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When the CONFIDENCE 114 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. The CONFIDENCE™ High Viscosity Spinal Cement is a self-curing, high viscosity, radiopaque acrylic bone cement (PMMA), previously cleared by FDA in premarket notifications K060300 and K112907. The formulation of the spinal cement has not changed from the original clearance.
2. The VIPER® and EXPEDIUM® Fenestrated Screw Systems are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end which allow for the controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement. The design of the distally fenestrated screws provides a controlled means to deliver PMMA cement into the vertebral body. The screws are available in diameters of 4.35, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0mm and lengths of 30-80mm (in 5mm increments). Screws with lengths of 30mm have three fenestrations and screw lengths of 35mm and longer have six fenestrations. The VIPER® fenestrated screws are compatible with the VIPER System, VIPER2 and EXPEDIUM 5.5 Spine Systems (K111136) and the EXPEDIUM fenestrated screws are compatible with the EXPEDIUM VERSE® System (K142185).

This FDA 510(k) summary describes the submission for the CONFIDENCE™ High Viscosity Spinal Cement and the VIPER® and EXPEDIUM® Fenestrated Screw Systems. It mostly focuses on establishing substantial equivalence to predicate devices and describes the materials and intended use. However, it does not provide detailed acceptance criteria or the specific studies that prove the device meets these criteria in the format requested.

The document states that "Non-clinical testing and clinical data were submitted to characterize the subject components in this notification. The data provided supports the substantial equivalence of the subject devices," and "The performance testing, clinical literature, and substantial equivalence justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, the specifics of these tests, including acceptance criteria, outcome measures, sample sizes, ground truth establishment, or expert qualifications, are not disclosed in this summary.

Therefore, many of the requested fields cannot be filled from the provided text.

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

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

• Cannot be filled. The document does not provide a table of acceptance criteria or specific performance metrics from studies. It broadly states that "performance testing" was done to demonstrate substantial equivalence.

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 filled. The document mentions "clinical literature" and "clinical data" but does not specify sample sizes, provenance, or study design (retrospective/prospective) for any test sets.

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 filled. The document does not discuss the establishment of ground truth or the involvement/qualifications of experts in any testing.

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

• Cannot be filled. No information on adjudication methods is present.

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 filled. This device is a bone cement and screw system, not an AI device for image interpretation. Therefore, an MRMC study comparing human readers with/without AI assistance would not be applicable.

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

• Cannot be filled. Not applicable as this is a physical medical device (bone cement and screws), not an algorithm or AI system.

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

• Cannot be filled. The document does not describe how ground truth was established for any studies mentioned.

8. The sample size for the training set

• Cannot be filled. Not applicable as this is a physical medical device, not an algorithm that requires a training set. If "training set" refers to mechanical testing or animal studies, those specifics are not provided.

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

• Cannot be filled. Not applicable for the reasons stated in point 8.

Conclusion:

This 510(k) summary serves to demonstrate substantial equivalence for a bone cement and fenestrated screw system. It highlights the physical characteristics, intended use, and similarities to predicate devices. However, it does not contain the detailed performance study information, acceptance criteria, or methodological specifics typically found in a clinical study report or a 510(k) summary for a diagnostic or AI-based device, which would address the points raised in the prompt. The document explicitly states "Non-clinical testing and clinical data were submitted," but the summary itself does not contain the specifics of these submissions.

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The Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebrai compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence Fenestrated Introducer Needle, a part of the Confidence Cement Delivery System, is combined of a cannula and a stylet. The cannula has a diamond-shape closed distal tip, and has numerous holes located around its distal section.

This document, K063067, is a 510(k) Summary for the Confidence Fenestrated Introducer Needle, a component of the Confidence Bone Cement Delivery System. This submission is for a medical device, not an AI/ML powered device, therefore the information requested cannot be fully extracted.

Here's a breakdown of what can be inferred and what cannot based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Not applicable: This document describes a physical medical device (an introducer needle) and not an AI/ML system. Therefore, there are no "acceptance criteria" or "reported device performance" in terms of algorithmic metrics (like accuracy, sensitivity, specificity) that would be relevant to an AI/ML device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, technological characteristics, and principles of operation.

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

• Not applicable: No test set in the context of AI/ML validation is mentioned. This is a physical device.

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

• Not applicable: No ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set

• Not applicable: No adjudication method is mentioned.

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: No MRMC study is mentioned. This is a physical device, not an AI system designed to assist human readers.

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

• Not applicable: No standalone algorithm performance is mentioned.

7. The type of ground truth used

• Not applicable: As this is a physical device, the concept of "ground truth" as it applies to AI/ML model training or validation does not apply. The validation for this type of device typically involves demonstrating manufacturing and functional equivalence to a predicate device, as well as adherence to relevant standards, not a comparison against expert-labeled data.

8. The sample size for the training set

• Not applicable: No training set is mentioned as this is a physical medical device, not an AI/ML product.

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

• Not applicable: No training set or associated ground truth is mentioned.

Summary of available information:

• Device Name: Confidence Fenestrated Introducer Needle
• Intended Use: For percutaneous delivery of bone cement during vertebroplasty/kyphoplasty procedures.
• Predicate Devices: Confidence High Viscosity Bone Cements (K060300, K062424)
• Substantial Equivalence Claim: Based on intended use, design, materials, technological characteristics, and principles of operation to the predicate device.

To reiterate, the provided document pertains to the regulatory clearance of a physical medical instrument and does not contain the kind of information relevant to the validation of an AI/ML powered medical device.

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The Disc-O-Tech Confidence EX High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence EX High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (22.5 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

The provided text is a 510(k) summary for a medical device (bone cement), and it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/software as a medical device (SaMD) product. The document focuses on establishing substantial equivalence for the bone cement itself, primarily based on material properties and intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies, as these concepts are not applicable to the content of this 510(k) summary. These details would be relevant for a software-based device that performs a diagnostic or prognostic function, not for a PMMA bone cement.

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