According to ASTM F1980.
• Clinical Evaluation: Stating that "V-STRUT© Vertebral Implant has demonstrated to be substantially equivalent to its predicate device KIVA® VCF Treatment System. No additional safety or effectiveness issues as the ones expected and documented in the literature for predicates and references devices have been raised." This is not a prospective clinical trial with specific performance metrics designed to prove the device meets acceptance criteria related to a specific diagnosis or outcome as would be expected for an AI device.

To directly answer your numbered questions based on the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not contain such a table because it's for a physical implant, not an AI/ML diagnostic device with performance metrics like sensitivity, specificity, etc. The performance is assessed through the non-clinical tests listed above, demonstrating it functions as intended and is safe.
2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/ML algorithm. The "testing" refers to lab-based biomechanical, biocompatibility, and sterility tests of the physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI/ML diagnostic interpretation (e.g., radiologist reads) is not relevant to this device.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not the function of this implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used: For the physical device, "ground truth" relates to standardized testing conditions and material properties (e.g., biomechanical strength, non-cytotoxicity), rather than a clinical diagnosis adjudication.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a vertebral implant, focusing on its substantial equivalence to a predicate device through non-clinical performance testing and a literature-based clinical evaluation, as opposed to the clinical trial and AI/ML specific performance metrics you've inquired about.

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The VK100® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Like the predicate devices. VK100® is provided as a two-component system with barium sulfate as a radiopacifier. VK100® is a polydimethylsiloxane material. The VK100® System consists of a cartridge containing the two VK100® material components and a dispensing system which blends the two components for injection into the injured vertebrae. The material cures in situ to form a non-resorbable polymer.

The VK100® material is supplied in a pre-filled cartridge:

The 2-cylinder cartridge keeps each component separate until administration, when both components are extruded through a mix element, which blends the mixture at a 1:1 ratio.

Each dose (cartridge of VK100® material) consists of:

• Reinforced Dimethyl Methylvinyl Siloxanes ●
• . Barium Sulfate powder
• Methylhydrogensiloxane Crosslinker
• . Platinum catalyst,

The provided text describes a medical device, the VK100® Percutaneous Vertebral Augmentation System, and its submission for FDA clearance. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically designed to prove all acceptance criteria.

However, based on the provided text, we can extract details related to safety and performance, particularly concerning extravasation.

Here is an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" for the VK100® in the conventional sense (e.g., "extravasation rate must be less than X%"). Instead, it compares the VK100®'s performance to predicate devices, implying that acceptable performance is at least equivalent to or better than currently marketed devices.

Therefore, the "acceptance criterion" derived from the clinical study section is an implied comparison to the extravasation rates of predicate PMMA cements.

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

• Sample Size for Test Set: 124 subjects
• Data Provenance: The study population included a "consecutive series of 124 subjects." The text does not explicitly state the country of origin or if it was retrospective or prospective. Given the description, it likely refers to a retrospective review of existing clinical data, described as a "radiographic evaluation of existing clinical data."

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

• Number of Experts: An "independent review" was performed, implying at least one expert, but the exact number is not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The text only mentions an "independent review" of radiographic images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Comparative Effectiveness Study: No. The device described, VK100®, is a percutaneous vertebral augmentation system (bone cement), not an AI diagnostic tool. Therefore, an MRMC study related to human reading with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Not applicable. The VK100® is a medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was based on radiographic evaluation by an independent reviewer(s) to identify extravasation and migration of the VK100® material. The "primary safety measure" was the "incidence or lack thereof of pulmonary emboli," which would be clinical outcomes data, but the evaluation itself was image-based.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The VK100® is a physical medical device, not an AI model that requires a training set. The clinical study described is a performance evaluation of the device in human subjects.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device type.

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