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The Balex Bone Expander System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The Balex Bone Expander System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of the Balex Bone Expander System are the reduction in pain and the increase of patient`s functional abilities, which allow for the patient's return to the previous level of activity.

The Balex Bone Expander System consists of the Balloon Expander and Balloon Catheter. They are used with Cement Dispenser System, Cement Mixer System and Syringe which are Class I, 510k exempt devices.

The Balloon Catheter consists of an inner-outer tube, inflatable balloon located at the balloon tip. The radiopaque markers located at the balloon tip end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a pressure gauge, compression cylinder, a connect Line and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. All the components are supplied sterile and are disposable.

The provided document is a 510(k) summary for the Balex Bone Expander System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance tests for safety and biocompatibility. It lists several non-clinical performance tests conducted, but it does not provide specific acceptance criteria values for these tests or detailed results demonstrating compliance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: While a list of performance tests is provided, specific quantitative acceptance criteria and corresponding reported device performance values are not included.
2. Sample size used for the test set and the data provenance: The document mentions "non-clinical tests" but does not specify sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as the document describes a non-clinical evaluation, not a study involving human or image-based ground truth established by experts.
4. Adjudication method for the test set: Not applicable for non-clinical performance and safety tests.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The evaluation is for a physical medical device (bone expander), not an AI algorithm.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not applicable in the traditional sense. The "ground truth" for the non-clinical tests would be defined by the standards and specifications against which the device is tested (e.g., burst pressure limits, material strength requirements).
8. Sample size for the training set: Not applicable as this is a physical medical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information (related to your questions, but not directly answering them due to content limitations):

The document lists the following performance tests and standards, implying that these are the areas where the device's performance was evaluated to ensure safety and effectiveness:

• Sterilization Validation Tests in accordance with ISO 10993-7
• Shelf Life Tests in accordance with ASTM F1980, ASTM F88, ISO11737-2
• Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Maximization sensitization, Material-mediated pyrogenicity, Acute Systemic toxicity, Intracutaneous reactivity)
• Extraction Test (Non-volatile Residue, Residue on Ignition, Heavy Metals, Buffering Capacity)
• EO Gas Sterilization Residual
• Appearance for Balloon
• Balloon Dimensions
• Burst Pressure (constrained and unconstrained)
• Balloon leakage
• Pressure gauge precision
• Inflation and deflation time
• Insertion force and withdrawal force
• Tensile and tensile bond strength
• Balloon fatigue test

The document concludes that "The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences." This indicates that the device met the internal specifications and regulatory requirements based on these tests, but the specific numerical acceptance criteria and performance data are not disclosed in this summary.

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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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