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XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

XeliteMed VertehighFix High Viscosity Spinal Bone Cement is provided as a twocomponent system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.

The provided text describes the 510(k) summary for a medical device, XeliteMed VertehighFix High Viscosity Spinal Bone Cement. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The acceptance criteria and study that proves the device meets those criteria are focused on non-clinical performance testing rather than clinical study data involving AI or human readers, as the device is a bone cement, not an AI-powered diagnostic tool. Therefore, many of the requested points regarding AI and human reader studies (MRMC, standalone AI, training set details) are not applicable to this type of device and submission.

Here's an interpretation of the text for the applicable criteria:

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

The document states that "Test data indicate that the final properties of XeliteMed VertehighFix High Viscosity Spinal Bone Cement are in compliance with the standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements' and are substantially equivalent to the predicate device."

While a specific table of numerical acceptance criteria and reported device performance values is not explicitly provided in this public summary, the general acceptance criterion is compliance with ISO 5833 and substantial equivalence to the predicate device (Mendec Spine K042415) for the following non-clinical tests:

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

The document does not specify the sample sizes (e.g., number of test specimens) used for each non-clinical test. The data provenance is from Xelite Biomed Ltd. in New Taipei City, Taiwan (R.O.C.), and the tests are inherently prospective as they are conducted on the newly manufactured device to demonstrate its properties.

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

This question is not applicable as the "ground truth" for bone cement performance is established by objective, standardized laboratory measurements according to ISO standards, not by expert consensus or interpretation of images.

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

This question is not applicable as there is no human interpretation or subjective adjudication involved in the objective non-clinical performance testing of bone cement.

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 question is not applicable as the device is a bone cement, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable as the device is a bone cement, not an AI algorithm.

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

The "ground truth" for this device's performance is based on established international standards (ISO 5833) and objective physical and chemical measurements of the bone cement's properties (e.g., mechanical strength, setting time, chemical composition, biocompatibility). For bacterial endotoxin testing, the ground truth is established by the USP Bacterial Endotoxins Test limits.

8. The sample size for the training set

This question is not applicable as the performance testing described is for a physical medical device (bone cement), not a machine learning model that requires a training set.

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

This question is not applicable for the same reason as point 8.

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V-STEADY and V-FAST bone cements are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

V-STEADY and V-FAST are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty . Bone cements are self-curing systems consisting of liquid and powder components:

• the powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
• The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.
  The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-FAST has a low initial viscosity and a long working time allowing to work extremely carefully when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.

The provided document is a 510(k) Premarket Notification for medical devices, specifically bone cements (V-STEADY and V-FAST). It describes the chemical composition, intended use, and comparison to a predicate device. However, this document does not contain information about the performance of a device that relies on artificial intelligence (AI) or machine learning (ML), nor does it detail a study that would involve acceptance criteria, human reader performance, ground truth establishment for AI/ML models, or sample sizes related to such studies.

The "Performance Data" section (Page 6) focuses on:

• Biocompatibility: Compliance with ISO-10993.
• Sterilization: Validation of the sterilization process according to various ISO standards.
• Material, Mechanical and Performance Characterization: Comparison of V-STEADY and V-FAST bone cements to the predicate device and reference devices based on mechanical properties (e.g., viscosity, setting time, strength) as per ASTM and ISO standards for bone cements.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on this document. The document describes a traditional medical device (bone cement), not an AI/ML powered device.

To answer your specific questions, if this were an AI/ML driven device submission, one would look for:

1. A table of acceptance criteria and the reported device performance: This would typically involve metrics like sensitivity, specificity, AUC, recall, precision, etc., for an AI algorithm against a defined ground truth, with specific thresholds for acceptance.
2. Sample sizes used for the test set and the data provenance: Details on the number of cases/patients in the test set, where the data came from (e.g., specific hospitals, regions), and whether it was collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on how many clinical experts (e.g., radiologists, pathologists) independently reviewed the test cases to establish the correct diagnosis or finding, and their experience levels.
4. Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert arbitration, additional review).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: A study setting where human readers interpret cases both with and without AI assistance to measure the improvement AI brings. The effect size would quantify this improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The performance of the AI algorithm by itself, without human input or review.
7. The type of ground truth used: Whether the ground truth was established by expert consensus, confirmed by pathology reports, based on long-term patient outcomes, or other methods.
8. The sample size for the training set: The number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but for the data used during the development phase of the AI model.

None of this information is present in the provided 510(k) filing because the device in question is PMMA bone cement, not an AI-powered diagnostic or therapeutic device.

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The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.

The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe.

The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.

Here's a breakdown of the acceptance criteria and study information for the Ascendx™ VCF Repair System, as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a discrete set of quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" values for the clinical study endpoints. Instead, it describes various tests and states that the device "conforms to its design specifications," "functioned as intended," and "met the necessary specifications for its intended use." For the clinical study, it concludes that the device achieved "pain and functional relief" and that its "safety and effectiveness supported substantial equivalence to the predicate."

Given the information, a table of the reported performance from the clinical study would look like this:

For non-clinical/bench testing, the document states:
"All bench testing confirmed that the product met the necessary specifications for its intended use."
This implies that for each of the numerous tests listed (e.g., compressive strength, maximum balloon inflation pressure, bond strength, fatigue testing, radiopacity, etc.), the device performed within predefined acceptable limits. Specific numerical acceptance criteria and performance values are not provided in this summary.

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

• Clinical Test Set Sample Size: 60 subjects treated with the Ascendx™ System and Ascendx™ Cement.
• Data Provenance: The document does not explicitly state the country of origin. It describes "clinical testing included evaluation of 60 subjects," which implies a prospective clinical study carried out by the manufacturer. It also mentions comparisons to "an investigation using the same cement without the Ascendx™ in 113 subjects" and "an investigation for 29 subjects undergoing treatment with the predicate device, and 31 subjects undergoing vertebroplasty." These comparison groups are likely from separate studies, but their temporal nature (retrospective/prospective) and provenance are not detailed here.

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

This information is not provided in the 510(k) summary. Clinical trials typically involve physicians assessing patient outcomes, but the specific number and qualifications of experts establishing "ground truth" (e.g., through blinded assessment of imaging or adjudicated outcomes) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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 device is a medical device (VCF Repair System), not an AI/software device for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

As stated above, this is a medical device, not an AI/software algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the ground truth was based on patient outcomes data including:

• Acute procedural success
• Pain levels
• Functional status
• Adverse events (leakage, subsequent fractures)
  These are typically assessed by treating physicians and reported by patients.

8. The Sample Size for the Training Set

This information is not applicable to this type of medical device. The device is a physical product, not an algorithm that requires a "training set" in the machine learning sense. The device was likely designed and refined through engineering iterations and bench testing, rather than an algorithmic training process.

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

This information is not applicable as it's not an AI/software algorithm. The "training" for such a device would involve engineering design, prototyping, and testing against design specifications, often in a lab setting (bench testing).

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The ARCUATE™ Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provides physicians with a means to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine in vertebroplasty procedures. The ARCUATE™ Vertebral Augmentation System kits are packaged with VISIOPLAST™ Spine Cement, which has been previously cleared by the FDA for use in the treatment of painful vertebral compression fractures.

The provided text is a 510(k) summary for the ARCUATE Vertebral Augmentation System, which is a submission to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific performance criteria and results.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, training set details) is not available in this document.

The document indicates that the purpose of this particular 510(k) application is to "include additional instruments to the previously cleared ARCUATE™ Vertebral Augmentation System (K063248)". This suggests that the substantial equivalence argument relies on the existing clearance of the base system and its components.

Here's a breakdown of what can be extracted and what is missing:

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

• Not Available: This document does not present specific performance criteria or a study demonstrating the device meets them. The device is a set of manual instruments for delivering bone cement, and the substantial equivalence is based on its similarity to other legally marketed systems. Performance data related to mechanical properties or clinical outcomes would typically be found in direct studies, which are not detailed here for this 510(k) submission.

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

• Not Available: No test set or associated data is described in this summary, as it's a substantial equivalence submission for additional instruments, not a de novo clearance requiring new clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Available: No test set or ground truth establishment is mentioned.

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

• Not Available: No test set or adjudication process is described.

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/Not Available: This is a submission for a medical device (surgical instruments and cement delivery system), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

• Not Applicable/Not Available: This is not an algorithm or AI product.

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

• Not Available: No ground truth establishment is described.

8. The sample size for the training set

• Not Available: No training set is applicable or described.

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

• Not Available: No training set or ground truth establishment is applicable or described.

Summary of the 510(k) Content:

• Device: ARCUATE™ Vertebral Augmentation System (specifically, additional instruments for a previously cleared system).
• Purpose: Percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine for vertebroplasty procedures.
• Indication: Treatment of painful pathological fractures of the vertebral body (due to osteoporosis, benign lesions, and/or malignant lesions).
• Substantial Equivalence: Demonstrated by comparison to several previously cleared systems and the VISIOPLAST™ Spine Cement (K042415) packaged with the system. The focus is on the device's design and intended use being similar to existing, cleared products.
• Regulatory Clearance: K070527 was cleared on May 4, 2007.

To find the missing information (performance criteria, specific study details), one would typically need to review the original 510(k) submission for the predicate devices that established the foundational clearance for vertebroplasty systems and PMMA bone cement, or the full K063248 submission for the ARCUATE™ Vertebral Augmentation System itself, if it contained such data. This specific document K070527 is an amendment for additional instruments, relying on prior clearances.

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The ARCUATE™ Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provide physicians with a means to augment the vertebral body with a mechanical device in order to prepare the site for vertebroplasty. Once the site is prepared, the ARCUATE™ Vertebral Augmentation instruments are used to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the ARCUATE™ Vertebral Augmentation System kits are packaged with and may only be used with VISIOPLAST™ Spine Cement, which has been cleared by the FDA for use in the treatment of painful vertebral compression fractures.

The provided text is a 510(k) summary for the ARCUATE™ Vertebral Augmentation System and discusses substantial equivalence, not a study evaluating the device's performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be answered from the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, not on presenting performance data from a specific study against acceptance criteria.

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

• Cannot be answered from the provided text. No specific test set or study data is described.

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)

• Cannot be answered from the provided text. No information about ground truth establishment is present.

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

• Cannot be answered from the provided text. No adjudication method is described.

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

• Cannot be answered from the provided text. This document describes a medical device for vertebral augmentation, not an AI-assisted diagnostic tool or an MRMC study.

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

• Cannot be answered from the provided text. This document describes a manual surgical instrument system, not an algorithm.

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

• Cannot be answered from the provided text. No ground truth information is provided.

8. The sample size for the training set

• Cannot be answered from the provided text. No training set for an algorithm is mentioned.

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

• Cannot be answered from the provided text. No training set or ground truth establishment for it is mentioned.

Summary of available information from the input:

• Device Name: ARCUATETM Vertebral Augmentation System
• Purpose of Application: To market the ARCUATE® Vertebral Augmentation System, which consists of manual instruments to augment the vertebral body with a mechanical device for vertebroplasty, followed by percutaneous delivery of PMMA bone cement (VISIOPLAST™ Spine Cement).
• Indications for Use: Treatment of painful pathological fractures of the vertebral body (resulting from osteoporosis, benign lesions, and/or malignant lesions like metastatic cancers and myeloma).
• Substantial Equivalence: The system was deemed substantially equivalent to the EQUESTRA™ Fluid Delivery System (K040483), Kit Mendec Spine and Delivery System (K062452), EBI Vertebroplasty System (K060148), and Vertefix™ Vertebroplasty Procedure Set (K042691). The VISIOPLAST™ Spine Cement was cleared under K042415.
• Regulatory Classification: Class II, Product Code NDN, KIH, HRX, HXG.
• Date of Clearance: March 13, 2007.

The document provided is a regulatory clearance letter based on substantial equivalence, meaning the FDA determined the device performs as intended and is as safe and effective as existing legally marketed devices. It does not contain a detailed performance study against specific acceptance criteria in the way one would find for a novel diagnostic or AI device.

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Vspspn is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Vspspn is a two-part (powder and liquid) radiopaque, polymethyl methacrylate acrylic resin. The powder and liquid components are mixed together at the point of use to form the resin. The product is supplied sterile, for single use.

This 510(k) submission (K063438) for Vspspn, an acrylic resin for treating pathological vertebral body fractures, does not include information about acceptance criteria or a study proving device performance against such criteria.

The submission focuses entirely on demonstrating substantial equivalence to a predicate device, Mendec Spine (K042415). It asserts that Vspspn has the "same design, incorporate the same materials, have the same performance and mechanical characteristics, have the same shelf life and equivalent packaging, and are sterilized by the same method" as the predicate.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used for performance evaluation.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific criteria.

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