Search Results

Kryptonite Bone Cement™ is a resinous material to be used as a cranial bone void filler. Kryptonite Bone Cement™ is a self-setting bone cement that is formed by combining and mixing three components, resulting in a mild exothermic polymeric reaction (less than body temperature) that polymerizes into a malleable putty and progresses to a hard cement-like complex. The three components of Kryptonite Bone Cement™ are a liquid pre-polymer isocyanate mixture, a liquid polyester polyol, and a powdered calcium carbonate.

AI/ML Overview

The provided text describes the 510(k) summary for Kryptonite Bone Cement™, a medical device for repairing cranial defects. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and detailed device performance metrics in a tabulated format.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not extractable from the provided text as this is a regulatory submission for a bone cement, not an AI/software as a medical device (SaMD).

Here's an attempt to address the points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria	Reported Device Performance
Material Properties	Comparable material handling properties (exotherm, mixing time, setting time) to cited predicate devices.	"Material characterization tests demonstrated comparable material handling properties, including exotherm, mixing time, and setting time to the cited predicates."
Biocompatibility	Pass all tests according to the specified ISO-10993 acceptance criteria and/or show equivalence through side-by-side testing with a predicate.	"Biocompatibility testing included the entire ISO-10993 test battery. Kryptonite Bone Cement passed all tests according to the specified acceptance criteria and/or through side-by-side testing with a predicate."
Mechanical Properties	Mechanical properties (static and dynamic) consistent with predicate devices under physiologically relevant loading conditions.	"Mechanical testing evaluated static and dynamic mechanical properties under physiologically relevant loading conditions. The results of these tests demonstrated mechanical properties were consistent with predicate devices."
Animal Study (in vivo performance)	Demonstrate equivalent performance in bone compared to a control (predicate device), with stable and well-tolerated macroscopic and microscopic evaluations.	"Animal studies in rabbits (e.g., calvarial defect study) were performed to demonstrate equivalent performance in bone. Macroscopic and microscopic evaluations demonstrate Kryptonite Bone Cement and control (predicate device) were stable and well tolerated in bone."

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

Sample Size (Test Set): Not specified for any of the tests. The document refers to "the entire ISO-10993 test battery" for biocompatibility and "animal studies in rabbits (e.g., calvarial defect study)" but does not quantify the number of samples or animals.
Data Provenance: Not specified. Standard pre-clinical testing for medical devices is typically conducted in a controlled lab environment by the manufacturer or contracted labs.

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

Not Applicable. This is a bone cement, not an AI/SaMD device requiring expert image review for ground truth. Ground truth for this type of device is established through physical, chemical, and biological measurements (e.g., material testing, histological analysis in animal studies).

4. Adjudication method for the test set

Not Applicable. See point 3.

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. This is a bone cement, not an AI/SaMD device.

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

Not Applicable. This is a bone cement, not an AI/SaMD device.

7. The type of ground truth used

Material properties: Measured values from standardized tests.
Biocompatibility: Results of standardized ISO-10993 tests (e.g., cytotoxicity, irritation, sensitization, genotoxicity, implantation).
Mechanical properties: Measured values from static and dynamic mechanical tests.
Animal studies: Macroscopic and microscopic histological evaluations by veterinary pathologists or histologists.

8. The sample size for the training set

Not Applicable. This device uses traditional pre-clinical testing, not machine learning, so there is no "training set."

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

Not Applicable. See point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1