(138 days)
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.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”