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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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