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510(k) Data Aggregation
(38 days)
KyphX® 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 (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.
The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801.
The provided document is a 510(k) premarket notification summary for a medical device called the "KyphX® Inflatable Bone Tamps." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process does not typically involve the elaborate clinical study designs and performance criteria associated with new drug applications or high-risk medical devices that require extensive clinical trials to establish efficacy and safety from scratch.
Therefore, the requested information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance cannot be fully extracted from this document because the 510(k) pathway primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data against a set of predefined acceptance criteria in the same way a new, unproven technology would.
Here's an analysis based on the information provided, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table of acceptance criteria and reported device performance in the sense of a clinical trial or a study proving a new device's efficacy against specific benchmarks. The 510(k) process focuses on demonstrating substantial equivalence to predicate devices. This means that if the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed predicate device, it can be cleared for market. The "performance" here is implied to be similar to the predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not mention any specific test set sample sizes or data provenance because it's not a report of a new clinical study with a test set. The substantial equivalence is based on the device's design, materials, and intended use being similar to existing cleared devices.
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):
No information is available regarding experts or ground truth establishment because this document is a regulatory submission for substantial equivalence, not a clinical study report.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information is available regarding adjudication methods.
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:
This device (KyphX® Inflatable Bone Tamps) is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This device is a physical medical instrument. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as it applies to diagnostic or prognostic algorithms is not applicable to this device. The substantial equivalence argument relies on the device's design, materials, and intended function matching those of predicate devices that have already been cleared for safety and effectiveness.
8. The sample size for the training set:
There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
Summary from the Document:
- Device Name: KyphX® Inflatable Bone Tamps
- Intended Use: "KyphX® 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 (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus."
- Predicate Devices:
- Basis for Equivalence: "The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801." (K033801 refers to Kyphon's cleared KyphX® HV-R™ Bone Cement, indicating that the overall procedure's safety and effectiveness were considered in a prior submission, and this device is equivalent to the tamp component of that system).
Conclusion:
This 510(k) submission demonstrates substantial equivalence by showing that the KyphX® Inflatable Bone Tamps have the "same technological characteristics and intended use" as already legally marketed predicate devices. It does not contain the detailed clinical study data, acceptance criteria tables, or AI-specific performance metrics that would be found in a Premarket Approval (PMA) application or a study for a novel diagnostic algorithm. The "study" proving the device meets criteria is essentially the FDA's review determining that it is substantially equivalent to previously cleared devices based on its design, materials, and intended use.
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