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The TRACKER Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The TRACKER Kyphoplasty System (KS) comprises the TRACKER-X, P (GSK System) and the TRACKER-I (GCD System). The TRACKER-X, P and the TRACKER-I System are packaged in their own containers and are then packaged together in a TRACKER Kyphoplasty System container. The TRACKER-I System is sold only as a System. The individual System Accessories are not sold separately. The GSK System consists of the TRACKER-P balloon expander and the TRACKER-X balloon catheter. The TRACKER-I is a cement dispenser kit intended for percutaneous access to bone and delivery of bone cement.

The provided document is an FDA 510(k) summary for a medical device called the "TRACKER Kyphoplasty System." This document is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study where the device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/diagnostic device is not applicable to this document.

This document describes a kyphoplasty system, which is a surgical tool used for reducing fractures and creating voids in bone, typically in kyphoplasty procedures. The "acceptance criteria" and "study" described here pertain to the engineering and material performance of the device, establishing its safety and effectiveness by demonstrating its equivalence to a predicate device.

Here's an breakdown of the device performance presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not specify general "sample sizes" in terms of patient data. The tests performed are engineering and material tests on the device itself.

• Data provenance: Not applicable in the context of patient data for a diagnostic study. The tests are laboratory-based and performed on the device components.

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):
Not applicable. The "ground truth" for these tests relates to engineering specifications and international standards (e.g., ISO for sterilization and biocompatibility, ASTM for shelf life). Experts would be engineers and scientists overseeing and conducting these specific types of technical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for ambiguous diagnostic cases, not for objective engineering or material performance tests.

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 not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" is defined by established engineering standards and specifications (e.g., ISO standards for sterilization and biocompatibility, ASTM for shelf life). The device's performance is measured against these pre-defined technical criteria.

8. The sample size for the training set:
Not applicable. This is not an AI/diagnostic device, and therefore no "training set" in that context exists.

9. How the ground truth for the training set was established:
Not applicable.

Summary of the Study:

The "study" presented here is a series of non-clinical performance tests conducted on the TRACKER Kyphoplasty System to demonstrate its safety and effectiveness through substantial equivalence to a predicate device (MEDINAUT Kyphoplasty System K153296).

The tests covered:

• Functional performance: Balloon Deflation, Burst Pressure, Fatigue Strength, Unconstrained Burst Strength, Inflated Dimension, Insertions and Withdrawal Force, Tensile Bond. For these, the document states "In all instances the device functioned as intended and all results were satisfactory and met all performance specifications."
• Sterilization validation: Performed according to ISO 11138-2, ISO 11135-1, and ISO 1422.
• Shelf life validation: Conducted per ASTM F 1980, validating a 3-year shelf life.
• Biocompatibility testing: Performed according to ISO 10993-1, 5, 7, 10, 11, including tests for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity. All tests met required endpoints.

The conclusion is that the TRACKER Kyphoplasty System is as safe and effective as the predicate device because it shares the same intended uses, indications, technological characteristics, principles of operation, and its performance data are satisfactory against relevant engineering and biocompatibility standards.

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