(28 days)
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.
§ 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.”