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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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The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).

HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

This document is a 510(k) summary for the HIGH V+ bone cement, which is a medical device for fixing vertebral fractures. The summary focuses on demonstrating the substantial equivalence of HIGH V+ to predicate devices (Vertecem and Spineplex) rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on non-clinical (bench) testing to show equivalence in material properties and functional characteristics.

Here's the breakdown of the information that can be extracted from the document, and where the requested details are not present:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, it presents various physical and chemical characteristics of the HIGH V+ and compares them to predicate devices and the ISO 5833 standard. The "acceptance" is implied by meeting or being comparable to these established benchmarks for bone cement.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for each individual non-clinical test. The document states "Test data indicate that the final properties of HIGH V+ are in compliance..." but does not detail the number of samples tested for each property (e.g., number of specimens for compressive strength).
• Data Provenance: The tests were conducted by Teknimed, SAS, located in L'Union, France. The data appears to be prospective as it's part of the premarket submission for a new device.

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. This is a non-clinical (bench) study involving material properties, not diagnostic interpretation or clinical outcomes requiring expert ground truth.

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

• Not applicable. This is a non-clinical (bench) study.

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 is a non-clinical (bench) study about a bone cement, not an AI-assisted diagnostic device.

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

• Not applicable. This is a non-clinical (bench) study of a physical material.

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

• For the non-clinical tests, the "ground truth" or reference for comparison is the established performance of legally marketed predicate devices (Vertecem, Spineplex) and the chemical/physical requirements outlined in the international standard ISO 5833 "Implants for surgery - acrylic resin cements."

8. The sample size for the training set

• Not applicable. This is a non-clinical study for a physical device, not a machine learning model requiring a training set.

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

• Not applicable, as there is no training set for this type of device submission.

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The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

The Soteira Shield Kyphoplasty System consists of a cement director (permanent implant), a delivery system (used to place the cement director within the vertebral body) and instruments that are used to achieve percutaneous access to the vertebral body and to create a cavity into which the cement director implant will be placed. The system is intended for use with commercially available PMMA bone cement.

The provided text describes a 510(k) premarket notification for the Soteira Shield Kyphoplasty System, a device for vertebral augmentation. The information focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria with specific acceptance thresholds for device performance.

Therefore, the concept of "acceptance criteria" as applied to a new AI/software device with quantitative performance metrics (e.g., accuracy, sensitivity, specificity) and a "reported device performance" against those criteria is not directly applicable here. The equivalence is demonstrated through comparative studies against established predicate devices.

However, based on the provided text, we can infer the "acceptance criteria" and "reported device performance" in terms of how the Soteira Shield Kyphoplasty System compares to its chosen predicate device (vertebroplasty) across various aspects.

Here's an interpretation of the request using the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for a 510(k) submission are typically centered around demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate. Quantifiable performance metrics against predefined thresholds, as seen in AI/software device evaluations, are not explicitly stated. Instead, the performance is assessed relative to the predicate.

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

The clinical study served as the primary "test set" for equivalence demonstration.

• Sample Size for Test Set:
  • Soteira Shield Kyphoplasty System: 69 subjects and 102 levels.
  • Control Device (Vertebroplasty): 28 subjects and 38 levels.
• Data Provenance: The study was a "prospective randomized study." The country of origin is not specified but implicitly within the US regulatory context (indicated by FDA 510(k) submission).

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

The text does not mention the use of experts to establish a "ground truth" in the diagnostic sense, as this is a medical device for treatment. The "ground truth" for the clinical study would be derived from clinical outcomes, patient-reported pain scores, functional assessments, and imaging assessments of cement leakage. The study's design (prospective, randomized) implies that standard clinical methodologies and assessments were used, likely carried out by treating physicians and study staff, but specific numbers and qualifications of "experts" for ground truth establishment are not provided.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for the test set data. In a prospective clinical trial like this, data collection and assessment would follow a pre-defined protocol, and outcomes (pain, function, adverse events, leakage) would be recorded. Any discrepancies in data recording or interpretation would typically be handled through standard clinical trial monitoring and data management processes, but a specific "adjudication method" beyond standard clinical practice is not detailed.

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

This is not applicable. The study is for a physical medical device (Kyphoplasty System) for treating vertebral fractures, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant to this submission.

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

This is not applicable. The device is a surgical system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was based on:

• Clinical Outcomes: Patient-reported pain levels, functional scores, and recorded adverse events.
• Imaging Data: Assessment of cement leakage.
• Medical Diagnosis: Diagnosis of osteoporotic compression fractures requiring intervention.

8. The Sample Size for the Training Set

This is not applicable. The Soteira Shield Kyphoplasty System is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "pilot study" mentioned could be considered an early phase of clinical data collection that might inform the design of the larger prospective study, but it doesn't function as a "training set" for an algorithm.

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

This is not applicable, as there is no "training set" in the context of an algorithmic device.

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Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty of kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Vertaplex is Polymethyl Methacrylate cement used for the treatment of painful vertebral fractures based on the predicate device Spineplex. Vertaplex can be injected directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty procedures to relieve pain.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) summary for a medical device (Stryker Vertaplex Radiopaque Bone Cement). It focuses on demonstrating substantial equivalence to a predicate device (Stryker Spineplex Radiopaque Bone Cement).

Here's what the document does state, which is relevant to your request, but doesn't fully answer it:

• Performance Standards: "Stryker Vertaplex has been developed in accordance with the FDA Guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement."" This implies that certain performance characteristics relevant to PMMA bone cement are expected to be met, as per the guidance document. However, the specific acceptance criteria from that guidance are not detailed in this 510(k) summary.
• Safety and Effectiveness: "In vitro testing shows that the device meets similar performance specifications as those for the predicate device." This indicates that some form of testing was done to compare its performance to the predicate, but again, the specific results, acceptance criteria, or a detailed study description are not provided.
• Biocompatibility: "All appropriate biocompatibility tests have been performed on Vertaplex and have met the standard requirements." This confirms biocompatibility testing was performed and met standards, but doesn't specify the tests or criteria.

The 510(k) process primarily relies on demonstrating equivalence rather than exhaustive clinical trials for de novo authorization. Therefore, the detailed study design (like sample sizes, ground truth establishment, MRMC studies, etc.) you're asking about is not typically part of what's presented in a 510(k) summary for this type of device.

Therefore, I cannot populate your table or answer most of your detailed questions because the provided text does not contain that information.

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Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.

Cobalt™ V Radiopaque Vertebroplasty Bone Cement provides two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement.

The provided text focuses on the 510(k) summary for Cobalt™ V Radiopaque Vertebroplasty Bone Cement and does not contain detailed information about specific acceptance criteria, device performance metrics, or a formal study design with corresponding results.

Therefore, many of the requested fields cannot be filled. Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, it does not provide specific acceptance criteria (e.g., tensile strength, setting time ranges) or numerical performance metrics.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   No information is provided regarding sample sizes, data provenance, or the nature of the test set for any performance evaluation. The testing described is "non-clinical laboratory testing."

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 document refers to non-clinical laboratory testing of a bone cement, not diagnostic image interpretation where expert ground truth would be established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as this refers to a medical device's performance in evaluating diagnostic results, which is not the case here.

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 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 device is a bone cement, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. The testing was non-clinical laboratory testing of material properties, not an evaluation against a medical ground truth like pathology for a diagnostic device.

8. The sample size for the training set:
   Not applicable. This device is a bone cement, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for a bone cement device.

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Vertefix™ Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The Vertefix™ Vertebroplasty Procedure Set contains the Vertebroplasty Injector Kit and Vertefix™ Radiopaque Bone Cement. The bone cement consists of two separate, premeasured sterilized components: 20g polymer powder and 9.2g liquid monomer. The powder contains 30% barium sulfate as a radiopacifier.

This 510(k) submission for the Vertefix™ Vertebroplasty Procedure Set focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/software medical device.

Therefore, many of the requested details, such as specific acceptance criteria, a test set with expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document. This submission primarily relies on non-clinical testing to demonstrate that the device meets existing standards for bone cement.

Here's the information that can be extracted or deduced from the provided text, with clarifications where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a bone cement device, the "acceptance criteria" are not reported as quantitative performance metrics for disease detection or classification, as would be expected for an AI device. Instead, they are related to material properties and clinical equivalence. The document states:

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

• Sample Size: Not applicable. This submission doesn't describe a clinical study with a "test set" in the context of an AI/software device evaluating patient data. The "testing" refers to benchtop and laboratory tests on the bone cement itself.
• Data Provenance: Not applicable. The data provenance would be from laboratory and benchtop studies, not patient data from specific countries or types of studies.

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

• Number of Experts: Not applicable. There is no "ground truth" derived from experts on patient data described in this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no test set of patient cases requiring adjudication.

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

• MRMC Study: No. This is not an AI-assisted device.
• Effect Size: Not applicable.

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

• Standalone Performance: No. This is not an AI algorithm.

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

• Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this device would be established by validated engineering standards, chemical analyses, and biomechanical testing protocols for bone cements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study (Non-Clinical Test Data):

The study described is a series of non-clinical tests designed to demonstrate the safety and effectiveness of the Vertefix™ Radiopaque Bone Cement.

• Tests Conducted: Material and chemical analyses, mechanical testing, and biocompatibility testing.
• Purpose: To provide reasonable assurance that the device conforms to the requirements for its use as a bone cement and is substantially equivalent to legally marketed predicate devices (Stryker Spineplex™ Radiopaque Bone Cement and Kyphon KyphX® HV-R Bone Cement Model C01A).
• Conclusion: The tests support the claim of substantial equivalence and that "any differences that may exist do not significantly affect the safety and effectiveness of the device."

This document focuses on the regulatory pathway for a conventional medical device (bone cement) based on its physical and chemical properties and comparison to existing products, rather than the performance evaluation of a software-based or AI-driven diagnostic/therapeutic system.

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Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time

I am sorry, but the provided text is for a medical device called "Vertebroplastic™ Radiopaque Bone Cement," which is a polymethylmethacrylate (PMMA) cement used for filling spinal vertebral body defects. This is a physical product and not an AI/ML powered device. As such, the concepts of "acceptance criteria for an AI model," "sample size for test set," "ground truth," "MRMC study," or "training set" are not applicable to this document.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies and acceptance criteria as would be found for an AI/ML device.

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