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The Dyflex-II is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Dyflex-II is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Dyflex-II is a non-cervical pedicle screw and rod system intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Dyflex-II of screws, rods, cross-link connectors, and bolts that can be implanted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile and the user need to sterilize them before use.

This is a 510(k) premarket notification for the Dyflex-II, a thoracolumbosacral pedicle screw system. The submission aims to demonstrate substantial equivalence to a predicate device, the 4STM Spinal System (K063708).

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a pedicle screw system, and its "performance" is primarily assessed through mechanical testing to ensure structural integrity and equivalence to the predicate device.

• Static Torsion Test
• Static Compression Bending Test
• Dynamic Compressive Fatigue Test | Tests performed according to ASTM F 1717 for all listed items. Results supported substantial equivalence despite minor exterior design differences. Met. |
  | Screw Size Range (Diameters) | Diameters: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm (Predicate) | Diameters: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm (Dyflex-II) |
  | Screw Size Range (Lengths) | Lengths: 30 to 55mm (Predicate) | Lengths: 30 to 50mm (Dyflex-II) |
  | Rod Size Range (Diameters) | Diameters: 5.5, 6.0mm (Predicate) | Diameters: 5.5, 6.0mm (Dyflex-II) |
  | Rod Size Range (Lengths) | Lengths: 30 to 200mm (Predicate) | Lengths: 30 to 200mm (Dyflex-II) |

Overall Conclusion: The Dyflex-II is deemed substantially equivalent to the predicate device based on similar indications for use, technological characteristics, material, principles of operation, and successful mechanical testing according to industry standards. The size range of the subject device is covered by or very similar to the predicate device.

The document provided is a 510(k) submission for a mechanical medical device (pedicle screw system), not an AI/software as a medical device (SaMD). Therefore, many of the requested items (e.g., test set sample size, provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.

Here's why and what information is pertinent to this submission:

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

• Not Applicable. This is a mechanical device. The "test set" refers to physical samples of the device components that undergo mechanical stress testing. The document does not specify the exact number of samples for each mechanical test (e.g., number of screws tested for static torsion). Data provenance is not typically described in terms of geographical origin for mechanical test results; rather, it refers to the conditions and methods under which the tests were conducted.

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

• Not Applicable. Mechanical test results for a pedicle screw system do not rely on expert interpretation to establish ground truth in the way medical images or clinical outcomes do. The "ground truth" is determined by objective physical measurements against established engineering standards (ASTM F 1717).

4. Adjudication method for the test set:

• Not Applicable. Since there's no expert interpretation or subjective assessment creating a "ground truth," no adjudication method is needed or described.

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. MRMC studies are relevant for devices involving human interpretation (e.g., radiologists reading images) where AI might assist. This is a mechanical implant.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used:

• Engineering Standards / Objective Measurements. For mechanical devices, the "ground truth" is defined by compliance with established engineering standards (e.g., ASTM F 1717) and objective measurements of mechanical properties (e.g., static torsion, compressive fatigue limits).

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable. No training set is involved.

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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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