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510(k) Data Aggregation
(56 days)
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
KyphX® Directional Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.
The KyphX Directional Inflatable Bone Tamps (IBTs) are designed to compress cancellous bone and/or move cortical bone as they inflate. The inflatable component of the IBT is near the distal tip of the device. The catheter shaft contains an outer lumen for IBT inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows directionality of inflation with a maximum inflated diameter that is perpendicular to the catheter shaft. One design has a uniform balloon that is concentric to the catheter shaft. Another design has a non-uniform balloon that is tangential to the catheter shaft. Directionality of the balloon is indicated by external markers on the proximal Y-adapter component. Each design enables fluoroscopic visualization of the deflated balloon.
The document provided is a 510(k) premarket notification summary for the KyphX Directional Inflatable Bone Tamps. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically seen for novel devices.
As such, the information required to fully answer the request, particularly regarding specific numerical acceptance criteria and a detailed study proving the device meets those criteria, is not present in the provided document. The submission focuses on mechanical testing, biocompatibility, and intended use as justification for substantial equivalence.
However, I can extract the available information that relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a device like a bone tamp, “acceptance criteria” are primarily related to meeting performance specifications of predicate devices and demonstrating safety and effectiveness for its intended use through non-clinical means. Specific numerical clinical performance metrics (like sensitivity, specificity, accuracy) are not typically defined or reported for such a device in this type of submission.
| Acceptance Criteria Category | Reported Device Performance (as described in the 510(k) Summary) |
|---|---|
| Intended Use | "are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous." (Meets the same intended use as predicate devices). |
| Sterilization | "sterilized using gamma radiation and meet the requirement of ANSI/AAMI/ISO11137 for gamma-sterilized devices." |
| Mechanical Performance | "Mechanical testing of the KyphX Directional Inflatable Tamps verifies the devices meet Bone the performance specifications of the IBT predicates." |
| Biocompatibility | "The materials used in the construction of the KyphX Inflatable Bone Tamps meet Directional the requirements for 'Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact' described in the FDA Blue Book Memorandum #G95-1, 'Use of Standard ISO-10993, International Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." |
| Substantial Equivalence | "The KyphX Directional Inflatable Bone Tamps meet physical and performance specifications the established for the IBT predicates. The products have the same fundamental scientific technology and intended use as the IBT predicates." |
2. Sample Size for Test Set and Data Provenance
The document describes mechanical testing and biocompatibility testing, not a clinical test set in the sense of patient data. Therefore, details like data provenance or a sample size for a clinical test set are not applicable or provided. The mechanical testing would involve a sample of devices, but the specific number is not disclosed in this summary.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission relies on engineering and biological testing, not expert interpretation of clinical data in the way an AI diagnostic device would.
4. Adjudication Method
Not applicable for this type of device and submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is a surgical instrument (bone tamp), not an AI-assisted diagnostic tool for interpretation of medical images.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no algorithm for this device.
7. Type of Ground Truth Used
For the KyphX Directional Inflatable Bone Tamps, the "ground truth" for the tests performed would be:
- Mechanical Testing: Engineering specifications and performance metrics of the predicate devices.
- Sterilization: Compliance with the ANSI/AAMI/ISO11137 standard.
- Biocompatibility: Compliance with the FDA Blue Book Memorandum #G95-1 and ISO-10993 standards.
8. Sample Size for the Training Set
Not applicable. This device does not use an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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